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Exciting Inside Sales Rep, High‑Earning Role - Selling Life‑Changing Stem Cell Therapy with Uncapped Bonuses! On‑Site in Downtown San Diego - APPLY TODAY! Projected OTE of $115k+ pacing forecast! TreVita is looking for high-performing Inside Sales Representatives to promote and sell our cutting-edge stem cell therapy packages. TreVita has helped hundreds of clients seeking advanced regenerative medicine solutions to help patients with chronic pain, autoimmune conditions, orthopedic injuries, neurological disorders, and age-related conditions. We partner with world-class medical teams specializing in advanced regenerative treatments not widely available in the U.S. If you are looking to make a difference in the groundbreaking regenerative medicine industry and are motivated by uncapped bonuses and the opportunity to transform patient lives through life-changing stem cell therapy solutions—we want to hear from you! What We Look For: • Smart, driven, ambitious, and determined to have success in sales, • Ability to retain information and implement company training, • Experience and/or strong interest in medical sales and regenerative medicine, • Cares about patient well-being and their entire customer experience with TreVita; from intake to recovery and every step of their patient journey along the way!, • We welcome new college graduates to apply! Why Apply? • Uncapped bonus structure with realistic $115K+ OTE, • 100+ warm, inbound leads monthly—no cold prospecting, • High-ticket deal sizes ($10K–$30K+) with a 2–6 week close cycle, • Clear advancement path + performance-driven culture, • Help patients access breakthrough regenerative treatments that change lives Who Thrives Here • Sellers who love high-volume, high-energy environments, • People who get excited about big bonuses and big impact, • Confident communicators who can guide emotional, high-stakes decisions, • Individuals who want to be part of a fast‑growing, innovative medical space What You’ll Do: • Own the full sales cycle — conduct outbound consultations, qualify warm leads, and book patients for regenerative care and stem cell treatment packages., • Drive high‑volume activity with 50–75 calls daily, nurturing new and existing leads to consistently generate $150K+ in monthly sales revenue., • Present and position TreVita’s all‑inclusive treatment packages—including VIP medical care, pre/post‑op support, surgery, recovery, travel, and concierge services—to maximize conversion., • Use consultative sales frameworks (Sandler, Challenger, SPIN) to build trust, uncover patient goals, and guide them through informed decisions with empathy and persistence., • Hit and exceed KPIs across lead conversion, call activity, follow‑up cadence, talk time, and overall productivity., • Maintain clean, accurate records and follow‑ups in HubSpot CRM., • Collaborate with marketing by providing actionable feedback to improve lead quality and sales outcomes. What We Look For continued: • Prior experience in regenerative medicine, medical or pharmaceutical sales, med spa, healthcare, biotech, or wellness sales strongly preferred., • Experience selling higher-ticket services ($5K+) with a relationship-based sales cycle., • High‑drive, commission‑focused performer with a relentless commitment to exceeding sales targets., • Strong communicator and skilled negotiator with the ability to build trust, influence decisions, and overcome objections., • Resilient, competitive, and consistently proactive with a positive, determined, go‑getter mindset., • Coachable, growth‑oriented, and motivated to continuously elevate performance., • Quick to adapt to new sales strategies, tools, and product offerings in a fast‑changing environment., • Exceptional empathy and ability to handle sensitive discussions., • Bilingual (English/Spanish) is a plus, not required. We offer a comprehensive compensation and benefits package where you will be rewarded based on your performance and recognized for the value you bring to the business. Starting base pay of $52,000+ uncapped commissions ($115k+ OTE). Please do not call the corporate phone line to inquire on your application status. This number is intended for patient support and inquiries only.

Account Executive Job Summary: The Account Executive (AE) is a key member of the i2Vision client services team, serving as the day-to-day point-of-contact across multiple client accounts to support the successful execution and delivery of projects in the pharmaceutical, biotech, and healthcare spaces. The AE ensures the effective coordination of timelines, deliverables, and communications across internal teams, clients, and external partners. Key Responsibilities: • Serves as the day-to-day point-of-contact for assigned client accounts and projects, supporting or leading client calls, facilitating communications and planning with the internal team, and providing status reports, meeting notes/debriefs, and follow-up correspondences, • Assist in the planning and execution of client deliverables, tracking projects to align with timing, budget, scope, and strategic objectives, • Assist in developing project timelines, trackers, scoping, and deliverable summaries (incl. output synthesis, post-mortems), • Support event/meeting coordination and logistics across internal & external stakeholders, including for advisory boards, scientific sessions, and workshops, • Collaborate closely with cross-functional internal team members to ensure timeliness, strategic alignment, accuracy & rigor, and quality of deliverables, • Demonstrate strong organizational skills and meticulousness for details from project initiation to client delivery, • Develop a strong command of agency capabilities, offerings, and expertise to support organic growth and other business development initiatives, • Foster and reinforce strong client relationships by anticipating needs, identifying key opportunities for synergies, and maintaining proactive & open dialogue Qualifications: • Bachelor’s degree from accredited institution required; background in life sciences (eg, biology, chemistry etc) strongly preferred., • ≥2 years of professional experience in agency, consulting, or related industries (pharmaceuticals, biotech, healthcare) in a Client Services or Account Management capacity required; HCP, eye care & ophthalmology, and launch experience preferred., • Exceptional organizational skills with a proven ability to prioritize and manage multiple engagements simultaneously, • Strong written and verbal communication skills, with high proficiency in Microsoft Office Suite (eg, Word, Excel, PowerPoint) and project management tools Benefits: • 401(k) + Matching, • Corporate ClassPass Account, • Dental insurance, • Employee assistance program, • Health insurance, • Health savings account, • Life insurance, • On-site Gym membership, • Flexible (Unlimited) Paid time off, • Professional development assistance, • Vision insurance Work Model & Location: Hybrid in San Diego, CA 92101

Manufacturing Associate I/II — Downstream Location: San Diego, CA Schedule: Full-Time, Onsite Pay Rate: $24/hr - $37/hr Position Summary The Manufacturing Associate I/II, Downstream will support GMP manufacturing operations with a primary focus on downstream processing activities, including purification and related sub-processes, in an onsite biopharmaceutical production environment. This role is best suited for an entry- to mid-level candidate with hands-on chromatography and AKTA experience, UFDF/TFF knowledge, strong GMP documentation habits, and the ability to work effectively in a fast-paced, team-oriented setting. Key Responsibilities • Perform downstream manufacturing operations in accordance with approved SOPs, batch records, and GMP documentation requirements., • Execute purification-related processing steps and support routine manufacturing activities in assigned GMP areas., • Set up, operate, maintain, and clean downstream bioprocessing equipment, including chromatography systems, UF/DF systems, filtration skids, and mixers., • Perform hands-on chromatography work, including AKTA operation., • Support UFDF or TFF processes; manual operation experience is a plus., • Complete batch records, equipment logs, and other GMP documentation accurately and in a timely manner following Good Documentation Practices., • Assist with SOP and batch record revisions as needed., • Perform basic troubleshooting of downstream process equipment and escalate issues appropriately., • Support cleaning, sterilization, setup, and readiness activities in manufacturing areas., • Collaborate with team members to meet production goals and support process improvements. Qualifications • Associate’s or Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemical Engineering, or a related scientific discipline preferred., • Entry- to mid-level experience in pharmaceutical or biotech manufacturing preferred., • Strong downstream processing experience required., • Hands-on experience with chromatography and AKTA systems required., • Experience with UFDF or TFF required; manual operation is strongly preferred., • Understanding of the science behind downstream processing, not just task execution., • Working knowledge of cGMPs, SOPs, batch records, and GMP documentation practices required., • Experience with protein chromatography, TFF, depth filtration, viral filtration, bulk drug substance formulation, final filtration, buffer preparation, and aseptic sampling is highly desirable., • Experience with UNICORN or similar control software is a plus., • Strong communication skills, attention to detail, and the ability to work cross-functionally are important for success in this role. Work Environment / Schedule • Fully onsite, 5 days per week, • Flexible schedule based on production needs, including options such as 8:00 AM - 4:00 PM or 9:00 AM - 5:00 PM, • Earlier or later hours may be needed depending on manufacturing demands, • Some overtime expected, with occasional weekend work and advance notice, • Approximately 70% floor operations and 30% documentation

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: Key Account Manager Location: Onsite - San Diego, CA Salary Range: $75,000-$150,000. About this role The Key Account Manager will be responsible for managing and growing key strategic accounts in the diagnostics and healthcare markets, including distributors such as McKesson, Medline, or Henry Schein, and other major healthcare networks. This individual will drive sales growth, expand channel partnerships, and increase market share for CorDx’s diagnostic products in both the POC and OTC categories. • Develop and execute account strategies to expand CorDx’s presence within major healthcare distributors (e.g., McKesson, Medline, Henry Schein, etc.)., • Manage existing relationships with key channel partners to maximize revenue, profitability, and brand visibility., • Identify and pursue new business opportunities in the diagnostic and healthcare sectors to achieve aggressive sales targets., • Collaborate with internal teams (marketing, supply chain, product management, regulatory) to ensure channel success and customer satisfaction., • Analyze account performance data, sales trends, and market insights to optimize channel strategies and pricing models., • Negotiate distribution agreements, pricing structures, and promotional activities with key partners., • Prepare regular sales reports and forecasts for senior leadership, highlighting growth opportunities and potential risks., • Lead product presentations, business reviews, and strategic meetings with distributor decision-makers., • Manage relationships with key stakeholders, including senior leadership, marketing and communication teams, and researchers., • Collaborate with cross-functional teams to identify opportunities for partnership and develop proposals to secure funding., • Coordinate with internal teams to ensure alignment and execution of strategic initiatives, including product launches, content creation, and event sponsorships., • Manage and track partnership metrics, including engagement, reach, and revenue generation. Qualifications • Bachelor’s degree in Business, Marketing, Life Sciences, or a related field (MBA preferred)., • 3–5 years of experience in sales, account management, or business development within the diagnostics or healthcare industry., • Proven track record of channel development and management with major distributors such as McKesson, Medline, Henry Schein, or Cardinal Health., • Strong understanding of the POC (Point-of-Care) and OTC (Over-the-Counter)diagnostic product landscape., • Demonstrated success in sales revenue generation and market share growth., • Excellent negotiation, communication, and relationship management skills., • Data-driven mindset with the ability to analyze sales metrics and translate insights into actionable strategies. Benefits • Comprehensive medical insurance., • 401(k) plan with generous company contributions., • Flexible paid time off (PTO) policy. 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.

