Pharmaceutical compliance jobs in San Diego, CaliforniaCrear alertas

Job Description Summary: Assists Pharmacist in the drug distribution process. Responsibilities: • Counts, packages, pre-packages and labels medication for inspection by pharmacist and fills routine orders for non-prescription pharmaceuticals., • Inputs patient and prescription data into logs and/or pharmacy computer system to process prescriptions and maintain patient profiles., • Assists and serves patients., • Assists pharmacists as directed., • Assists in the ordering, stocking, and maintenance of drug inventory., • Orders and manages inventory from: P.I.C. (Pharmaceuticals for Indigent Care); samples, and the 340B Drug Discount Purchasing Program., • Coordinates with providers as to dispensing of prescribed formularies in the dispensary/pharmacy., • Complies with Cash Register Policies and Procedures, • Assists in the preparation of reports and written documentation, as required by the department, company, state and federal agencies., • Participate in Quality Assurance and Compliance activities., • Maintains knowledge of third parties and billing (i.e. Medicare Part Ds and Medicals). Must be able to submit claims and PA’s, • Maintains and submits orders to maintain an adequate inventory of forms, clerical and pharmaceutical supplies, paper and equipment., • Follows established departmental policies and procedures, objectives quality assurance program, safety, environmental and infection control standards., • Enhances professional growth and development through participation in educational programs, current literature, in service meetings and workshops., • Attends meetings as required. Education: High School Diploma or GED Certification(s)/License(s) Required: CA Pharmacy Technician License Experience: 1-2 years’ experience in a retail pharmacy setting preferred Verbal and Written Skills to perform the job: Bilingual (English/Arabic). Familiarity with basic word processing, spreadsheet, and database applications. Accurate keyboarding skills. Technical knowledge and skills required to perform the job: Excellent verbal, written and interpersonal communication skills and the demonstrated ability to work with diverse individuals and groups. Demonstrate high levels of self-initiation and direction. Knowledge of communities we serve. Knowledge and experience working in medical settings and interacting collaboratively with medical teams. Skill in analyzing situations and making timely decisions. Physical and Mental Requirements: Work involves sitting, talking, hearing, using hands to handle, feel or operate objects, tools, or controls, and reaching with hands and arms. The employee may be required to push, pull, lift, and/or carry up to 20 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. La Maestra Community Health Centers is an equal opportunity employer and does not discriminate on the basis of race, religion, color, sex, national origin, age, sexual orientation, gender, disability or any other legally protected status. Company DescriptionThe La Maestra Circle of Care® is a holistic, solution-based approach to addressing the health and wellbeing needs of diverse emerging communities—because complete wellness requires more than just a trip to the doctor. Since the first clinic opened in 1990, La Maestra’s board and staff recognized that for a patient and family to be healthy, they must have barrier-free access to integrated services including nutritious food, safe affordable housing, job training or continuing education opportunities, and programs that promote wellbeing. La Maestra’s staff, who is from the diverse populations served, has embraced the Circle of Care® philosophy, working together to identify the total needs of patients and attend to them through preventive care, education, treatment, and referrals to services that address the social determinants of health, ultimately guiding patients and their families to wellbeing and self-sufficiency. The Circle of Care® involves a network of integrated services provided by La Maestra Community Health CentersThe La Maestra Circle of Care® is a holistic, solution-based approach to addressing the health and wellbeing needs of diverse emerging communities—because complete wellness requires more than just a trip to the doctor. Since the first clinic opened in 1990, La Maestra’s board and staff recognized that for a patient and family to be healthy, they must have barrier-free access to integrated services including nutritious food, safe affordable housing, job training or continuing education opportunities, and programs that promote wellbeing.\r\n\r\nLa Maestra’s staff, who is from the diverse populations served, has embraced the Circle of Care® philosophy, working together to identify the total needs of patients and attend to them through preventive care, education, treatment, and referrals to services that address the social determinants of health, ultimately guiding patients and their families to wellbeing and self-sufficiency. The Circle of Care® involves a network of integrated services provided by La Maestra Community Health Centers

Job DescriptionDescription: Company Overview: Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space. We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression. Vividion has been recognized as a Top Workplace by The San Diego Union-Tribune from 2022 to 2025. Job Summary: Vividion Therapeutics, Inc. is seeking a highly motivated and experienced Accounts Payable Manager who thrives in a dynamic, high-growth biotechnology environment. Reporting to the Controller, this role owns the end-to-end Invoice-to-Pay (I2P) process and provides leadership across accounts payable operations, corporate card and Travel & Expense (T&E) programs, use tax, vendor compliance, and payment execution. This is a hands-on, player-coach role that balances people leadership with direct involvement in complex, judgment-driven, or high-risk activities, including payment approvals, close-related activities, audits, and system configuration. The role manages and develops an AP Specialist while maintaining accountability for process integrity, internal controls, and scalable execution. This role offers the opportunity to shape and scale AP operations while maintaining proximity to execution in a highly regulated environment. The ideal candidate brings strong analytical and problem-solving skills, sound judgment, systems fluency, and a collaborative mindset that supports cross-functional partnership with Accounting, Procurement, and Finance leadership. Requirements: Essential Duties and Key Responsibilities: Invoice to Pay Ownership • Own end to end I2P operations, including invoice intake, processing, three way match exception resolution, vendor support, payment readiness, and AP subledger integrity., • Review and approve payment proposals, ensuring policy compliance, supporting documentation, and accurate execution., • Resolve escalated issues related to vendor payments, invoice discrepancies, and system or workflow bottlenecks., • Maintain AP related internal controls, documentation standards, and appropriate segregation of duties., • Oversee vendor master data controls, including W 9/W 8 collection, bank verification, and compliance validation., • Own year end 1099/1098 reporting operations, including vendor tax data readiness, coding accuracy, reconciliations, and filing support., • Lead administration of the corporate card and T&E audit program, including policy enforcement, exception escalation, and periodic control reviews., • Perform secondary reviews of corporate card and T&E audits to validate specialist judgments and interpret policy nuances., • Partner with Accounting to ensure timely and accurate AP close, including accruals, reconciliations, subledger integrity, and variance analysis., • Analyze RNI and unmatched items and drive timely resolution in partnership with Procurement and Accounting teams., • Partner with Procurement on vendor lifecycle governance and ensure AP system configurations support operational and compliance requirements., • Establish and maintain KPIs for I2P performance, including cycle times, exception rates, vendor compliance, payment accuracy, and tax and reporting readiness., • Identify system or process issues and lead remediation, optimization, or enhancement efforts., • Bachelor’s degree in Accounting, Finance, Business, or a related field, or equivalent practical experience., • 5 to 8 years of progressive accounts payable experience, including leadership or senior ownership responsibilities; industry experience in biotechnology, pharmaceutical, or medical device sectors strongly preferred., • Strong proficiency in financial and operational systems, including Workday Financial Management, Concur, Jaggaer, QuickBooks, and similar AP, procurement, and expense management platforms., • Hands on experience with vendor compliance, W-9/W-8 validation, and 1099/1098 reporting processes., • Experience with use tax assessments, controls, reconciliations, and reporting., • Strong analytical and problem solving skills, with the ability to interpret data, apply judgment, and resolve complex AP and payment issues; advanced Excel proficiency required to support analysis and reporting. The anticipated base salary for this position ranges from $100,000 to $120,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance. EEO & Employment Eligibility: Vividion Therapeutics, Inc. is an equal opportunity employer. All applicants will receive consideration for employment without regard to disability or veteran status. Privacy Policy: The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit .

Job Description SUMMARY Supports client accounts and laboratory logistics by providing customer support to clients, patients, Prometheus sales representatives, and other departments including marketing and billing. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Responsible for receiving incoming phone calls and requests for test results, information on diagnostic and therapeutic products from pre-printed marketing materials, specimen transport kit requests, and miscellaneous requests from clients, patients, and sales representatives., • Routes questions to supervisor or senior client services representative that are outside of their job knowledge., • Communicates information for partnered pharmaceutical products from pre-printed marketing materials., • Provides sales materials upon request to customers and TSS representatives., • Utilizes PrOS for patient information to properly respond to inquiries., • Responsible for maintaining records of client interactions or transactions, using MasterControl to capture diagnostic customer complaints, inquiries, or comments, as well as actions taken., • Supports field Technical Sales Specialists (TSS) with responsibility for multiple sales districts and the management of accounts in absence of TSS related to supplies, literature, test add-ons or kits., • Forwards billing questions to medical accounts for handling., • Describes Prometheus products and programs to customers., • Communicates and educates patients, physicians and clients on company coupon programs (including Clinical Experience Programs)., • Enters client information in Sales Logix database on a daily basis., • Notifies physician offices of abnormal results and cancelled tests via phone and fax on a daily basis., • Provides pre-authorization and appeal information/documents to physicians and patients upon request., • Ensure HIPAA Confidentiality and Compliance policy, procedures and standards are adhered to at all times., • Maintain competencies required for the position and specific areas assigned., • Assists with scheduling of mobile phlebotomy services., • Provide portal support for clients (resetting passwords, navigation, etc.). SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Must be able to multi-task, prioritize and follow through on projects and assignments. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE Generally requires 2 years’ experience in a related medical customer service role. Healthcare, biotech, and/or medical billing setting highly preferred. Computer literacy is essential with proficiency in Microsoft Word, Excel, and PowerPoint. Candidate should possess analytical and problem solving skills; have very good verbal and written communication skills. Previous handling of inbound and outbound call center phones preferred. LANGUAGE SKILLS Ability to write routine reports and correspondence. Excellent verbal communication skills with ability to speak effectively with customers or employees of organization. Ability to develop and maintain strong and effective working relationships with internal and external customers. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. REASONING ABILITY Ability to solve basic problems while on the telephone. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to understand basic medical terminology as they relate to department and position. CERTIFICATES, LICENSES, REGISTRATIONS None required. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.

Job Description Role Overview PrideStaff is seeking a detail-oriented Associate to support our client’s research and production pipelines. You will operate primarily within a controlled cleanroom environment, assisting with the end-to-end production of pharmaceutical products. This role is dynamic, shifting between raw material processing, formulation support, and essential warehouse logistics. Key Responsibilities • Cleanroom Operations: Execute daily tasks in a sterile environment, including the processing of raw materials and precision labeling of finished product containers., • Formulation Support: Assist scientists and senior technicians in the formulation process, ensuring ingredients are handled and mixed according to specific research project requirements., • Sanitization & Maintenance: Maintain the integrity of the controlled environment by sanitizing lab equipment and work surfaces according to strict validated protocols., • Documentation & Compliance: Accurately complete Batch Records and follow Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure 100% compliance with regulatory standards., • Warehouse & Logistics: Support warehouse activities, including receiving raw materials, inventory management, and preparing components for the cleanroom suite. Qualifications & Skills • Education: High School Diploma/GED required; Associate’s degree in a science-related field is a plus., • Experience: Prior experience in a cleanroom, or highly regulated manufacturing environment is preferred., • Attention to Detail: Ability to follow complex, multi-step instructions without deviation., • Physical Requirements: Ability to stand for extended periods and wear full cleanroom attire (including gown, mask, gloves, and hood)., • Technical Literacy: Comfortable using digital inventory systems and basic laboratory equipment.Company DescriptionPrideStaff is a national staffing organization, delivering innovative solutions to the challenges employers face every day. Over the years, PrideStaff has been a consistent industry leader, developing technology and service processes that allow our organization to deliver superior performance. With locations across the United States, we're well positioned to partner with clients and candidates to ensure a successful match of employee talent with customer needs. When it comes to your success, we leave nothing to chance! Our Mission: Consistently provide client experiences focused on what they value most.PrideStaff is a national staffing organization, delivering innovative solutions to the challenges employers face every day. Over the years, PrideStaff has been a consistent industry leader, developing technology and service processes that allow our organization to deliver superior performance. With locations across the United States, we're well positioned to partner with clients and candidates to ensure a successful match of employee talent with customer needs. When it comes to your success, we leave nothing to chance! \r\n\r\nOur Mission: Consistently provide client experiences focused on what they value most.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Quality Control Associate for Environmental Monitoring (EM) plays a critical role in maintaining the environmental conditions required for GMP manufacturing. This position is responsible for performing routine and specialized sampling, analyzing trends, documenting results, and ensuring controlled areas maintain compliance with regulatory and internal quality standards. As part of the QC EM team, you will perform hands-on monitoring of air, surfaces, and personnel, as well as water system and utility testing to ensure facility integrity. You will be responsible for maintaining accurate, real-time documentation and supporting investigations into any environmental excursions or anomalies. Working closely with QC, QA, and Production, this role ensures that manufacturing and testing environments remain in a constant state of control to support the production of high-quality therapeutic products.Responsibilities • Conduct routine environmental monitoring in controlled and classified areas in alignment with GMP, ISO, and regulatory requirements., • Perform sampling of air, surfaces, water, and equipment using approved methods., • Document sampling activities and results accurately in accordance with GMP and data integrity standards., • Analyze environmental monitoring data to identify trends, excursions, and required corrective or preventive actions., • Escalate atypical results promptly and support the investigation, documentation, and closure of deviations and CAPAs., • Maintain calibration, readiness, and routine upkeep of environmental monitoring equipment., • Support audit and inspection readiness through compliant documentation and area oversight., • Collaborate with QC, QA, and Production to address findings, implement improvements, and maintain a state of control., • Follow gowning and cleanroom entry procedures consistently and perform duties in full cleanroom attire., • Participate in continual learning, safety programs, and ongoing process improvements.Required Qualifications, • Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field., • 2–5 years of experience in environmental monitoring or quality control within a regulated environment (pharmaceutical, biotech, medical device, or similar)., • Knowledge of GMP, ISO, FDA expectations, and environmental monitoring standards., • Experience performing environmental sampling and handling EM equipment., • Strong documentation, data integrity, and analytical skills., • Ability to work effectively in controlled environments, including cleanrooms., • Strong organizational and time‑management skills for handling multiple priorities.Preferred Qualifications (Nice‑to‑Haves), • Experience with viable and non‑viable particle monitoring, active air sampling, and cleanroom incubation workflows., • Familiarity with LIMS or other laboratory information systems., • Experience supporting audits, inspections, or EM program review., • Strong communication and cross‑functional collaboration skills., • Experience with troubleshooting trends or environmental anomalies.Work Environment & Physical Demands, • Significant time spent in GMP cleanrooms, including full gowning., • Prolonged standing during sampling activities and extended computer use for documentation and trending., • May require lifting of equipment or materials up to 20 pounds., • Ability to work within laboratory, cleanroom, and manufacturing environments as part of routine monitoring.Shift/Schedule, • Primary shift options:Sunday through Thursday \u007C Tuesday through Saturday, • Typical hours: 12:00 PM to 9:00 PM (may vary based on business needs), • Flexibility is required, and occasional adjustments to shift times or days may be necessary. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Product Quality Specialist supports Capricor’s cell therapy programs by assisting in the implementation of cGMP requirements, regulatory expectations, and industry best practices. This role contributes to product quality activities that enable clinical and commercial production, including documentation review, investigation support, data trending, and coordination of quality processes. The position requires effective cross-functional collaboration across sites, program teams, and partner functions to help ensure products consistently meet established quality standards and organizational objectives. Responsibilities * Quality Management and Oversight: • Ensure cGMP compliance throughout all stages of product development, including clinical and commercial production., • Support investigations and provide quality oversight for deviations, CAPAs, OOS/OOT/invalid results, and change controls; ensure timely and effective root cause analysis., • Review product-related investigations and provide clear, well-supported assessments of product impact., • Act as the product quality steward, providing oversight of product quality trends, specifications, stability, and critical quality attributes (CQAs)., • Participate as a non-voting representative atMaterial Review Board (MRB) to provideproduct impact assessments and disposition recommendations., • Analyze product quality data to detect trends, variability, or emerging risks; recommend corrective or preventive measures as needed., • Oversee and maintain the lifecycle of product specifications, including justification, and revisions., • Collaborate closely with QC and analytical development teams to ensure sampling plans, test methods, and acceptance criteria remain appropriate and scientifically justified., • Provide Quality support for QC investigations, including OOS/OOT assessments, invalid results, and method performance trends., • Contribute to product-specific quality risk assessments (ICH Q9) covering CQAs, manufacturing controls, process risks, and testing risks., • Ensure product control strategies remain current, robust, and aligned with evolving process understanding., • Support stage-appropriate process validation and continued process verification activities, as applicable. Supplier and External Partner Management: • Support the quality oversight with contract testing labs, distributors, and other key external partners., • Participate in audits of third-party facilities as necessary to verify compliance with cGMP and regulatory requirements., • Serve as a subject matter expert and provide guidance to internal stakeholders on quality best practices, regulatory expectations, and cGMP requirements., • Support training initiatives and quality improvement projects that strengthen the organization’s culture of quality., • Collaborate cross‑functionally to uphold compliance standards. Basic Qualifications, • Bachelor’s degree in Life Sciences, Biotechnology, or a related field., • 4+ years of experience in manufacturing, process engineering, quality assurance or quality control, with a focus on biologics, cell therapy / advanced therapies, or similar fields within the biotech or pharmaceutical industry., • Strong knowledge of cGMP regulations, FDA/EMA guidelines, and ICH Q-series guidelines applicable to cell-based and biologic products., • Strong working knowledge of ALCOA+ and data integrity expectations., • Excellent written and verbal communication skills with a strong ability to present information clearly and logically., • Effective teamwork skills, ability to foster collaboration, and work effectively in a fast-paced, cross-functional environment., • Exhibits strong attention to detail and adherence to established QA procedures. Preferred Qualifications, • Experience with aseptic processing, sterility assurance, and quality control testing for cell therapies., • Experience supporting product quality in clinical and commercial settings, including batch release, deviation management, and regulatory inspections., • Experience supporting stability programs or specification-related documentation., • Hands-on experience with deviation management, CAPAs, and change controls, including drafting investigation summaries., • Familiarity with regulatory requirements for autologous and allogeneic cell-based / advanced therapies., • Experience reviewing or supporting trending of product quality data. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionDescription: The Quality Associate, Microbiology is responsible for performing routine environmental and utilities monitoring of the cGMP manufacturing facilities. Conducts microbiological and chemical testing including endotoxin, bioburden, total organic carbon (TOC), and conductivity to support product release and facility compliance. Additional responsibilities include assisting with data trending, supporting method validation activities, and contributing to the drafting of protocols, reports, and SOPs related to microbiological operations. The role also involves timely and compliant reporting of test results and participation in investigations as needed. JOB RESPONSIBILITIES • Conduct Bioburden and endotoxin testing of in-process and products samples., • Perform environmental monitoring (EM) of classified cleanrooms and controlled areas., • Collect and test water samples from purified water and WFI systems., • Maintain accurate and compliant documentation in accordance with cGMP, GDP, and internal SOPs., • Assist in investigations of microbiological deviations and support CAPA implementation., • Collaborate cross-functionally with Manufacturing, QA, and Validation teams., • Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements., • Other duties as assigned. JOB REQUIREMENTS Education and Experience • BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience., • Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices., • Knowledge of standard laboratory equipment., • Basic understanding of microbiological techniques, aseptic practices, and laboratory safety., • Good organizational and problem-solving skills., • Ability to follow written procedures and work in a regulated environment., • Must always adhere to good documentation practices., • Detail oriented with strong written and verbal communication skills., • Ability to work independently, within prescribed guidelines, or as a team member., • Willingness to work in cleanroom settings and handle biohazardous materials under proper PPE and gowning protocols., • Experience with Microsoft suite (e.g. PowerPoint, Word, and Excel).Requirements:

