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Job DescriptionVTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that computerized systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and execution of validation protocols, risk assessments, and documentation to support the lifecycle of cGxP systems. RESPONSIBILITIES: • Authoring and Executing Software Test Protocols., • Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ) with Final Report., • Scheduling and execution of qualification activities, • Qualification data collection and analysis against acceptance criteria., • Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications., • Software Design Specification drafting and review., • Documentation generation and updates (SOPs, PFMEA, Forms, etc.), • Meeting attendance and project coordination., • Provide all services in accordance with FDA cGxP guidelines and regulations.QUALIFICATIONS:, • Bachelor's degree or higher in Engineering, Life Sciences, or related discipline., • 5+ years of relevant FDA-regulated industry experience., • Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5., • Familiarity with Python and Test Scripts., • 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation., • Must have experience working in an FDA-regulated environment., • Experience with Automation Equipment such as HMI's, Robotized Manufacturing Systems and Vision Sensors. Experience in manufacturing and testing of Medical Devices., • Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc., • Exceptional technical writing, review and analytical skills. VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. Powered by JazzHR OQZgGR6YKe

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Position: Business Development Director Location: Onsite - San Diego, California Position Type: 5 days Onsite Exempt Position Salary Range: $100,000-$200,000 Job Summary: We are seeking an experienced and strategic Business Development Director to drive growth, partnerships, and revenue expansion within the biotechnology industry. This role is responsible for identifying new business opportunities, cultivating relationships with key stakeholders, and leading strategic initiatives to enhance market presence. The ideal candidate will have a strong background in biotech, life sciences, or pharmaceuticals, along with expertise in strategic partnerships, licensing, and market expansion. Key Responsibilities: • Strategic Planning & Commercialization, • Develop and execute business strategies aligned with corporate objectives., • Lead full business cycles, including market entry, product expansion, and transformation during decline phases., • Implement pricing strategies, optimize channel mix, and allocate resources to balance short-term profitability with long-term growth., • Example: Created a 3-year growth roadmap that elevated market share from Top 5 to Top 2., • Team Leadership & Organizational Development, • Build and restructure medium-to-large teams, ensuring a strong talent pipeline., • Lead teams through cultural and structural mechanisms rather than direct authority., • Revitalize legacy teams to drive engagement and prevent stagnation., • Example: Transformed a commission-based sales team into a triad model (sales + solution + delivery), increasing efficiency by 50%., • Resource Integration & Ecosystem Building, • Establish and manage strategic partnerships across industries and regions, including government relations, supply chain alliances, and capital partnerships., • Design win-win partnership frameworks to enhance business growth., • Leverage external opportunities such as policy incentives, industry expos, and media PR., • Example: Partnered with industry associations to establish standards, making the company’s product a recommended industry solution., • Data-Driven Operations & Risk Management, • Utilize financial models (e.g., LTV, CAC) to optimize business performance., • Build and implement business health metrics, including cash flow alerts and inventory turnover strategies., • Identify and mitigate risks related to channel arbitrage, over-reliance on key clients, and compliance challenges., • Example: Implemented a dynamic pricing system to stabilize gross margins amid raw material price fluctuations., • Change Leadership & Crisis Management, • Navigate industry disruptions, such as regulatory shifts and technological obsolescence, leading successful transformations., • Manage enterprise-level crises, including brand reputation issues and executive departures., • Build team consensus through town halls, incentive realignment, and agile decision-making., • Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Business Administration, or a related field. An MBA or Ph.D. is a plus., • 10+ years of business development experience in the biotech, pharmaceutical, or life sciences industry., • Proven track record in strategic partnerships, licensing, and deal negotiations., • Strong network and relationships within the biotech and life sciences sector., • Excellent communication, negotiation, and leadership skills., • Ability to analyze market trends, competitive landscapes, and financial data to drive business decisions., • Medical Insurance Plan, • Retirement Plan, • Paid Time Off, • Training & Development

Job Description ACROBiosystems is a worldwide leader in developing and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone company in the life science and healthcare industry. We value the fast growth in a global market over a challenging time by excelling through quality, performance, and innovation, empowering our employees with trust, value, and respect, embracing diversity, and encouraging cross-functional collaboration and continuous learning. Job Summary The Regional Marketing Manager will develop, execute, and monitor local marketing strategies across the US region with a focus on local event strategies to optimize marketing event activities and raise company awareness, managing offline events throughout the entire of their life cycle. The manager must be able to gain a thorough understanding of our products and services, work with a multitude of stakeholders and represent ACROBiosystems in a professional manner while positively shaping the ACROBiosystems’ identity, profile, and visibility within the life science community. This position must also be able to work the occasional night and/or weekend, to provide on-site events and internal team support. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. • Develop local marketing plans to optimize marketing event ROI and raise company awareness., • Build offline and online event strategies to optimize marketing event activation and raise company awareness., • Develop localized promotional materials and campaigns tailored to regional regulations and cultural nuances with the internal team., • Collaborate with the digital marketing team on social media promotion, webinars, and newsletter optimization. Track and analyze the results to enhance engagement with local customers and optimize local strategies., • Coordinate related logistics related to trade shows/events; connect with different vendors and carriers to ensure the events run smoothly., • Create detailed reports and engaging presentations to effectively communicate findings and insights to internal stakeholders. This includes synthesizing complex data into clear, actionable recommendations that support organizational objectives., • Conduct thorough research about customer behavior and preferences, including interviewing, surveying, and focus groups, to analyze customer data that can enhance marketing initiatives., • Continuously monitor competitor activities and performance metrics to assess market positioning and identify competitive advantages. This involves analyzing their strategies, product offerings, and marketing efforts to inform our own strategic planning., • Supervise and mentor the offline event marketing team and foster a collaborative environment., • Manage distributors, collaborators, and partners in the US., • Master’s degree in life science or related discipline required., • Advanced degree or MBA preferred., • 5+ years of B2B or B2C marketing experience in the biotechnology or pharmaceutical industry., • Passionate about the life sciences and pharmaceutical industry and aligned with company values., • Excellent written, communication, and presentation skills., • Proficiency in marketing solutions and applications such as Salesforce, Adobe, Canva and Constant Contact, or other similar tools; as well as Microsoft Office especially Excel and PowerPoint., • Strong leadership, stress resistance, with an innovation mindset., • Strong analytical, critical thinking, and problem-solving skills, • Ability to develop strategic vision and execute resulting plans., • Multi-tasking and time-management skills, with the ability to prioritize tasks and meet deadlines., • Project management experience with the ability to coordinate multiple stakeholders globally., • Willing to travel to marketing events and activities across the US.Salary: $90,000-$120,000 DOE Location: San Diego, CA or San Jose, CA (Hybrid) Work Environment & Physical Demands Office While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment. 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.

Job Description COMPANY DESCRIPTION: Syner-G BioPharma Group 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 BioPharma Group 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 Staff Process Engineer / Project Engineer with deep expertise in manufacturing and packaging equipment, process engineering, and project execution. This hybrid role combines technical leadership in process engineering with project management responsibilities to drive compliance, efficiency, and innovation across manufacturing operations. The ideal candidate will have a strong understanding of regulatory requirements, equipment commissioning, and cross-functional collaboration to support critical business initiatives. KEY RESPONSIBILITIES • Reviewing equipment drawings and specifications to ensure alignment with process requirements and regulatory standards, • Creating, reviewing, and approving Turnover Packages (TOPs) and other commissioning documentation, • Verifying Owner-Furnished Contractor-Installed (OFCI) equipment lists for accuracy and completeness, • Scoping, selecting, and reviewing transmitters, sensors, and instrumentation for manufacturing and packaging equipment, • Supporting equipment commissioning and qualification activities, including FAT/SAT and IQ/OQ documentation, • Providing process engineering input during design reviews, equipment selection, and installation phases, • Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations, • Develop and improve SOPs, work instructions, and quality documentation related to manufacturing and packaging processes with a focus on lifecycle management, • Lead and implement change management strategies for manufacturing and packaging, supporting product lifecycle changes and minimizing operational impact, • Manage and review equipment change requests to ensure timely, accurate, and compliant updates, • Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach, • Plan, execute, and oversee manufacturing and packaging projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements, • Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross-functional teams, • Identify project risks and implement risk mitigation strategies including process improvements, supply chain redundancy, and regulatory compliance, • Analyze existing manufacturing and packaging workflows, identify opportunities for process improvements, and implement best practices to increase efficiency and reduce risk, • Drive continuous improvement initiatives to streamline manufacturing and packaging processes, enhancing compliance, productivity, and cost-effectiveness, • Provide technical expertise and troubleshooting support for manufacturing and packaging issues, including root cause analysis and corrective action planning, • Support manufacturing operations including support, issue trending, and improvement projects, • Ensure that all manufacturing and packaging specifications meet regulatory/process standards, • Serve as a key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align manufacturing strategies with overall business objectives, • Support product launches, updates, and regulatory requirements by coordinating with cross-functional teams to achieve timely and compliant product releases, • Act as a product manager for manufacturing and packaging equipment, ensuring that product development aligns with market needs and regulatory standards, • Monitor market trends and competitor products to identify opportunities for innovation and improvement in manufacturing and packaging equipment, • Develop and maintain product roadmaps, ensuring alignment with business goals and customer needs Education • Minimum of 7–11 years of experience in pharmaceutical manufacturing and packaging, with specific expertise in process engineering and equipment management, • Strong background in equipment commissioning, instrumentation, and process validation, • Excellent communication skills with the ability to work effectively across departments and influence stakeholders, • Strong project management skills, with the ability to manage multiple projects simultaneously, • Strong leadership and team management abilities, • Detail-oriented with strong analytical and problem-solving capabilities Physical Demands • Regular use of computer keyboard and mouse; reaching with hands and arms; talking and listening, • Frequent walking and sitting; occasional lifting of objects up to 25 pounds, • Occasional standing, stooping, or kneeling 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. 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 BioPharma Group 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 BioPharma is an E-Verify employer.

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Position: Senior BD Manager Location: Onsite - San Diego Position Type: 5 days Onsite Exempt Position Salary Range: $90,000-$150,000 Job Summary: We are seeking a results-oriented Senior Business Development Manager to support CorDx’s growth initiatives by identifying new business opportunities, managing strategic partnerships, and contributing to revenue expansion within the diagnostic sector. This role will focus on market research, relationship management, and deal execution in alignment with corporate strategy. The ideal candidate will have strong experience in business development or commercial operations within the biotechnology, medical device, or pharmaceutical industries. Key Responsibilities: • Market Development & Opportunity Identification, • Identify and evaluate new business opportunities, market segments, and potential partners aligned with company objectives., • Support market entry strategies and product launch initiatives through competitive and market analysis., • Assist in developing pricing and go-to-market strategies to support new product and market growth., • Partnership Management & Deal Execution, • Manage and grow relationships with key customers, distributors, and industry partners., • Support contract negotiations, licensing discussions, and partnership agreements., • Ensure smooth execution of partnership deliverables and monitor ongoing performance., • Sales Enablement & Commercial Support, • Collaborate with Sales, Marketing, and Product teams to align business development initiatives with commercial goals., • Provide market insights and customer feedback to guide product development and marketing strategies., • Track and report on business development KPIs, deal pipeline, and revenue opportunities., • Cross-Functional Collaboration, • Work with internal stakeholders in Regulatory, Finance, and Operations to support deal execution and partnership management., • Assist in coordinating participation in industry conferences, expos, and networking events to increase market presence., • Operational & Risk Management, • Analyze financial and operational data to support business proposals and partnership opportunities., • Identify potential risks related to market shifts, competitive threats, and operational challenges, recommending mitigation strategies. Requirements • Bachelor’s degree in Life Sciences, Biotechnology, Business Administration, or a related field. An MBA is preferred., • 5–8 years of business development, sales, or strategic partnerships experience within the biotech, diagnostics, or life sciences industry., • Demonstrated ability to manage business relationships, negotiate agreements, and support revenue-driving initiatives., • Strong communication, interpersonal, and organizational skills., • Solid understanding of market trends, competitive analysis, and commercial operations within a regulated industry., • Preferred Qualifications:, • Experience in distributor management, or international business partnerships., • Familiarity with regulatory frameworks (FDA, ISO 13485) and intellectual property considerations in the biotech space., • Strong analytical skills with the ability to interpret financial models and market data., • Prior experience working in a high-growth, fast-paced environment is a plus. Benefits • Highly competitive compensation package., • Comprehensive medical insurance., • 401(k) plan., • Flexible paid time off (PTO) policy., • Additional substantial benefits.