A precision oncology company is hiring a Senior Director of Market Access to lead U.S. market access, pricing, and reimbursement strategy for the upcoming launch of a first-in-class targeted therapy in a rare, biomarker-defined solid tumor indication. This leader will ensure broad, timely, and sustainable patient access while shaping the value evidence strategy in a high unmet need disease area. While the initial focus is on the lead asset, the role will evolve over time to include direct reports and contribute to the global launches of a broader oncology pipeline. What You'll Do • Develop comprehensive market access, pricing, channel, and reimbursement strategy to support launch and lifecycle management., • Lead payer engagement strategy across national and regional commercial payers, PBMs, Medicare, and Medicaid., • Collaborate with HEOR to develop compelling clinical, humanistic, and economic value propositions and evidence generation plans., • Develop, train, and implement promotional resources and reimbursement pull-through that support field account teams; ensure programs comply with SOPs and MLR review., • Build launch pricing and contracting strategies, with lifecycle considerations to ensure continued market competitiveness and patient access., • Drive cross-functional collaboration across Marketing, Medical, Regulatory, Legal, Pricing, HEOR, Trade & Distribution, and Field Access teams., • Monitor the U.S. and global policy, reimbursement, and pricing landscape and assess strategic implications for the pipeline., • Engage external partners including payers, healthcare providers, thought leaders, and decision-makers to build partnerships and gather insights., • Influence the design of clinical development programs through global price, market access, and commercial opportunity assessments., • Oversee budgeting and financial planning for all market access activities. What You Bring • BS/BA degree in a related discipline; 10-15 years of related experience., • Biotech or pharmaceutical industry experience in U.S. market access, managed markets, and/or payer strategy., • Rare disease and oral oncology drug experience strongly preferred., • Demonstrated success with U.S. market access commercialization and launches., • Deep knowledge of payer landscapes, specialty pharmacy distribution, integrated delivery networks, formulary decision-making, and payment/access models., • Experience conducting market research to inform access strategy and positioning., • Experience providing input into global market access and pricing strategies for pipeline assets., • Excellent communication and presentation skills with the ability to present to diverse stakeholders, including external partners, HCPs, and senior leaders., • Strong organizational, project management, and problem-solving skills., • Ability to thrive in a fast-evolving environment., • On-site role (4 days per week) with approximately 20% travel to vendor partners and relevant conferences/meetings. Compensation Expected base salary range: $264,000 - $327,000, plus short-term incentive eligibility and equity participation. Final offer depends on experience, background, and interview performance.

Oncologist / Principal Investigator - Clinical Research leadership Location: Los Angeles, CA (relocation assistance provided) Employment Type: Full-Time, On-Site Salary: $700k-800k base salary, bonuses and incentives Overview We are representing an exceptional research-focused oncology organization seeking a Principal Investigator (PI) to oversee a highly experienced clinical team and drive breakthrough studies with biotech sponsors. This is a full-time, research-only role, offering the opportunity to guide cutting-edge oncology trials in a fast-growing, data-driven clinical environment. The position is ideal for an oncologist who wants to transition from purely clinical practice into a leadership role at the intersection of science, medicine, and industry, helping advance next-generation cancer therapies. Key Responsibilities • Serve as the Principal Investigator for oncology trials across multiple modalities and sponsors., • Provide medical oversight, ensure patient safety, and maintain protocol compliance and data integrity., • Supervise and mentor sub-investigators, nurse practitioners, and clinical operations staff., • Collaborate closely with sponsors, CROs, and internal study teams to drive enrollment and site performance., • Support scientific and operational strategy, SOP refinement, and future site development., • Participate in investigator meetings, safety reviews, and regulatory inspections. Ideal Candidate • MD or DO with board certification or eligibility in Hematology/Oncology (or related discipline)., • 2+ years post-fellowship experience (early-career attendings encouraged to apply)., • Demonstrated clinical excellence and the ability to manage oncology patients in a research setting., • Prior Sub-I or PI experience preferred but not required — full GCP training and mentorship provided., • Strong communication skills, collaborative mindset, and enthusiasm for research and innovation., • Must be committed to a full-time, on-site position. Why This Opportunity • Exceptional Organization — culture of scientific rigor, integrity, and collaboration., • Exposure to Cutting-Edge Oncology Programs — work on next-generation therapeutic approaches., • Leadership Trajectory — opportunity to expand into multi-site or network-level leadership., • Competitive Compensation — highly attractive package with relocation and performance incentives. This search is being managed exclusively by Plexus Partners. Interested candidates can submit a CV or express interest in confidence to:

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization. Reports to: Regional Business Manager / Regional Business Director Biocon – North America – Commercial Position Overview • The Sr. Territory Account Manager (TAM) serves as the primary commercial lead for a defined geography, responsible for driving strategic account growth across priority healthcare settings with emphasis on Oncology, Retina, and Immunology., • The role requires ownership of territory performance through sophisticated account planning, deep understanding of healthcare economics, and effective engagement of complex institutional and community-based stakeholders including health systems, integrated delivery networks, infusion centers, hospital outpatient departments, specialty clinics, and priority community accounts., • The TAM is expected to evaluate each account through clinical, operational, and economic lenses to identify growth opportunities, remove barriers to adoption, and accelerate portfolio performance. Success requires strong business acumen, disciplined execution, and the ability to align internal and external stakeholders to achieve sustainable market growth., • This role partners closely with National Accounts, Market Access, Medical, Marketing, and Sales Leadership to translate enterprise strategy into account-level execution while positioning Biocon for current and future specialty portfolio success. Core Responsibilities Strategic Territory Leadership • Own territory performance and deliver quarterly and annual sales objectives across Oncology, Retina, and Immunology as dictated by business priorities., • Develop and execute integrated territory business plans that prioritize accounts based on business opportunity, patient flow, access dynamics, and competitive potential., • Continuously assess territory performance and adapt strategy based on evolving market conditions, account movement, and portfolio priorities. Institutional Account Management • Lead strategic engagement across complex accounts including health systems, infusion centers, specialty clinics, hospital outpatient departments, and targeted community practices., • Map account stakeholders and decision pathways, including clinical, operational, pharmacy, reimbursement, and administrative influencers., • Build long-term business relationships with key decision-makers including physicians, pharmacy leadership, infusion directors, practice administrators, and reimbursement stakeholders. Business Acumen & Economic Understanding • Evaluate account opportunities through economic drivers including buy-and-bill dynamics, reimbursement confidence, margin sensitivity, formulary impact, and site-of-care economics., • Understand how operational priorities, treatment protocols, contracting environment, and financial considerations influence account decisions., • Translate account economics into actionable strategies that support adoption and long-term utilization. Specialty Portfolio Execution • Prioritize Oncology as the lead specialty focus while building capability and growth across Retina and Immunology., • Deliver specialty-relevant clinical, economic, and value messaging tailored to customer priorities and treatment environments., • Support launch readiness and market development for future specialty portfolio expansion. Cross-Functional Orchestration • Partner closely with National Account Managers to ensure contract pull-through and account progression., • Collaborate with Market Access, Medical, Marketing, and Commercial Excellence to align field execution with enterprise priorities., • Bring forward field insight, customer trends, and competitive intelligence to strengthen organizational decision-making. Opportunity Acceleration & Execution Discipline • Identify barriers to product adoption and lead coordinated plans to advance account progression., • Maintain disciplined CRM documentation in Veeva, including account plans, opportunity tracking, and business intelligence., • Optimize territory investments and resources to maximize return on effort and business impact. Compliance & Corporate Responsibility • Execute all territory activities in compliance with corporate policy, legal requirements, and industry regulations., • Identify and report adverse events (AEs) and product quality complaints (PQCs) according to company procedures and timelines. Background and Experience Required • Bachelor’s degree required; advanced degree preferred., • Minimum 7 years of pharmaceutical, biotech, specialty, or institutional healthcare sales experience preferred., • Demonstrated success managing complex healthcare accounts with multiple stakeholders and long sales cycles., • Strong specialty selling experience in Oncology preferred, with Retina and Immunology highly valued., • Proven understanding of institutional account management across health systems, infusion centers, specialty clinics, and buy-and-bill environments., • Strong understanding of reimbursement models, formulary processes, account economics, and site-of-care decision drivers., • Demonstrated business planning, prioritization, and strategic execution skills., • Strong analytical ability with capability to interpret business drivers and competitive opportunity., • Effective communication skills across clinical, operational, and financial stakeholders., • Proficiency with CRM systems (Veeva preferred), Microsoft Office, and virtual platforms including Microsoft Teams and Zoom., • Proven ability to work independently while collaborating effectively across cross-functional teams., • Strong adaptability, organizational discipline, and execution focus in evolving market environments., • Ability to travel based on territory needs, including occasional evening and weekend work., • Proficiency in speaking, reading, writing, and comprehending English is required.