Job Description A short-term opportunity is available for a licensed Pharmacist ready to contribute expertise in medication management and patient care during a 4-week contract. This role involves working the 2nd shift with rotating weekends in a fast-paced pharmacy environment, providing comprehensive pharmaceutical services in compliance with legal and safety standards. Key Responsibilities: • Accurately dispense prescription medications and monitor patient medication adherence and potential overuse., • Ensure medication supply and prescriptions comply with legal regulations and patient suitability., • Maintain confidential patient records and pharmacy documentation with precision., • Advise patients on medication usage, potential side effects, and answer related inquiries., • Conduct consultations on prescription and over-the-counter drugs, including storage, dosage, side effects, and interactions., • Offer additional patient services such as smoking cessation guidance, blood pressure, and cholesterol monitoring., • Educate patients on the use of medical devices like blood pressure monitors and glucose meters., • Compound medications and prepare sterile solutions following established procedures., • Supervise and collaborate with pharmacy staff including technicians and clerks., • Manage inventory efficiently to ensure adequate pharmaceutical and medical supplies., • Identify drug-related problems and communicate effectively with healthcare professionals., • Valid California Pharmacist license (in-hand)., • Open to retail pharmacists with a willingness to train and adapt to hospital pharmacy settings., • Second shift: 2:30 PM to 11:00 PM Candidates prepared to take on this role and contribute from day one are encouraged to apply to explore this exciting contract assignment. Compensation for this position ranges from $61.00 to $76.00. Eligible candidates may also receive healthcare benefits, housing, and meals/incidentals. Full details of our healthcare benefits plan can be found here. This posting is open for 60 days after the posting date.

Job Description A short-term opportunity is available for a Pharmacist to join a healthcare facility in San Diego, CA, on a 4-week contract basis. This role offers the chance to provide essential pharmaceutical services on the 2nd shift, from 2:30 PM to 11:00 PM, with rotating weekends. Key Responsibilities: • Accept and accurately dispense prescription medications., • Monitor patient medication compliance and identify patterns of overuse., • Ensure legal compliance regarding medicine supplies., • Verify the suitability of prescribed medications for patients., • Maintain confidential and accurate patient records., • Counsel patients on medication usage, potential side effects, and answer any questions., • Offer consultations on prescription and over-the-counter medications covering storage, dosage, side effects, and drug interactions., • Provide additional patient services including smoking cessation, blood pressure measurement, and cholesterol management., • Educate patients on the correct use of medical devices such as blood pressure monitors and glucose meters., • Compound medications for internal and external use, including preparation of sterile solutions., • Supervise pharmacy staff such as technicians and clerks., • Maintain inventory of pharmaceutical and medical supplies., • Valid California Pharmacist license required., • 2nd Shift: 2:30 PM to 11:00 PM Apply now to embark on this rewarding 4-week assignment and make a meaningful impact in patient health management. Compensation for this position ranges from $61.00 to $76.00. Eligible candidates may also receive healthcare benefits, housing, and meals/incidentals. Full details of our healthcare benefits plan can be found here. This posting is open for 60 days after the posting date.

Job Description A short-term opportunity is available for a licensed Pharmacist to support a facility in El Cajon, CA. This 4-week contract position requires a professional who can manage prescription dispensing and provide critical medication counseling within a 2nd shift schedule, including rotating weekends. Key Responsibilities: • Accept and dispense prescription medications with accuracy and attention to regulatory compliance., • Monitor patient medication adherence and identify over-usage patterns., • Maintain confidential patient records and pharmacy files precisely., • Advise patients on medication usage, possible side effects, storage, and drug interactions., • Provide patient services such as smoking cessation support, blood pressure checks, and cholesterol management., • Educate patients on proper use of medical devices like blood pressure monitors and glucose meters., • Compound medications and prepare sterile solutions following proper protocols., • Oversee pharmacy staff including technicians and clerks., • Manage pharmaceutical and medical supply inventories., • Active California Pharmacist License (in-hand) required., • Experience in retail pharmacy is welcome; training will be provided if needed., • Strong communication skills and ability to work in a multidisciplinary team., • 2nd shift: 2:30 PM to 11:00 PM Apply now to take the next step toward this rewarding contract opportunity. Compensation for this position ranges from $61.00 to $76.00. Eligible candidates may also receive healthcare benefits, housing, and meals/incidentals. Full details of our healthcare benefits plan can be found here. This posting is open for 60 days after the posting date.

Job DescriptionSummary: The Senior Research Associate, Protein Sciences will play a key role in advancing our mission to develop novel therapeutics for cardiometabolic diseases. This position will primarily support the expression and purification of therapeutic candidates and assist with molecular cloning efforts, as well as analyze and present data and contribute scientific insights to drive our research forward. The Senior Research Associate will collaborate closely with cross-functional teams to accelerate progress, delivering reproducible, reliable data and solutions that help move promising therapies closer to patients who need them most. • Manage the expression and purification of proteins in mammalian cell systems, supporting multiple teams and molecular biology efforts as needed., • Develop and employ processes to produce endotoxin-free material., • Operate and maintain relevant laboratory equipment including incubators, biosafety cabinets, FPLCs, and other related instruments., • Review and contribute to the creation and revision of SOPs related to expression and purification practices and maintain accurate reporting in an electronic lab notebook system., • Knowledge of mammalian cell transfection techniques, especially lipofection, for CHO and HEK293 cells., • Familiarity with chromatography techniques such as protein A, ion exchange, Ni-NTA, and desalting., • Knowledge of endotoxin-removal procedures and methods for maintaining instrumentation to prevent endotoxin contamination., • Experience with FPLC operation and troubleshooting, particularly using ÄKTA Avant or ÄKTA Pure systems.Experience with molecular biology techniques, including cloning (restriction enzyme digestion/ligation, Golden Gate assembly, or Gibson assembly), bacterial transformation and culture, and DNA preparation and characterization., • Strong analytical and problem-solving skills with attention to detail., • Excellent organizational and time-management abilities., • Strong verbal and written communication skills.Ability to work both independently and collaboratively in a fast-paced environment.

Job Description The Vice President of Quality will establish, lead and develop the quality function, in line with the company’s stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment. Key Responsibilities: • Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical and nonclinical studies, PV vendors, and CROs, • Maintain efficient systems and processes that ensure Contineum and its vendor network comply with GXP standards, • Ensure the appropriate identification, evaluation, and management of risks associated with quality, • Maintain and continuously improve the Quality Management System, providing guidance and strategic direction for GxP quality standards and their deployment., • Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations, • Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle, • Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and external teams to implement corrective and preventive actions, • Lead the quality review process, ensuring the effective review and approval of batch records, release testing, and other quality-related documentation, • Create and implement risk-based quality strategies that identify and address potential quality risks, • Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues, • Ensuring vendors adhere to relevant quality programs, regulations, and guidelines, and preparing them for regulatory inspections, • Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP and PV activities, • Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations, • Stay updated on industry developments, regulations, guidance, and best practices, and providing training and mentoring on global GXP/PV regulations and guidance, • Ensuring preparedness for pre-approval and routine regulatory inspections conducted by global Regulatory Health Authorities, • BS/BA in biology or related Life Sciences discipline, or equivalent experience, • Minimum of 15 years of experience with increasing responsibilities, including leadership of a Quality function with a focus on biotech or pharmaceutical product development, • Strong working knowledge of global regulatory requirements, including GMP, GCP, and ICH guidelines, • Expertise in Quality Management Systems (QMS), • Extensive knowledge of quality risk assessment and management methodologies, with a successful track record in their application and risk mitigation, • Proven experience in establishing and managing a quality organization and GXP and CSV experienced team members, • Track record of success in a biotech start-up or fast-paced, innovative, dynamic environment, with the ability to remain flexible, proactive, resourceful, and efficient, • Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment, • Strong management, interpersonal, and communication skills, with a history of effectively collaborating with senior scientific, medical, and operations staff, • Demonstrated ability to lead and motivate cross-functional teams, • Willingness and desire to “roll up your sleeves” and perform activities and responsibilities to support the team We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $300,000- $350,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including: • 90% employer-covered benefits, • Flexible PTO, • A very generous holiday schedule that includes a week off in August and time off around the winter holidays, • A well-stocked kitchen with snacks and beverages, • Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match., • The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Job Description COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: We are looking for an Automation Engineer who provides administrative and technical oversight of Building Automation Systems (BAS) in a GMP-regulated environment, with a primary focus on documentation, change coordination, system monitoring, and compliance support rather than hands-on programming. Acts as a liaison between Facilities, Quality, IT, and external vendors to ensure BAS systems remain compliant, reliable, and inspection-ready. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented or changed as necessary.) • Updating and maintaining BAS/BMS documentation, including SOPs, design documents, and lifecycle deliverables such as DSs, FSs, CAs, RTMs, and RAs., • Authoring and executing validation documentation, including BMS IOQs, engineering tests, protocols, and final reports., • Owning and managing BAS-related change records, ensuring proper documentation, impact assessment, and GMP compliance., • Coordinating and overseeing routine BAS work-order maintenance activities., • Reviewing BAS data, including OOS point investigations, user access reviews, and quarterly alarm reviews., • Supporting cross-functional communication between Facilities, Quality, IT, and vendors to maintain system reliability and audit readiness. Education: • Experience working with BMS/EMS platforms, especially Siemens Desigo., • Background in GMP documentation, validation, and CSV/SDLC processes., • Familiarity with BAS operations in biotech or pharmaceutical environments., • Understanding of BAS/BMS system structure, alarm logic, and point configuration review., • Skilled in writing, reviewing, and managing controlled documents and validation protocols., • Strong communication, organization, and cross-functional coordination abilities., • Ability to manage multiple priorities in a fast-paced, compliance-driven environment. ESSENTIAL FUNCTIONS: Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $97,000 to $110,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job Description Genomic Life is seeking a motivated Regional Sales Director to join our growing team! The Regional Sales Director (RSD) is a highly entrepreneurial and motivated individual contributor with experience in healthcare markets and proven ability to sell sophisticated healthcare products to both sophisticated and generalist buyers. This individual is responsible for driving revenue and membership growth exclusively through new logo sales. As the market facing leader within their respective geography, this person will be expected to generate corporate and broker interest and work diligently to close qualified leads. Each RSD will work closely with company management to help create and deliver on revenue goals. This person will be a team player sometimes sharing accounts across regions where shared relationships exist within the broker/client community. Achieving profitable revenue growth while maintaining a deep passion for the new world of genomic medicine and an urgent desire to improve health through genetics-based prevention are expected. Job Type: Full time Salary Range: $110-155k plus commission Preferred Region: Northeast or Midwest Responsibilities: • Work with a passionate entrepreneurial team to meet or exceed sales goals on a multi-year basis, • Communicate the company's value propositions through entrepreneurial efforts and the use of a variety of technology tools as well as traditional channels including presentations and proposals, conference participation, and other networking opportunities, • Leverage internal subject matter expertise, medical directors and clinical resources in a manner that elevates close ratios for complex, large sales, • Maintain technical and professional knowledge by attending internal sales meetings and instructional meetings, reviewing professional publications, participating in professional organizations, and growing personal networks, • Document customer interactions and maintain data related to activities, opportunities and distribution partners within Salesforce with a willingness to adopt new technology in the changing world of AI based applications for sales., • Develop and review sales pipeline strategies and create and execute on strategic selling plans for key pursuits, • Multiple years of experience as a high performing sales representative in the healthcare field, • Bachelor's degree or higher and the ability to communicate our science broadly to anyone from C-suite to HR benefits generalists, • Ability to read, learn, understand and communicate broadly on the benefits of genetic testing and genomic medicine, • Ability to work well within a team concept that encourages sales reps to engage, communicate and share success in order to achieve company goals, • Background of selling diagnostic or pharmaceutical products in the healthcare space and the confidence to cross fields to develop strong broker relationships in the employer benefits space, • Curious mind and strategic thinker with proficiency in problem solving and critical business measurements, including ROI, Breakeven, and other quantitative measures used by consultants and clients to make data-driven decisions, • Ability to travel 40% of the time, • Presentation and public speaking skills About Genomic Life: Genomic Life's mission is to be the best in the world at navigating individuals to the genomics that matter. We provide clinically relevant proactive genetic testing all in one program, making it easy to prevent, diagnose, and treat disease. Our nationwide team is driven to make a difference for the members, clients, and patients we serve. We are bringing the science of today to the medicine of tomorrow. We are passionate about what we do and the extraordinary transformation that genomics will have on healthcare.