Job Description Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name "Erasca" has an important embedded meaning: it is a contraction of our audacious hope to "erase cancer" that drives our mission and everything that we do on behalf of patients with cancer. The Director or Senior Director, Safety Science will provide safety science and pharmacovigilance support to molecules across the Erasca portfolio. The position will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development portfolio. They will bring safety expertise to interactions with internal stakeholders and regulatory authorities and must have the ability to interact effectively in a multifunctional and multicultural team setting. Additionally, the Director or Sr Director, Safety Science will work closely with Safety Operations for case review, medical review, and study oversight for patient safety. Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. Essential Duties and Responsibilities: • Develop and maintain an understanding of the safety profile of assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)., • Provide Safety Science leadership for clinical development programs and program teams and integrate safety science strategy aligned with clinical development plan(s)., • Provide medical review of cases inclusive of case narratives and causality assessments of AE/SAE reports., • Contribute to the drafting of safety assessments and drug safety reports for individual cases or aggregate data for signals or in response to Regulatory Authority requests., • Responsible for signal detection and management activities including, but not limited to, ISMP maintenance., • Responsible for the preparation and maintenance of safety sections of the ISMP, DSUR, IND Annual reports and/or Reference Safety Information in the IB., • Contribute to regulatory authority submissions and provide medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties., • Represent Medical Drug Safety in communication with health and regulatory authorities and at independent Data Safety Monitoring Committee meetings., • Evaluate risk minimization strategies and take accountability for the medical-scientific content in Risk Management Plans, including risk minimization measures, risk minimization action plans and REMS programs, as relevant., • Review clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication., • Present important safety issues to program teams for internal and external review., • Serve as safety science representative for clinical trial team meetings or investigator/site meetings., • May support non-molecule projects, due diligence evaluations, and other projects as needed., • Responsible for coordination and collaboration with vendors servicing Safety Science., • Accountable for the safety components of study reports, publications, aggregate reports, and high-level regulatory documents., • Healthcare professional degree required. MD or PharmD highly preferred, other relevant clinical degrees may be considered., • 6 or more years of drug development experience in the pharmaceutical or related industry including at least 4 years in drug safety for oncology clinical development., • Broad understanding of the scientific aspects of safety, PV (including GVP, GCP), and clinical/patient risk management is essential., • Expert knowledge of regulations governing pharmacovigilance., • Exposure to Safety Operations and experience with data entry and administration of drug safety databases, such as Oracle Argus, a plus., • In depth knowledge of clinical research, including FDA and international regulations, clinical study design, and documentation; exposure to early clinical development preferred., • Experience interacting with regulatory authorities (i.e. FDA, EMA) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums required; filing experience highly preferred., • Strong presentation skills, effective at summarizing and presenting key considerations and decision points., • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. Along with our casual, collaborative, and fun work and the chance to make your mark in our mission to erase cancer, Erasca offers a comprehensive and competitive benefits package that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term Disability, Basic and Voluntary Life/AD&D Coverage, Flexible Spending Accounts (FSA, HSA, and Commute), Critical Illness and Accident Coverage, Pet Insurance, Employee Assistance Program, 401(k) Plan with Erasca contribution, and the opportunity to participate in an Employee Stock Purchase Program. Erasca, Inc., is an Equal Opportunity Employer and takes pride in maintaining a diverse and inclusive environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of sex , race, religion, national origin, ancestry, physical or mental disability, protected medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military and veteran status or any other basis protected by federal, state or local law or ordinance or regulation.

Job DescriptionSalary: 160,000 - 210,000 About Codera Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Site Director, Clinical Operations is responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of Coderas clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. Using available systems and tools, the Site Director, Clinical Operations will monitor and oversee site activities both onsite and remotely to ensure that patients rights, safety and well-being are protected and that the data generated at sites are complete and accurate. The Site Director, Clinical Operations will be accountable for patient enrollment and overall delivery of high-quality patient data in established timelines for all designated sites and/or assigned region. Essential Duties and Responsibilities Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines Develop and cultivate strong site relationships and ensure continuity of site relationships Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance Identify, assess, escalate and resolve site performance or quality issues in a timely manner Complete feasibility and site identification activities for new clinical studies Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments) Facilitate communication with appropriate site staff involved in start-up and IRB/EC submissions Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance Responsible for the development of site specific recruitment, retention and follow-up plans Facilitate and support investigator site audits and/or inspection activities as needed Perform remote data review and query resolution for designated sites Contribute to overall clinical operations team knowledge by sharing best practices and participating in improvement initiatives Coach and mentor colleagues as needed Contribute to the review of Coderas systems and procedures as needed May be involved, when needed, in other areas of study management and staff training Execute other duties as assigned Qualifications Bachelors Degree in a Life Science discipline required Bachelors Degree in Nursing or RN a plus Minimum 3 years of direct site monitoring experience required Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required Thorough understanding of FDA, ICH and GCP guidelines and applicable local regulations Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle Detail-oriented, organized and committed to quality and consistency Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines Excellent team-interaction skills and ability to work successfully in team settings Ability to work in a dynamic environment with a high degree of flexibility Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs Excellent written and verbal communication skills Experience and proven proficiency in CTMS and eTMF systems preferred Must be willing and able to travel up to 50-65% While relocation is not required, the successful candidate must be able to travel frequently (5065%) to sites located in Washington (WA), Oregon (OR), California (CA), and Arizona (AZ). Proximity to a major airport and flexibility for multi-day travel are essential.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description This role is field-based, and candidates should live within a reasonable distance from the primary city. The geography includes the following locations: • Los Angeles, CA, • San Diego, CA, • San Francisco, CA, • Seattle, WA, • Salt Lake City, UT The RMM will act as the face of the AbbVie Marketing team with our External Experts, developing, implementing, and maintaining interactions for the purpose of insight generation within assigned geographies. Additionally, the RMM works within a team-based environment to optimize brand performance across AbbVie Immunology. Key Responsibilities: Strategic Marketing • Lead projects compliantly and effectively through the promotional review process to deliver high-quality work in a timely fashion (meets deadlines). Ensures that regulatory guidelines and AbbVie processes are followed, • Manage strategy, execution and budgeting for national and regional conventions, External Expert consulting, advisory boards, and commercial peer-to-peer education programming., • Continually applies knowledge and evaluates the effectiveness of key marketing tactics, making strategic recommendations to leadership on opportunities for brand optimization, • Ability to provide in-depth insights based on the brands key business questions to provide input on marketing strategy, resource optimization and tactic development that drives brand performance, • Lead partnerships with field leadership in assigned geography to optimize pull-through of marketing strategies, • Responsible for understanding a geographical area’s market drivers, competitive landscape, provider dynamics and competitive intelligence across the assigned geography, • Identify, build, and strengthen commercial relationships with External Experts, emerging leaders, and relevant patient and professional associations within assigned geography, • Develop regional engagement plans for External Experts and ensure consistent tactical execution throughout the year to drive key marketing engagement, • Demonstrate In-depth understanding of external and internal drivers across multiple external stakeholder groups and appropriately connecting AbbVie’s Integrated Brand Teams on opportunities for collaboration based on aligned objectives, in compliance with industry standardsQualifications Key Skills • Mastery of verbal and non-verbal communication and presentation skills, live and virtual, to effectively engage internal leadership and external stakeholders, • Experience working in a collaborative working environment with integrated, cross-functional teams by understanding priorities, key responsibilities and influencing without direct authority to drive results, • Ability to navigate a field and headquarter based matrix organization, to impact and/or drive decision making across functions to drive strategy and brand performance, • Ability to work in a fast-paced environment Qualifications: • Bachelor’s Degree, • Previous experience in sales, sales management, or marketing with at least 2 years of experience in Immunology (preferred), • Previous Gastroenterology experience preferred, • Travel up to 75% of the time including evenings and weekends, • Valid driver’s license: Ability to pass a pre-employment drug screening test and meet safe driving requirements. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. * This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job DescriptionDo You Want to Improve the Future of Healthcare? • Want to enable the world's top scientist to deliver impactful healthcare solutions faster?, • Do you believe that the best team wins?, • Do you thrive on providing innovative solutions to unique challenges? This position is an onsite role in San Diego, CA The Automation Engineer will help design, build, and deliver world-changing laboratory automation systems. The role will assemble automation workcells and custom engineering projects, conduct instrumentation operational and Green Button Go driver testing, assist with the electrical system design and implementation of the workcells, develop and test Green Button Go workcell processes, and periodically assist with the site-installation of the project. Responsibilities: • Conduct Operational Acceptance Testing of components for our projects, • Assemble automation workcells and custom engineering projects, • Assist with the electrical and control system design of automation projects and products, • Configure electrical, pneumatic, and communications on automation workcells and custom engineering projects, • Conduct Green Button Go instrumentation driver testing, • Develop and test Green Button Go application processes for automation workcells and custom engineering projects, • Bachelor’s degree in Bioengineering, Mechanical Engineering, or comparable field required, • Experience in Pharma/Life Sciences industry and using laboratory instrument from Beckman, Tecan, Agilent, etc. is preferred., • Experience working with hand tools (drills, saws, wrenches, etc.) is a plus, • Experience in robotic automation (SCARA or 6 DOF robot arms) is is a plus, • Experience working through a project engineering (from initial requirements setting, design, procurement, build, testing, and delivery), • EE knowledge around safety and power circuits is a plus, • Software/programming skills, especially with C#, preferred, • Ability to write professional technical reports and procedures, • Must be task focused and have a results-oriented attitude and approach to the job responsibilities Total Compensation target is $75,000 - $85,000 annually. Benefits include 401K with company match, Flexible Vacation Policy, Health Benefits, Investment in Professional and Personal Development, and much more. Biosero provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. In addition, Biosero complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Biosero is committed to diversity and inclusion. We seek individuals from all backgrounds and appreciate and celebrate the diversity of our growing team. Powered by JazzHR HChRhrQ8eR

Job DescriptionSalary: Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. We can't sponsor H1B. Arcetyp LLC is looking for a Certified Pharmacy Technician. This position is onsite and located in Okinawa, Japan. POSITION RESPONSIBILITIES: • Perform a full range of pharmacy technician procedures., • Perform pharmaceutical dispensing duties including filling new outpatient prescriptions, refilling prescriptions, and entering orders into databases., • Perform information consultation duties including supporting new and refill prescriptions, supporting patient requests, supporting physicians requests, monitoring fordrug interactions, and reporting adverse drug reactions., • Perform quality improvement duties including performing drug storage inspection, reviewing expired supplies, and producing error and workload reports anddocumentation., • Assist with supply process duties including assisting with stocking/restocking shelves, inventory maintenance, and producing not in stock reports as directed byGovernment Supervisor., • Utilize pharmacy computer and robotic systems in accordance with MTF protocols., • Participate in executing the Emergency Preparedness Plan (drills and actual emergencies) as scheduled by the MTF (typically semiannually)., • Participate in peer review and performance improvement activities., • Participate in the implementation of the Family Advocacy Program as directed by government supervisor., • Participation shall include, but not be limited to, appropriate medical examination, documentation, and reporting., • Attend and/or comply with all annual training classes required by the Command, to include but not limited to online annual training provided by the MTF, disastertraining, infection control, Sexual Harassment, Bloodborne Pathogens, Fire and Safety, Chemical,Biological, Radiological, Nuclear and Explosives (CBRNE), and all other required training., • Actively participate in the commands Performance Improvement Program. Participate in meetings to review and evaluate the care provided to patients, identifyopportunities to improve the care delivered, and recommend corrective action when problems exist., • Perform efficiently in emergency patient situations following established protocols, remaining calm, informing appropriate persons, and documenting events., • Anticipate potential problems/emergencies and make appropriate interventions., • Notify supervisor, director, or other designated person regarding problems that the HCW is unable to manage., • Comply with the standards of The Joint Commission, applicable provisions of law, and the rules and regulations of any and all governmental authorities pertaining tolicensure and regulation of health care personnel and medical treatment facilities, the regulations and standards of medical practice and the MTFs medical staffby laws., • Participate in continuing education to meet own professional growth., • Participate in the provision of in-service training to clinic staff members., • Provide training and/or direction as applicable to supporting government employees (e.g., hospital corpsmen, students, etc.)., • Operate and manipulate automated systems such as CHCS, AHLTA, ADS, Essentris, and Clinical Information System (CIS), participate in clinical staff PerformanceImprovement (PI) and Risk Management (RM) functions, as prescribed by the Commander., • Attend and participate in various meetings as directed by government supervisor., • The HealthCare Worker (HCW) shall comply with the HIPAA (Health Insurance Portability and Accountability Act) privacy and security policies of the treatment facility., • Perform timely, accurate, and concise documentation of patient care. NECESSARY SKILLS AND KNOWLEDGE: • Maintain a level of productivity comparable with that of other individuals performing similar services., • Adhere to and comply with the Department of the Navy, Bureau of Medicine and Surgery, and local instructions and notices in effect during the term of the contract., • Practice aseptic techniques as necessary; comply with infection control guidelines to include the proper handling, storage, and disposal of infectious wastes, and theuse of universal precautions to prevent the spread of infection., • Function with an awareness and application of safety procedures., • Apply an awareness of legal issues in all aspects of patient care and strive to manage situations in a reduced risk manner., • Exercise awareness and sensitivity to patient/significant others' rights, as identified within the MTF., • Maintain an awareness of responsibility and accountability for own professional practice., • Maintain DoD email account as directed by government supervisor., • Exercise appropriate delegation of tasks and duties in the direction and coordination of health care team members, patient care, and clinic activities., • Each HCW providing service under this contract or resultant task orders shall undergo an orientation and shall complete mandatory Navy and DoD on-line training asrequired., • Be able to comply with all applicable Federal, State, and local laws, Department of Defense, Department of Navy, Bureau of Medicine and Surgery, and MTFinstructions and policies., • Proficiency in Microsoft Office software applications including Word, Excel, Access, PowerPoint, and Outlook. MINIMUM QUALIFICATIONS: • Possess and maintain a current certification and registration by the Pharmacy Technician Certification Board (PTCB)., • HCW shall be in good standing and under no sanction or suspension by the Federal Government., • Possess and maintain current certification in either the American Heart Association BLS for Healthcare Providers or American Heart Association Healthcare ProviderCourse., • Able to read, write, speak, and understand the English language fluently and maintain good communication skills with patients and other health care personnel., • Ability to pass all background/suitability checks., • A valid drivers license; ability to travel locally as needed. PREFERRED QUALIFICATIONS: • A thorough understanding of the military lifestyle and experience working with military family members., • Working knowledge of relevant military, state, federal, and local laws and resources., • Highly developed written, oral, and presentation communication skills. Min. Citizenship Status Required: U.S Citizenship. LOCATION: Okinawa, Japan COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Pay and Benefits from our client: we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities. Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.