Associate Director CMC Company Description: Revelation Biosciences, Inc. is a clinical-stage biotech company dedicated to restoring immune balance by targeting inflammation through its proprietary Gemini formulation. The company is advancing a diverse pipeline of programs evaluating Gemini across multiple indications, including the treatment of chronic kidney disease, prevention of post-surgical infections, and management of acute kidney injury. Position Overview The Associate Director of Chemistry, Manufacturing, and Controls (CMC) will lead the strategic development, manufacturing, and regulatory compliance of pharmaceutical products at Revelation Biosciences. They will oversee technical projects, manage CDMO partnerships, and author/review CMC documentation for regulatory submissions (IND, BLA/NDA) to ensure compliance with global health authorities. Duties and Responsibilities CMC Leadership: • Author, review, and manage CMC sections for INDs, CTAs, BLAs, and MAAs, ensuring compliance with ICH/EMA/FDA guidelines., • Act as the CMC regulatory lead across programs, driving timelines, identifying risks, and ensuring proactive mitigation strategies in a resource-constrained, agile environment., • Serve as the primary interface with Contract Development and Manufacturing Organizations (CDMOs). Education and Skills Requirements • Bachelor’s degree (or higher) in Chemistry, Pharmacy or related scientific field., • 5-10+ years in pharmaceutical CMC development, with 3+ years in regulatory affairs or project management., • Experience supporting early-stage and clinical development programs, ideally within small or emerging biotech companies., • Experience preparing and contributing to IND submissions and in regulatory requirements (FDA/EMA) for biologics or small molecules., • Proven ability to lead projects, collaborate cross-functionally and influence in a small team setting., • Strong communication and regulatory writing skills, with attention to detail., • Strong understanding of the drug development lifecycle, especially in early clinical development environments., • Ability to operate both strategically and tactically in a lean organization with evolving priorities.

Clinical Data Scientist – Hybrid or Remote Overview A growing organization in the healthcare and life sciences technology space is seeking a Clinical Data Scientist to support the final stages of its clinical data pipeline. This role focuses on transforming complex clinical datasets into clean, standardized, analysis‑ready deliverables for use in clinical research and regulatory submissions. The ideal candidate is detail‑oriented, technically versatile, and passionate about delivering high‑quality clinical data. You will work closely with cross‑functional teams—including Clinical Operations, Data Platform Engineering, and AI/ML teams—to ensure accuracy, traceability, and compliance across all data outputs. This role may be hybrid or fully remote; candidates in the SF Bay Area are preferred but not required. Key Responsibilities Data Transformation & Delivery • Convert raw, manually abstracted, and AI‑processed clinical data into standardized formats (e.g., CDISC SDTM/ADaM) or client‑specific data models., • Perform comprehensive data cleaning and validation checks., • Partner with engineering teams to automate data cleaning and validation workflows., • Follow all applicable privacy, security, and compliance requirements (e.g., HIPAA)., • Promote ethical handling of sensitive clinical data. Qualifications Education • Strong proficiency in SAS, R, Python, and SQL., • Familiarity with version control (Git) preferred., • Experience with CDISC SDTM/ADaM standards., • Demonstrated expertise in cleaning and stitching complex datasets., • Ability to work with unstructured text or NLP‑derived outputs is highly desirable., • Exceptional attention to detail and accuracy., • Strong written and verbal communication skills., • Travel: Up to 5%, • Compensation: Competitive salary range based on experience, qualifications, and location., • Eligible for equity, annual performance bonus, and comprehensive benefits.

Job Description Maintenance Technician- TalentZok OVERVIEW Are you looking for a new career opportunity with an exciting company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Maintenance Technician in San Diego, CA who possesses: • 3+years+ of maintenance technician experience for property management, • Set of own tools highly preferred, • Ability to perform routine maintenance and minor repairs for apartments Email resumes to or call 949.204.3861 FULL DESCRIPTION: Under the supervision of the Maintenance Supervisor, the Maintenance Technician is responsible for maintaining the physical condition and appearance of the site, related fixed and portable equipment and installation, and establishing a safe environment for the facility. The selected candidate will be responsible for: • Diagnoses and performs minor and routine maintenance/repairs involving the following, but not limited to:, • Interior/exterior lighting repair, • Minor plumbing repair, • Minor appliance repair, • Carpentry work, • Basic pool care, • Wall repair/painting, • Minor water irrigation systems, • Stairs, gates, fences, patios, railings, gutters, pool area, tile, spa, pool furniture, • Tile, carpet, flooring, • Fireplaces, ceiling fans, • Shutters, doors, cabinets, windows, sliding glass doors Door locks and locks, • Water Intrusion, • Repairs concrete, masonry roof, and fencing when required, • Assists with grounds work when necessary, • Provides highest quality of service to tenants, staff and visitors, • Routinely assists in performing duties to restore apartments to "market ready" status, • When conducting property inspections, including models, offices, vacant or occupied units, all employees have the responsibility of determining if any potential liability or safety hazards are present on behalf of the Company. Any potential liabilities should be reported to your Maintenance Manager., • Immediately corrects unsafe conditions (i.e., broken gates leading to pools, broken steps, open holes, broken/burned out exterior lights, etc.), • Inspects and maintain all tools in excellent condition, • Performs work area clean-up and safety-related duties, • Adhere to all safety procedures regarding the proper use of personal protective equipment (PPE) as tasks dictate, • Use safety equipment (goggles, masks, gloves, etc.) as tasks dictate, • Knows and adheres to all federal, state, and local laws as well as all policies and procedures, • Participates in standby emergency schedule for evening, weekend and holiday coverage, • Maintains regular and on-time attendance in the workplace, • Supports and follows operational policies and standards, • Supports and follows the safety program The selected candidate will also possess: • Constantly standing and/or walking, • Frequent bending/squatting/kneeling, • Frequent climbing of stairs and/or ladders, • Frequent reaching above shoulders, • Frequent grasping with left and/or right hand, • Frequent use of finger dexterity, • 2-3 years' experience in the maintenance field required., • Must have a valid driver's license., • Must have his or her own basic hand tools., • Knowledgeable and skilled in the safe use and maintenance of the following tools:, • Hand Tools: Various wrenches, screwdrivers, grips, sledgehammer, hammer, snips, posthole diggers, saws, etc., • Power Tools: Wrenches, grinder, sander, drill, saws, etc., • User-Moving Aids: Wheelbarrows, dollies, hand trucks, buckets, hoists, jacks, step-ladders, full ladders, double ladders, • Mechanical Equipment: Basic knowledge of motor equipment such as power washers, blowers and compressors, • Must be vaccinated against COVID-19. Salary Range: $23-$25/hr For immediate and confidential consideration, please email your resume to or call 949.204.3861. More information can be found at Company DescriptionTalentZok was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.TalentZok was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Executive Director or Sr. Director, Clinical Development (MD) On-site in San Diego, Remote if outside San Diego Must have an MD Must have extensive metabolic/endocrinology experience in industry Must have early clin development experience Overview The organization is seeking a senior physician leader with extensive experience in obesity and cardiometabolic drug development to establish and lead clinical strategy across its therapeutic pipeline. This role will provide medical and strategic direction for programs spanning early clinical research through late-stage development, with particular focus on obesity and related metabolic disorders. The Executive Director will guide the advancement of novel therapeutics by integrating clinical science, regulatory strategy, and operational execution. The successful candidate will have a proven record of leading complex clinical programs, influencing cross-functional teams, and delivering high-quality clinical data in a biotechnology or pharmaceutical environment. Key Responsibilities Clinical Strategy & Portfolio Leadership • Define and oversee clinical development strategy for obesity and metabolic disease programs across all phases of development., • Provide senior medical leadership for study design, conduct, and interpretation, including endpoints, patient populations, safety oversight, and benefit–risk evaluation., • Serve as the company’s internal medical authority for metabolic disease programs and advise executive leadership, project teams, and external partners., • Provide accountability for execution and quality of assigned clinical programs., • Oversee development of clinical protocols, amendments, and integrated development plans., • Ensure study deliverables are completed within timelines, budget, and quality expectations., • Serve as the senior medical representative in interactions with regulatory agencies for assigned programs., • Partner with Regulatory Affairs, Clinical Operations, Biostatistics, CMC, and Program Management to align development and submission strategies., • Lead medical contributions to key regulatory documents including INDs, investigator brochures, clinical study reports, and regulatory briefing materials., • Participate in regulatory meetings and health authority interactions (e.g., FDA, EMA)., • Lead collaboration across clinical operations, pharmacovigilance, translational sciences, biostatistics, and commercial teams., • Build relationships with key opinion leaders, investigators, and advisors in obesity and metabolic disease., • Medical degree (MD) required, • 18+ years of clinical development experience within the pharmaceutical or biotechnology industry, • Demonstrated experience leading clinical studies in obesity or metabolic disease, • Significant leadership experience, including oversight of teams or programs, • Track record of directing clinical programs across multiple development stages, • Strong understanding of drug development strategy, clinical operations, and planning, • Expertise in clinical data analysis and interpretation, • Familiarity with SOPs, GCP, ICH guidelines, and regulatory compliance, • Experience supporting regulatory submissions and agency interactions (IND, NDA/BLA), • Board certification in Endocrinology, Diabetes, Metabolism, or related specialty, • Experience within a clinical research or biotech operational environment, • Strategic thinking and program prioritization, • Strong cross-functional collaboration and leadership, • Effective decision-making and problem solving, • Organizational and communication skills, • Full-time position, • Competitive compensation based on experience, • Equity participation and performance bonus eligibility, • Retirement plan with employer match, • Medical, dental, and vision coverage, • Flexible spending programs, • Life insurance and employee assistance programs, • Paid time off and holidays