Job DescriptionTo support our growth, Janux Therapeutics is searching for a Senior Manager of Data Management to manage day-to-day operations of data management activities. The Senior Manager will ensure compliance with regulatory requirements and industry standards to improve operational efficiency. They will also manage activities with vendors to support our oncology clinical trials and maintain high quality data management deliverables in a timely manner.This role needs a proactive, and resourceful professional who has strong experience in hands-on data management activities within oncology indications.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: • Develop and oversee project level data management strategy., • Oversee CRO data management activities that support clinical trials., • Provide expertise to clinical development functions in data capture, handling, and data management processes., • In-study management for data management activities for Janux clinical studies, including coordinating tasks and deliverables across multiple clinical trials., • Evaluate Electronic Data Capture (EDC) and eSource data capture (ePRO) for implementation., • Contribute toward the drafting and implementation of Data Management Standard Operating Procedures (SOP) in collaboration with cross functional teams per regulatory requirements (ICH/GCP/CFR) and uphold industry standards in vendor outputs (SDTM/CDISC and CDASH)., • Act as primary Data Management contact for assigned projects to cross functional teams., • Review clinical documents (eg. Protocols, Case Report Forms, Statistical analysis outputs, and clinical study report)., • Review and/or develop all core Data Management Documents, including but not limited to Data Management Plans, eCRF Specifications, Data Validation Specifications, CRF Completion Guidelines, Data Transfer Agreement(s) (DTAs), Data Review Plans, and Data Integration Specifications for clinical studies., • Assist in and/or oversee external data reconciliations (SAE, central labs, etc.)., • Oversee and approve the User Acceptance Testing (UAT) of EDC, including relevant documents as needed due to protocol amendments or study needs., • Ensure clinical data within EDC is of high quality for statistical review, interim review, and/or final database lock. Coordinate data reviews between cross functional teams at Janux., • Manage projects assuring timeline and budgetary compliance in data management., • Participates in the preparation and presentation of data, when applicable. Represent Data Management in Sponsor/Regulatory Agency assessments and/or audits., • Up to 20% travel may be required based upon business needs., • Perform other tasks as necessary.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Bachelor’s degree required, advanced degree preferred. A degree in Biomedical or Life Sciences is preferred., • 6+ years of Data Management in pharmaceutical, biotech, and/or CRO, including 3 years of Management experience, including vendor oversight., • Advanced knowledge of data management process for clinical trials and the applicable regulations, experience in oncology and early phase studies required., • Ability to coordinate and drive delivery of activities of outside Data Management vendors., • Knowledge of and experience with EDC databases (especially Medidata Rave) integrations between EDC and IRT systems, CDASH/SDTM standards, medical terminology, medical coding dictionaries, data reconciliations, and quality control processes., • Knowledge and understanding of GCP, ICH and FDA requirements as applicable for Clinical Data Management (CDM)., • Ability to manage multiple initiatives and shift priorities within a small biotech environment., • Excellent interpersonal skills, strong verbal and written communication skills with the ability to work independently and collaboratively in a dynamic team environment.In addition to a competitive base salary ranging from $168,000 to $175,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Job Title: Veterinary Research Scientist Primary Responsibilities: This position requires a broad knowledge of the anatomy and physiology of small and large animals to help develop and support in vivo models to screen therapeutics and devices being developed for various disorders. Experience with surgical, dosing and sampling techniques is required. In addition, the Veterinary Scientist is responsible for assisting in the clinical care of animals on surgical studies including post-operative monitoring and evaluations. Principal Duties and Responsibilities * Perform surgical support and provide anesthesia, surgical, and analgesic technical expertise/advice to facilitate protocol development. * Provide clinical and technical support to internal and external customers, regarding surgical models and services. * Serve as the Research Lead or Study Director responsible for preclinical studies in various species. * Assist in the preparation and review of study protocols and reports. * Provide support for activities of the Institutional Animal Care and Use Committee (IACUC), including protocol review, program review, and facility inspections. * Assist in activities to ensure the facility is in compliance with all applicable regulations, guidelines, and standards that relate to animal care and use. (USDA, FDA, and AALAC) * Train staff on in-vivo procedures * Make recommendations and assist in establishing and enhancing veterinary and animal care standards * Will administer controlled substances and be responsible for maintaining appropriate records. * May develop new or innovative surgical techniques or other procedural improvements appropriate to research studies. * Perform special projects and assist with administrative efforts as needed. Candidate Requirements: * Background in lab animal (in vivo) research with a focus on surgical techniques is a must. * Ability to perform study duties and responsibilities in multiple species with minimal supervision. * Must be flexible to work various schedules and hours as well as provide comprehensive, after hours, and on-call coverage as needed. * This position requires good communication skills and attention to detail. * Strong work ethic, self-motivation, and the ability to adapt to a dynamic team/work environment are keys to success. Education: * Degree in veterinary medicine (BVM, DVM, or VMD) preferred. * Graduate-level degree (M.S. or Ph.D.) in pharmaceutical science, life sciences, or pharmacology considered. Experience: * Minimum 5-7 years of relevant industry experience depending on education level. * Experience working with both small and large animals preferred. * Working knowledge of imaging modalities (TEE, C-arm) will be a plus * A comprehensive understanding of the requirements for GLP study execution and documentation is required.

Job DescriptionCompany Description CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. Job Description We are seeking a skilled and experienced Process Engineer III/ IV with deep expertise in small molecule manufacturing to join our engineering consulting team. This role combines technical leadership with strategic client engagement, supporting process design, scale-up, optimization, and regulatory compliance across a variety of pharmaceutical and chemical industry projects. The Process Engineer III will lead the design and execution of process scopes—such as unit operations, systems, or facility areas—on small to medium-sized projects. You will manage scope, budget, and schedule, while maintaining clear communication with clients and internal teams. This role also includes mentoring junior staff, contributing to high-quality deliverables, and supporting capital project planning and regulatory alignment. This position can be based near any CRB location Key Responsibilities • Lead and support client projects focused on small molecule API process development, scale-up, and manufacturing optimization., • Conduct site assessments, gap analyses, and provide recommendations for process improvements and compliance., • Develop process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), and mass/energy balances., • Translate client requirements into actionable design scope and document decisions, open issues, and action items., • Identify and escalate scope changes or design deviations to project leadership., • Collaborate with cross-functional teams including architecture, mechanical, electrical, and construction., • Prepare technical reports, proposals, and presentations for internal and client stakeholders., • Support capital project planning including feasibility studies, equipment selection, and facility design., • Ensure alignment with industry standards including cGMP, FDA, EMA, and ICH guidelines., • Participate in advanced project activities such as:, • Technical bid tabulations, • Vendor package management, • Factory acceptance testing, • Risk assessments (e.g., HAZOP, HACCP), • 3D model reviews and coordination, • Sequence of operations and functional specification reviews, • Mentor junior engineers and design staff., • Lead system design programming and planning with support from senior engineers., • Participate in cross-discipline squad checks and drive overall project quality.Qualifications Minimum Qualifications • Bachelor’s or Master’s degree in Chemical Engineering or a related discipline (ABET-accredited)., • Minimum of 5 years of experience in small molecule process engineering, preferably in a consulting or client-facing role., • Strong understanding of chemical synthesis, purification, and formulation processes., • Experience in design firm or operating company settings within a related industry., • Strong written and verbal communication skills., • Intermediate experience with applicable industry and regulatory guidance and building codes., • Advanced technical knowledge and experience with small molecule API manufacturing equipment and utility systems, such as chemical reactors, filters, centrifuges, dryers, vacuum pumps, scrubbers, purified water, process compressed gases, and engineered heat transfer fluid systems., • Experience designing and implementing engineering controls for containment of highly potent APIs., • EIT or PE certification., • Experience coordinating and managing design within project teams and with external partners., • Familiarity with commissioning, startup, qualification, and troubleshooting of process systems., • Experience with regulatory environments and validation documentation., • Prior experience in engineering consulting or client services., • Familiarity with process safety, risk assessments, and HAZOP studies. Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Job Description COMPANY DESCRIPTION: Syner-G is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market. We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality. Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations. KEY RESPONSIBILITIES: (This list is not exhaustive and may be supplemented and changed as necessary.) • Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification., • Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR)., • Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures., • Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities., • Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments., • Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes., • Support the resolution of regulatory observations or manufacturing site issues. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Education: • 4-7 years of experience within the biotech, pharmaceutical, or medical device industry., • Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required., • Validation expertise in Equipment, CSV, Method, and Process., • Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation. Physical Demands: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. COMPENSATION: The expected salary range for this position is $88,000 to $104,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. LEGAL STATEMENT: Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Job DescriptionDescription: At Kumquat, we strive to develop life changing medicines in an efficient and innovative way with the shared mission of patient focus. The Medical Director plays an essential role in leading the development program of a study drug, innovative clinical trial design, execution of clinical studies with the study management team, and data quality to bring better clinical trials to more patients. We want you to join our mission and be part of our passionate and collaborative community, we value individual and team accountability and also see the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional descriptions. Job Description: Integral member of a cross functional team for a study drug from the first in human study all the way to registration by: • Developing protocols and protocol amendments for an oncology product, • Work with cross-functional team to develop eCRFs, • Actively participating in study/ site start-up activities, data review and interpretation, site engagement (including SIVs and committees), and provide general medical support to the study team(s), • Maintains up-to-date knowledge on the emerging treatment landscape in study specific areas, • Cultivate meaningful peer-to-peer collaborations and nurture a culture of curiosity to enable faster, simpler, and more patient-centric ways of operationalizing our studies., • Work with colleagues across Kumquat to promote communication and community. Optimizing growth opportunities and capabilities to successfully contribute and operate in a diverse and global environment. Drive new thinking by identifying new opportunities and options to embrace value creation., • Ensure GCP/GVP compliance, data integrity, and take a balanced risk-based approach in the work you are focused on, seeking guidance or direction as needed., • Provide input into work instructions and SOPs to ensure consistency across programs and ensure efficiency, • Author or support authoring of the clinical development plan for the assigned product, • Work closely with medical safety and clinical scientist, medical monitoring of ongoing clinical trial, • You are a talented and passionate human, inspired by our shared purpose to innovate clinical trial delivery to bring better trials to more patients., • You thrive in environments of ambiguity and collaboration where the ability to make sound decisions quickly while seeking advice when needed is essential., • You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener., • You thrive leading or being an active member of large or small diverse teams., • Expectations:, • Knowledge of Clinical development such as study design, protocol execution, medical monitoring, data quality and drug development., • Provides subject matter expertise on activities or through supporting the design and execution of clinical trials and/or enabling projects, • Contributes to the outcome of one or more clinical trials and/or enabling projects., • Understands, applies proficient knowledge of, and ensures adherence to ICH, GCP, and regulatory guidelines within clinical trials or enabling activities., • Builds relationships with sites and investigators and partners to ensure the execution of clinical trials. Requirements: • MD/DO required, • Oncology and or hematology experience as practicing physician preferred, • Minimum of 5 years of relevant experience in the pharmaceutical industry in clinical development, biotech experience preferred., • Phase 1 study trial experience in either solid tumor or hematologic malignancies with a focus on small molecules preferred, • Working knowledge of Drug Development and Clinical development activities and deliverables., • Ability to travel up to 10% of the time domestically or internationally Salary Description: $283k- $357k