Job DescriptionDescription: SUMMARY Under supervision, the Manufacturing Technician, Production Support, will perform routine manufacturing activities in GMP manufacturing areas, solution preparation, dispensing raw material, bioprocessing support and autoclave operation. Operations will be performed according to Standard Operating Procedures (SOP), Work Instructions (WI) and Master Batch Records (MBR). Perform manufacturing steps, execute routine MBRs, and revise documents such as MBRs and SOPs as needed. Flexible shift schedules and overtime may be required. JOB RESPONSIBILITIES • Perform GMP manufacturing activities in assigned areas., • Perform routine cleaning activities in GMP manufacturing areas, • Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products., • Set-up, operate, maintain and clean bioprocessing equipment., • Demonstrate good aseptic technique., • Perform dispensing raw material., • Basic troubleshooting of bioprocess equipment., • Perform manual cleaning and sterilization of parts and components., • Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices., • Draft and revise SOPs and batch records., • Address production issues and report any compliance related concerns to the supervisor. JOB REQUIREMENTS Education and Experience • High School Diploma, Bachelor's or advanced degree in life sciences or related discipline, or equivalent education and experience., • High school diploma with 3 or more years of experience in the pharmaceutical or biotech industry, • Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. Knowledge, Skills and Abilities: • cGMP manufacturing for biological products is preferred., • Fundamental knowledge of current biologics regulations and cGMP for drug substance operation., • Proficient with Microsoft Word and Excel., • Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions., • Demonstrated ability to follow and document activities in written procedures and/or logbooks., • Detail oriented, strong team player., • Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.Requirements:

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our Discovery Biology Department as a Senior Scientist I and work as part of a team to drive success. The Senior Scientist I will support ongoing RNA-based drug discovery projects in several therapeutic areas. The successful candidate will have experience in neuroscience drug discovery and a deep understanding of human neurobiological processes that drive CNS disease pathophysiology. The Senior Scientist I will employ a variety of in vivo, ex vivo, and in vitro techniques to advance oligonucleotide therapeutics for CNS indications. Essential Responsibilities: • Carry out assigned laboratory functions applying knowledge and skill in an accurate, timely manner., • Support the establishment and maintenance of primary and IPSC-derived neuronal cell models., • Support in vivo studies by performing basic animal handling and specialized CNS techniques (e.g. intracerebroventricular and intrathecal injection), • Perform brain and spinal cord dissections and tissue processing. Collect bodily fluids, e.g. blood and cerebrospinal fluid., • Implement multiple state-of-the-art techniques in molecular biology, biochemistry, and microscopy to determine drug distribution, efficacy, safety, and mechanism of action., • Critically evaluate, interpret, summarize, and present data to internal project teams and leadership., • Maintain a current knowledge of relevant literature, competitive landscape, and methodologies specific to oligonucleotide-based therapeutics targeting CNS disorders., • Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience., • Maintain updated and well-organized lab notebooks., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company., • Execute daily laboratory operations with an approach designed to minimize risks and hazard waste streams to carry out assignments., • 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: • Ph.D. in Neuroscience, Pharmacology, or related scientific discipline, • 3+ years post-doctoral or biotech/pharmaceutical industry experience in neuroscience research and drug discovery., • In-depth knowledge in the field of neuroscience, CNS disease and therapeutic modalities., • Expertise in the rodent stereotaxic surgery techniques including intracerebroventricular and intrathecal injection, • Expertise in rodent brain and spinal cord dissection., • Experience with tissue processing, embedding and microtomy of brain tissues, fixation and immunohistochemistry., • Experience in gene expression analysis using qPCR and protein analysis techniques., • Broad knowledge of scientific experience with track record of scientific achievement demonstrated by peer-reviewed publications., • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • Ability to work as part of a team with a drive to partner effectively with internal and external leaders., • Experience with oligonucleotide-based therapeutics is highly desirable., • Prior experience in biotech/pharmaceutical industry a plus., • Experience in primary neuronal cell cultures and human iPSC-derived neural cells is a plus., • Experience in collection of cerebrospinal fluid samples is a plus., • 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., • 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, • Paid Vacation, • Paid Holidays, • United States (Required), • 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 DescriptionPosition: Business Development Manager / Director - Toxicology & Safety Assessment (Preclinical Studies) Location: Home-based - West Coast (San Diego preferred) Salary: $150,000 to $200,000 Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK, and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make. Just last year, we supported over 1,000 preclinical safety studies, helping our clients advance their drug candidates with confidence. Our teams work across small molecules, ADCs, biologics, and gene therapies, partnering with more than 3,000 global customers. To learn more, visit . About the Role Are you a toxicologist or preclinical scientist who enjoys connecting great science with real-world impact? This could be your next step. We're looking for a scientifically minded Business Development Manager or Director to join our U.S. team, covering the West Coast, with a preference for candidates based in San Diego. This role is ideal for someone with a strong background in toxicology, safety pharmacology, or preclinical development who's ready to move beyond the bench and into a more strategic, client-facing role. You'll work closely with our internal scientists to shape proposals, ensure client expectations are realistic and achievable, and help translate complex safety assessment needs into tailored solutions. Your scientific insight will be key to building trust with clients and turning conversations into successful, long-term partnerships. It's a remote role with regular travel across the region and perfect for someone who wants to stay close to the science while stepping into a more commercial, outward-facing position. We are interviewing for this role on an ongoing basis. So don't miss out on this opportunity and apply as soon as possible. Key Responsibilities • Lead business development efforts across the West Coast, identifying and securing new opportunities with biotech and pharma clients in the toxicology and safety assessment space., • Build and maintain strong relationships with senior stakeholders, positioning Pharmaron as a trusted, long-term partner., • Collaborate with internal scientific and operational teams to develop tailored proposals and ensure successful project delivery., • Drive cross-functional initiatives to expand Pharmaron's market presence and service adoption., • Represent Pharmaron at key industry events, conferences, and client meetings., • Maintain a robust pipeline of qualified opportunities and consistently meet or exceed revenue targets., • Provide market insights and competitive intelligence to inform strategic planning.Candidate Profile, • Advanced degree in Toxicology, Pharmacology, Biology, or a related scientific discipline (PhD preferred)., • 8+ years of experience in the pharmaceutical or CRO industry, including hands-on experience in preclinical safety assessment., • Proven success in business development or client-facing roles within preclinical development., • Strong understanding of the CRO landscape and GLP-compliant safety studies., • Excellent communication, negotiation, and relationship-building skills., • Strategic thinker with a results-driven mindset and high level of self-motivation. Benefits: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance, • 401(k) plan with generous employer match If you have any questions about the role or application process, please contact Elisa Di Caterino - Talent Acquisition Partner on Linkedin ED1-#LI

Job DescriptionCompany Description Consider joining Lancaster Laboratories where people are the most important element in our chemistry. Celebrating 50 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide. Job Description • Perform cell and molecular biology techniques, including tissue culture, nucleic acid isolation, RT-qPCR, and next-generation sequencing (NGS)., • Design, execute, troubleshoot, and optimize assay workflows to enhance experimental performance and reliability., • Analyze primary and secondary NGS sequencing metrics to support research projects., • Analyze, interpret data and share results with stakeholders in one-on-one meetings and group settings., • Collaborate with bioinformatics and translational team members to generate datasets and identify biomarkers supporting translational medicine, • Develop and run cell-based assays to characterize drug target pathway activity or PD biomarkers in primary cells or cell lines, • Maintain thorough, accurate and complete records of experiments performedQualifications, • Strong and effective communication skills in one-on-one conversations and in group settings, • Strong problem-solving and organizational skills, • Experience with NGS platforms (Illumina preferred), library prep and analyzing sequencing metrics, • Experience in developing and running transcriptomics experiments (bulk and single cell RNA seq) and library preparation for genomic and transcriptomic sequencing., • Experience using cell and molecular biology techniques, including tissue culture, nucleic acid isolation, RT-qPCR, cell culture skills including cell lines and primary cells, • Experience developing ex-vivo cell-based assays to assess immune responses from human whole blood, PBMCs, and various immune cell subsets, • BS or MS in immunology, cell biology, or related biomedical science, • 3-5 years of experience in academia and/or industry Additional Information What we offer: • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match, • Paid vacation and holidays Position is full-time, 8am - 5pm with occasional overtime required. Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries. We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment. Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

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 Description Elevate Your Career in Pharma Logistics: Join PDS Tech Commercial as a Shipping and Receiving Specialist! Location: San Diego, CA 92121 (Onsite) Pay Rate: 20.90 – 26.56/hour (based on experience) Shifts Available: * Position 1: Monday–Thursday | 12 AM – 10:30 AM * Position 2: Thursday–Sunday | 12 AM – 10:30 AM * Position 3: Thursday–Sunday | 12 AM – 10:30 AM Make an Impact That Matters PDS Tech Commercial is partnering with a world-class pharmaceutical manufacturing leader to hire a Shipping and Receiving Specialist at their state-of-the-art facility in San Diego. This role plays a vital part in supporting the production and delivery of breakthrough therapies that improve lives. If you thrive in a fast-paced, quality-driven environment and take pride in precision, this is your opportunity to be part of something meaningful. What You’ll Do * Maintain accurate, GMP-compliant records for all incoming and outgoing materials. * Execute data entry and ERP transactions with accuracy and timeliness. * Coordinate shipping, receiving, inventory control, and material staging to support production schedules. * Load, unload, and transfer materials using industrial equipment; ensure proper storage and labeling. * Inspect and verify materials and documentation for accuracy and completeness. * Participate in cross-functional projects to improve processes and develop Standard Operating Procedures. * Operate radiation detection equipment safely and efficiently. * Uphold all cGMP, HS&E, and site policies, while completing required training. Note: Ability to lift up to 40 lbs required. What You’ll Bring Education: * High School diploma or GED required. * Associate or bachelor’s degree in business, logistics, or a related field preferred. Experience & Skills: * Minimum 1 year of experience in distribution, warehousing, or manufacturing within a regulated industry. * Hazardous shipping training a plus. * Strong communication, computer, and organizational skills. * Proficiency in Microsoft Office and familiarity with inventory or procurement systems. * A proactive, safety-conscious approach with a “can-do” attitude and excellent customer service mindset. Why Join Us At PDS Tech Commercial, we connect skilled professionals with opportunities that make an impact. Partnering with a globally recognized leader in pharmaceuticals means joining a team that values excellence, innovation, and integrity. You’ll work in a collaborative, clean, and safety-focused environment where your attention to detail helps bring life-changing treatments to patients around the world. We offer: * Competitive pay based on experience * Opportunities for growth and skill development * A culture rooted in teamwork, accountability, and purpose Take the Next Step If you’re ready to contribute to a mission that truly matters, apply today to become a Shipping and Receiving Specialist with PDS Tech Commercial in San Diego. Your precision keeps progress moving — and patients thriving. Pay Details: 20.90 to 26.56 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Company DescriptionSince 1977, the PDS family of companies has become among the largest and most respected staffing companies in the United States. A vital part of the PDS family, PDS Tech Commercial connects highly skilled employees with Fortune 500 clients’ needs for project support such as contingent labor, statement of work/offload engineering projects, and permanent placements. PDS Tech Commercial has staffing partnerships with leading organizations based in the United States and globally. We hire jobseekers daily for openings across skill categories, including Engineering, IT, Business Professional, Administrative, Accounting/Finance, Skilled Trades and Industrial. We offer eligible associates an ala carte benefits package, that can include direct deposit, free career counseling, 401(k), select paid holidays, short-term disability insurance, skills training, employee referral bonuses, and an affordable medical coverage plan. Now part of The Adecco Group, our shared synergies combined with the investment Adecco continues to make in PDS offers significant advantages to both clients and associates alike. We share Adecco’s dedication to unlocking our Associates’ potential by unleashing the Future@Work and to the importance of human and labor rights, diversity and inclusion, environmental responsibility, and more.Since 1977, the PDS family of companies has become among the largest and most respected staffing companies in the United States. A vital part of the PDS family, PDS Tech Commercial connects highly skilled employees with Fortune 500 clients’ needs for project support such as contingent labor, statement of work/offload engineering projects, and permanent placements.\r\n\r\nPDS Tech Commercial has staffing partnerships with leading organizations based in the United States and globally. We hire jobseekers daily for openings across skill categories, including Engineering, IT, Business Professional, Administrative, Accounting/Finance, Skilled Trades and Industrial.\r\n\r\nWe offer eligible associates an ala carte benefits package, that can include direct deposit, free career counseling, 401(k), select paid holidays, short-term disability insurance, skills training, employee referral bonuses, and an affordable medical coverage plan.\r\n\r\nNow part of The Adecco Group, our shared synergies combined with the investment Adecco continues to make in PDS offers significant advantages to both clients and associates alike. We share Adecco’s dedication to unlocking our Associates’ potential by unleashing the Future@Work and to the importance of human and labor rights, diversity and inclusion, environmental responsibility, and more.