Job Responsibilities: • Negotiate contracts/pricing, • Purchase items/materials needed to support production, • Process order reqs, including POs, • Adhere to all compliance and ISO/GMP standards, • Identify, qualify & partner with suppliers, including int. suppliers, • Perform cost reduction analysis, • Address/resolve receiving/inspection/accounting issues with suppliers/clients, • Develop improved procurement/purchasing strategies/programs, • Review & monitor MRO, • Implement policies & procedures to track & report key metrics – support cost reduction & increased productivity, • Implement continuous improvement initiatives, • Research alternative sources for goods & materials, • Monitor market trends, competitor strategies & other suppliers, • Act as dept. POC, • Act as culture champion for the organization, • Other duties as needed Job Requirements: • 7+ years of relevant industry experience (Biopharma/Biotech experience highly preferred) – 2+ years international procurement/purchasing experience, • Bilingual (Spanish) required, • CPIM, CSCP or CPM Cert. preferred, • Excellent verbal & written communication skills, • Excellent strategic thinking, • Strong team leadership skills

Clinical Research Associate Location : San Diego, CA (Hybrid 1 day/week) Reports to : Associate Director Clinical Trial Management Job Type : Full Time FLSA : Exempt Company Overview Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company’s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications. Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide. Job Summary We are seeking an in-house Clinical Research Associate with oncology experience to independently monitor and manage clinical sites participating in studies with pegargiminase. No travel requirements are anticipated as all monitoring visits will be conducted remotely. Additional responsibilities will include support for the maintenance of monitoring related documents and trackers. The position will report to the Associate Director Clinical Trial Management and will be hybrid position requiring a minimum of one day per week in the San Diego office. We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible, and willing to take on additional responsibilities as required. Key Responsibilities • Support study monitoring startup tasks including the development of plans and manuals, training, reviewing, and approving essential documents, facilitating completion of clinical study agreements and shipment of investigation product., • Perform clinical monitoring activities to ensure that the clinical studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and applicable regulatory requirements, • Independently conduct monitoring visits to ensure accuracy of data entry with source documentation and perform study drug accountability or manage outsourced CRA performing these activities, • Review clinical site regulatory documents to ensure completeness and retrieve documents for the Trial Master File, • Maintain the internal Trial Master File and periodically review, • Support the preparation of project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries as required, • Monitor and track clinical research progress and provide status update reports, • Liaise with clinical sites and provide guidance on site/study issues Required Qualifications • Bachelor’s degree, preferably in science or healthcare, • Demonstrated clinical research experience with a minimum of 2 years monitoring experience in the biotech/medical diagnostics/pharmaceutical industry, CRO, or in a hospital setting with experience in oncology, • Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines, • Excellent written and verbal communication skills, • Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint, • Ability to work independently and prioritize multiple projects in a fast-paced environment. Physical / Work Environment • This role is mainly a desk role requiring proper ergonomics. Salary Range • Annual base salary: $80,000 to $110,000 Equal Employment Opportunity Statement Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.

Program Manager, Clinical - Biotechnology/Pharmaceuticals QUICK FACTS • Location: San Diego, CA 92130, • Pay range: $75 - $90/hr, • Shifts: Standard business hours, • Duration: Contract (6 months with high potential for extension or permanent placement)EXPERIENCE/EDUCATION YOU WILL NEED, • 10+ years in pharmaceutical/biotech program management, • Experience leading clinical development programs (IND/CTA, NDA/MAA), • Strong cross-functional leadership and vendor oversight skills, • PMP certification or equivalent preferred, • Ability to manage complex timelines, risks, and stakeholder communicationMAIN DUTIES OF THE JOB, • Lead and coordinate clinical development teams across multiple projects, • Develop and maintain Clinical Development Plans and schedules, • Manage risks, timelines, and external vendor relationships, • Support clinical program execution, ensuring milestones are met

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Senior Project Manager is a mid-level individual contributor responsible for managing defined projects and supporting broader programs within the medical diagnostics portfolio. This role ensures effective planning, coordination, and execution of project activities across functional teams. The Senior Project Manager plays a key role in driving project success through collaboration, problem-solving, and process discipline. The Responsibilities * Leads the execution of assigned projects within larger programs, ensuring delivery on time, within scope, and within budget. * Collaborates with teams across R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance & Marketing to align project activities and helps resolve issues. * Develops and maintains detailed project plans, timelines, and resource forecasts. Tracks progress and adjusts plans as needed. * Identifies project risks and issues early while working with stakeholders to develop mitigation and resolution strategies. * Maintain accurate project documentation and provide regular status updates to program leadership and stakeholders * Ensures all program activities comply with relevant regulatory standards (e.g., FDA, ISO, etc.). Maintains accurate documentation and audit readiness. * Translates business strategy into actionable program plans. Develops roadmaps, defines milestones, and manages interdependence across functions including R&D, Regulatory, Clinical Affairs, Quality, Operations, Finance, and Marketing. * Serves as the primary liaison between senior leadership and program teams. Facilitates communication, manages expectations, and ensures transparency across all levels of the organization. * Identifies potential risks and implements mitigation strategies. Leads change management efforts to ensure successful adoption of program outcomes. * Provides regular updates to senior leadership, including dashboards, KPIs, and executive summaries. * Champions best practices in program management. Drives process improvements and contributes to the evolution of the business portfolio. * Performs other work-related duties as assigned. Required: * Bachelor's degree in engineering, Life Sciences, Business, or related field. * PMP certification required or equivalent demonstrated capability. * 7+ years of experience in program/project management, preferably in medical devices, diagnostics, biotech, or healthcare technology. * Proficiency in project management tools (e.g., MS Project, Smartsheet). * Proven track record of leading complex programs with cross-functional teams in a regulated environment (e.g., FDA, ISO, etc.). * Strong business acumen, highly analytical, and strategic thinking. * Exceptional communication (verbal & written), negotiation, and influencing skills. * Ability to summarize complex project and technical subject matter into concise oral and written communications to Executive Management. * Knowledge of timeline and budget management, manufacturing design transfer, Risk Management & Design Control. * General knowledge of R&D, Regulatory, Clinical Affairs, Quality and Operations activities as they relate to the development of a medical device or product. * Demonstrates the ability to lead the program team from inception to product launch using corporate design control processes and procedures. Is able to tailor the design control processes & procedures to fit the specific project needs and circumstances. * Ability to work cohesively with multi-disciplinary scientific working groups. * Must be able to lead, manage, and communicate action items and results from and in meetings in a logical fashion. * Excellent prioritization, organization, and the ability to multitask. * Develop project execution strategy with the ability to independently manage ambiguity. * Experience in QSR (Quality System Regulations) and ISO medical device standards as well as a working knowledge of current FDA, IVDD, and other regulations. * Works independently with minimal guidance; influences across functions and levels. * Leads initiatives with significant business impact. * Solves complex problems requiring innovative thinking and cross-functional collaboration. * Travel: Must be willing to travel up to 10% domestic and international. * This position is not currently eligible for visa sponsorship. Internal Customers: * Finance on budgeting and resource planning. * Clinical Affairs for project deliverables. * Quality Assurance for project activities, design transfer and risk management. * Senior Management on project reporting and planning. * Interacts with Marketing on project deliverables. * Regulatory and Clinical Affairs on project deliverables and planning. * Operations and R&D External Customers: * Third-party vendors and suppliers * Project-specific development partners The work environment is a combination of laboratory, manufacturing, office, & remote home office. No strenuous physical activity, though occasional light lifting of files and related materials is required. 60% of time in meetings, working with team, or talking on the phone, 40% of the time at the desk on computer, doing analytical work. Occasional domestic and international travel required. Travel includes airplane, automobile travel and overnight hotel. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. The salary range for this position is $135,000 to $165,000. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___ #LI-AC1

Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation. MMR has offices in Canada, USA, and Asia. This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in the engineering and project management of equipment, systems and facilities for life sciences facilities. This role is based in San Diego, California. Some travel to other client sites is expected. This role is for a Building Automation Engineer (Siemens) to work on the design, project execution and commissioning of process systems in the biopharmaceutical industry. The ideal candidate should possess leadership skills to lead/mentor junior engineers, equipment vendors, and contractors. Responsibilities • Provide technical guidance into the design, project management, commissioning and start-up of automation systems, for upgrades, renovations and expansions of client facilities and processes. Concept Design, Basic Design, Detailed Design Procurement Construction Project Monitoring/Governance Commissioning & Qualification • The ideal candidate has experience in Building Automation Systems (BAS) such as Siemens Insight, Siemens Desigo in biopharmaceutical industry., • Prepare/perform/review electrical drawings, such as Panel Drawings, wiring diagrams, single line drawings., • Perform programming / configuration on BAS., • Review programming of equipment vendors and other automation firms, • Perform automation / electrical troubleshooting on electrical panels and control systems, • Facilitate work efforts with other disciplines such as Process Engineering, Mechanical, Validation, and client’s internal stakeholders., • Prepare/review User Requirements Specifications (URS), Functional Requirements Specifications (FRS), SDS, DDS, Valve & Alarm Matrices., • Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification., • Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates., • Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, and provide updates., • Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs)., • Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases., • Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc., • As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable, • Visit construction and installation sites., • Supervise contractors during critical installations of process equipment and associated utilities., • Excellent written and spoken English is required including the preparation of technical documents in English, • Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, Change Controls., • Knowledge of GAMP and data integrity requirements, • Engineering degree, preferably in Electrical, Electromechanical, Controls, Chemical, Mechanical Engineering or a related discipline., • Knowledge of Siemens Insight or Desigo, including reading code and making small code modifications., • Ability to read electrical drawings, and Siemens BAS Code (Insight or Desigo)., • Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity., • Possess mentorship skills, to coach and develop junior and intermediate employees., • Basic knowledge of AutoCAD is an asset. Salary range: 110,000$ -140,000$ based on experience. Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Previous Pharmaceutical/Biotech experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical /biotechnology and highly regulated industries. Its services include Engineering, Project Management, and Validation. MMR Consulting has offices across North America and Asia. This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The work will require working out of the client’s facilities in San Diego Area. Responsibilities • Provide technical guidance into the commissioning, start-up and operations of various pharmaceutical / biopharmaceutical facilities and utilities such as Chilled Water, Chillers, Steam/Boilers, Air Compressor, Heating Hot Water, and Ventilation & Air Conditioning (HVAC)., • Lead the commissioning deliverables such as drawings walkdowns - PFDs, P&IDs, equipment and distribution loop layouts, specification review, Commissioning Test Plans & checklists during the project lifecycle., • Able to support field installation and perform field execution of commissioning test cases., • Serve as technical SME on the commissioning aspects of utilities and facilities with industry best practices and guidelines., • Lead procurement, field installation, commissioning throughout the project lifecycle to ensure timely completion and to ensure all engineering specifications are met., • Support development of Project Commissioning Plans (PCPs) to ensure the action plan to test the system is applicable and relevant., • Coordinate meetings with cross-functional departments, to drive commissioning reviews, project progress, facilitate decisions, and provide updates., • Travel may be occasionally required for meetings with equipment fabrication vendors., • Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, and commissioning phases., • Visit construction and installation sites, wearing necessary safety PPE., • You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc., • Supervise contractors during critical testing of system and equipment., • Other duties assigned by client, and/or MMR, based on workload and project requirements., • As this position requires working on client sites, you will need to comply with the client’s safety rules, where applicable Qualifications • 5-8+ years of experience in commissioning of Mechanical Utility systems, such as Chilled Water, Chillers, Steam/Boilers, Air Compressor, Heating Hot Water, and Ventilation & Air Conditioning (HVAC) within the pharmaceutical/biotech industry or related industries., • Experience in developing and executing commissioning deliverables., • Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexities., • Engineering degree, preferably in Mechanical, Electrical or Chemical., • Travel may be required on occasion., • Ability to handle multiple projects and work in a fast-paced environment., • Strong multi-tasking skills Compensation: $110,000-$130,000 per year based on industry experience Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Number ICIMS-2026-10049 Job function Marketing Job type Full-time Location Werfen - San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 2nd Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Position Summary The Product Manager - Lab Automation and Workflow is responsible for the development and implementation of the global product strategy and associated marketing programs. The role focusses on Werfen's Autoimmunity Solutions, working in coordination with Business Line Product Managers, Global Systems Support, R&D, Operations, Quality, Regulatory, Medical Affairs, as well as with affiliates commercial teams. We are looking for someone passionate about continuous improvement and lean methodologies, workflow optimization, and who can have major impact on the growing success of our specialized Autoimmunity portfolio. The Product Manager uses sound judgment and decision-making to work independently within assigned accountabilities. Activities are performed in accordance with standard operating procedures (SOPs), Quality Systems Regulations (QSRs), safety, and administrative regulations and policies. Responsibilities Key Accountabilities • Prepare and coordinate global marketing programs related to lab automation and workflow., • Own the lab automation and workflow program and positioning for the Autoimmunity Business Unit, including understanding laboratory testing, workflow best practices, and opportunities to optimize overall Autoimmunity section performance., • Develop and deliver effective training programs and educational presentations for internal and external audiences, focused on lab automation and workflow., • Contribute to the planning, creation, and maintenance of analytical tools, advertising, and promotional materials., • Collaborate closely with affiliates' marketing, workflow, and sales teams worldwide to ensure successful implementation of the Autoimmunity workflow program, providing mentorship and supporting customer-facing activities., • Participate in formal and informal market research and report insights into the marketing management team., • Support and update global stakeholders-including Marketing, Sales, and customers-through clear and consistent communication., • Establish and nurture strong relationships with key stakeholders across Werfen affiliates, customers, R&D, Manufacturing, Supply Chain, Finance, RA/QA/QE, Clinical Software, Global Systems Support, and other Strategic Business Units., • Maintain and grow relationships with global workflow stakeholders and develop new connections across clinical and technical areas., • Develop and maintain competitive intelligence files, conduct competitive analyses, and serve as a subject matter expert., • Comply with applicable standard operating procedures (SOPs), ISO, FDA and other applicable Quality System regulations, as well as with applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies. Networking/Key Relationships This position requires extensive collaboration and partnership with multiple Autoimmunity and Werfen teams: • Research & Development, • Quality Assurance, • Regulatory Affairs, • Quality Engineering, • Manufacturing, Operations & Logistics, • Product Complaints Group, • Global Systems Support, • Finance Minimum Job Requirements Education • Knowledge in Life Sciences: Medical Technology, Biology, Biotechnology, Chemistry, • Minimum of three years of experience required in clinical laboratory and/or the healthcare/biotech industry, preferably in the in vitro diagnostics (IVD) sector, in one of the following functions: workflow project management, marketing, applications support, or other related, • Experience using lean methodology and analytics to accomplish measurable process improvement, • Knowledge of the clinical lab environment, ideally with in vitro diagnostics in an FDA-regulated environment required., • Ability to adapt to an evolving business and industry, leveraging previous knowledge, interpersonal skills, project management skills, and self-motivation., • Solid project management, decision-making, and organizational skills required., • Lean Six Sigma knowledge and practical, hands-on experience required., • Proven track record independently producing quality and timely work in a fast-paced environment with demonstrated agility, resilience, and initiative., • Comfortable working under multiple deadlines and priorities., • Demonstrated experience in successful use of excellent written and verbal communications, quantitative skills, and professional interpersonal skills required, including presentation skills and the ability to translate customer needs into product specifications., • Creative thinker with the ability to help promote novel reagents and systems in a crowded market highly preferred., • Knowledge of immunology and immunoassay technology is preferred, particularly with ELISA, chemiluminescent systems, or other solid phase technologies. Travel RequirementsUp to 30% of travel is required. Work 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. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. Other Duties and Acknowledgement: The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen. The annual base salary range for this role is currently $115,000 range to $140,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs. This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