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Senior Director, Quality Assurance & Quality Systems provides strategic and operational leadership for all quality activities supporting Capricor’s clinical-stage and advancing commercial-stage organization. This role has full accountability for the design, execution, and continuous improvement of the Quality Management System (QMS) to ensure sustained regulatory compliance, inspection readiness, and robust quality oversight across development, manufacturing (including cell therapy production), and potential commercialization of Deramiocel and StealthX™-based programs. The Senior Director partners closely with executive leadership, Regulatory Affairs, CMC, Clinical, Manufacturing, and other cross-functional teams to enable late-stage development, BLA submissions and responses (including addressing any quality-related aspects of the Deramiocel pathway), commercial readiness, and scalable growth while embedding a proactive, risk-based quality culture across the enterprise.Responsibilities • Define and execute the enterprise quality strategy aligned with late-stage clinical development, BLA/regulatory submissions, potential commercial launch, and post-approval lifecycle management for cell and exosome-based therapies., • Serve as the senior Quality leader and strategic advisor to executive and operations management on compliance matters, inspection readiness, quality risk management, and GxP expectations in a biotech environment., • Own and continuously enhance the enterprise QMS to support clinical, manufacturing, and commercial operations, including Document Control and Change Management, Deviations/Investigations/CAPA, Training and Qualification, Data Integrity and Records Management, and other core quality processes., • Ensure quality systems are phase-appropriate, scalable, efficient, and fully aligned with FDA GMP regulations (21 CFR Parts 210/211, 820, and biologics-specific guidance), ICH guidelines, ISO standards, and global expectations for advanced therapies., • Ensure ongoing compliance with FDA, GMP, and applicable global regulations for clinical trials, manufacturing, and potential commercial activities, including cell therapy and exosome platforms., • Lead preparation for, management of, and response to regulatory inspections (including PAIs), partner audits, and health authority interactions; act as the primary Quality representative during agency engagements and inspections., • Provide comprehensive quality oversight for clinical quality assurance, including GCP compliance and support for ongoing trials such as HOPE-3 extensions or related activities., • Oversee quality support for manufacturing, testing, process validation, technology transfer, comparability studies, and supply chain activities for late-stage and commercial products (e.g., Deramiocel cell therapy production)., • Ensure timely and effective resolution of quality events, deviations, CAPAs, complaints, and out-of-specification results, with appropriate escalation, root cause analysis, and management visibility., • Collaborate closely with Clinical, Regulatory Affairs, CMC/Process Development, Manufacturing, Supply Chain, Quality Control, and Commercial teams to integrate quality principles throughout the product lifecycle and enable efficient, compliant decision-making., • Establish, monitor, and report quality KPIs, trends, risk indicators, and compliance metrics to senior leadership and the Quality Management Review., • Drive continuous improvement initiatives, including process optimizations, lessons learned from inspections/audits, and enhancements to strengthen compliance maturity, operational efficiency, and inspection outcomes., • Build, lead, and mentor a high-performing QA and Quality Systems organization; develop talent, succession plans, and training programs to support organizational scaling and commercialization milestones., • Foster a collaborative, accountable, and inspection-ready mindset across the quality team and broader company.Requirements, • Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related field; advanced degree (e.g., MS, PhD) preferred., • 12+ years of progressive Quality Assurance experience in pharmaceutical or biotechnology environments, with significant focus on biologics, cell therapies, or advanced therapy medicinal products., • 7+ years of senior leadership experience with direct ownership and oversight of enterprise Quality Management Systems in a growing organization., • Hands-on experience supporting late-stage clinical programs, BLA submissions, pre-approval inspections (PAIs), and commercial readiness/launch activities for regenerative medicine or biologics products., • Deep knowledge of FDA regulations (including 21 CFR Parts 210/211, 820, biologics-specific guidance), GMP, ICH guidelines (Q8-Q12, etc.), and global standards relevant to cell and exosome therapies., • Demonstrated success leading regulatory inspections (PAIs, routine GMP inspections), responding to findings, and maintaining inspection readiness in dynamic settings., • Proven ability to scale QMS and quality organizations in a rapidly growing biotech company preparing for commercialization., • Strong executive presence with the ability to influence, collaborate with, and advise cross-functional teams and senior leadership., • Excellent communication, problem-solving, decision-making, and strategic thinking skills.Work Environment / Physical Demands, • Office-based with routine presence in GMP manufacturing and laboratory environments to support oversight, audits, inspections, and quality activities., • Extended periods of computer use for documentation review, data analysis, metrics reporting, and quality system management., • Occasional lifting of office or light materials up to 10 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionThe Vice President, Regulatory Affairs & Quality Assurance will provide strategic and operational leadership across Regulatory and Quality functions in Janux’s growing biotech environment. This individual will be responsible for developing and executing regulatory and quality strategies that enable efficient advancement of the company’s pipeline from early development through commercialization, while ensuring sustained compliance with global regulatory and GxP requirements.Reporting to the Chief Medical Officer, the VP will be a key partner to clinical development, CMC, manufacturing, and commercial teams and will represent the company in interactions with global health authorities.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Regulatory Leadership & Strategy, • Develop, implement, and maintain global regulatory strategies across all stages of development, including IND/CTA preparation, clinical development, marketing applications (BLA), and post‑approval lifecycle management., • Lead and oversee regulatory submissions and filings in the U.S. and internationally, ensuring high-quality, compliant, and timely deliverables., • Serve as the primary regulatory advisor to executive leadership, providing risk‑based guidance aligned with corporate development goals, • Manage and lead interactions with global health authorities (FDA, EMA, etc.), including meetings, briefings, responses, and negotiations., • Oversee regulatory intelligence activities, monitor evolving regulations and guidance to anticipate and mitigate regulatory risk., • Quality Assurance & Compliance, • Establish and maintain a robust, scalable Quality Management System (QMS) covering GxP activities (GLP, GCP, GMP, GVP) across internal operations and external partners., • Provide executive oversight of quality assurance functions, including audits, inspections, deviation management, CAPAs, and vendor qualification., • Ensure inspection readiness and successfully lead regulatory inspections and partner audits., • Promote a culture of quality, compliance, and continuous improvement across the organization., • Cross‑Functional & Organizational Leadership, • Build, mentor, and lead high‑performing Regulatory and Quality teams., • Partner closely with Clinical Development, CMC, and Supply Chain to align regulatory and quality strategies with program timelines., • Contribute to enterprise‑level planning, governance, and decision‑making as a member of the senior leadership team.EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES, • Bachelor’s degree required; advanced degree (MS, PhD, PharmD, or MD) in a life science discipline preferred., • 15+ years (20 years preferred) of progressive experience in Regulatory Affairs and CMC/Quality within the biotechnology or pharmaceutical industry., • Global Phase 1 through 4 regulatory experiences required., • Demonstrated experience leading global regulatory strategies and successful major submissions (e.g., INDs, BLAs, NDAs, MAAs)., • Deep working knowledge of FDA, EMA, and ICH guidelines and regulatory frameworks, including GxP requirements., • Proven ability to build and lead cross functional teams in a fast‑paced, evolving biotech environment, • Strong executive presence with the ability to influence internally and externally with health authorities and key stakeholders including KOLs, PIs and providers.Travel Requirements

Job DescriptionThe Senior Manager of Supply Chain will be responsible for the strategic operational oversight of all aspects of clinical supply chain to ensure timely drug supply for Janux’s clinical programs. Reporting into the Director of Supply Chain, this role will also collaborate with other functions within CMC, Clinical Operations, Regulatory and Quality Assurance (QA) to forecast and support clinical trial supply requirements including clinical drug manufacturing schedules and inventory, packaging, labeling, and distribution activities.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Prepare, maintain, and periodically re-evaluate demand forecasts and supply strategies to ensure uninterrupted IMP supply to clinical sites while minimizing product waste throughout the clinical trial., • Contribute to and review Interactive Response Technologies (IRT) specifications; manage IRT systems in alignment with the overall supply strategy., • Collaborate with cross-functional teams to create and approve labeling designs in compliance with regulatory requirements., • Manage packaging activities at the Clinical Packaging Organization (CPO) and coordinate with QA for release., • Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records., • Oversee distribution and inventory of clinical trial material across depots and sites., • Manage drug return, destruction process, and accountability at the depots., • Coordinate material shipments from CDMO to storage facilities and CPOs., • Review and approve third-party vendor invoices, ensuring accuracy and compliance with contractual terms., • Partner with QA on quality events, investigations, deviations/CAPA, batch record review and drug disposition., • Manage expiry date extensions, documentation, and related distribution activities., • Participate in forecast meetings with Clinical Operations. Prepare presentation materials and communicate inventory updates and operational strategies., • Identify and lead process improvement initiatives to enhance efficiency and compliance., • Perform other responsibilities as assigned.REQUIRED SKILLS AND QUALIFICATIONS, • Bachelor’s degree in a scientific or pharmaceutical discipline., • 6+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management., • Inventory management and vendor oversight experience in all phases of drug development for biologics with global clinical supply distribution is required., • Strong knowledge of cGMP, GCP regulations, and Annex 13 and VI., • Solid understanding of clinical research protocol requirements and experience developing IRT specifications., • Familiarity with biologics manufacturing processes is highly desirable., • Experience with logistic systems and shipping required., • Effective communication and direction., • Ability to identify project risks and rapidly develop and implement risk mitigation strategies in a fast-paced environment with changing priorities.In addition to a competitive base salary ranging from $164,000 to $173,000, we offer stock options, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.Job Type: Full-time Benefits:· 401K· Medical insurance· Dental insurance· Vision insurance· Supplemental disability insurance plans· Flexible schedule· Life insurance· Flexible vacation· Sick time· Incentive stock option plan· Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Quality Systems Specialist (Veeva) is responsible for supporting Capricor’s transition to the Veeva electronic Quality Management System (eQMS) and providing ongoing system administration, configuration, and maintenance. This role plays a key part in ensuring the eQMS meets GxP, regulatory, and operational requirements while enabling efficient and compliant quality processes.The Specialist will support implementation activities, system configuration, validation, user support, continuous improvement, and cross‑functional collaboration. This is a highly visible role critical to Capricor’s modernization of quality systems and digital infrastructure.Responsibilities * eQMS Transition & Implementation • Co‑lead the transition from the legacy QMS to Veeva eQMS, supporting planning, execution, and go‑live readiness., • Participate in system implementation activities including:, • Gathering and documenting user and business requirements (URS)., • Configuration of Veeva Vault Quality modules (QMS, Docs, Training)., • Data migration planning, mapping, execution, and verification., • Coordinate and support system validation activities (IQ/OQ/UAT), including documentation and testing oversight., • Support hypercare and post‑implementation stabilization activities., • Configure and maintain quality workflows, lifecycles, roles, permissions, and security settings., • Manage configuration of Veeva processes including Deviations, CAPA, Change Control, Training, and Document Control., • Maintain metadata structures, document hierarchies, and controlled vocabulary., • Serve as a Veeva eQMS System Administrator for Capricor., • Support Veeva releases by performing impact assessments, regression testing, and required documentation updates., • Manage system issues, enhancements, and change requests in partnership with Veeva Support., • Identify opportunities to enhance system usability, workflow efficiency, and user experience., • Analyze system metrics (cycle times, overdue items, trending data) to drive optimization., • Conduct user training sessions, onboarding, and refresher training for Veeva Vault applications., • Serve as a Veeva eQMS Subject Matter Expert (SME) to support end users with troubleshooting and best practices., • Provide guidance on system usage to ensure compliance and data integrity.Required Skills, • Education & Experience: Bachelor’s Degree and 5+ years of experience in a pharmaceutical, biologics, or FDA‑regulated environment., • Certification: Veeva Vault certifications (Administrator, Quality Suite) or equivalent hands‑on experience administering and configuring Veeva Vault., • Quality Background: Minimum 3+ years of Quality Assurance or Quality Systems experience in a GMP‑regulated environment., • Regulatory Knowledge: Knowledge of GxP regulations and industry guidance including 21 CFR Part 11, 210, 211, and ICH Q8/Q9/Q10., • Technical Skills: Experience supporting system implementation, validation, configuration, and release management activities., • Soft Skills: Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non‑technical stakeholders., • Tools: Proficiency with Microsoft Office applications.Preferred / Nice-to-Have Skills, • Experience migrating from a legacy QMS to Veeva Vault., • Understanding of electronic signatures, data integrity principles, and audit trail requirements., • Experience working with IT, Validation, and QA teams on system qualification activities., • Prior involvement in developing SOPs, workflows, or training content for eQMS systems., • Strong analytical and problem‑solving abilities with experience interpreting system metrics.Work Environment / Physical Demands, • Primarily office‑based with extensive computer use for system configuration, documentation, and administration., • Ability to sit for extended periods while working on system or documentation tasks., • Occasional lifting of materials up to 15 pounds. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our CMC Department as a Supply Chain Specialist and work as part of a team to drive success. The Supply Chain Specialist, Clinical Supplies will support the planning, coordination, and execution of global clinical supply activities for company-sponsored clinical trials. This role will partner cross-functionally with Clinical Operations, CMC, Quality, Regulatory, and external vendors to ensure uninterrupted supply of investigational product (IP) to clinical sites while maintaining compliance with GxP, regulatory, and company requirements. The ideal candidate is detail-oriented, highly organized, and experienced in managing clinical supply logistics in a fast-paced pharmaceutical or biotech environment. Essential Responsibilities: • Develop and promote a workplace culture that values diversity of thought, promote integrity and create an atmosphere that supports coaching and fosters accountability., • Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company., • Support end-to-end clinical supply chain activities including forecasting, planning, packaging, labeling, distribution, returns, and reconciliation of investigational product., • Coordinate with internal stakeholders and external CMOs, depots, and logistics vendors to ensure timely manufacturing and delivery of clinical supplies., • Maintain and track inventory levels at depots and sites; proactively identify and mitigate potential supply risks., • Generate and manage clinical supply forecasts and resupply strategies based on enrollment projections, drug product expiry dates, and study timelines., • Support creation and review of packaging and labeling specifications in alignment with study protocols and regulatory requirements., • Manage Interactive Response Technology (IRT/RTSM) supply settings and ongoing updates in collaboration with Clinical Operations and vendors., • Prepare and review shipment documentation and ensure compliance with import/export and country-specific requirements., • Reconcile clinical supplies, including returns, destructions, and accountability documentation., • Contribute to development and continuous improvement of SOPs, work instructions, and supply chain processes., • Ensure all activities comply with GCP, GMP, and applicable regulatory guidelines., • Maintain accurate documentation and support audits and inspections as needed., • Provide Operational support services to CMC development and manufacturing functions., • Reviews and recommend updates for departmental SOPs, may draft updates to SOPs depending on experience and level., • Maintain all appropriate corporate standards for facility safety and hazardous material management. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Bachelor’s degree in supply chain, life sciences, or related field., • BS with 3 years of experience or MS with ½ years of experience in clinical supply chain, clinical operations, or pharmaceutical logistics., • Excellent organizational, written and verbal communication skills; and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • Working knowledge of GxP requirements and global clinical trial supply practices., • Experience coordinating with CMOs, depots, and third-party logistics providers., • Familiarity with IRT/RTSM systems and clinical supply management tools., • Strong organizational skills with the ability to manage multiple studies and priorities simultaneously., • Experience supporting global, multi-site clinical trials (Phase I–III)., • Understanding of temperature-controlled shipping and cold chain management., • Experience with import/export documentation and international shipping regulations., • Must be able to work independently with supervision as needed., • Proficient at working independently as well as in cross-functional team settings, • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA therapeutics to treat a broad spectrum of diseases. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Data: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • Recruiters & Staff Agencies: ADARx Pharmaceuticals (ADARx) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to ADARx or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of ADARx and the Company will not owe any referral or other fees with respect thereto., • Compensation: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation: Includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Conditional Offer of Employment: Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Beloteca, Inc. is a generic pharmaceutical development company specializing in the development of injectable products. It is desirable that the candidate have past practical experience and education in handling chemicals, operating laboratory equipment, generating and manipulating data, as well as computer database and word-processing skills. Job Description: • Independent execution of various standard laboratory techniques, including but not limited to H/UPLC, GC, water content analysis per USP, appearance assessment, water activity per USP, • May participate in qualification/verification of assays, • Assay and documentation review and report writing, • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices., • Execution of more advanced analytical techniques with assistance such as LC/MS, DSC, and TGA, • Independent preparation of samples, solutions, instrument set-up and breakdown, • Independent preparation of data packets and creation of stability data sheets and Certificates of Analysis to summarize analytical testing, • Assisted participation in Out of Specification investigations and the documentation of analytical deviations along with Qualified Investigators and management, • BS in Biology, Chemistry and/or related science discipline., • Computer literacy in Windows applications and the MS Office., • Excellent oral and written communication skills are essential., • Minimum of 3 years experience with HPLC, UPLC, GC, Karl Fisher, pH, • Ability and willingness to work flexible hours., • Great attention to detail, quality, and a desire for success., • Self-motivated individual with the ability to learn, lead and strengthen the Beloteca, Inc. team.