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our growing organization as an on-site Associate Director / Director, Regulatory Affairs and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, and highly flexible within a fast-paced environment. The Assoc. Director / Director, RA is responsible for oversight and management for all of ADARx’s global regulatory filings and dossiers. Essential Responsibilities: • Accountability for managing the full life cycle of regulatory dossier preparation and submission including INDs, IMPDs, etc., • Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications., • Coordinate across functional teams to assemble and submit responses to regulatory inquiries during dossier/application review cycles., • Lead cross-functional teams to develop and to improve systems to increase efficiency of regulatory processes, including the development of Regulatory-specific SOPs., • Lead and/or support regulatory submissions, consultations, and other discussions with global regulators on digital health topics, including the FDA, notified bodies, in-country representatives, distributors, and other counsels., • Contribute to the preparation of research reports and presentations for internal project teams, leadership team members, and external audiences., • Presentation of results in both written and oral format and delivery of completed reports within a multidisciplinary team., • Promotes a team-oriented culture within and between departments., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company as well as external consultants as necessary., • Maintain all appropriate corporate standards for office and lab safety. 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 or higher in a related field., • Minimum 6-12 years of biotech/pharmaceutical industry., • Minimum 2-5 years in a management role within Regulatory., • Experience in interfacing and responding to relevant global regulatory authorities., • Must have up to date understanding and knowledge of fundamental regulatory requirements for pharmaceuticals across a wide range of territories (e.g., FDA, EMA, MHRA, PMDA, ANVISA, TGA, etc.)., • Ability to travel domestically and internationally (10%)., • Must be able to work independently 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., • Master’s degree and/or PhD a plus., • Regulatory Affairs Certification a plus., • 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 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 DescriptionSalary: $110,000.00 - $130,000.00 - based on experience About Arthrosi Therapeutics Arthrosi Therapeutics is a clinical-stage biotech company committed to transforming the treatment paradigm for gout and related inflammatory diseases. Our lead candidate, AR882, is a best-in-class oral URAT1 inhibitor currently in Phase 3 clinical development. We are seeking to build a strong quality team that will play a pivotal role in our journey to regulatory approval and beyond. Position Summary The Quality System Manager, under the supervision of Quality Leadership, is responsible for executing and supporting day-to-day activities of GxP quality systems, with particular emphasis on document control, change control, and deviation management. This role ensures that quality processes are implemented in compliance with applicable regulatory requirements (FDA, EMA, ICH, ISO) and internal quality standards to maintain inspection readiness and support product development through commercialization Key Responsibilities Document Control • Administer the electronic Document Management System (eDMS) ensuring documents are created, reviewed, approved, distributed, and archived in compliance with regulatory and company standards., • Coordinate controlled document lifecycle: drafting, formatting, issuance, revision, retirement, and archival., • Maintain document templates, numbering systems, and access permissions., • Facilitate change control process by logging, tracking, and monitoring changes to GxP systems, procedures, and controlled documents., • Assist in risk assessment and impact analysis of proposed changes., • Coordinate cross-functional review and approval of change requests, ensuring timely closure., • Log and track deviations, errors, or nonconformances in the Quality Management System (QMS)., • Coordinate investigation activities, ensuring root cause analysis and appropriate corrective and preventive actions (CAPAs) are documented., • Monitor deviation and CAPA timelines to ensure compliance with internal metrics and regulatory expectations., • Administer the required training related to SOPs, policies, and GxP compliance., • Maintain accurate and complete quality records to ensure inspection readiness at all times., • Support preparation for internal audits, external audits, and regulatory inspections., • Generate routine metrics on document control, change control, deviations, and CAPA performance., • Proactively identify areas for process improvement within quality systems., • Support initiatives to streamline workflows, enhance compliance, and increase efficiency. Qualifications Education • 4-8 years of experience in a GxP-regulated environment (pharmaceutical, biotechnology, or medical device industry)., • Experience with electronic Quality Management Systems (eQMS), Document Management Systems, or, • Understanding of FDA, EMA, and ICH GxP regulations and guidelines., • Strong organizational and time-management skills with ability to manage multiple priorities., • Excellent written and verbal communication skills., • Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook)., • Attention to detail and commitment to data integrity Preferred Attributes • Prior experience working in a company advancing a product from late-stage development to commercial launch., • Hands-on experience implementing or scaling electronic QMS tools and inspection readiness platforms. Why Join Arthrosi? • Opportunity to make a significant contribution to addressing a disease with significant unmet medical need., • Opportunity to make a significant impact in a small, agile organization advancing a promising late-stage oral therapeutic., • Dynamic and collaborative environment where science, innovation, and execution come together., • Competitive compensation and equity participation with high-growth potential., • Flexible work model and a mission-driven culture anchored in scientific excellence and patient impact.

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 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 The successful candidate will have a strong knowledge of GMP concepts, regulatory requirements, various process platforms, and equipment technologies. They will have the ability to execute and lead projects through early phases of design, including feasibility, programming, master planning, concept, and BOD. This position will require facilitating design workshops with client’s key stakeholders and end users. This position will require a close collaboration with process engineers and architects, as well as effective coordination with others within a team environment. Strong leadership, interpersonal communication, public speaking, and technical writing skills will be necessary to be successful in this role. Core Activities • Works with clients and process engineers to define and document design basis., • Works closely with process engineers to ensure coordination across process, equipment, regulatory compliance and facility design., • Collaborates with architectural team to ensure cohesive design for the overall facility., • Ability to conceptualize and communicate design ideas to clients in real time., • Ability to facilitate design workshops with key stakeholders and end users, as well as facilitating stakeholder consensus., • Ability to execute high-level master plan and develop building- or site-level expansion strategies., • Researches and applies cGMP regulatory and building codes and standards to facility design., • Develops and generates studies, presentations and reports., • Ability to generate concept design plans and sections, cleanroom classification plans, GMP flow diagrams, room summary list, and other deliverables appropriate for feasibility, programming or concept phases of design., • Cultivates an industry presence through professional society memberships and activities, speaking engagements, and publication of blogs, articles, or white papers., • Participates in proposal development and preparation, and project interviews., • Provides mentorship to Process Architects III and IV as well as Architectural Intern/Design staff.Qualifications, • Accredited Professional Degree in Architecture (B.Arch, M.Arch, and/or D.Arch) or Canadian/International equivalent, • Architectural license in good standing within home state, with ability for reciprocal licensure through NCARB, • NCARB Certification, • Proficiency in Revit and Microsoft Office suite, • Relevant knowledge of International Building Code, OSHA Regulations and ADA Standards, • Ability to interface with clients and external partners, • Flexibility for moderate travel in support of project-based or training activities, • Excellent verbal and written communications and presentation skills, • Experience with advanced technology industry projects including R&D labs, biotechnology, pharmaceutical, food and nutrition, and/or consumer products, • Experience with international clients and/or projects, • Expert-level knowledge of cGMP and regulatory concepts and requirements, • Entrepreneurial, client focused, and leadership skills, • Experience with Enscape, Rhino or other 3D modeling/visualization software, • LEED Accreditation, WELL Certification or similar sustainability credentials The pay range for a candidate selected for this position who is based in San Diego is typically $128,906 to $206,250 annually. The base salary range represents the low and high end of the salary range for this position. The selected candidate’s actual pay will be based on various factors, including but not limited to work location, qualifications, and relevant experience. In addition, CRB offers a total rewards package that includes comprehensive insurance coverage as well as the opportunity to participate in one or more annual incentive programs based on company and individual performance. #LI-JV1 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/Affirmative Action 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 DescriptionCompany Description Eurofins Scientific is a network of independent companies 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 laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With more than 20 U.S. locations, Eurofins Built Environment Testing offers Industrial Hygiene (IH) and Indoor Air Quality (IAQ) services to protect health in built environments. Clients include consultants, industry, real estate, healthcare, government, and homeowners. Services cover a wide range of tests, including asbestos (PLM/TEM), mold, bacteria, VOCs, allergens, Legionella, radon, lead, silica, and more. Job Description The Lab Manager will manage a team of Mold and Asbestos Analysts and other Laboratory staff, provide leadership and be responsible for ensuring compliance of laboratory operations. Will help maintain/adjust workflow to meet TAT, make recommendations, as needed, to improve laboratory functionality, and supervising staff. Will be responsible for ensuring compliance and integration of facility operation with quality assurance, ethics, safety and other corporate and regulatory policies and procedures. Essential Duties and Responsibilities 1. Provide leadership and manage/assist other staff members in the operational team., 2. Assists with the coordination and timely completion of all analytical and operational training for the local lab staff., 3. Prepare and analyze aerobiological, environmental, and water samples for fungal, asbestos and bacteria analysis., 4. Serve as an operational point of contact for clients regarding all services performed in the lab., 5. Coordinates with the local salesperson to assist with client concerns., 6. Determines the local client needs and leads the effort in adding new testing services as needed to meet the local client needs., 7. Coordinates the work of the local lab and assists in setting work priorities to minimize costs, scheduling conflicts or delays., 8. Reviews and modifies group schedules based on current and projected workloads and staffing. Prioritizes the activities of the groups to ensure key goals are achieved and customer service needs are addressed. Manage personnel schedules for Monday-Friday and Tuesday-Saturday staff., 9. Builds and maintains positive customer relationships through direct interaction with customers, project managers, and sales personnel., 10. Fosters morale and teamwork. Fulfills supervisory responsibilities with direct reports to achieve strong staff performance. Mentors key employees., 11. Demonstrates and promotes the company vision. Communicates facility-specific goals and objectives to employees. Communicates and implements company initiatives designed to foster teamwork and communication., 12. Establishes and maintains an active and positive safety culture and ensures that the Employee Health and Safety procedures are implemented and followed to maintain facility operations that are compliant with appropriate policies and regulations., 13. Reviews SOPs used in the facility and ensures their implementation so that the facility is operated in a compliant manner which allows it to produce defensible data., 14. Supports the Human Resources function to ensure that all policies and programs are applied consistently throughout the laboratory. Secondary Duties 1. Remains current on new technological developments and provides scientific leadership in establishing new analytical services as needed, works with Technical Director., 2. Assists the QA manager in development, implementation, and data collection of QA processes for the different analytical tests., 3. Assists in pursuing, receiving, and maintaining necessary laboratory accreditations., 4. Recommends and coordinates sample transfer as necessary., 5. Assists co-workers with analytical questions as necessary., 6. Ordering and inventory control for lab supplies and equipment. • Strong Professional background in working with Mold and Asbestos Samples, • Previous Supervisory/Management experience required, preferably 2 yrs., • BS degree in Microbiology, Biology, or equivalent degree, • Minimum 3 years of previous hands on laboratory experience Additional Information Compensation Range: candidates who qualify with minimum requirements start at $75,000 annually. Higher compensation will be considered for more qualified experienced candidates. Position is full-time, exempt status. Experienced and qualified candidates are encouraged to apply. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: Company 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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It 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. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6.95 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Job DescriptionCleanroom Technician Job Description You will work towards achieving production goals and handling unscheduled peaks in workload to ensure timely product release and prevent back orders. You will also perform in-process quality checks on sub-assemblies and finish products, and maintain accurate records in accordance with Good Documentation Practices (GDP). Responsibilities • Conduct daily production and packaging activities in compliance with GMP and SOPs., • Identify and report corrective actions for technical issues related to raw materials and finished products., • At least two years of previous assembly/packaging experience., • Experience in a regulated medical device manufacturing or pharmaceutical environment is preferred., • Ability to understand coagulation-based manufacturing processes., • Familiarity with GDP, GMP, GLP, FDA, and ISO., • Knowledge of qualification and validation trials is a plus. The pay range for this position is $18.75 - $20.63/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in San Diego,CA. Application Deadline This position is anticipated to close on Oct 26, 2025. About Aerotek: We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

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 DescriptionDescription: The Director of Clinical Pharmacology will be responsible for developing and executing clinical pharmacology strategies for small molecule assets in the company portfolio. They will provide expertise in characterizing the pharmacokinetics properties, dose optimization strategies, pharmacometrics assessments, investigating drug interaction potential, food-effect, characterizing QT prolongation potential. They will represent the function in cross-functional meetings and collaborations with key stakeholders like Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC. Responsibilities will include planning and reviewing study designs & analysis plans; analysis & interpretation of PK, PK/PD data. They will also be responsible for authoring and defending the Clinical Pharmacology sections of regulatory filings. Job Responsibilities • Develop and execute clinical pharmacology and pharmacometrics strategies, including dose and schedule determination and dose optimization, to mitigate risks and support development of small molecule candidates from pre-IND and first-in-human testing through all phases of clinical development., • Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical development, biostats, regulatory, nonclinical and research to support and impact development decisions, • Responsible for protocol design of clinical pharmacology trials, study planning, review, data analysis / interpretation, and reporting of individual studies implemented to support clinical pharmacology components of project plans., • Prepare appropriate documents or sections of clinical protocols, clinical study reports with respect to Clinical Pharmacology studies or data., • Author regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquiries related to PK/PD, and clinical pharmacology., • Identify and manage consultants and vendors and monitor work with external vendors to ensure compliance with agreed protocols, quality standards and timelines., • Review external data, analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data., • Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs. Strong communication skills with the ability to convey pharmacology data to cross functional teams, senior management and external investigators. Prior experience with NDA/BLA/MAA filings is desirable and prior experience with health authority and authoring responses required.