Job Description Summary #LI-Hybrid (Balance of in-person and virtual working, with an average of 12 days a month on site) Internal Title: Principal Scientist II or Senior Principal Scientist Location: San Diego, CA Novartis is a leader in neuroscience with a robust and diverse pipeline of innovative therapies. We are seeking a translational modeler eager to accelerate oligonucleotide therapeutics ("xRNA"), including antibody-xRNA conjugates, from discovery through clinical translation. In this role, you will partner with multi-disciplinary teams to shape and lead optimization strategies and advance programs from candidate selection to first-in-human studies. As part of a truly translational modeling team, you will work closely with clinical pharmacology and pharmacometrics groups to support clinical programs, applying quantitative systems pharmacology (QSP) approaches to inform key decisions spanning early dose optimization through life-cycle management. This role reports to a Modeling and Simulation(M&S) team lead and is situated within Avidity Therapeutics, a Novartis company. Job Description Key responsibilities: • Act as the M&S representative on several programs. Develop and execute modeling strategies, contribute to project team discussions, and guide model-informed decisions from therapeutic design to first-in-human dose selection and beyond., • Build and apply mechanistic models (PK/PD, QSP, and PBPK/PD) that link drug pharmacology, tissue biodistribution, mechanism(s) of action, and downstream effects., • Integrate modeling into the design and interpretation of preclinical in vivo and in vitro studies to support candidate selection, optimization, and advancement towards the clinic., • Engage in strategic initiatives within M&S, such as developing translational modeling strategies for new platforms and modeling workflows that extend across multiple projects or coordinating modeling activities for a disease area., • Proactively seek opportunities to increase the understanding and adoption of translational modeling among internal partners and expand the impact and visibility of modeling through external collaborations. Essential requirements • Ph.D. in biology, bioengineering, pharmaceutical sciences, biophysics, or a related field. Master's degree with 5+ years of industry experience and demonstrated impact (e.g., publications) will be considered., • General Modeling Skills: Expert level proficiency in core modeling fundamentals is required, including scripting languages (e.g., MATLAB, R), construction of ordinary differential equation (ODE) models, parameter estimation, data visualization, and foundational data science concepts., • Industry Modeling Skills: Proficiency in pharmacokinetics and pharmacodynamics (PK/PD), quantitative systems pharmacology (QSP), and/or mechanistic physiologically based PK/PD (PBPK/PD) is required. Proficiency in pharmacometrics concepts (Population PK, exposure-response modeling) is preferred., • Domain Expertise: Prior experience with the integration of computational modeling and biological concepts is required. Experience modeling in the neuroscience disease area is preferred but not strictly required. Experience with oligonucleotide therapeutics (siRNA, ASO, PMO, etc.), antibodies, and/or antibody-drug conjugates (ADCs) is strongly preferred., • Collaboration and Communication: Demonstrated ability to communicate modeling results to a multidisciplinary audience for collaborative work and/or to facilitate strategy and decision-making. Fluent in English (oral and written). Candidates with demonstrated impact as a modeler, preferably in the pharmaceutical/biotech industry, and with commensurate experience and proficiency may be considered for the Principal Scientist II (3+ years) or Senior Principal Scientist (5+ years) role. This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered The salary for this position is expected to range between: Principal Scientist II: $126,000 and $234,000/ year Senior Principal Scientist: $152,000-$261,000/year The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click ___. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $126,000.00 - $234,000.00 Skills Desired Algorithms, Data Engineering, Innovation, Mentorship, Modeling And Simulation, Simulation Software, Waterfall Model

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future. To strengthen our team in San Diego, we are looking for you as a(n) Director of Business Development - BioPharma. The Director of Business Development, Biopharma - U.S. Market is a senior commercial leader responsible for driving revenue growth, expanding market penetration, and strengthening strategic customer relationships across the United States. This leader will oversee all U.S. commercial activities for Wacker's CDMO offerings, including pDNA, mRNA, and microbialderived protein services across early and latestage programs. This role requires a visionary, resultsdriven leader with deep experience in the U.S. biopharmaceutical ecosystem, strong customer networks, and a proven track record of building and developing highperforming business development, account management, and technical commercial teams. The Head of Business Development will shape and execute regional gotomarket initiatives, foster a culture of excellence and customercentricity, and position Wacker Biopharma as a trusted partner for innovative biologics development and manufacturing. Key Responsibilities • Develop and implement a comprehensive U.S. regional sales strategy aligned with global commercial objectives, focused on revenue growth, market penetration, and profitability across Biopharma CDMO capabilities (pDNA, mRNA, and proteins derived from microbial expression systems)., • Recruit, lead, mentor, and develop a highperforming regional sales organization, including Business Development Managers/Account Managers, and Subject Matter Experts; foster a culture of accountability, continuous improvement, and customer success., • Drive strategic business development initiatives that identify new opportunities, expand the customer base, and strengthen Wacker Biopharma's presence across U.S. biotech and pharmaceutical hubs., • Establish ambitious sales targets, implement robust forecasting methodologies, and manage the regional sales pipeline to consistently meet or exceed revenue goals., • Monitor regional market trends, competitive activity, customer needs, and emerging technologies to inform strategic planning, product development, and marketing programs., • Partner closely with Marketing, Project Management, R&D, Operations, and Legal to ensure seamless gotomarket execution, new offering launches, and differentiated customer experiences., • Manage strategic key account relationships, ensuring exceptional service delivery and identifying opportunities to expand longterm partnerships., • Develop and manage the U.S. regional sales budget, optimizing resource allocation to enhance sales efficiency and commercial ROI., • Oversee the effective use of CRM systems (e.g., Salesforce), ensuring data integrity, reporting accuracy, and continuous refinement of commercial processes., • Perform other duties as assigned Job Qualifications: • Bachelor's degree required; advanced degrees preferred., • Minimum of 10 years of experience within life science commercial or business development organizations., • Proven ability to translate market knowledge into impactful sales strategies and execution plans., • Strong financial competence, including experience with sales forecasting, budgeting, and commercial analytics., • Outstanding leadership, coaching, and teambuilding capabilities across multilayered commercial functions., • Exceptional communication, negotiation, and presentation skills, with the ability to influence at all organizational levels., • Deep understanding of the sales cycle for complex biologics CDMO services and solutions., • Proficiency in CRM software (e.g., Salesforce) and sales analytics platforms., • Ability to excel in a fastpaced, complex, and globally integrated environment., • Demonstrated track record of consistently exceeding sales targets and driving significant revenue growth in a competitive market., • Proven experience leading and developing teams that include Business Development, Account Management, and technical Subject Matter Experts., • Experience with direct sales models and channel partner management., • Ability to travel as required. Key Experience • Strong hunting and prospecting abilities with proven pharma/biotech business development or direct sales experience and a robust network within innovative biopharma communities across North America (and ideally Europe/Asia)., • Strong negotiation and presentation skills, business acumen, and commercial judgment., • Experience using Salesforce or similar CRM systems to manage leads, pipelines, and opportunities., • Excellent interpersonal and communication skills; adaptable, selfmotivated, and capable of working independently., • Strategic and critical thinker with the ability to process market insights, identify opportunities, and design effective commercial strategies., • Highly collaborative, able to operate effectively within a matrix organization and motivate colleagues across global locations., • Foundational understanding of biologics manufacturing and core scientific concepts related to bioprocessing and biotherapeutics (e.g., proteins, antibodies, DNA, gene therapies, cell therapies)., • Foundational understanding of intellectual property considerations across North America/Europe/Asia., • Foundational understanding of the regulatory environment affecting pharma/biotech in North America/Europe/Asia. The anticipated salary range for candidates who will work in San Diego is $205,000-220,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi state employer and this salary range may not reflect positions that work in other states. What do we offer? WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development. • Compensation and Incentive plans, • Medical, Dental, and Vision Insurance effective day 1, • Paid Time Off in addition to personal days and holidays, • Paid parental leave, • Wellbeing fund, • Flexible hybrid work arrangements, • 401(k) with company match, • Education Assistance Program, • Career development and advancement opportunities Wacker is an Equal Opportunity Employer. We actively promote the equality of opportunity for all who are qualified and bring the requisite experience, talent, skill and potential, without regard to age, disability, sex, race, religion or belief, marriage/civil partnership, pregnancy/maternity, sexual orientation, or any other protected characteristics. We welcome all applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

Job Description Summary The Biotherapeutics Analytics and Bioanalytics group in Novartis San Diego is seeking a Principal Scientist to join the Biologics Research Center. The primary responsibility of this role is to develop and apply fit-for-purpose analyses of ex vivo samples to enable early-stage project teams to address key scientific questions required for successful project progression. Although the group supports projects deploying a wide variety of biotherapeutic modalities (antibodies and smaller formats, multi-specifics, protein conjugates, recombinant proteins and both cell and gene therapy, the initial focus of this position is the targeted delivery of nucleic acid modalities to various cell types of interest. The ideal candidate is a hands on bench scientist who can interact with various project teams to define stage-appropriate analyses, work with junior associates to jointly implement the required measurements, and present the results to the project team to enable decisions. Job Description Internal Job Title:Principal Scientist I Position Location: onsite, San Diego,CA #LI-onsite *This role is based onsite in San Diego, CA. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. The Biotherapeutics Analytics and Bioanalytics group in Novartis San Diego is seeking a Principal Scientist to join the Biologics Research Center. The primary responsibility of this role is to develop and apply fit-for-purpose analyses of ex vivosamples to enable early-stage project teams to address key scientific questions required for successful project progression. Although the group supports projects deploying a wide variety of biotherapeutic modalities (antibodies and smaller formats, multi-specifics, protein conjugates, recombinant proteins and both cell and gene therapy, the initial focus of this position is the targeted delivery of nucleic acid modalities to various cell types of interest. Key responsibilities: * Interact with early-stage discovery teams to understand goals and current challenges faced by the project * Propose fit-for-purpose analyses best suited to address question at hand * Implement effective sample analyses pipelines to process and analyze ex vivo samples from numerous projects * Assign/oversee the work of more junior associates in addition to their own bench responsibilities * Collate results and explain implications to the research team * Explore opportunities in both equipment and digital automation to increase sample throughput Essential Requirements: * BS or MS degree in an applicable life sciences field, with 10+ years' experience working in a research laboratory in the biotech/pharma industry, or PhD with 2+ years of related industry experience. * Demonstrated experience supervising junior level associates (or supervision of outsourced work). * Demonstrated experience developing and running nucleic acid-based analyses from both in vitroand ex vivosamples (mRNA knockdown assessment, stem loop qPCR based measurements, ddPCR etc.). * Effective collection, documentation, processing and interpretation of data from multiple experiments followed by independent design of the next experiment. Desirable Requirements: * Experience with classical protein and biotherapeutic analytical techniques including ligand binding assay development. * Working understanding of various modes of chromatography and protein mass spectrometry. The salary for this position is expected to range between $108,500 and $201,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills andexperience, and upon joining Novartis will be reviewed periodically. Novartis may change the publishedsalary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of therole, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life anddisability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Inaddition, employees are eligible for a generous time off package including vacation, personal days,holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click ___. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $108,500.00 - $201,500.00 Skills Desired Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curious Mindset, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Drug Development, Drug Discovery, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory, Lifesciences, Machine Learning (ML), Management, Medical Research, Molecular Biology {+ 10 more}