Job DescriptionSales Executive – Freight Forwarding Purpose of Role Drive profitable new business through consultative, solutions-based selling across a full suite of global logistics and supply chain services. Maintain integrity, accuracy, and transparency in all revenue reporting and client discussions. Why This Is a Great Place to Work • Privately held, financially strong, and growing nationwide, • Highly respected reputation for ethics, service quality, and operational reliability, • True entrepreneurial culture — sales reps are empowered, not micromanaged, • Fast decision-making from leadership (no bureaucracy), • Best-in-class operations teams that make it easier to onboard and retain accounts, • Industry-leading technology: real-time tracking, API/EDI integrations, advanced WMS, • Strong support from regional EVP-level sales leaders, • Competitive compensation structure tied to performance, • Long-term career stability with national and international expansion plans What You Will Sell Core Freight Forwarding Services • International & domestic air freight, • International & domestic ocean freight, • FTL, LTL, cross-dock, distribution, • Bonded and FTZ services, • Storage, inventory management, • Pick/pack/ship, kitting, labeling, • E-commerce fulfillment with advanced WMS (Extensiv), • Expedited/time-definite (NFO, charter, critical shipments), • White-glove and high-value handling, • Project cargo: heavy-lift, OOG, crating, rigging, • Automotive, • AI / High-tech, • Pharmaceutical, • Aerospace, • Government / DOD, • Medical devices, • Retail / cosmetics, • Shipment management platform with real-time visibility, • Full API/EDI integration for automation, • Atlanta, • Dallas, • Houston, • Chicago, • Los Angeles, • San Diego, • San Francisco, • San Jose Requirements Core RequirementsRemote Sales Requirements • Remote roles require $2M+ annual GP Professional Standards • Demonstrates integrity, commitment, and passion, • Must be currently employed in a logistics sales role, • No non-compete preferred, • Strong verbal and written communication skills, • Proficient with Excel, PowerPoint, and Word Sales CapabilitiesConsultative Selling • Ability to diagnose customer needs and design customized logistics solutions, • Comfortable discussing automation, EDI/API integration, and operational efficiencies, • Proven history of building loyal, portable client relationships, • Can articulate monthly revenue, GP, margins, and industry mix without embellishment, • Clear prospecting strategy (cold calling, cadence, vertical targeting), • Skilled in CRM execution and organized follow-up, • Strong discipline in pipeline management and forecasting Experience Requirements • Minimum 5+ years of successful freight forwarding sales experience, • Ability to demonstrate true account portability and retention, • Must be accurate — no inflated performance claims Benefits • Medical, dental, and vision insurance, • 401(k) with company match, • Life, short-term, and long-term disability coverage, • Paid vacation, sick time, and holidays, • Flexible/remote options for high-performing sales reps, • Competitive base salary + strong commission structure, • Annual performance bonuses, • Company laptop and mobile reimbursement, • Ongoing sales, compliance, and technology training, • Supportive, fast-moving culture with strong operations backing

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description As a Senior Field Engineer you will conduct on-site Field Evaluations of electrical equipment for compliance to regulatory product safety standards (UL, NFPA, CSA, ANSI, etc.). Perform construction and engineering review of electrical equipment in a multitude of industries (manufacturing, laboratory, medical, commercial, retail, food service, etc.). 100% travel both domestic and internationally, though majority of travel will be within the lower 48 (must possess or be able to obtain a passport). Territory: San Francisco, CA; Los Angeles, CA; Las Vegas, NV; Phoenix, AZ. RESPONSIBILITIES The Senior Field Engineers’ duties and responsibilities include, but are not limited to: • Perform Field Evaluations under the Eurofins E&E North America/MET Labs Field Labeling program, • Review scope of work and identify all necessary items prior to arranging travel, • Responsible for coordinating all travel arrangements, • Communicate with client, AHJ, contractors, and other relevant parties, • Identify applicability of national codes and standards, • Review manuals, schematics, BOMs, site procedures, data sheets and more, • Document construction details and any non-conformances during the inspection, • Assess compliance to the relevant UL, NFPA, CSA, or ANSI standards, • Determine eligibility of equipment for labeling and issue all final reports, • Submit all expenses and necessary documentation for billing, • Meet or exceed minimum billing goals while meeting project deadlines, • Grow relationships with clients and promote our company and the various services we offerQualifications The ideal candidate will demonstrate the following experience, skills, and personal attributes: • Electrical Engineering Bachelor’s Degree preferred and/or equivalent experience., • MUST have direct Field Engineering experience with a Nationally Recognized Testing Laboratory (NRTL) or Field Evaluation Body (FEB) using product safety standards., • Experience as a Follow-Up Inspector is not relevant unless there is experience performing multiple UL 508A training seminars., • Conversant with UL 508A, UL 61010-1, UL 73, NFPA 70, & NFPA 79., • Though not required, experience with Hazardous Location and CSA standards is desired., • Must have strong technical writing skills and experience with Microsoft Office Suite., • This position requires strong verbal and written communication skills and excellent interpersonal skills as the candidate will interact with customers on many different levels., • Must be able to work in elevated and/or confined spaces. Must be able to lift 30+ pounds., • This position requires a strong electrical background and understanding of electrical systems., • Must possess sound problem-solving skills., • Skillful ability to work independently., • Position is entirely remote. Must be near a major airport. Additional Information Salary Range: • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description Direct Counsel is seeking a Corporate Associate Attorney (Licensing) to join a leading Am Law 100 firm in its San Diego office. This is an outstanding opportunity for an associate attorney interested in sophisticated licensing, commercial contracting, and technology transactions within the life sciences, biotechnology, pharmaceutical, medical device, and software sectors. About the Role The Licensing & Technology Transactions team works closely with cutting-edge companies developing groundbreaking technologies and therapeutics. As a Corporate Associate Attorney, you will draft and negotiate complex commercial agreements, support strategic corporate transactions, and advise clients on intellectual property, regulatory considerations, and deal structures across all stages of the product and company lifecycle. This role offers substantial client contact, the ability to interact with scientists and business leaders, and meaningful responsibility on impactful transactions. What You’ll Do * Draft, review, and negotiate a broad range of commercial agreements, including: * Licensing, collaboration, development, and research agreements * Clinical trial, manufacturing, supply, and service agreements * Patent license agreements and IP assignments * Material transfer agreements, NDAs, and distribution agreements * Strategic alliance and commercialization arrangements * Advise clients on contract interpretation, risk assessment, and compliance issues * Conduct due diligence on IP assets and contractual obligations in corporate transactions * Review high-volume commercial documents such as confidentiality agreements and terms and conditions * Collaborate with scientists, executives, and cross-functional business teams to align legal strategies with operational and commercial goals * Stay current on regulatory and legal developments affecting life sciences and technology transactions What We’re Looking For * A highly skilled Associate Attorney with 3+ years of experience drafting and negotiating commercial contracts for life sciences or technology clients * Strong understanding of intellectual property issues, including patents, trademarks, trade secrets, and copyrights * Experience with software licensing, SaaS agreements, and technology transactions preferred * Familiarity with data privacy considerations and emerging issues involving AI * Excellent negotiation, communication, and problem-solving skills * Ability to manage competing priorities, meet deadlines, and maintain exceptional attention to detail * A collaborative mindset and professionalism when working with clients, colleagues, and cross-disciplinary teams Qualifications * JD or LLM from an ABA-accredited law school * Admission to practice in California (or eligibility to sit for/admit via reciprocity) * Background in biology, immunology, biochemistry, or a related scientific field strongly preferred * Experience supporting biotechnology, pharmaceutical, medical device, digital health, or related technology clients Compensation & Benefits The annualized salary range for this Associate Attorney position is $260,000 – $310,000, depending on experience and other permitted job-related factors. Attorneys are bonus-eligible and receive access to a comprehensive benefits package.

Job Description Invivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics®. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer treatments for over 30 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used by over 700 clinical laboratories in over 160 countries. Our global network of laboratories offers internationally standardized next generation molecular and flow cytometry panels to support drug development and accelerate drug approvals worldwide. We work with pharmaceutical partners and international regulatory agencies across the globe to develop companion diagnostics, which are necessary to gain approval of new drugs and treatments for cancer patients. Our harmonized ISO15189 accredited and CLIA/CAP clinical laboratories offer a test menu focused on biomarkers which are clinically actionable to support therapeutic decisions, measurable residual disease (MRD) testing, patient stratification, and trial enrollment, all designed to accelerate approvals of new oncology drugs and treatments. For 30 years, we have been at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Business Process Analyst who will be responsible for leading process improvement efforts in the company’s Operations, Manufacturing, and other functional areas by identifying and implementing innovative methodologies to automate or streamline processes. Primarily focuses on initiatives that leverage and optimize the company’s enterprise resource planning (ERP) system and advanced data analysis tools. Responsible for guiding critical business initiatives, ensuring they are planned and executed to successfully implement best-in-class solutions. Provides ongoing support for the resolution of business systems issues. Coordinates between operational departments and IT on a wide variety of technical improvement projects by actively managing or assisting various functional groups in IT improvement projects. Activities are performed independently and in accordance with standard operating procedures (SOPs), Quality Management System (QMS), safety and administrative regulations and policies. Core Responsibilities Include: • Partners with company management and IT team to identify and prioritize projects that optimize the ERP system for process automation and streamlining., • Documents and bridges current state/future state by developing clear, actionable requirements for implementation., • Develops and communicates detailed requirements and specifications for implementation of projects and system changes., • Evaluates system or process modifications to assess their impact on business operations and provides well-informed recommendations., • Demonstrates strong analytical skills and a thorough understanding of product and process flows., • Communicates effectively and presents findings to various stakeholders, ensuring clarity and engagement., • Applies advanced expertise in Power BI and Oracle Cloud to improve data analysis and reporting functions., • Utilizes Value Stream Mapping and other Lean Six Sigma techniques to ensure the successful execution of projects., • Provides analytical support including cost savings estimates, safety improvements, and quality enhancements associated with each project., • Prepares and facilitates meetings with management, project stakeholders, and steering committees, providing timely updates to stakeholders., • Produces reports, timelines, and graphics to communicate expectations and progress to management, customers, investors, and other relevant parties., • Manages projects effectively to ensure clarity of scope, resource allocation, stakeholder input and buy-in, implementation, and post-implementation evaluation and reporting., • Operates autonomously while achieving objectives and collaborates effectively with cross-functional teams to deliver results., • Maintains proper documentation and coordinates or performs testing of system modifications to ensure accuracy and compliance., • Complies with applicable standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies., • Operates within Quality Management Systems and is familiar with CAPA, Non-conformities, and other quality management processes., • Bachelor’s degree in engineering or other technical related field of study and, typically, 3-4 years’ applicable experience with project management, process improvement initiatives within life sciences, pharmaceuticals, or diagnostics operations. Equivalent combination of education and experience may be considered., • Proficiency in Business Intelligence tools such as Power BI., • Proficiency with ERP systems (e.g., Oracle Cloud)., • Sound knowledge of statistical methods and data modeling., • Sound knowledge of Project Management concepts and tools. PMP certification advantageous., • Lean/Six Sigma certification preferred., • A beautiful modern facility centrally located in San Diego County, with many jobs conducive to flexible scheduling and telework options., • A welcoming breakroom for gathering with hosted hot/cold beverages and healthy convenience foods, and an available micro-market to get you through the day., • A positive workplace culture with an emphasis on support, respect and belonging., • A diverse and inclusive work environment where you will learn, grow, and make new friends., • Competitive pay, discretionary bonus program, incentive stock options, generous benefit options, 401k with a fully vested employer match, and generous time off benefits. Invivoscribe is an Equal Opportunity Employer.