Job DescriptionSalary: $150,000 - $175,000 About Codera Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Associate Director, Clinical Trial Operations is responsible for assisting the study team by performing tasks related to study start-up, study/site management, clinical operations and monitoring, inspection readiness and IRB/EC submissions of Coderas clinical trials according to Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. The Associate Director, Clinical Trial Operations will interface with Site Directors and the study team to support operational aspects of study start-up and execution. Essential Duties and Responsibilities • Support the execution of Phase I-IV studies including study start-up, site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s) and applicable study plans, • Prepare and manage potential investigator site lists, assist in identifying clinical trial sites and contribute to site feasibility and site selection decisions, • Communicate with investigators and site staff on issues related to feasibility, essential document collection and local IRB/EC submissions., • Support study start-up activities including the facilitation of site selection internal approvals, review of and facilitation of ICF internal approvals and essential document approvals for IP release, • Prepare and review study documents (e.g., essential document packets, study plans, site Informed Consent Forms (ICFs), etc.) to ensure quality and consistency, • Support study start-up by performing primary or secondary reviews of Essential Document Packages and completing Investigator background checks, • Assist with development and distribution of study materials (e.g. ISF binder), tools and documents, • Responsible for oversight of the central IRB/EC, • Prepare and submit required study documents to central IRB/EC, • Support central IRB/EC annual reviews and study updates, • Communicate with central IRB/EC as needed, • Support site and local IRB/EC annual reports and updates, as needed, • Assist with the facilitation of the site contract and budget process, • Manage translation of necessary documents through translation vendor, • Support creation of and updates to study translation plan, • Support setup and management of Clinical Operations vendors (e.g. rater training, home healthcare)., • Facilitate and track vendor system access requests., • Assist in Clinical Trial Management System (CTMS) maintenance including entry of study and site level updates, assistance with running reports and reviewing CTMS entry accuracy, • Review study documents received from the study team for completeness and accuracy and upload to the Trial Master File (TMF), • Assist with TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times., • Assist with development and management of ancillary study site supplies such as ISF binders, patient facing materials, patient welcome kits or study related site materials, • Assist with oversight of study site training, • Support inspection preparedness and study/site audit and/or inspection activities, as needed, • Execute other duties as assigned Qualifications • Bachelors Degree with minimum 5 years of relevant clinical trial experience required, • Experience with feasibility and study start-up, • Experience and proven proficiency in CTMS and eTMF systems, • Experience with Veeva Systems preferred, • General knowledge of clinical site monitoring, feasibility and study start-up preferred, • Detail-oriented, organized, and committed to quality and consistency, • Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines, • Excellent team-interaction skills and ability to work successfully in global team settings, • Ability to work in a dynamic environment with a high degree of flexibility, • Possess a willingness and ability to work hands-on and with a sense of urgency in a fast-paced, entrepreneurial environment, • Must be proficient in Microsoft Word, Excel, and PowerPoint Codera, LLC is an equal opportunity Employer. Codera, LLC is a an E-Verify employer.

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 The Senior Director, Business Development is a senior leadership role responsible for developing and executing high-value business development strategies, securing large-scale project opportunities, and expanding CRB’s market influence. Reporting directly to the Vice President of Business Development, this position will be responsible for delivering sustainable, profitable growth in a specific region or industry vertical. This individual will serve as a strategic business leader, collaborating with executive leadership, operations, and marketing to implement consistent business development processes, enhance client relationships, and drive market penetration. This role requires a proven track record of closing high-value deals ($100M+ EPC or Design-Build preferred), expertise in strategic sales, and the ability to influence executive decision-makers. The Senior Director is expected to operate with a high level of autonomy, leading and mentoring business development teams while directly engaging in key sales opportunities. Key Responsibilities · Develop, implement, and oversee high-impact business development strategies aligned with corporate, regional, and industry-specific growth goals. · Identify and pursue large-scale, high-value business opportunities, securing long-term contracts and partnerships that drive sustained revenue growth. · Lead strategic account planning, sales pipeline development, and forecasting, ensuring alignment with company financial targets. · Build and maintain executive-level client relationships, positioning CRB as a trusted advisor and go-to service provider. · Drive go-to-market strategy execution, integrating market research, competitive analysis, and innovative sales approaches. · Develop and manage regional and industry-specific sales plans, tracking progress and adjusting strategies based on market conditions. · Directly lead and coordinate high-stakes negotiations, proposal development, and contract finalization for major project pursuits. · Could lead and manage regional business development teams, including setting and managing KPIs, mentoring team members, and fostering a high-performance sales culture. · Evaluate industry trends, competitive landscape, and market positioning to inform business development strategy and capitalize on emerging opportunities. · Support CRB’s thought leadership efforts, including participation in industry panels, conference speaking engagements, and content development. · Partner with marketing, operations, and executive leadership to enhance CRB’s brand visibility and client engagement strategy. · Oversee the seller-doer program, ensuring technical and operational leaders are effectively engaged in business development efforts. · Maintain and update CRM tools (Microsoft Dynamics, Salesforce) to track business development activities, client interactions, and sales opportunities. Qualifications · Bachelor’s degree in Engineering, Architecture, Construction, Marketing, or Business Administration (preferred). · 10+ years of experience in business development or sales leadership, preferably in the life sciences, pharmaceutical, food & beverage, or science & technology sectors. · Proven track record of closing high-value ($100M+) EPC or Design-Build projects. · Deep understanding of complex sales processes, account management, and business development best practices. · Strong executive presence and relationship management skills, with the ability to influence and engage C-suite decision-makers. · Experience managing sales teams and business development professionals in a matrixed environment. · Expertise in CRM tools (Microsoft Dynamics, Salesforce) and sales performance tracking. · Demonstrated ability to develop and execute strategic growth initiatives, expanding company market share and client base. · Strong industry network, with active engagement in professional societies, industry associations, and executive roundtables. · Exceptional negotiation, presentation, and communication skills, with a focus on complex deal structuring. Additional Skills · Recognized industry thought leader, with a strong reputation and influence in the life sciences and/or food & beverage sectors. · Experience coordinating business development efforts across multiple geographies and industry verticals. · Ability to develop, manage, and optimize BD team performance, ensuring alignment with corporate objectives. · Strong understanding of financial modeling, project feasibility, and risk assessment for large-scale projects. Travel Requirements Travel requirements will vary based on geography and business needs. Some regions may require extensive travel (up to 70%) while others may have more moderate travel expectations (20-30%). The Director Business Development should be flexible and willing to travel as needed for client meetings, industry events and internal coordination The full pay range for the position in California is $178,819.00 to $286,111.00, based on experience. 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/Affirmative Action 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 We are seeking a highly motivated and qualified individual to join our Clinical Department as a Senior-Executive Director, Clinical Development to service as a key clinical leader responsible for driving the strategy, design, and execution of early and late-stage clinical programs across ADARx’s therapeutic areas. The Senior-Executive Director, Clinical Development, will provide strong clinical leadership for clinical trials, collaborating cross-functionally with R&D, regulatory, biometrics, and commercial teams. This position will be focused on clinical trials and clinical operations outside the US. Essential Responsibilities: • Develop and promote a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability., • Establish and maintain excellent working relationships with critical collaborative partners throughout the company., • Lead and provide strategic oversight for the planning and execution of clinical trials being conducted outside the US, including in Australia, UK and/or China, for programs across multiple therapeutic areas., • Serve as the medical lead for clinical studies outside the US, ensuring safety data review, protocol compliance, and high-quality data output., • Author and review key clinical documents including protocols, IBs, CSRs, regulatory submissions, and scientific publications., • Engage and collaborate with regulatory authorities, KOLs, and external experts., • Collaborate with preclinical, translational, and biomarker teams to support data integration and decision-making., • Ensure that all clinical activities are conducted in compliance with ICH-GCP, FDA and local regulations, and ADARx SOPs., • Contribute to the preparation of research reports and presentations for internal project teams, leadership team, and external audience., • Maintain all appropriate corporate standards for facility safety. 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: • MD (or equivalent medical degree), PharmD or PhD in a relevant discipline., • Bilingual in English and Mandarin., • 7–10+ years of clinical development experience in the biotech or pharmaceutical industry., • Experience serving as the development lead for clinical trials., • Demonstrated track record in leading both early and late stage clinical trials., • Proven track record in clinical study execution outside the US., • Strong understanding of biostatistics, data interpretation, and clinical operations., • Experience with RNA therapeutics, rare diseases, or oligonucleotides is a plus., • Excellent leadership, communication, and cross-functional collaboration skills., • Excellent written and verbal communication skills and effective presentation of complex scientific data to cross-functional and senior management teams are essential for this role., • Broad knowledge of scientific experience with track record of scientific achievement demonstrated by peer-reviewed publications., • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • 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., • 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: We are a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. 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.

Job DescriptionSalary: $75,000.00 - $100,000.00 We are a small, agile pharmaceutical company advancing late-stage small molecule assets in therapeutic areas with significant unmet need. As we prepare for pivotal clinical trials, we are seeking a highly experienced and detail-oriented Clinical Trial Material (CTM) Consultant to provide part-time, contract-based support for clinical supply strategy, execution, and comparator sourcing. The CTM Consultant will support activities related to the planning, sourcing, and management of clinical trial materials for late-stage development programs, including comparator sourcing and coordination with CDMOs, CROs, and depots. This part-time contract role is ideal for someone with deep experience in clinical supply operations who can operate independently and contribute strategic insight while managing hands-on tasks. ESSENTIAL DUTIES AND RESPONSIBILITIES • Develop and execute clinical supply plans for late-stage clinical trials, including forecasting, packaging, labeling, distribution, and return/reconciliation planning, • Identify and manage sourcing of commercial comparators for global clinical trials, including negotiating supply agreements and managing vendors, • Coordinate with internal teams, CDMOs, depots, and CROs to ensure timely availability and delivery of clinical supplies to trial sites, • Provide strategic input on supply chain design, including depot network selection, packaging configurations, and overage estimates, • Monitor inventory levels, expiry, and resupply needs throughout the trial lifecycle, • Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and all applicable regulatory requirements, • Support documentation, including SOPs, supply plans, shipping records, and reconciliation reports JOB QUALIFICATIONS Education, Certifications, Experience • Bachelors degree in a scientific or technical discipline; advanced degree preferred, • Minimum of 8+ years of experience in clinical supply management, preferably within late-stage development, • Proven experience sourcing and managing commercial comparator products for global trials, • Strong knowledge of GMP/GCP and clinical packaging, labeling, and distribution processes, • Experience working with external vendors, CMOs, and third-party logistics providers, • Comfortable operating in a small team and startup environment with limited infrastructure, • Highly organized, proactive, and self-directed with excellent problem-solving skills, • Experience with IRT systems and supply chain forecasting tools is a plus. SPECIAL WORKING CONDITIONS • Hybrid office environment - must be located in San Diego, • Domestic travel up to 10% may be necessary, • Department: Manufacturing, • Reports To: Director, Clinical Supply, • Position Type: Contract (30 hours a week)

Job Description About Us: Infusion For Health is a rapidly expanding private-equity-backed healthcare provider specializing in infusion therapies for chronic conditions. We are dedicated to improving the lives of our patients through exceptional care and innovative treatments. As we continue to grow throughout California and beyond, we are seeking talented and motivated sales professionals to join our team. Position Overview: We are seeking a highly motivated and dynamic Infusion Sales Representative to drive growth for our infusion centers in the San Diego regions. As an Outside Sales Rep, you will be responsible for managing provider relationships and generating referrals from physicians, particularly in oncology, hematology, gastroenterology, and rheumatology. This home-based role involves up to 60% travel within the territory to build strong relationships and expand business opportunities. Key Responsibilities: • Develop, implement, and report on sales strategies and goals, ensuring key performance metrics are met and exceeded., • Achieve and exceed sales quotas, driving revenue growth for the company., • Cultivate and maintain relationships with high-volume physician practices, particularly those specializing in oncology, hematology, gastroenterology, and rheumatology., • Educate physicians and their teams on Infusion For Health’s services, fostering trust and encouraging referrals., • Identify key target providers, create engagement strategies, and work to increase referral volume., • Monitor provider performance and collaborate to implement tactics that drive higher referral rates., • Work alongside pharmaceutical reps, health plans, and local health systems to enhance service delivery and further expand the business., • Proven experience in sales, with a strong track record in developing physician relationships and driving referrals in oncology, hematology, gastroenterology, and/or rheumatology, specifically in infusions., • A minimum of 3-5 years of sales experience, preferably in healthcare, health services, or medical sales., • Strong presentation and communication skills, with the ability to engage effectively with physicians, office staff, and other key stakeholders., • Bachelor’s degree in business, healthcare, or a related field., • Strong analytical, organizational, and problem-solving skills to manage territories and track sales performance., • Base Salary: $85,000 - $120,000, • Be part of a pioneering healthcare company making a significant impact on patients' lives., • Work with a dynamic, supportive team that values your sales expertise and contributions. At Infusion for Health, we are committed to equitable pay for all employees, and we strive to be transparent with our pay practices. The estimated base salary for this position is $85,000 to $120,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position is also eligible for uncapped monthly incentives.