Job Description Summary #LI_Hybrid Location: Cambridge or San Diego (USA) We are seeking an enthusiastic and motivated PK Sciences project team representative to develop and implement translational or clinical pharmacology strategies to support the pursuit of transformative new medicines through late clinical development. Our unique organizational structure enables colleagues to work seamlessly in the translational and/or clinical space, offering opportunities for development and bench-to-bedside-to-bench translation. Experience in late discovery into clinical development is preferred. The scope of the role potentially includes small molecules, biologics/therapeutic proteins, antibody drug-conjugates, radioligand therapies and/or cell therapies across major therapeutic areas in Novartis, including oncology, immunology, cardiovascular renal metabolism, neuroscience, and global health. This position drives close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), and Operations through PK science sub-teams to achieve a holistic and integrative perspective of the ADME/clinical pharmacology properties of candidates and drugs. Collaborates effectively with broader, crossdisciplinary project teams to ensure PKS strategies are well integrated into project plans and scientific discussions. Job Description Key responsibilities: • Represent the PK Sciences function in project teams, interactions with stakeholders within the organization and interactions with regulatory agencies, as appropriate, • Proactively contributes to developing drug candidates across Research Development and Commercial continuum, providing expert pharmacokinetic / drug metabolism and clinical pharmacology input, • Work with teams to elucidate the understanding of PK/PD relationships and develop dosing strategies and predictions, • Develop and execute clinical pharmacology strategies, including input into nonclinical and clinical study design, and analyzing PK and PK/PD data, to support compound development from discovery through late development, • Provide PK, dosage, and PK/PD components of study protocols, reports, project summaries and development plans, and author pharmacokinetic/clinical pharmacology/biopharmaceutics sections of IND/IMPDs and NDA/BLAs as well as prepare appropriate responses to Health Authority questions, • Drive close interdisciplinary collaboration among the PK Science disciplines, Drug Disposition (ADME, BA), Modeling & Simulation (M&S), through PK science sub-teams., • Works in close collaboration with clinicians and clinical development colleagues to integrate PKS insights into study design, data interpretation, and project decisionmaking, • Use of Artificial intelligence (AI) / Machine Learning (ML) approaches to enable model guided molecular design, preclinical and clinical data automation, authoring regulatory documents, and the use of predictive models This role reports to Therapeutic Area group in PK Sciences within Translational Medicine (TM) in Biomedical Research. PKS is a global organization situated within Translational Medicine (TM), the clinical research arm of Biomedical Research within Novartis. PK Sciences plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, bridging drug discovery and clinical application. PK Science is an enterprise-wide organization, working across both Biomedical Research and the Development organizations to advance the scientific knowledge of pharmacokinetics, metabolism and clinical pharmacology. Essential requirements: • Ph.D. / Pharm.D. with relevant experience in clinical pharmacology, drug metabolism and pharmacokinetics or a related background., • A minimum of 0-2 years of experience in drug discovery and/or development in a relevant environment (academia, CRO, biotech or Pharma). 2+ years of experience preferably in a lead role overseeing ADME/DMPK project strategy, either in discovery or clinical development to be considered for Principal Scientist II, • Extensive and in-depth knowledge of pharmacokinetics including, drug metabolism and PK/PD evaluation, experience in working in project teams (preferably global) as well as sound awareness of recent developments in drug development and regulatory sciences., • Exposure to working in a cross-functional, matrixed, project-team environment., • Strong oral and written communication skills. Desirable Requirements: • Hands-on project experience with Artificial intelligence (AI) / Machine Learning (ML) approaches is a plus Leadership / Novartis Behaviors in Action • Delivers results through disciplined execution, continuous improvement, and a strong focus on value and outcomes., • Demonstrates an enterprise mindset and strong ownership by prioritizing resources and decisions for maximum Novartis and patient impact., • Role models Novartis leadership behaviors through visible actions, continuous self reflection, and openness to feedback, • Builds trust through transparent communication, clear accountability, and consistent delivery against commitments. AI fluency: • Brings strong AI and digital fluency, using enterprise tools to enhance insight generation, decision making, and team productivity. This is a dual posting. The final level & title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered. The salary for this position is expected to range between: Principal Scientist I: $108,500 and $201,500 per year. Principal Scientist II: $119,700 and $222,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $108,500.00 - $201,500.00 Skills Desired Chemistry, Clinical Pharmacology, Clinical Research, Drug Discovery, Initiative, Medical Research, Patient Care, Physiology, Quality Control, R&D (Research And Development), Simulation Software, Translational Medicine

Job Description Summary #LI-Hybrid Internal job title: Executive Director Location: San Diego, California USA As the Head of Neuromuscular Diseases within Translational Medicine, you will serve as a senior scientific and strategic leader responsible for shaping and delivering the translational strategy for neuromuscular and neurogenetic therapeutic programs. You will provide expert guidance bridging research, early clinical development, and biomarker/experimental medicine innovation to advance assets from discovery through proof-of-concept and into full development. In addition, you will lead or integrate global, cross-functional teams to design, implement, and execute cutting-edge translational strategies, and act as an influential thought partner in neuromuscular disease biology, clinical development, and emerging therapeutic modalities. Job Description Key Responsibilities: Strategic Leadership & Scientific Direction • Define and oversee the long-term translational strategy for the Neuromuscular Pillar, ensuring scientific excellence and alignment with broader BR and TM organizational priorities., • Serve as a senior advisor and thought leader within neuromuscular disorders, leveraging deep specialty expertise to inform program design, biomarker strategy, and patient-relevant endpoints. Program & Portfolio Leadership • Lead global translational teams across Phase I-IIa ("Discovery" through TDP), driving implementation of highquality development strategies in single or multiple neuromuscular indications., • Represent TM on global program teams (GPT) and decision boards, ensuring that neuromuscular programs meet quality, regulatory, and differentiation objectives. Translational & Clinical Development Excellence • Lead the design and execution of FirstinHuman (FIH) and Phase IIa studies, working collaboratively with clinical, regulatory, biomarker, and profiling partners., • Leads the creation of clinical components of key documents e.g., Clinical Trial Protocols (CTPs), Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents etc. with high levels of quality and consistency Leadership of People, Culture, and Matrix Teams • Serve as a culture champion, promoting empowerment, innovation, and collaboration across TM and broader BR organizations., • Mentor and develop scientific talent across translational and clinical functions. External Impact & Partnerships • Lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders, • Contribute to opportunity assessments and due diligence for neuromuscular and adjacent therapeutic areas. Governance, Compliance & Documentation Essential Requirements: • MD and PhD required with clinical subspecialty training in neurological diseases with deep expertise in neuromuscular disorders and gene therapies, • A minimum of 10-15 years of extensive experience in translational medicine, early clinical development, or experimental therapeutics., • Demonstrated success leading complex global programs and cross-functional scientific teams., • Proven ability to shape development strategies, execute early clinical studies, and influence regulatory/packages supporting differentiation., • Experience working in pharmaceutical/biotech company strongly preferred. Desirable Requirements: • Direct people management experience The salary for this position is expected to range between $288,400 and $535,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills andexperience, and upon joining Novartis will be reviewed periodically. Novartis may change the publishedsalary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of therole, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life anddisability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Inaddition, employees are eligible for a generous time off package including vacation, personal days,holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $288,400.00 - $535,600.00 Skills Desired Clinical Decision Making, Clinical Research, Clinical Trials, Disease Area Knowledge, Drug Development, Leadership, People Management, Risk Management, Strategy Development