Job Description Job Description: ADARx is seeking a qualified and highly motivated individual Lab Manager to join the R&D Department. The Lab Manager will provide operational and scientific support for a fast-paced biotechnology research environment to ensure smooth functioning of the lab while maintaining compliance with safety standards. This role is ideal for a highly experienced professional who can operate independently, proactively manage laboratory operations, and ensure the efficient, compliant, and safe execution of research activities. The Lab Manager will serve as a key partner to scientific teams, requiring minimal supervision and a strong ability to anticipate and resolve issues. Essential Responsibilities: • Oversee day-to-day laboratory operations to ensure efficiency, organization, safety, and compliance (e.g., company policies, OSHA, EPA, EHS, local guidelines)., • Oversee proper functioning and maintenance of all laboratory equipment, including calibration, maintenance and repairs., • Serve as a liaison with external vendors and landlord, manage service contracts, and operate as the primary point of contact for lab-related issues, troubleshooting independently when possible., • Manage shipping and receiving of laboratory materials, including reagents, and samples, ensuring proper compliance with company’s policies and IATA shipping certificate., • Oversee inventory management, ordering, and stock levels for reagents, consumables, and supplies; maintain equipment inventory., • Lead lab safety programs, including chemical hygiene, waste disposal, emergency procedures, safety inspections and training., • Support onboarding and training new lab personnel on lab protocols and safety practices., • Implement best practices to support a growing and evolving R&D organization, including establishing, maintaining and improving lab processes, SOPs and workflows., • Manage lab scheduling, space utilization, and shared equipment across Discovery Biology and Discovery Chemistry research teams., • Partner closely with scientists, IT, Legal, and external vendors and act as a trusted operational advisor to internal stakeholders and research leadership., • Identify opportunities to streamline operations, reduce costs, and improve productivity., • Anticipate future lab needs based on scientific and business demands., • Oversee day-to-day laboratory and vivarium operations to ensure efficiency, organization, safety, and compliance (e.g., company policies, OSHA, EPA, EHS, local guidelines)., • Bachelor’s degree in Biology, Chemistry, Biochemistry, or a related scientific field., • Minimum of 5 years of experience managing laboratory operations in a pharmaceutical, biotech, or life sciences environment., • Demonstrated ability to work independently with minimal supervision., • Strong knowledge of laboratory safety, compliance standards, and best practices., • Proven experience managing equipment, vendors, and lab budgets., • Experience supporting discovery and/or development-stage research., • Must be able to work independently with supervision as needed., • Must be collaborative and work well with other team members in a matrix team environment., • Excellent written and verbal communication skills are essential for this role., • Strong organizational skills with attention to detail and accuracy., • Ability to maintain a high level of confidentiality and exercise discretion., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges., • Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Occasional after-hours availability may be required to respond to critical equipment alarms or other urgent laboratory matters. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Compensation: • This is a full-time position, Monday-Friday, • Pay is commensurate with experience, • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Provide strategic leadership for the design, implementation, and continuous improvement of the company's data integrity program across GxP operations supporting clinical and commercial pharmaceutical and combination products. Define and oversee company-wide governance frameworks, policies, and requirements to ensure alignment with global data integrity regulations and ALCOA++ principles. Serve as a cross-functional leader and subject matter expert, partnering across the organization to embed data integrity principles and compliance into systems, processes, and culture. Responsibilities • Lead the development, implementation, and continuous improvement of data integrity policies, procedures, and program elements in alignment with global regulatory requirements., • Establish and oversee data integrity governance programs, partnering cross-functionally to drive strategic initiatives and foster a culture of data integrity., • Develop and maintain systems for data integrity impact assessments, risk evaluations, and remediation plans, ensuring timely completion of commitments., • Evaluate data management, documentation, and record control practices across systems and formats to ensure compliance with data integrity requirements., • Implement and maintain processes to assess computerized systems, software, and equipment for compliance with 21 CFR Part 11, Annex 11, and related guidance., • Lead and oversee comprehensive data integrity audits and assessments to identify risks, gaps, or discrepancies, and lead mitigation and remediation activities., • Drive corrective and preventive actions and process improvement initiatives to strengthen data integrity controls and system reliability., • Develop, analyze, and report data integrity metrics and key performance indicators to senior leadership., • Design and deliver training programs to promote data integrity awareness and ensure consistent understanding across the organization., • Provide subject matter expertise and support during regulatory inspections and partner audits, articulating data integrity program elements and strategy., • Monitor global regulations, emerging guidance, and best practices through active engagement with relevant professional organizations (e.g., ISPE, PDA)., • Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline., • Minimum of ten (10) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including at least five (5) years in a leadership role with increasing responsibility., • Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards., • Demonstrated expertise with ALCOA++ principles, data lifecycle management, and data governance frameworks., • Proven experience applying 21 CFR Part 11, Annex 11, and other relevant regulations and guidance governing data integrity and information security., • Strong understanding of information technology and data management systems, including system validation, security, and enterprise data governance., • Proven ability to lead complex, cross-functional projects and build effective partnerships to advance data integrity and compliance objectives, demonstrating strong organizational, planning, and prioritization skills., • Strategic thinker with demonstrated success in driving continuous improvement, innovation, and proactive risk management., • Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels., • Advanced degree preferred., • Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent). California pay range $180,000—$210,000 USDCalifornia pay range $180,000—$210,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Post-Marketing Product Quality Compliance Manager will oversee post-market product quality activities in compliance with FDA regulations and internal Quality System requirements. This role leads and develops a team responsible for product quality complaints, post-distribution quality monitoring, and the execution of quality-driven field actions, including recalls and market withdrawals. The manager provides strategic direction, coaching, and performance management to ensure timely, compliant, and effective execution of post-market quality processes while fostering a culture of quality and continuous improvement.Responsibilities * Post-Market Surveillance & Data Analysis • Manage the end-to-end product quality complaint process from intake through closure., • Assess complaints for product quality impact, GMP compliance risk, and field action triggers., • Trend and analyze post-market quality data to identify recurring or systemic issues., • Provide Quality oversight of vendors supporting complaint intake or triage., • Ensure accurate, complete, and timely complaint documentation., • Perform initial Quality assessments and ensure appropriate complaint classification., • Escalate potential adverse events to Pharmacovigilance per established procedures., • Escalate critical or high-risk quality issues in a timely manner., • Identify and assess potential recalls, market withdrawals, or corrections., • Lead quality-driven recalls, including regulatory notifications, documentation, and effectiveness checks., • Drive CAPAs resulting from post-market quality issues and verify effectiveness., • Maintain and improve SOPs related to complaints, post-market monitoring, recalls, and vendor oversight., • Oversee Internal Audit program and Inspection Readiness., • Act as a Quality SME during FDA inspections and audits., • Support preparation of inspection responses and supporting documentation related to post-market quality activities.Requirements, • Education: Bachelor’s degree in Life Sciences, Engineering, or a related field (Master’s preferred)., • Professional Experience: Minimum 7 years of experience in Quality within a regulated pharmaceutical, biologics, or cell therapy environment., • Leadership: 2 years of people management experience., • SME Knowledge: Hands-on experience with product complaints, post-market quality surveillance, and recalls or field actions., • External Oversight: Experience overseeing external vendors in a regulated Quality environment., • Regulatory Foundation: Strong knowledge of FDA Quality System and post-market requirements. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Job Description: We are seeking a highly motivated and qualified leader to join our Biostatistics Department as a Senior Biostatistician and work as a team lead to drive success. The Senior Biostatistician will provide strategic and hands-on statistical leadership to support the discovery, development, and clinical advancement of RNA-based therapeutics. This role partners closely with cross-functional teams to design, analyze, and interpret complex data across preclinical and clinical programs, ensuring scientific rigor and regulatory compliance throughout the drug development lifecycle. Key Responsibilities • Lead statistical strategy, study design, and data analysis for RNA-based programs across discovery, preclinical, and/or clinical development., • Develop statistical analysis plans (SAPs), protocols, and supporting documentation in alignment with regulatory expectations., • Provide statistical expertise for dose-finding, PK/PD modeling, biomarker analysis, and translational studies., • Collaborate cross-functionally with Clinical Development, Biometrics, Bioinformatics, Regulatory, and Discovery teams., • Oversee and review statistical outputs from CROs and external partners, ensuring quality and adherence to timelines., • Perform and interpret advanced statistical analyses using appropriate methodologies for high-dimensional and longitudinal data., • Contribute to regulatory submissions, investigator brochures, clinical study reports, and scientific publications., • Communicate statistical results clearly to both technical and non-technical stakeholders. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Remote work is on a case-by-case basis. Qualifications • PhD or MS in Biostatistics, Statistics, Mathematics, or a related quantitative field., • 5+ years of biostatistics experience in the pharmaceutical or biotechnology industry., • Direct experience supporting RNA-based therapeutics (e.g., siRNA, mRNA, antisense oligonucleotides)., • Strong understanding of drug development processes, including preclinical and clinical trial design., • Proficiency in statistical programming and analysis tools (e.g., SAS, R)., • Experience working with CROs and managing outsourced statistical activities., • Knowledge of regulatory guidelines (ICH, FDA, EMA) and submission requirements., • Experience with early-phase clinical trials and translational medicine., • Familiarity with bioinformatics or omics-related data analysis., • Prior involvement in regulatory interactions or submissions., • Must be able to work independently with supervision as needed., • Must be collaborative, work well with other team members in a matrix team environment., • Strong organizational skills with attention to detail and accuracy., • Ability to maintain a high level of confidentiality and exercise discretion., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges., • This is a full-time position, Monday-Friday., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job DescriptionSalary: About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjgrens Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artivas pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cells NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit. Position Summary The Clinical Logistics Manager will oversee the end-to-end management of investigational product (IP) and non-IP clinical drug supply forArtivasAlloNK,off-the-shelf (allogeneic) cell therapy clinical programs. This individual will play a key role in ensuringtimelyand compliant delivery of clinical materials to global trial sites, managinglogisticsvendors, andmaintainingrobust site communication. The role requires close collaboration with Clinical Operations, Quality, CMC, Regulatory Affairs,MaterialsManagementand external partners to support the successful execution of cell therapy clinical trials. Key Responsibilities Clinical Supply & Logistics Management • Manage the full lifecycle of investigational product (IP) and non-IP materials, including forecasting, labeling, packaging, distribution, and returns/reconciliation., • Manage inventory of IP and non-IP materials both internally and externally, • Ensure compliance withGxP, IATA, and country-specific regulations governing cell and gene therapylogistics., • Oversee temperature-controlled shipments and chain-of-custody documentation to ensure product integrity., • Serve as the primarylogisticscontact for clinical sitesregardingproduct availability, shipment tracking, and issue resolution., • Provide training and guidance to clinical sites on handling, storage, and return of IP/non-IP materialsas needed., • Manage relationships and performance of third-partylogistics(3PL), packaging, and labeling vendors., • Support vendor qualification, audits, and oversight in collaboration with Quality and Procurementas needed., • Work closely with Manufacturing teamsand Materials Managementto align supply chain activities with production schedules., • Partner with Clinical Operations to ensure seamless coordination between supplylogisticsand trial execution., • Develop and implement process improvements for inventory management, forecasting, and sitelogisticscoordination., • Contribute to the design of digital tools or dashboards for real-time tracking of shipments and inventory. Qualifications and Experience • Bachelors degree in Life Sciences, Supply Chain Management, Pharmacy, or related fieldrequired; advanced degree preferred., • 5+ years of experience in clinical supply chain,logistics, or clinical operations within the biotech or pharmaceutical industry., • Experience managing IP/non-IPlogisticsfor advanced therapy medicinal products (ATMPs) or biologics preferred., • Proventrack recordof vendor management and oversight of global supply chains., • Strong understanding ofGxP, IATA, GDP, and cold-chain management principles., • Excellent project management and organizational skills., • Strong communicationand stakeholder management abilities across cross-functional teams and clinical sites., • Detail-oriented with the ability to troubleshoot and resolve logistical challenges under tight timelines., • Experiencewith clinical supply management systems (IRT/RTSM, ERP, or equivalent). Why you should apply: We have a fantastic team and philosophy! We are passionate We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit.We are transparent - believers in flat, accessible, and open communication paths.We are inclusive committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: A beautiful facility An entrepreneurial, highly collaborative, and innovative environment Comprehensive benefits, including: • Medical, Dental, and Vision, • Group Life Insurance, • Long Term Disability (LTD), • 401(k) Retirement Plan, • Employee Assistance Program (EAP), • Flexible Spending Account (FSA), • Paid Time Off (PTO), • Company paid holidays, including the year-end holiday week, • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $115,000 - $130,000. Exact compensation may vary based on skills and experience.

Job Description About Capricor Therapeutics Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX™ platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future. About the Role We are seeking a highly skilled Formulation Scientist to join Capricor Therapeutics and drive the development of stable, lyophilized exosome-based formulations for our groundbreaking therapies. In this critical scientific role, you will lead formulation design, optimization, and characterization, ensuring compliance with cGMP and supporting IND-enabling studies. You will collaborate with cross-functional teams, including analytical sciences, process development, and regulatory affairs, to advance our novel exosome-based drug delivery platforms. This role offers a unique opportunity to shape the future of exosome therapeutics, contributing directly to Capricor’s mission to transform the biotech industry and improve lives. Responsibilities Strategic Scientific Leadership • Develop and execute innovative formulation strategies for exosome-based drug products, aligning with Capricor’s mission to deliver transformative therapies for rare diseases, including DMD., • Stay ahead of advancements in exosome, lipid nanoparticle (LNP), and lyophilization technologies, implementing cutting-edge solutions to maintain a competitive edge., • Design and optimize exosome-based formulations for therapeutic modalities (e.g., nucleic acids, proteins, biologics), ensuring stability at 4°ree;C or room temperature for enhanced shelf-life., • Lead lyophilization process development for drug substances (DS) and drug products (DP), optimizing excipients, cryoprotectants, and thermal characterization (e.g., DSC, Freeze-Dry Microscopy) to extend stability., • Develop storage buffers (e.g., LNP-based) to support flexible storage conditions (4°ree;C, room temperature, -20°ree;C) and improve DS/DP integrity., • Perform physicochemical and biophysical characterization using techniques such as DLS, TEM, HPLC, LC-MS, DSC, and fluorescence-based assays to assess formulation performance., • Develop and validate quality control (QC) methods to evaluate stability, particle size, encapsulation efficiency, and biological activity of exosome-based DS/DP., • Collaborate with analytical scientists, process engineers, and regulatory affairs teams to define critical quality attributes (CQAs) and support IND submissions., • Partner with process development to transition formulations from R&D to clinical and commercial scale, ensuring scalability and GMP compliance., • Drive advanced formulation optimization to enhance exosome stability and delivery, leveraging data-driven approaches to meet regulatory and clinical demands., • Monitor and analyze key performance indicators (KPIs) for formulation processes, implementing corrective actions to improve efficiency and reliability., • Stay current with scientific literature and industry trends, contributing to Capricor’s innovation in exosome-based therapeutics. Requirements Minimum Qualifications • Education: Ph.D. in Pharmaceutical Sciences, Biochemistry, Bioengineering, Chemical Engineering, or a related field with 4+ years of biopharmaceutical industry experience; Master’s degree with 6+ years of relevant industry experience considered., • Experience: 4+ years of hands-on experience in biologics or vesicle-based formulation (e.g., exosomes, LNPs, liposomes, mAbs, peptides) in the biopharmaceutical industry., • Lyophilization Expertise: Direct experience with lyophilization process development, including excipient selection, thermal characterization, and cycle optimization for DS/DP stability., • Stability Optimization: Proven expertise in optimizing formulation stability at 4°ree;C or room temperature through forced degradation, real-time, and accelerated stability studies., • Analytical Skills: Proficiency in analytical techniques, including HPLC, LC-MS, DLS, TEM, and DSC, for formulation characterization., • Scientific Leadership: Demonstrated ability to plan and lead initiatives as a hands-on bench scientist in a fast-paced research environment., • Regulatory Knowledge: Strong understanding of cGMP, ICH guidelines, and compliance with 21 CFR Part 1271 and cGTP for injectable formulations., • Skills: Exceptional problem-solving, attention to detail, and communication skills, with a collaborative approach to cross-functional teamwork., • Direct experience with exosome-based therapeutics or vesicle-based systems (e.g., LNPs, liposomes)., • 5+ years of industry experience in biopharmaceutical or regulated environments within GMP or QC settings., • Expertise in GMP manufacturing, scale-up, and technical transfer to CMOs., • Experience authoring CMC sections for IND submissions or supporting regulatory interactions., • Proficiency in data analysis tools (e.g., Microsoft Excel, statistical software) and familiarity with process monitoring techniques., • Strong scientific communication and technical writing skills for reports, publications, and patent filings. Location Policy This position is based in San Diego, CA, with flexibility for occasional remote work as needed. Work Environment/Physical Demands • Physical Requirements: Ability to sit and stand for extended periods, lift/carry laboratory equipment and materials up to 40 pounds, move about the lab, and communicate effectively via telephone or in person. Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry through exosome-based therapeutics, we’d love to hear from you!