Job Description Pharmaceutical Sales Representative – Specialty & Entry Level We are a diverse and fast growing Biopharmaceutical company that is committed to focusing on patient health while delivering consistently high performance. Our Pharmaceutical Sales Rep team provides the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help our Pharmaceutical Sales Representatives set goals based on our organization’s potential and what we hope it will become. We are looking for a consistent and driven high performance with proven selling skills to join its innovative and skilled Pharmaceutical Sales Rep organization. Each Pharmaceutical Sales Rep will be responsible for establishing, promoting and maintaining a high level of sales. Our Pharmaceutical Sales Representative responsibilities: • Promote and sell products to current and potential customers within a defined geography., • Develop, analyze, prioritize and execute in order to execute territory plans to achieve business results through compliant means., • Uses functional and technical knowledge of pharmacology products, healthcare, pharmaceutical market places, managed care, and customer markets to meet or exceed customer needs. Understand and execute sales territory management and customer development., • Establish and maintain excellent communications and sound working relationships with physicians and healthcare providers., • Actively participate in scheduled Company sales meetings, district and regional conference calls and other business meetings., • Demonstrate honesty and integrity while modeling behaviors consistent with company standards and policies for business and compliance related matters., • Other related duties as required. Requirements The Pharmaceutical Sales Rep opening qualifications: • Have some sales abilities or sales experience in quota driven role, • Some education and/or knowledge of pharmaceutical and healthcare products, • Demonstration of sustained, high performance in current position or a strong aptitude for learning, • High sense of urgency in particular with regards to customer service orientation, • Strong business acumen and ability to understand market opportunities, • Strong knowledge of the business and market in the assigned territory is preferred, • Ability to thrive in a highly driven culture that is performance based, fast paced, and results oriented, • Private Health Insurance, • Paid Time Off, • Training & Development, • Performance Bonus Please apply today for this opportunity. We are committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet

Job Description Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. Process Validation Engineer (Contract) Location: California Duration: 8-12 months Job Description: We are seeking a highly skilled and motivated Process Validation Engineer to join our team on a contract basis and serve as a bridge between R&D and manufacturing. This is an excellent opportunity for anyone who is a Scientist in Vaccine Manufacturing Science and Commercialization – Bioreactor & Fermentation Development to become more involved on the design side. The successful candidate will represent validation as a Subject Matter Expert (SME) and provide validation oversight monitor project results and drive sustainability. Equipment includes Chromatography columns, Wave rockers, and Bioreactors (50-2K L). Key Responsibilities: • Develop validation plans, protocols, and summary reports to perform shakedowns and functional testing. This role offers a unique chance for scientists to engage in the design and validation of critical equipment., • Work closely with the Manufacturing Sciences and Technology (MSAT) team to develop technical documents for the drug product line. This collaboration provides an excellent opportunity for scientists to contribute to the design and optimization of drug product lines., • Provide hands-on process and equipment support for the upstream area of an egg-based vaccine manufacturing facility, including execution of project start-ups for Harvesters, Centrifuge skid, Clarification, and Tangential Flow Filtration., • Provide technical leadership and subject matter expertise for Equipment and Process Qualification (SAT, IQ, OQ, PQ) activities., • Review and execute protocols, operate and troubleshoot automation equipment, and coordinate project management with vendors and contractors., • Work independently and interface directly with personnel from multiple departments, including Technical Development, Manufacturing, Engineering, Manufacturing Support, MSAT, Quality Control (QC), and Quality Assurance (QA). This role allows scientists to engage with various teams and gain experience in the design and validation processes., • Process Validation: Support industrialization, validation studies, and pre-approval inspections for drug products. Equipment includes Chromatography columns, Wave rockers, Bioreactors (50-2K L)., • Technical Support: Provide day-to-day assistance to manufacturing for process improvements, troubleshooting, and ensuring compliance with cGMP and regulatory standards., • Technology Transfer: Enable the transfer of processes from development to manufacturing while driving innovation. Qualifications: • Bachelor's degree in Engineering, Life Sciences, or a related field., • Proven experience in process validation within a pharmaceutical or biotechnology environment., • Strong knowledge of GMP regulations and validation principles., • Excellent problem-solving and analytical skills., • Ability to work independently and as part of a team. This role is a contract position lasting 8-12 months, based in California. The successful candidate will have the opportunity to work with a leading pharmaceutical company and contribute to the development and validation of critical processes and equipment. Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, tuition reimbursement, and other unique incentives. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

Job DescriptionBioPhase partners with the best Biotech, Pharmaceutical, and Medical Device companies in San Diego, and is in need of Recent Grads and Research Associates in the following disciplines- Molecular BiologyCell BiologyBioChemistryChemistryGeneral BiologyMicrobiologyAll related Scientific Disciplines Salary Range - $60k - $95k per year WILL TRAIN. Duties include both cutting edge Research activities and exciting opportunities in Biotech Manufacturing. For confidentiality reasons, additional information to be provided upon request. Multiple upper level positions also open for those candidates with BS Degrees in the above or related areas with 0-2 years of experience. Please feel free to apply and send your resume ASAP for details. #Zip

Job Description Role: Head of Regulatory Affairs Key Responsibilities: The Head of Regulatory Affairs is a key member of the leadership team, providing expert regulatory guidance and leadership for all development programs. This role is responsible for defining, developing, and implementing global regulatory strategies that support the company's product pipeline from preclinical research through clinical development and eventual market authorization. Essential functions and responsibilities Regulatory strategy and leadership • Develop and implement innovative global regulatory strategies for the company's product pipeline, ensuring alignment with corporate objectives., • Build a network of key regulatory strategic advisors to address specific questions, • Provide tactical and strategic regulatory guidance to cross-functional teams, including R&D, clinical development, manufacturing (CMC), and commercial operations., • Serve as the primary liaison with regulatory authorities, such as the FDA, EMA, and other international agencies. This includes leading interactions and negotiations throughout the product development lifecycle., • Oversee the preparation, submission, and maintenance of all critical global regulatory filings. This includes Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biologics License Applications (BLAs), and other relevant submissions., • Ensure timely and high-quality preparation of all regulatory documents, including meeting packages, briefing books, and annual reports., • Interpret and apply evolving regulations and guidance documents, communicating any impact on ongoing projects or future development plans to company leadership., • Build, lead, and mentor a small team of internal regulatory professionals and manage external consultants and vendors as needed., • Education: A Bachelor's degree in a relevant scientific discipline is required; an advanced degree (M.S., Pharm.D., or Ph.D.) is preferred., • Experience:, • Typically requires 10–15 years of progressively responsible experience in regulatory affairs within the biotech or pharmaceutical industry, with significant experience in developing new clinical assets., • Minimum of 5–8 years of experience in a leadership role within regulatory affairs is often required., • Proven track record of success in leading regulatory submissions and securing approvals from agencies such as the FDA., • Skills:, • Deep knowledge of global regulations and requirements, including ICH, FDA, EMA, and other relevant guidelines., • Hands-on experience with biologics and/or small molecule drug development., • Exceptional written and verbal communication skills., • Strong leadership, negotiation, and problem-solving abilities., • Ability to work effectively in a fast-paced, entrepreneurial environment Protego offers competitive benefits including medical, dental, vision, employer paid life and long-term disability insurance, 401(k) match, PTO and federal holidays.

Job DescriptionAt PSC Biotech, we provide the life sciences industry with expert engineering, technical, and consulting services that drive operational excellence, ensure regulatory compliance, and enhance productivity. Your Role We are seeking a skilled Validation Engineer with hands-on experience in building automation systems and facility validation within GxP-regulated environments. This role will focus on the commissioning, qualification, and validation (CQV) of computerized systems and facility equipment, including HVAC, clean utilities, and environmental controls across pharmaceutical warehouses, laboratories, and production spaces. The ideal candidate will leverage tools like Siemens Desigo to monitor and manage facility performance, support system integration, and ensure compliance with GAMP 5 and 21 CFR Part 11 standards. • Support and execute the validation lifecycle for GxP computerized systems, utilities, and facility equipment., • Author and review CSV documentation, including URS, risk assessments, IQ/OQ/PQ protocols, and summary reports., • Utilize building automation platforms (e.g., Siemens Desigo) to track facility conditions, equipment alarms, and system performance., • Coordinate CQV activities for HVAC, plumbing, clean utilities, and environmental monitoring systems., • Manage change controls, deviations, and CAPAs related to facility systems and automation platforms., • Collaborate with cross-functional teams, vendors, and contractors to ensure alignment with project timelines and regulatory expectations., • Provide technical guidance during audits and inspections, ensuring documentation and systems meet compliance standards. Requirements • Bachelor’s degree in engineering or a related technical discipline., • 5+ years of experience in validation engineering, with emphasis on facility systems and building automation in the pharmaceutical/life science industry., • Proficiency in Siemens Desigo or similar building management systems., • Strong understanding of GAMP 5, 21 CFR Part 11, and GxP compliance., • Experience with both software and hardware validation activities., • Excellent technical writing, communication, and project coordination skills., • Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy. • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents, • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more., • 401(k) and 401(k) matching, • PTO, Sick Time, and Paid Holidays, • Education Assistance, • Pet Insurance, • Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)., • Financial Perks and Discounts Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $100,000 - $130,000 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. #LI-JL1

Job DescriptionDescription: At Kumquat, our mission is to bring meaningful medicines to patients through science, efficiency, and innovation. The Medical Director is a key partner in this effort—guiding the development of study drugs, shaping thoughtful clinical trial designs, and working closely with study teams to deliver high-quality trials that truly serve patients. We invite you to join our mission and become part of a passionate, collaborative community. We believe in shared accountability and in the potential of every team member to learn, grow, and achieve more than what’s defined in a job description. The Medical Director will report to the SVP of Clinical Development and lead a cross-functional team for one or more study drugs by: • Providing general clinical and strategic input to senior management., • Collaborating closely with preclinical and drug discovery teams to exchange insights, providing clinical expertise and guidance on the development and clinical advancement of new molecules., • Designing clinical development plans., • Lead or contribute, as applicable, to the development and review of all study conduct-related documents, ensuring they are accurate, clear, and aligned with protocol and regulatory standards., • Leading engagement with regulatory authorities in a clinical capacity, representing the company as a medical expert in meetings, briefings, and official communications., • Actively contributing to study and site start-up activities., • Overseeing and executing clinical studies for one or more drugs, ensuring accountability for their successful conduct in alignment with the clinical development plan., • Interpreting clinical data from ongoing studies, ensuring accurate analysis and providing medical insight to guide study conduct and decision-making., • Proactively engaging and building strong relationships with key opinion leaders and clinical investigators., • Acting as a proactive partner to external stakeholders across multiple countries, providing support for local needs and priorities., • Stay current on emerging treatments and developments relevant to the company’s interests and study-specific therapeutic areas., • Cultivating meaningful peer-to-peer collaborations and nurturing a culture of curiosity to enable faster, simpler, and more patient-centric ways of operationalizing our studies., • Working with colleagues across Kumquat to promote communication and community., • A talented and passionate professional, inspired by our shared purpose to innovate clinical trial delivery and bring better medicines to more patients., • Comfortable thriving in environments of ambiguity and collaboration, making sound decisions quickly while seeking advice when needed., • Skilled in organizing and problem-solving to run efficient teams., • An effective communicator, sharing information transparently and strategically., • Comfortable working openly and actively listening to colleagues., • Experienced in leading or being an active member of large or small, diverse teams., • Collaborative and humble, valuing team input, continuous learning, and shared success while contributing expertise and guidance. Expectations: • Knowledge of clinical development, including study design, protocol execution, and drug development—especially early-phase clinical development., • Provides subject matter expertise by supporting the design and execution of clinical trials and/or enabling projects across geographies., • Independently develop plans, with minimal guidance, to support the design and execution of clinical trials and/or enabling projects., • Applies proficient knowledge of, and ensures adherence to, ICH, GCP, and regulatory guidelines within clinical trials or enabling activities., • Participates in identifying vendors, building relationships with sites and investigators, and partnering to ensure the execution of clinical trials., • Works closely with investigators and clinical site staff. Requirements: • MD or MD/PhD with oncology and/or hematology expertise., • At least 3 years of relevant experience in early development within the pharmaceutical or biotech industry., • Phase 1 trial experience in solid tumors or hematologic malignancies, with a preferred focus on small molecules., • Working knowledge of drug development and clinical development activities and deliverables., • Ability to solve complex problems, take new perspectives on existing solutions, and exercise judgment based on analyzing multiple sources of information., • Ability to explain complex information clearly and effectively.

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 Description About Tr1X Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit . Position Summary The Associate Director, Clinical Quality (ADCQ) is a key member of the Quality team ensuring the Tr1X clinical practices meet the highest standards of quality, compliance, and continuous improvement and aligned with industry standards and all applicable regulations (local, state, FDA, and other relevant agencies). The ADCQ reports to the Executive Director, Quality and is responsible for all aspects of Clinical Quality. The ADCQ leads GCP compliance strategies and is an integral part of all clinical program teams. The ADCQ works with both internal and external stakeholders to meet timelines and internal deliverables and is a partner with the clinical program teams to ensure regulatory compliance is achieved. The person in the ADCQ role is someone who has broad and diverse knowledge of clinical quality in support of clinical program objectives. The responsibilities of this position require the ADCQ to be highly collaborative and possess advanced interpersonal and influencing skills. Key Responsibilities • Oversee all aspects of Clinical Quality for internal and external processes, including CROs, vendors, and investigator sites., • Review internal and external documentation to ensure quality, regulatory compliance and audit-readiness., • Document internal regulatory processes and evaluate quality events, incidents, queries, and complaints., • Utilize guidance regulatory documents, international standards, and industry standards and interpret and apply to clinical trials and activities., • Conduct audits of clinical documentation, investigator sites, vendors, systems., • Lead root cause analyses and implement corrective and preventive action plans., • Collaborate with internal and external stakeholders to align quality strategies with organizational goals., • Assume a lead role in representing clinical quality at internal meetings and in preparing and drafting clinical quality policies, procedures, regulatory submissions and GCP training., • Communicate any critical compliance risks to senior management and recommend possible solutions., • Assist in the development of documentation and implementation of systems and SOPs., • Support all Quality team needs as identified by management., • Keep abreast of and make recommendations to management on new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc., • Bachelor's degree in a scientific discipline or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained., • Minimum 8 years of related experience with a minimum 5 years of experience in clinical quality management in the pharmaceutical or biotech industry., • Experience and knowledge in the establishment and management of quality systems, vendor and investigator site audits, and CRO oversight., • Working knowledge and adherence to FDA, ISO and ICH regulatory guidance and regulations, clinical quality operations, and CTD/eCTD standards., • Exceptional interpersonal skills with the ability to effectively develop supportive and collaborative relationships., • Superior organizational, communication, and problem-solving skills., • Experience with cell therapy products and prior participation in regulatory inspections desirable., • Legally authorized to work for any employer in the U.S., • Periodic travel is required to CROs and vendor sites. Working at Tr1X At Tr1X, our team is united by a singular shared mission: to transform patients' lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwavering commitment to patients, science and one another, we foster an environment where team members feel engaged, supported and empowered to make a meaningful impact. We envision a world where autoimmune diseases are not just being treated but are cured. Base Pay Range Anticipated: $175,000 - $200,000 Tr1X considers a variety of factors to determine salary such as education, years of experience, time in the position level, training, knowledge, skills, geographic location, and the market value of the position. Compensation and Benefits Tr1X provides a fair and competitive total rewards program that includes base salary; discretionary annual target bonus; incentive stock options; 401(k) retirement plan with company contribution; health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance; paid time off (PTO); and paid holidays. Tr1X embraces a diverse, open, and inclusive environment and believes a strong culture connection is key to success. Tr1X is committed to fairness in recruitment, hiring, transfer, promotion or any other employment practice without regard to race, color, citizenship, national origin, ancestry, religion, sex, pregnancy, marital status, sexual orientation, gender, gender identity and expression, age, physical and medical disability, medical condition, genetic information, political affiliation, protected veteran status, or any other characteristic protected by law. If you are an individual needing assistance to complete an employment application or would like to request an accommodation, please contact the Human Resources department at . Notice to Employment Agencies The Tr1X talent acquisition program is managed through internal resources, and unsolicited referrals and resumes are not accepted from employment agencies, unless advance written authorization is granted from the human resources department. Tr1X shall not be liable for any fees arising from any unsolicited or unauthorized candidate information received relative to position vacancies.

Job DescriptionDescription: REPORTS TO Chief Operating Officer JOB DESCRIPTION/SUMMARY The Senior Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. This position is responsible for primary authorship and supporting CMC regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements maintaining the electronic trial master files, reviewing, and overseeing the production of clinical and regulatory documents in support of product development applications. ESSENTIAL DUTIES AND RESPONSIBILITIES The main Regulatory Affairs responsibilities of this role include but are not limited to the following: • Serves as the regulatory lead on CMC development teams, providing guidance and oversight., • Manages administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time., • Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings., • Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed., • Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs., • Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams., • Collaborates with and supervises contributions from contractors and vendors., • Develops and manages project timelines for regulatory submissions., • Manages and maintains the electronic trial master files for regulatory, clinical, and non-clinical departments., • Bachelor's degree in scientific discipline with at least 5 years of experience in CMC Regulatory Affairs., • Proven success in preparing and submitting CMC sections of INDs, CTAs, NDAs, and MAAs, • Deep understanding of global regulatory frameworks and evolving guidelines, • Ability to lead in a fast-paced, collaborative environment with shifting priorities, • Strategic mindset with a hands-on approach to problem-solving and execution, • Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD., • Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle., • Working knowledge of FDA and ICH regulatory guidance and regulations., • High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom, • High attention to detail and excellent proofreading and editing skills, • Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion, • Ability to multi-task, professional demeanor, strong attention to detail, • Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude, • Must be dependable; someone willing to go the extra-mile to get things done Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA Notice to Agency and Search Firm Representatives Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Job Description NOW HIRING OVERNIGHT CLEANROOM MANUFACTURING TECHS! Location – Mira Mesa, CA Shift – 3rd Shift (9:30PM – 6:00AM Monday –Friday) **train on 2nd shift Pay Rate - $19/HR+ Job Description Join our team as a Cleanroom Technician where you will engage in daily production and packaging activities in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). You will work towards achieving production goals and handling unscheduled peaks in workload to ensure timely product release and prevent back orders. Collaboration with the Team Leader and other team members will be crucial to detail critical raw materials, in-process procedures, and specifications. You will also perform in-process quality checks on sub-assemblies and finish products, and maintain accurate records in accordance with Good Documentation Practices (GDP). Responsibilities • Conduct daily production and packaging activities in compliance with GMP and SOPs., • Achieve assigned production goals and manage unscheduled workload peaks., • Collaborate with Team Leader to detail critical raw materials and specifications., • Identify and report corrective actions for technical issues related to raw materials and finished products., • Perform in-process quality checks on sub-assemblies and finished products., • Address line issues and other production problems, notifying Team Leader of required corrective actions., • Maintain accurate records and documentation in line with GDP and SOPs., • Utilize computerized Materials Resource Planning (MRP) inventory system for reporting lot controlled ingredients on batch records., • Experience with cleanroom operations and understanding of GDP and SOP in a manufacturing environment., • Ability to provide detailed examples of SOP application in previous roles., • Knowledge of machine operation, multitasking, quality assurance, packaging, and inspection., • At least two years of previous assembly/packaging experience., • Experience in a regulated medical device manufacturing or pharmaceutical environment is preferred., • Ability to understand coagulation-based manufacturing processes., • Familiarity with GDP, GMP, GLP, FDA, and ISO., • Knowledge of qualification and validation trials is a plus. Pay and Benefits The pay range for this position is $18.75 - $20.63/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in San Diego,CA. Application Deadline This position is anticipated to close on Oct 24, 2025. About Aerotek: We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow. Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Company DescriptionWe know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meet their goals, skills, and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role in solving companies’ construction, manufacturing, and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are-everything spirit to the test as your career continues to grow.

Job Description Overview Join our PharMerica team! PharMerica is a closed-door pharmacy where you can focus on fulfilling the pharmaceutical needs of our long-term care and senior living clients. We offer a non-retail pharmacy environment. Our organization is in high growth mode, which means advancement opportunities for individuals who are looking for career progression! Schedule: Mon-Fri 12p-830p ; 1230p-9p & 2p-1030p Approximately every other weekends Sat/Sun 1130a-8p ; 12p-830p We offer: DailyPay Flexible schedules Competitive pay Shift differential Health, dental, vision and life insurance benefits Company paid STD and LTD Tuition Assistance Employee Discount Program 401k Paid-time off Tuition reimbursement Non-retail/Closed-door environment Our Pharmacy group focuses on providing exceptional customer service and meeting the pharmacy needs for hospitals, rehabilitation hospitals, long-term acute care hospitals, and other specialized care centers nationwide. If your passion is service excellence and top-quality care come join our team and apply today! Responsibilities • May be responsible for cleaning and maintaining Sterile Compounding room and QA as per USP 797 guidelines for a high-risk pharmacy and state law as directed by supervisor., • Works under direct supervision of a Registered Pharmacist, fills prescriptions and prepares Sterile Compounding according to standards of quality, customer service, productivity guidelines and State Board of Pharmacy regulations., • Knowledge of Long-Term Care and Alere high risk pregnancy medications., • May be responsible for staging, preparing, filling orders for residents at long term care facilities., • Responsible for staging, preparing, filling orders for Alere, high-risk pregnant women., • May be responsible for compounding Sterile Compounding orders and syringes for Alere in a Class 100 clean room including compounding medications from non-sterile powders as directed by Pharmacists, IV Supervisor, and/or Director of Pharmacy., • May be responsible for data entry and to assist pharmacist with calling nursing home and/or Alere for refill orders., • Responsible for maintaining, cleaning and accountability of pumps., • Responsible for filing, answering phones, and stocking areas in the IV department as appropriate and as directed by supervisor., • Works with Lead IV Technician in maintaining a clean/safe work environment, checking equipment for calibration, safety, and cleanliness., • Responsible for replenishment and maintenance of Emergency Drug Kits (EDK) provided to Long Term Care Facilities., • Responsible for communicating with Pharmacist or Supervisor, or Lead Technician with any concerns regarding USP 797 and Operations., • May be responsible for shipping and tracking Alere packages through overnight 3rd party logistics company., • Performs other tasks as assigned. Qualifications • High School Diploma or equivalent., • 6 months - 1 year of IV pharmacy technician experience., • Excellent oral and written communication skills., • Licenses/Certifications: As required by state regulations.

Job Description Position: Senior Scientist, In Vivo - Cell & Gene Therapy Salary Range: $100,000 - $125,000 / yr Location: Carlsbad, CA About Pharmaron Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services. We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit . Job Overview: Pharmaron is seeking a Senior Scientist to join our In Vivo team. In this high-impact role, you will lead preclinical studies with a strong emphasis on central nervous system (CNS) models, supporting pharmaceutical and cell and gene therapy programs. You will design, oversee, and interpret in vivo studies while ensuring scientific rigor, regulatory compliance, and effective collaboration across teams. This is an excellent opportunity to contribute to groundbreaking research in CNS and other therapeutic areas, while helping advance innovative therapies through preclinical development. Key Responsibilities • Lead the design, conduct, analysis, and reporting of in-vivo studies, ensuring scientific rigor and regulatory compliance., • Partner with sponsors to develop scientifically sound and cost-effective study designs that meet project needs., • Oversee study scheduling and resource allocation in coordination with in vivo scientists, veterinary staff, and QA/QC teams., • Prepare study protocols and reports, maintaining high standards of accuracy and clarity., • Provide subject matter expertise in animal handling, restraint, dosing, and surgical procedures in rodents and large animals., • Act as a liaison between sponsors and internal teams, fostering transparent communication and timely responses to sponsor requests., • Ensure all study activities adhere to regulatory guidelines (USDA, FDA, AAALAC, OSHA) and IACUC protocols., • Contribute to internal research projects aimed at expanding and optimizing service offerings., • Ph.D. in a relevant scientific field with 3+ years of laboratory animal research experience., • Proven track record in study direction and team leadership within a preclinical or CRO environment., • Strong background in cell and gene therapy programs, with hands-on expertise in animal models and surgical procedures., • Technical expertise in immunology, cell culture, flow cytometry, and experience establishing new laboratory capabilities., • Proficiency in Microsoft Office and statistical analysis software., • Skilled in technical writing of study protocols, reports, and documentation for GLP studies., • Solid foundation in physiology, anatomy, and pharmacology with application in preclinical settings. Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China. Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators. Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package: • Insurance including Medical, Dental & Vision with significant employer contributions, • Employer-funded Health Reimbursement Account, • Healthcare & Dependent Care Flexible Spending Accounts, • 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance, • 401k plan with generous employer match Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences. #LI-MC1