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. Capricor is seeking a Manager or Senior Manager of Commercial Logistics to lead the day-to-day operational execution of commercial distribution activities for our growing portfolio. This individual will oversee GxP‑compliant logistics, cold‑chain distribution, serialization and DSCSA processes, and 3PL partnerships that support product launch readiness and ongoing commercial operations. This role is critical as Capricor transitions from clinical-stage to commercial-stage operations and scales its distribution capabilities globally.Responsibilities • Lead daily commercial distribution operations for domestic and international drug product shipments, ensuring product integrity and on-time delivery., • Oversee cold‑chain logistics, including temperature‑controlled packaging, lane qualification, and excursion management., • Manage order fulfillment, shipment visibility/tracking, delivery confirmation, and exception handling processes., • Ensure full compliance with GDP/GxP, FDA/ICH guidelines, and internal SOPs., • Manage all commercial packaging components, including storage, issuance, staging, reconciliation, and pack-out readiness., • Partner with Manufacturing, Quality, packaging vendors, and 3PLs to ensure compliant and timely pack-out operations., • 3PL & External Vendor Oversight, • Serve as primary operational lead for 3PLs, couriers, and commercial distribution partners., • Monitor partner performance (KPIs, QBRs, service levels), escalate operational issues, and ensure adherence to contractual commitments., • Own serialization and DSCSA processes across packaging, distribution, and trading partners, including EPCIS data flow oversight., • Lead investigations and remediation for serialization issues, EPCIS failures, and DSCSA compliance gaps., • Support route‑to‑market design, depot setup, packaging/labeling logistics, and readiness activities for U.S. and global launches., • Build scalable processes to support new indications, increased commercial volumes, and geographic expansion., • Maintain GDP‑compliant records including temperature logs, shipping documentation, investigations, and change controls., • Support Quality in audits, inspections, and lot‑release logistics., • Analyze logistics and serialization performance metrics to identify improvement opportunities., • Education: Bachelor’s degree in Supply Chain, Business, Life Sciences, Engineering, or related field., • Experience: 6+ years pharmaceutical/biotech logistics and distribution experience, including cold‑chain operations and GxP/GDP compliance., • Technical Expertise: Hands‑on expertise in serialization and DSCSA (EPCIS, aggregation, product identifiers)., • Vendor Management: Proven experience managing 3PLs and commercial distribution centers., • Systems: ERP experience (NetSuite, SAP, Oracle) with distribution, inventory, or order management workflows., • Skills: Strong analytical, communication, cross‑functional collaboration, and problem‑solving skills.Preferred Qualifications, • Experience: Supporting commercial product launches in pharma/biotech., • Knowledge: Cell therapy, gene therapy, or complex biologics distribution., • Familiarity: Import/export, global distribution, and customs processes., • Certification: Project management certification or experience (e.g., PMP). Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. Capricor is looking for a Senior Director of Pharmacovigilance with deep expertise within biotechnology, ideally in rare diseases or cell therapies. This role will play a pivotal part in building the pharmacovigilance function as we advance our lead programs following recent clinical milestones. This individual will ensure high-quality, compliant safety processes, oversee vendors and safety surveillance, and facilitate rapid communication of safety concerns. This new headcount position supports our major milestone of positive Phase 3 results and continued advancement of deramiocel.Responsibilities • Design, implement, and manage a robust, compliant, and scalable global pharmacovigilance system, including policies, procedures, and infrastructure suitable for cellular therapy products., • Develop and lead pharmacovigilance activities essential for program progression, including creation of the Risk Management Plan (RMP), Pharmacovigilance System Master File (PSMF), and required safety labeling sections., • Select, onboard, and oversee pharmacovigilance operations vendors and safety database providers to ensure high-quality case management, reporting, and regulatory compliance., • Direct and execute global safety surveillance activities, including monitoring, evaluation, and interpretation of safety data from various sources such as spontaneous reports, literature, and post-approval studies., • Lead signal detection and management processes, ensuring periodic review and updates to the RMP and PSMF., • Oversee and review aggregate safety reports (e.g., PSURs/PBRERs, DSURs) for submission to global health authorities., • Serve as the pharmacovigilance lead during health authority inspections (e.g., FDA, EMA) and internal audits., • Collaborate closely with Regulatory Affairs on submissions and labeling, with Clinical Operations/Development for seamless safety transitions, and with Commercial and Medical Affairs teams to provide expertise and training on safety reporting., • Chair and lead the internal Safety Review Team (SRT) for ongoing evaluation of product benefit-risk profiles., • Interface with vendors such as PPD and Syneos, clinical trial teams, CMO, and commercial partners to prepare safety documentation and oversee post-marketing clinical safety surveillance., • Work cross-functionally to drive business impact, team success, and continuous improvement in pharmacovigilance operations., • Monitor emerging safety data, regulatory trends, and therapeutic advancements in rare diseases and biologics to inform strategy., • Perform such other duties as may be assigned from time to time.Requirements, • Bachelor's degree in a health science field (MD, PharmD, PhD, or equivalent preferred)., • Minimum of 8+ years of progressive experience in Pharmacovigilance/Drug Safety within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or management role., • Mandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU markets., • Deep understanding of global PV regulations, guidelines, and ICH standards (e.g., FDA, EMA, MHRA, and other major health authority requirements)., • Proven experience in establishing or significantly contributing to the implementation of a validated safety database and PV quality management system., • Exceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholders., • Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines., • Ability to work independently, multi-task, and meet aggressive deadlines in a fast-paced, resource-constrained environment., • Willingness to travel up to 20-30% for inspections, meetings, and collaborations., • Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)., • Equivalent combination of education and experience may be considered.Preferred Qualifications, • Experience with cellular or gene therapy products, or other complex biologics/rare diseases., • Ability to transition between strategic planning and hands-on operational execution in a small biotech environment., • Demonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory compliance.Work Environment & Physical Demands, • Professional office environment (San Diego, CA) or remote work setup with standard business hours, subject to flexibility for global interactions., • Ability to sit for extended periods during virtual or in-person meetings and computer work. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionJob Summary: We are seeking a skilled and versatile technical Project Manager to lead cross-functional teams in the execution of customer projects, customer production demand, and internal infrastructure initiatives. The ideal candidate will have a strong background in project management within the life sciences and/or diagnostics sector, with proven experience driving projects from concept through completion in a regulated environment. This role will collaborate with R&D, Manufacturing, Quality, IT, and external partners to ensure projects are delivered on time, within scope, and in compliance with quality and regulatory standards. Key Responsibilities: • Lead planning, execution, and delivery of Life-Sciences based development projects, customer project schedules, and internal infrastructure improvements, • Develop and drive detailed project plans, timelines, budgets, and resource allocations; monitor progress against milestones and adjust as needed, • Coordinate cross-functional teams, including customers, R&D, Manufacturing, Quality, and contractors in order to achieve project objectives, • Manage stakeholder communications, including regular status updates, risk assessments, action tracking, and issue resolution, • Advocate for customer project and product demand, • Facilitate project meetings, workshops, customer progress reviews, and internal progress reviews, • Working closely with stakeholders, ensure compliance with customer requirements, regulatory requirements, and company quality systems, • Identify, assess, and mitigate project risks; drive implementation of corrective actions as needed, • Oversee project documentation, including requirements, protocols, validation plans, and technical reports, • Support change management and training initiatives for new processes and systems, • Drive continuous improvement in project management practices and operational efficiencyRequired Skills & Qualifications:, • Bachelor’s degree or advanced degree in life sciences, engineering, business, or related field, • 3+ years of project management experience in biotech, diagnostics, pharmaceutical, or medical device industry, • Project Management Professional (PMP) certification or equivalent preferred, • Experience managing projects in a regulated environment (e.g., ISO13485, FDA), • Strong knowledge of formulation, filling, assembly, final kitting, and distribution in a consumables based manufacturing environment, • Strong knowledge of project management methodologies (Agile, Waterfall, etc.) and tools (e.g., MS Project, Smartsheet), • Excellent problem-solving, analytical, and organizational skills, • Proven ability to communicate effectively with technical and non-technical stakeholders at all levels, • Demonstrated leadership in cross-functional team environments, • Experience with resource management, budget tracking, and issue resolution

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring an experienced Validation Engineer to support equipment, process, software, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP, Annex 11, and global regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance. • Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems., • Generate and execute validation documentation for manufacturing equipment, utilities, and computerized systems in accordance with cGMP, GxP, and Annex 11 requirements., • Support CQV activities for sterile injectable manufacturing equipment and site utilities, ensuring seamless integration and qualification., • Lead CSV efforts, including risk assessments, validation plans, and test scripts for computerized systems to maintain data integrity., • Validate and qualify various equipment and utilities i.e Depyrogenation Ovens, • Troubleshoot and resolve issues related to validated equipment, processes, and systems; implement CAPA as needed., • Maintain accurate validation documentation and ensure audit readiness., • Additional responsibilities as assigned to drive project success. Requirements • Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences., • 4–5 years of validation experience within pharmaceutical, biotech, or medical device industries., • Strong knowledge of CSV and CQV principles, including regulatory expectations for sterile injectable manufacturing., • Familiarity with Annex 11, data integrity requirements, and industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations., • Experience with equipment, cleanroom systems, HVAC, purified water, compressed air, and other critical utilities., • Proficiency in writing and executing IQ/OQ/PQ protocols, validation reports, and computerized system validation documentation., • Strong analytical and problem-solving skills., • Excellent written and verbal communication abilities., • Strong time management and organizational skills., • Detail-oriented mindset with a commitment to maintaining high-quality standards., • Must be authorized to work in the US., • No C2C at this time. BenefitsW2 Temp positions include our medical and sick time benefits Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $90,000 to $125,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

Job Description Job Description: We are seeking an experienced, collaborative, and strategic physician leader with deep expertise in obesity and metabolic disease clinical development to help build and execute the clinical vision for the Company’s portfolio. This role will be responsible for defining and driving clinical strategies across early- and late-stage development programs, with a particular focus on obesity, cardiometabolic, and related metabolic indications. The Senior Director, Clinical Development (MD) will play a critical leadership role in advancing innovative therapies through the clinic, combining scientific rigor, regulatory insight, and operational excellence. The ideal candidate brings a strong track record of leading obesity and metabolic clinical trials, working cross-functionally, and delivering high-quality clinical outcomes in a fast-paced biotech environment. Essential Responsibilities: Clinical Strategy & Leadership • Lead the development and execution of clinical development strategies for obesity and metabolic disease programs across multiple stages of development., • Provide medical and scientific leadership for clinical trial design, execution, and interpretation, including endpoint selection, patient populations, safety monitoring, and benefit–risk assessments., • Serve as the primary medical expert for obesity/metabolic programs, advising internal teams, investigators, consultants, business development partners, and investors., • Champion clinical excellence and accountability across all assigned programs., • Define clinical priorities and oversee the development of protocols, amendments, and integrated development plans tailored to obesity and metabolic indications., • Ensure delivery of high-quality clinical study outputs on time and within budget., • Act as the primary medical point of contact for regulatory agencies for assigned programs., • Partner closely with Regulatory Affairs, Clinical Operations, Program Management, CMC, and other functions to ensure alignment and execution., • Lead preparation, review, and contribution to key regulatory documents, including IND submissions, investigator brochures, clinical study reports, and regulatory briefing packages., • Participate in and support FDA/EMA meetings and regulatory interactions related to obesity and metabolic disease development., • Establish and maintain strong working relationships across clinical operations, regulatory, biostatistics, translational science, safety, and commercial teams., • Build and maintain relationships with key external stakeholders, including key opinion leaders in obesity and metabolic disease, investigators, consultants, and patient advocacy organizations. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • Medical Degree (MD)., • Minimum 8+ years’ experience in leading clinical studies within the biotech/pharmaceutical industry., • Experience leading studies for obesity or metabolic disease in the pharma industry, • Minimum 5 years of leadership experience with excellent line management skills., • Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills., • A proven track-record of leading clinical trials at all stages., • Expertise in the areas of drug development, clinical operations and strategic planning., • Expertise in scientific and clinical data review and interpretation, including in-depth analysis and presentation of data from strategic perspectives, • Expertise with SOPs, GCP, ICH guidelines, regulatory compliance requirements, and risk mitigation strategies., • Experience with FDA/EMA processes (IND filing, NDA filings)., • Board certification in Endocrinology, Diabetes, Metabolism or similar discipline, • Experience in operations management within a clinical research setting., • Strong leadership skills with the ability to work in a dynamic, fast-paced environment., • Strong understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Attention to detail while discriminating between critical and non-critical activities and to follow established processes., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday, occasionally overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information.

Job DescriptionCompany Description CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. Job Description We are seeking a Lead Architect to drive design excellence and technical innovation across diverse project types. This role requires leadership in all phases of design—from concept through construction administration—while ensuring compliance with building codes and regulatory standards. The Lead Architect will collaborate with multidisciplinary teams, manage complex priorities, and serve as the primary architectural contact for clients, internal teams, and construction partners. Key Responsibilities • Lead and execute all phases of design: programming, planning, concept development, detailed design, and construction administration., • Produce advanced design documentation, including code analyses, life safety plans, floor plans, sections, elevations, details, schedules, and specifications for large-scale projects., • Develop studies, presentations, and reports for internal and external stakeholders., • Apply International Building Code and other regulatory requirements throughout project delivery., • Coordinate closely with engineering and construction teams to ensure constructible, integrated designs., • Oversee quality reviews, coordination meetings, and technical verification of design documents., • Support construction activities, including RFIs, submittal reviews, and progress reporting., • Assist project managers with resource planning, budgeting, scheduling, and deliverable quality., • Mentor architectural staff and act as Architect of Record for assigned projects., • Resolve complex design, code, and construction challenges.Qualifications Minimum Qualifications • Accredited professional degree in Architecture (B.Arch, M.Arch, or D.Arch) or international equivalent., • Architectural license in good standing and NCARB certification., • 15+ years of professional experience in an AEC firm., • Proficiency in Revit and Microsoft Office Suite., • Deep knowledge of International Building Codes, OSHA regulations, and ADA standards., • Strong leadership and client-focused approach., • Ability to travel moderately for projects or training., • Exceptional communication and presentation skills., • Successful track record of cross-discipline project coordination., • LEED, WELL, or similar sustainability accreditation., • Experience in CRB’s core markets: R&D labs, biotechnology, pharmaceutical, food & nutrition, consumer products, and international projects. #LI-JV1 #LI-HYBRID Additional Information All your information will be kept confidential according to EEO guidelines. CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening. CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails. CRB offers a complete and competitive benefit package designed to meet individual and family needs. If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Job DescriptionDescription: *This is a 9 to 10 month temporary in-person position, with an expectation of 5 days in-office per week. * Company Overview: Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space. We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression. Vividion has been recognized as a Top Workplace by The San Diego Union-Tribune from 2022 to 2025. Job Summary: Vividion Therapeutics, Inc. is seeking an experienced Accounting Manager to provide temporary backfill for an established Accounting Manager position during a defined period in 2026. Reporting to the Controller, this role will support a high-growth biotechnology environment by maintaining continuity across core monthly close responsibilities and advancing two defined 2026 accounting initiatives. This is a hands-on Accounting Manager role that owns core general ledger responsibilities, with a primary focus on monthly close execution and nonclinical and preclinical accounting. The role requires a senior accounting professional who can assume ownership of in-flight work, operate within established processes and controls, and deliver accurate, timely results with minimal ramp time. While the primary focus is execution and continuity, practical efficiencies identified through day-to-day ownership may be implemented where appropriate and aligned with existing frameworks. Success in this role will be measured by maintaining close quality and timelines, ensuring progress on defined initiatives without disruption, and providing clear documentation and handoff at the conclusion of the assignment. Requirements: Essential Duties and Key Responsibilities: Nonclinical & Preclinical Accounting Ownership • Own accounting for nonclinical and preclinical activities, including progress to completion methodologies, accrual models, and project level reporting cadence., • Prepare, maintain, and standardize complex accounting schedules; review staff prepared models for accuracy, scalability, and audit readiness., • Own month end close activities for assigned areas, including journal entry preparation, reconciliations, and close related analyses., • Review nonclinical and preclinical schedules and entries to ensure completeness, accuracy, and appropriate application of accounting judgment., • Lead accounting participation in the ongoing ERP implementation, including requirements definition, data mapping, data conversion, UAT, reporting validation, and post go live stabilization—ensuring decisions preserve and improve monthly close ownership for the function long term., • Own record to report fixed asset accounting, including asset additions, disposals, transfers, impairments, and depreciation., • Maintain and reconcile the fixed asset subledger, ensuring accuracy, completeness, and alignment with general ledger balances., • Lead the completion of the company’s fixed asset inventory, building on work already underway, by designing final audit procedures, defining documentation standards, and coordinating execution in partnership with the Facilities team., • Review inventory results, investigate and resolve discrepancies, and ensure appropriate capitalization, retirement, or impairment treatment., • Prepare variance analyses and financial reporting packages, providing insight into key drivers, risks, and process performance., • Identify and implement opportunities for process improvement, automation, and standardization—particularly within Excel based models—while preserving logic, controls, and auditability., • Operate within a parent company aligned internal control framework and support audit and compliance activities as needed. Required • 6+ years of combined public accounting and industry experience within biotechnology, pharmaceutical, or medical device environments; Big 4 experience preferred., • Bachelor’s degree in Accounting or Finance; CPA preferred., • Demonstrated ability to apply technical accounting guidance (GAAP/IFRS) to complex, life science specific transactions with sound judgment., • Advanced Excel proficiency, including ownership of complex, logic driven accounting schedules., • Strong organizational, analytical, and communication skills with the ability to partner effectively across Accounting, FP&A, Procurement, IT, Facilities, and scientific teams., • Proven success driving accounting process improvements and accelerating close and reporting cycles., • Experience developing policies, SOPs, and standardized models that support scalable, well controlled operations. The anticipated hourly pay for this temporary role ranges from $60.00 to $70.00 depending on relevant skills, competencies, experience, and education. EEO & Employment Eligibility: Vividion Therapeutics, Inc. is an equal opportunity employer. All applicants will receive consideration for employment without regard to disability or veteran status. Privacy Policy: The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit .

Job Description A healthcare facility in Chula Vista, CA seeks a licensed Pharmacist for a 4-week contract role with immediate start. This position offers the opportunity to work a 2nd shift schedule from 2:30 p.m. to 11 p.m., including rotating weekends. The contract nature allows candidates interested in short-term assignments to gain valuable experience in a dynamic environment. Key Responsibilities: • Accept and dispense prescription medications accurately and efficiently., • Monitor patient medication compliance and identify over-usage patterns., • Ensure legal compliance regarding medicines supply and proper medication suitability., • Maintain confidential patient records and pharmacy files with accuracy., • Provide patient consultations on medication usage, side effects, drug interactions, and storage., • Offer additional patient services such as smoking cessation programs, blood pressure measurement, and cholesterol management., • Educate patients on the proper use of medical devices like blood pressure monitors and glucose meters., • Compound medications and prepare sterile solutions adhering to safety standards., • Supervise pharmacy staff including technicians and clerks., • Manage inventory of pharmaceutical and medical supplies., • Current California Pharmacist license in-hand., • Experience in retail pharmacy is acceptable; training will be provided for candidates new to the role., • 2nd Shift: 2:30 p.m. 11:00 p.m. Apply now to accelerate your pharmacy career with this focused contract opportunity. Compensation for this position ranges from $61.00 to $76.00. Eligible candidates may also receive healthcare benefits, housing, and meals/incidentals. Full details of our healthcare benefits plan can be found here. This posting is open for 60 days after the posting date.

Job Description Job Description: The Principal Scientist, Toxicology will provide scientific and operational leadership for non-clinical toxicology activities supporting drug discovery and development programs. This role is responsible for the strategic design, execution, oversight, interpretation, and reporting of outsourced GLP and non-GLP toxicology and related nonclinical studies to support global regulatory submissions. Essential Responsibilities: Study Monitoring & Nonclinical Oversight • Serve as Study Monitor with responsibility for oversight of all phases of outsourced GLP and non-GLP studies, including study enabling activities, study setup, protocol development, on-site monitoring of study conduct at CRO sites, and review of data and reports., • Provide scientific guidance, feedback, and directives to Study Directors and non-clinical sub-team members, including coordination of:, • CMC/Formulation planning to support study requirements, including manufacture, release testing, and shipping, • Sample shipping and logistics in collaboration with Operations, • Study timeline development in partnership with Project Management, • Maintain GLP compliance for all aspects of GLP studies and ensure adherence to internal SOPs and regulatory expectations., • Archive final study reports and associated data in IQVIA in accordance with regulatory and company requirements., • Collaborate closely with multidisciplinary drug discovery and development teams including CMC, Clinical, Regulatory Affairs, Pharmacokinetics, Bioanalytical, and Project Management., • Interface with drug safety team leads and represent toxicology as the primary point of accountability for the design, execution, data interpretation, and reporting of in vivo toxicokinetic (TK), tolerability, and investigative studies., • Develop protocols, procedures, data templates, and report templates for non-GLP studies and ensure submission-ready study reports to support advancement of drug candidates., • Contribute to and/or author nonclinical sections of global regulatory filings, including Pharmacology, PK, and Toxicology sections for INDs, NDAs, Marketing Applications, and regulatory briefing documents., • Oversee and manage CRO performance, timelines, budgets, and deliverables to ensure high-quality outcomes., • Contribute to budget estimates for nonclinical studies and ensure actual costs remain aligned with projected budgets on a quarterly and annual basis. Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: • PhD in Toxicology, Pharmacology, or a related life science discipline (DVM or equivalent may be considered), • 8+ years of relevant experience in pharmaceutical or biotechnology drug development, with demonstrated leadership in nonclinical toxicology, • Extensive experience overseeing outsourced GLP and non-GLP toxicology studies, • Direct experience supporting IND and later-stage regulatory submissions, • Strong knowledge of global nonclinical regulatory requirements (FDA, EMA, ICH), • Proven ability to lead cross-functional teams and manage external vendors, • Excellent scientific writing, communication, and presentation skills, • Must be able to work independently as well in cross-functional team settings with supervision as needed., • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism., • Self-motivated with excellent interpersonal, organizational and communication skills with the ability to take a hands-on approach to work effectively in a dynamic and collaborative, fast-paced environment., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • This is a full-time position, Monday-Friday, occasional overtime., • Pay is commensurate with experience., • Equity-based compensation, • Performance-based bonuses, • 401(k) with Company Match, • Medical, Dental, Vision, • Flexible Spending Account, • Life Insurance, • Employee Assistance Program, • Employee Discounts, • Gym Membership, • Paid Vacation, • Paid Holidays, • United States (Required), • Background Check, • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of renowned VC firms. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement: • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position., • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations., • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law., • Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses., • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Job DescriptionThe Clinical Trial Manager will play a pivotal role in the strategic implementation and execution of clinical trials from study start-up to close-out. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs., • Ensure inspection readiness by maintaining comprehensive study documentation and files., • Organize and lead study and departmental meetings, including minute-taking and document archiving., • Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings)., • Ensure team compliance with study-specific training and perform TMF reviews for completeness., • Support clinical sites in audit and inspection preparation., • Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements., • Monitor subject and site activity/metrics and perform quality checks across study components., • Proactively identify, troubleshoot, and escalate issues impacting deliverables., • Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation., • Collaborate with CROs to ensure timely collection and archiving of TMF documents., • Partner with regulatory affairs on essential document submissions., • Support study close-out activities including TMF and drug reconciliation and CSR readiness., • Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads., • Participate in process improvement and quality initiatives related to study execution., • Other duties as deemed necessary.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor’s degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered., • Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out., • Global clinical trial management experience, especially in the EU, highly desirable., • Strong working knowledge of ICH/GCP regulations., • Proficiency with electronic systems such as eTMF, CTMS, EDC, etc., • Ability to work independently and thrive in a collaborative team environment., • Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset., • Excellent interpersonal, written, and verbal communication skills., • Proficiency in MS Office and comfort with technology. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Job Summary: The Regulatory Manager will support and execute the planning, preparation, and submission of regulatory documents to global health authorities. In this role, you will support regulatory project planning, timelines, communications, and ensure successful regulatory submissions and deliverables on time. You will help maintain the internal systems and processes that enable efficient regulatory execution. This position is ideal for someone who thrives in a fast-paced, collaborative biotech environment and wants to contribute directly to bringing innovative therapies to patients. Key Responsibilities: • Manage submission timelines and coordinate document deadlines across Regulatory, Clinical, CMC, Nonclinical, and Quality functions, • Prepare, review, format, and publish high quality regulatory documents (e.g., IND/CTA, amendments, DSURs, meeting packages, eCTD modules) for FDA and other global regulatory agencies, • Manage project communication and stakeholder expectations, providing transparent status updates and risk identification, • Experience or familiarity with eCTD publishing systems and document management platforms (e.g., Veeva Vault, Egnyte, SharePoint), • Conduct technical quality checks, bookmarking, hyperlinking, and ensuring compliance with eCTD and regional requirements, • Maintain submission archives and lifecycle management in accordance with regulatory guidance and internal SOPs, • Track agency correspondence and commitments; assist in preparing responses to health authority requests, • Support development and continuous improvement of regulatory processes, templates, and standards, • Assist with regulatory intelligence monitoring, • Support regulatory authority interactions, • Bachelor's or higher degree in a scientific discipline, • Minimum of 5 years of experience in regulatory operations, regulatory affairs, or eCTD publishing within the biotech/pharmaceutical industry, • Strong attention to detail, organizational skills, and ability to manage multiple tasks under tight timelines, • Excellent written and verbal communication and interpersonal skills, • Experience in a small or early-stage biotech environment, • Strong knowledge of global investigational submission standards and processes (eCTD, FDA/EMA requirements, ICH guidelines), • Familiarity with regulatory publishing tools (e.g., Lorenz DocuBridge, Veeva RIM, GlobalSubmit, eCTDmanager) and document management systems We offer a competitive total compensation package, as well as working in a supportive team environment. The anticipated salary range for candidates is $138,000- $148,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Contineum offers competitive compensation and benefits, including: • 90% employer-covered benefits, • Flexible PTO, • A very generous holiday schedule that includes a week off in August and time off around the winter holidays, • A well-stocked kitchen with snacks and beverages, • Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match., • The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Job DescriptionCompany Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description THE POSITION: Medical Information is a critically important customer-facing function that supports the safe and effective use of pharmaceutical company products by providing timely, scientifically balanced, evidence based, nonpromotional information in response to unsolicited requests from healthcare professionals, patients, caregivers, and payers. Medical Information also plays an important role in post-marketing handling of adverse events and product complaints. As part of the Medical Information Contact Center (MICC) team, this position delivers industry-leading services, which include Contact Center staffing for responding to product information requests, identifying and handling of adverse events and/or product quality issues, and medical writing as needed to generate written response for use in response to medical questions received. This position requires clinical and therapeutic knowledge, critical and analytical thinking, and customer/patient-centric approach. Medical Information Specialists typically support multiple pharmaceutical clients, multiple products, and multiple therapeutic areas. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: MEDICAL INFORMATION SUPPORT • Respond to medical information inquiries from physicians, pharmacists, nurses, and other health care professionals, consumers, and payers. Utilize medical information skills to identify, research, and critically evaluate medical literature to create responses to medical information inquiries., • Utilize writing skills for adverse event and product complaint narrative during intake as well as medical inquiry custom responses., • Handle requests across multiple channels and platforms (phone, email, CRM, chat, etc.), • Identify adverse events and product complaints during interactions with customers. Perform intake sufficient to generate adverse event and product complaint reports in compliance with EVERSANA-MICC and client standard operating procedures. Knowledge of FDA’s postmarketing adverse event reporting regulations and safety terminology. Ability to make accurate assessments regarding what information needs to be obtained and level or depth of information to be collected., • Coordinate processes necessary for responding to product quality-related complaints. This process may involve interactions with personnel in the following departments: Quality Assurance, Regulatory Affairs, and the complainant., • Maintain product, therapeutic area, and client specific requirements knowledge., • Ensure good documentation, high quality, and excellent customer service., • Medical writing and Medical Information content development. Provide medical writing to assist in drafting of Medical Information response documents [FAQs, Scientific Response Documents (SRDs), Custom Response Documents (CRDs)] and/or work collaboratively with medical writing team to develop these materials.  Staffing at scientific medical affairs booths., • On-call responsibilities on an as assigned basis. EXPECTATIONS OF THE JOB: • Metrics: Maintain and contribute toward process improvement which positively impacts metrics associated with activities of the Medical Communications l Contact Center; metrics are subject to change annually or more often as deemed necessary., • Customer Services: Maintain and improve customer services associated with activity of the Medical Communications Contact Center., • Hours: Able to work full time and be flexible with work scheduling as required by clients and management. An individual in this position must be able to successfully perform the expectations listed above. Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. • Education: Advanced healthcare degree (preferred PharmD or higher)., • Education: Advanced healthcare degree (preferred PharmD or higher)., • Licensure: Pharmacist license., • Experience and/or Training: Experiences in a Contact Center and Pharmaceutical industry environment., • Technology/Equipment: Technology proficiency in the areas of telephony, Medical Information database, Microsoft Office, and video conference platforms., • Knowledge: Therapeutic expertise. Ability to critically evaluate medical literature. Medical Information contact center systems and processes., • Experience in Drug Information or a specialty area, particularly in Oncology, Hematology, Immunology, rare disease, Neurology, Cardiology, or other specialty., • Positive Attitude and Energy: Exhibits an upbeat attitude, a genuine interest in others and a sense of humor. Energizes others and heightens morale through her/his attitude., • Communication Skills: Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate., • Innovator: Transforms creative ideas into original solutions that positively impact the company’s performance. The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Additional Information OUR CULTURAL BELIEFS: Patient Minded I act with the patient’s best interest in mind. Client Delight I own every client experience and its impact on results. Take Action I am empowered and empower others to act now. Grow Talent I own my development and invest in the development of others. Win Together I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters I speak up to create transparent, thoughtful and timely dialogue. Embrace Diversity I create an environment of awareness and respect. Always Innovate I am bold and creative in everything I do. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter

Job DescriptionCompany Description At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description The Virtual Field Representative will be responsible for the commercialization of Vertex Pharmaceuticals therapies via teleconference and/or telephone to selected health care offices and providers. They will provide impactful key clinical information and educational materials as part of their remote engagements. VFRs will need to be flexible regarding job responsibilities as they will include a variety of tasks: white space coverage, vacant territory coverage, as well as partnering with Vertex employees to ensure stakeholder needs are addressed. The VFR will create positive virtual interactions and foster appropriate growth for Client’s products. Additionally, they will possess excellent customer service skills and have polished marketing and commercial acumen to meaningfully engage current office stakeholders and develop trusting healthcare provider relationships within those offices. Those skill sets will also be needed to explain the features of assigned products as well as addressing questions and concerns to ensure appropriate therapeutic use. Furthermore, they will possess the ability to learn and communicate on complex medical topics, industry compliance guidelines, Vertex programs, pharmacy, and insurance landscapes. EVERSANA Deployment Solutions offers our VFRs competitive hourly compensation, lucrative bonus potential, paid time off, company paid holidays, excellent training, employee development programs, 401-k plan with an employer match, and an incredible list of comprehensive employer benefits that includes medical, dental, and vision insurance along with a whole host of other valuable programs. ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: • Complete assigned disease state and product training, upon approval, within required timeframes to set the standard s, developing a comprehensive understanding of the market, disease state, clinical information, and core selling messages, • Deliver review committee approved, education-focused messages, as well as the assigned therapeutics area disease-state information to selected HCPs., • Partner with existing Vertex employees to build and execute business plans., • Enhance HCP awareness of Vertex Pharmaceuticals products and clinical data. Equip HCPs with appropriate tools to facilitate a robust clinical conversation, enabling them to teach their patients about the assigned therapeutic area., • Build HCP trust, knowledge, and confidence in identifying possible treatment gaps in appropriate patient groups., • Increase awareness of the assigned therapeutic area and empower HCPs to identify treatment gaps in diagnosed patients., • Expected to achieve call activity and adherence goals; as well as brand performance objectives set forth by the Client, • Ensure that sample and literature requests are generated accurately and perform appropriate follow up and investigation on product shipments as needed, • Maintain database entries on targeted customer calls including attempts, product discussions, literature requests, and sample requests, • Provide feedback and recommendations to team leadership on areas and opportunities for improvement, • Comply with all company, PDMA, compliance and regulatory policies and guidelines, • Work independently from "remote" home office, • Cultivate assigned virtual territory & be accountable for measurable results, • All other duties as assigned #LI-CG1 Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required. • Bachelor's degree from an accredited college or university, • 2 + years sales experience in an outbound Virtual/Tele-sales or field sales role preferably with a healthcare or pharma emphasis, • Pain experience is preferred, • Launch experience is a plus, • Strong sales aptitude on a highly competitive markets, documented sales results, and a rich understanding of the total office call, • Proficiency in Microsoft Office software especially Word, Excel and Outlook required with the and ability to learn new software as needed, • Excellent communication & rapport building skills, • Ability to learn complex medical topics, adhere to established compliance guidelines, patient assistance programs, pharmacy and insurance/market access landscapes, • Aptitude and confidence to converse with physicians, as well as all levels of medical office staff, • Stable internet connection adequate to support voice over VoIP calls and virtual call platforms Additional Information Patient Minded - I act with the patient’s best interest in mind. Client Delight - I own every client experience and its impact on results. Take Action - I am empowered and hold myself accountable. Grow Talent - I own my development and invest in the development of others. Win Together - I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters - I speak up to create transparent, thoughtful and timely dialogue. Embrace Diversity - I create an environment of awareness and respect.. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at . Follow us on LinkedIn | Twitter