Job DescriptionDescription: SUMMARY Responsible for all aspects of purification process development from process definition to process characterization for support of pipeline projects. Designs a series of experiments that contribute to project objectives. Develops new processes and technologies to achieve improved product quality and reduce production cost. Interacts with management on advanced technical matters. JOB RESPONSIBILITIES ESSENTIAL FUNCTIONS • Applies engineering and scientific principles in the process definition, process optimization, scale-up, technology transfer, process characterization, and process validation activities associated with the purification of biopharmaceuticals., • Designs, implements, and conducts a series of scientific experiments which contribute to project objectives. Leads troubleshooting processes, instrumentation, and equipment., • Serves as a technical resource in technology transfer from process development to clinical cGMP manufacturing including definition of bill of materials, batch record drafting/review, and discrepancy resolution. Serves as a process development representative during purification operations. Provides technical troubleshooting and recommends process equipment improvements., • Designs and perform a series of bench scale experiments such as sterile membrane filtration, depth filtration, tangential flow filtration, viral clearance filtration, as well as chromatography., • Develop and recommend new processes and technologies to achieve cost effectiveness and improved product quality. Proactively identifies purification issues and suggests solutions., • Collaborates with cell culture, formulation, analytical, MSAT, Quality, and Validation for achievement of project objectives. May manage external collaborators., • Effective communicator of ideas, project goals and results across functions., • Interacts with management on advanced technical matters., • Authors and reviews regulatory filing documentation as well as process validation and characterization reports. Authors internal reports at appropriate milestones. JOB REQUIREMENTS Education and Experience • Proficient in programming, operating, and troubleshooting the following chromatography systems: AKTA pure, AKTA ready, and AKTA pilot., • Proficient in designing and conducting chromatography development studies., • Proficient in designing and conducting filtration studies using Scilog FilterTec and labscale TFF systems., • Understands purification process design limits for implementation in a clinical manufacturing environment., • Initiates, designs, and executes experiments independently. Capable of independent data interpretation. May apply advanced modeling or statistical analysis tools where appropriate., • Highly skilled communicator of ideas, project goals, and results., • Capable of working effectively in teams., • Knowledge of cGMP and familiarity with large scale manufacturing support.Requirements:

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Supply Chain Manager Location: Onsite - Atlanta, or San Diego Salary Range: $80,000 - $120,000 Job Overview The Supply Chain Manager oversees supply chain and logistics operations to ensure efficiency, productivity, and compliance within the pharmaceutical manufacturing industry. This role involves developing strategies, monitoring performance, and implementing policies to optimize processes, reduce costs, and align supply chain activities with company objectives and regulatory standards. Key Responsibilities • Strategic Planning: Design and implement supply chain strategies to meet company goals, forecast demand, and adapt to market changes., • Operations Management: Oversee procurement, production, warehousing, and distribution, ensuring seamless operations and optimized workflows., • Vendor Relations: Manage supplier relationships, negotiate contracts, and evaluate performance for quality and cost-effectiveness., • Inventory & Demand: Maintain optimal inventory levels, implement control techniques, and align production with customer trends., • Logistics: Coordinate transportation and work with third-party logistics (3PL) providers to ensure timely deliveries., • Cost Management: Monitor costs, create budgets, and implement savings strategies while maintaining quality standards., • Data Analysis: Analyze supply chain performance metrics and recommend process improvements., • Risk Management: Identify risks, ensure regulatory compliance, and enforce health and safety policies. Education & Experience: • Bachelor’s degree in Supply Chain, Logistics, Business, or related field., • Strong knowledge of supply chain processes, logistics, compliance, and quality assurance., • Proficiency in ERP and supply chain software (e.g., SAP, Oracle)., • Excellent organizational, project management, and leadership abilities., • Advanced Education & Certifications: Master’s degree or certifications such as CPIM, CSCP, or CLTD., • Industry & Regulatory Knowledge: Familiarity with FDA, GMP, and ISO 13485 regulations. Experience in global logistics and applying lean supply chain principles., • Highly competitive compensation package., • Comprehensive medical, dental, and vision insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy., • Additional substantial benefits. Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.

Job DescriptionCompany Description • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices., • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Responsibilities: • Accurately document all testing activities, maintain detailed data records manually and electronically, and ensure compliance with documentation standards., • Follow Good Laboratory Practices (GLP) and safety protocols to maintain a clean, organized, and safe working environment., • Safely handle chemicals and cleaning agents, using appropriate Personal Protective Equipment (PPE) such as lab coats, gloves, and protective eyewear. Training will be provided on all handling procedures., • Understand and strictly follow established test protocols and training procedures., • Identify and report any deviations from expected results or test methods., • Clearly and promptly communicate any anomalies or observations during testing., • Provide updates on test progress to relevant stakeholders., • Work collaboratively with team members and adapt quickly to changes in testing procedures or protocols., • Identify the need for escalation to supervisors or test owners when necessary., • High School Diploma or equivalent is required., • Previous lab experience., • Effective verbal and written communication skills in English., • Basic computer proficiency and ability to input data accurately., • Strong attention to detail, patience, and ability to follow instructions precisely.Additional Information All your information will be kept confidential according to EEO guidelines.

Job Description Loza & Loza LLP, a fast growing and dynamic intellectual property practice with a national presence, is seeking experienced patent attorneys with a proven track record of successful client representations. This position can be fully telecommuting and offers flexible hours. Firm Culture: Our firm is made up of experienced, tech-savvy, and entrepreneurial attorneys, and we hope to add similar attorneys/agents to our team. We have a cohesive group of attorneys with unsurpassed technical expertise and work quality. This is a great opportunity for those who take pride in providing excellent work quality and client service. Our firm provides a great platform from which to support clients without the overhead of traditional firms, allowing attorneys to keep more of their billables. Patent Attorney Qualifications: Minimum of 4+ years or more solid patent prosecution experience. This position is for an experienced/senior patent attorney with a background or degree in chemistry (e.g. organic chemistry, polymer chemistry, medicinal chemistry, inorganic chemistry, pharmaceutical chemistry or other related field) is required. Must be detail oriented, self-starter, highly motivated, and possess exceptionally strong technical and writing skills. At least one state bar license, a USPTO patent bar registration, and good standing are required How to Apply: If you are interested in working with us, please send a resume, three (3) published U.S. patent applications, and three published responses to office actions to . Company DescriptionFirm Culture: Our firm is made up of experienced, tech-savvy, and entrepreneurial attorneys with unsurpassed technical expertise and work quality.Firm Culture: Our firm is made up of experienced, tech-savvy, and entrepreneurial attorneys with unsurpassed technical expertise and work quality.

Job Description Director of Manufacturing San Diego, CA (North County) 180-220k About Us We are a leading company in the pharma sector, committed to delivering high-quality consumer products that enhance well-being. Our dedication to excellence in manufacturing and innovation has made us a respected name in the industry. We are seeking a highly skilled Director of Manufacturing to lead our operations and drive continued success. Position Overview The Director of Manufacturing will oversee all aspects of the production process, ensuring efficient operations and the delivery of top-quality products. This role involves leading a team of manufacturing professionals, optimizing processes, and collaborating with cross-functional teams to meet company objectives while maintaining rigorous safety and quality standards. Key Responsibilities • Strategic Leadership: Develop and execute plans to enhance manufacturing efficiency and achieve production targets aligned with organizational goals., • Team Management: Lead, mentor, and train a team of manufacturing professionals, fostering a culture of accountability, collaboration, and high performance., • Process Optimization: Identify and implement process improvements to reduce waste, increase productivity, and streamline operations., • Quality Assurance: Champion a quality-focused culture, integrating Lean Six Sigma tools and practices to ensure product excellence., • Regulatory Compliance: Ensure adherence to all relevant industry regulations and standards governing manufacturing and product safety., • Cost Management: Oversee budgets, monitor expenses, and drive cost-saving measures without compromising quality., • Cross-functional Collaboration: Partner with departments such as R&D, supply chain, and finance to support broader company objectives., • Continuous Improvement: Promote best practices and employee engagement to sustain a culture of operational excellence., • Performance Monitoring: Establish and track KPIs to assess performance and identify areas for improvement., • Education and Experience: Bachelor’s degree in Engineering or Operations Management (Master’s in Business Administration or Engineering preferred); 10+ years of manufacturing leadership experience, including 5+ years in a senior role. Proven experience in pharmaceutical/nutraceutical manufacturing processes., • Lean Manufacturing Expertise: Proven success with Lean principles (e.g., 5S, Kaizen) and Six Sigma Black Belt certification. Must have a solid understanding of equipment, automation, and processes - with proven time on the manufacturing floor., • Technical Skills: Strong engineering background with expertise in root cause analysis, troubleshooting, and high-volume production management., • Industry Knowledge: Familiarity with regulated manufacturing environments and compliance with standards like GMP and FDA regulations., • Leadership: Experience managing teams, optimizing labor resources, and implementing training programs., • Financial Acumen: Proficiency in budgeting, cost analysis, and financial forecasting., • Experience with advanced manufacturing technologies, such as automation or robotics., • Competitive salary and comprehensive benefits package., • Relocation assistance and performance-based incentives available.

Job Description Manufacturing Automation Engineer – Hands-On Innovator Wanted Salary: $1120-140K + Bonus Potential Location: North County San Diego, CA. Relocation Available for Exceptional Candidates Are you a mechanical-minded problem solver with a passion for automation? Do you thrive in fast-paced, high-tech manufacturing environments where innovation drives performance? We’re seeking a hands-on Manufacturing Automation Engineer to lead production and packaging automation initiatives, bringing fresh ideas to optimize and expand our cutting-edge operations. In this role, you’ll be the go-to expert for troubleshooting, refining, and upgrading packaging and production systems—keeping our lines running at peak performance while identifying new ways to innovate. You’ll work directly with engineering leadership, collaborating with maintenance, quality, and production teams to deliver smarter, faster, and more reliable processes. What You’ll Do · Design, develop, and implement automated solutions for filling, bottling, labeling, cartoning, and other packaging systems. · Program, maintain, and optimize PLC, HMI, and SCADA systems. · Troubleshoot automated machinery to minimize downtime and maintain product quality. · Improve overall equipment effectiveness (OEE) through lean and Six Sigma principles. · Research and apply cutting-edge automation, robotics, IoT, and smart factory technologies. · Lead equipment qualifications and ensure compliance with GMP, FDA, and other industry standards. · Train production teams on new automation systems and processes. What You Bring · Bachelor’s degree in Mechanical, Electrical, Automation, Industrial, or Mechatronics Engineering. · 6+ years of hands-on automation experience in pharmaceutical, nutraceutical, supplement, or food manufacturing. · Expertise with PLC programming (Allen-Bradley, Siemens), HMI/SCADA configuration, and industrial networking. · Familiarity with robotics (ABB, FANUC, Yaskawa) and vision inspection systems. · Proven track record in process improvement and automation project delivery. · Lean/Six Sigma certification highly preferred. Why Join Us? You’ll have the opportunity to shape the future of our production operations, working with state-of-the-art technology and a collaborative, innovation-driven team. If you’re ready to take ownership, solve complex challenges, and make an immediate impact, we’d like to talk.

Job DescriptionDescription: Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as an approved drug for the treatment of cancers and immune-mediated inflammatory diseases. We are currently seeking a highly motivated, creative CMC drug substance professional to join our CMC team in San Diego. This candidate will report to the senior director and head of CMC. This candidate is expected to work closely with Kumquat internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. This is a position with responsibility for synthetic route design and scouting, process development and manufacturing. The ideal candidate will have an in-depth understanding in all aspects of modern synthetic chemistry, process development, and non-GMP/GMP manufacturing. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will have the opportunity to work on multiple programs within the company’s pipeline which comprises potentially first-in-class approaches & novel-novel targets. Role responsibilities • Evaluate available candidate synthetic routes and develop stage appropriate route modification and process optimization strategies., • Select external CRO/CDMO partners based on project needs and the external parties’ technical capabilities, quality system, and track records., • Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget., • Plan and oversee drug substance process optimization, GMP manufacturing, and stability evaluation., • Track process development/validation history and manage CMC drug substance related documents in support of life cycle of quality improvement and regulatory filing/updates., • Work closely with a cross-functional team within and outside of the CMC department to align with key stakeholders (CMC, clinical, quality assurance and regulatory, etc.)., • Author and review CMC drug substance related sections for regulatory filing and annual updates., • Stay current on industry trends and regulatory requirements to ensure delivery of quality products under non-GMP and GMP environments., • Prepare and communicate research results in both oral and written format., • Supervise junior CMC Drug Substance team members., • Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence.Requirements:, • Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 10 years of related experience (title for this position will be commensurate with the candidate’s experience and qualifications), • Strong synthetic organic chemistry knowledge and problem-solving skills., • In-depth knowledge of industry practices in drug substance manufacturing and supply., • Desire and ability to maintain constructive working relationship with the CMC analytical development team and the CMC drug product team., • In-depth knowledge of cGMP regulations and compliance., • Track record of accomplishment in managing CMC drug substance projects at early and late development stages., • Direct experience with small molecule API NDA filing is preferred., • Ability to enable external CRO/CDMO to achieve project goals on time and under budget. Salary Description: $185k-$250k

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/Affirmative Action 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.