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future. To strengthen our team in San Diego, we are looking for you as a(n) Marketing Leader. The Marketing Leader for Wacker Biopharma is responsible for developing and overseeing the execution of the marketing plan for driving market share gain in the development and manufacturing of Biologics including but not limited to Microbial Proteins, pDNA, mRNA and other therapeutics and related workflows. This includes segmenting the market, developing targets and aligned value propositions and channel campaign focused on driving business throughout the commercial funnel. Reporting directly to Global Head of Commercial, this role drives strategic marketing initiatives, leads market insight activities, and partners crossfunctionally to enhance Wacker's overall value proposition across the industry. Key Responsibilities Strategic Marketing Leadership • Define, implement, and continually refine the global marketing strategy for Wacker BioPharma., • Develop cutting-edge, multichannel marketing campaigns that elevate Wacker's market presence and support commercial objectives. Market Intelligence & Competitive Analysis • Conduct detailed market, customer, and competitor analyses to identify emerging trends, growth opportunities, and potential risks., • Translate insights into actionable strategies that support commercial objectives and innovative initiatives. Brand Positioning & Value Proposition • Collaborate closely with the commercial team, corporate communications, and innovation teams to craft and optimize a compelling value proposition for Wacker's BioPharma services., • Ensure consistent messaging and brand alignment across all communication channels and materials. Events, Trade Shows & Industry Presence • Lead the planning, management, and execution of Wacker's presence at industry trade fairs, congresses, conferences, and exhibitions., • Represent Wacker at key global industry events, strengthening relationships with partners, customers, and thought leaders., • Ensure strategic participation that maximizes visibility, lead generation, and brand impact. Campaign Performance & Reporting • Monitor, track, and report on the effectiveness of marketing activities, campaigns, and event performance., • Derive optimization measures to continuously improve marketing ROI and operational efficiency., • Implement KPIs, dashboards, and data-driven processes to guide decision-making. Team Leadership & Cross-Functional Collaboration • Lead and develop the marketing team to deliver high-quality, timely, and impactful marketing outcomes., • Foster strong collaboration with Sales, Corporate Communications, R&D, and Executive Leadership to ensure aligned goals and coherent market presence. Job Qualifications: • Degree in Marketing, Business, Life Sciences, or related field; advanced degree preferred., • Extensive experience in B2B marketing within the biopharma, biotech, CDMO, or life science sector., • Proven track record of strategic marketing leadership and execution., • Strong analytical skills with ability to translate insights into effective action., • Excellent communication, leadership, and stakeholder-management abilities., • Professional communication skills both written and oral as well as listening., • Interpersonal flexibility and versatility to work independently but also collaborate proactively within a matrix team organization., • Strong aptitude to learn and grow job related knowledge, • Solid computer and large data handling skills, SAP & SalesForce experience is preferred, • High level of interpersonal and influential leadership skills (multi-cultural, multi-functional teams) are needed to be effective in this position. The anticipated salary range for candidates who will work in San Diego is $165,000-$190,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi-state employer and this salary range may not reflect positions that work in other states. What do we offer? WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development. • Compensation and Incentive plans, • Medical, Dental, and Vision Insurance effective day 1, • Paid Time Off in addition to personal days and holidays, • Paid parental leave, • Wellbeing fund, • Flexible hybrid work arrangements, • 401(k) with company match, • Education Assistance Program, • Career development and advancement opportunities Wacker is an Equal Opportunity Employer. We actively promote the equality of opportunity for all who are qualified and bring the requisite experience, talent, skill and potential, without regard to age, disability, sex, race, religion or belief, marriage/civil partnership, pregnancy/maternity, sexual orientation, or any other protected characteristics. We welcome all applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

Join Human Longevity and be a part of revolutionizing the future of medicine! Healthcare, reimagined. Proactive. Precise. Personalized. About Human Longevity At Human Longevity, our mission is to revolutionize medicine by bridging the gap between health span and life span, where our members continue to enjoy optimal health and functionality well into 100+. We provide preventative, predictive and personalized longevity precision medicine that enhances performance and functionality. Our goal is to help our clients enjoy every facet of life by empowering them with technology input and actionable health plans. At Human Longevity, we believe in the science behind longevity medicine, not sensationalism. Our AI-data driven longevity platform blends data and cutting-edge science to create personalized goals for our members, delivering exceptional care all in a relaxing luxurious environment. What is the opportunity? The Physician will report to Medical Director of clinic location, with oversight by leadership of Nucleus Medical Group (medical group partnered with Human Longevity). They will assume responsibility for a wide scope of care, including ordering and evaluating tests as well as performing treatments as clinically indicated. They will be responsible for delivering the longevity precision medicine to our members as set forth by the leadership team. This role requires a focus on optimal proactive preventive care, longevity medicine guidance, optimization of client retention, and passion in growing our AI technology as well as furthering longevity science. Join our team of highly trained, passionate clinicians! What’s in it for you? You will be working with world renowned specialists and longevity trailblazers. From Dr. Craig Venter to our Buck Institute partnership along with our internal team of medical leaders, Human Longevity is a place where clinicians not only save lives daily, but can also thrive in knowledge-based growth, connections to community thought leaders, and scientific advancements. As our team members are essential to the lives of our members and also to our company, you will receive the full membership advantages of Human Longevity for your own personal health as well. Our passion is in extending not just the lives of our members, but also of our team members. What will you do? The Physician will provide advanced clinical medical care in the examination, assessment, and provision of comprehensive care for our members. Our clinicians maintain a clean work environment as well as positivity towards staff and assist in tech as well as clinical developments of our company. Clinicians also are responsible in directing and coordinating the activities of medical assistants they work with, while consulting with and taking direction from medical director. A harmonious work environment is crucial to our company. We encourage mutual learning from all of our clinicians. Tasks and Responsibilities • Provide precision medicine-based concierge longevity care to roughly 200 clients, • As the client’s private longevity precision medicine physician, he/she is responsible for providing client’s medical and health management services, • Participate in the Nucleus Medical Group, focusing on day-to-day clinical operations and development, as well as personalized, prevention focused medical care and targeted health promotion services, • Provide regular clinical support within the practice and also via telemedicine modalities (e.g. phone, email, video chat), • Provide direct clinical oversight to a group of pre-assigned clients; assure high client satisfaction and high client retention rate, • Coordinate with HLI’s Care Delivery System daily to deliver medical care and to support client’s consultation services with medical specialist, • Supervise a team of nurses, technologists, and clinicians in a client-centered model, help clients set health goals, and support daily clinical work, • Help contribute to consolidated report development for quality control purposes, • Regularly review and deliver consolidated reports to clients and develop health goals, • Provide clinical management for clients in collaboration with multidisciplinary internal and external clinician partners, • Assist in training and development of internal and external longevity precision care and specialist physicians committed to delivery of genomics-based, technology-driven medicine Minimum Qualifications (Must have) • 10+ years of experience working as a primary care-oriented physician with background in internal medicine or family practice, • Have the passion and skills to delight clients with service-oriented approach and empathetic client interaction., • Board Certified or pending Board certification in Internal Medicine or Family Medicine. Other certifications considered on a case-by-case basis., • Must have or be willing (and qualified) to obtain an unrestricted medical license for California, • Commitment to practice of science-based medicine, • Demonstrate ability to manage, motivate, and empower diverse clinical teams, • Interest in or relevant experience in implementation of innovative medical care models, • Excellent communication skills, • Strong leadership and team-oriented with excellent interpersonal skills. Preferred Qualifications • Functional and/or Integrative Medicine training, • Experience working in direct pay or concierge medical settings, • Able to thrive in an often ambiguous, challenging, and fast-paced environment, • Experience in working with early stage medical or biotech companies, • Health coaching and behavioral change training, • Knowledge of clinical genetics Compensation Package • Competitive compensation and benefits, • Plus Stock Options What do you need to succeed? To ensure success, the Physician will be detail-oriented with the ability to deliver care in a compassionate manner; personalizing care that ensures optimal health and comfort. Collaboration amongst departments of services and care are crucial in our clinician’s success as well as the success of our company. We also encourage our physicians to engage in technological and medical advancements and developments. Human Longevity, Inc. is an equal opportunity employer DISCLAIMER: The information on this description has been designed to indicate the general nature and level of work. It is not designed to be interpreted as a comprehensive inventory of all duties and responsibilities of an employee to this job.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing. In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years. We're looking for a strong business developer with experience in the drug discovery space to join our team! As a Business Development Manager overseeing key accounts, here's what you'll do: • Will be responsible for sales of Eurofins Discovery full portfolio comprised of chemistry, pharmacology, both products and services within assigned key accounts by maintaining current business, expanding to new therapeutic areas and gaining new revenue from other portfolio offerings., • Maintain a proficient understanding of the drug discovery process and selling the portfolio to the US client base., • Prospect within key accounts for the client persona that requires services or products for use in drug discovery., • Build client relationships through use of strategic selling skills and various collaborative approaches with frequent client visits and business reviews., • Provide recommendations and feedback for operational strategy needed to meet client requirements., • Develop key account business plans to grow account-by-account on a strategic basis and monitor against the goals of the plan on quarterly basis. This includes developing KPIs for accounts to demonstrate success in growing the portfolio of business. Pivoting the plan based on changes in customer need as pertinent and working closely with the operational sites within Eurofins Discovery to adopt to customer requirements., • Report on and strategize on competitor activities observed in the region/ globally., • Provide monthly reports against key metrics as defined., • Develop collaborative relationships with Sr. Leaders of the Eurofins Discovery companies in order to support their business and gain knowledge from them about the business., • Work closely with Eurofins sales teams that have relationships with the strategic account in other regions around the globe to effectively implement the account strategy., • Work closely and collaboratively with Marketing to design and implement territory and regional strategies to promote the portfolio and the Eurofins Discovery brand., • Utilize sales and marketing channels effectively including web site, ecommerce, marketplaces and participate effectively and proactively in customer events such as webinars, tradeshows and customer site events., • Travel approximately 30-50% of the time. What we are looking for: • 5+ years’ of experience in field sales with strong understanding of drug discovery and in particular discovery chemistry., • Experience developing and managing large key accounts typically pharma and biotech., • A minimum education of a B.S. chemistry or pharmacology or related discipline and 5 years of sales experience in selling products and services for drug discovery. Excellent knowledge of the pharmaceutical drug discovery and development process, preferably but not necessary to have worked in drug discovery., • Understanding and prior experience in the CRO market and proven ability to analyze and act on the global business trends to drive regional business development activities., • Strong presentation skills. Collaborative nature to work with multiple internal stakeholders., • Ability to endure normal travel to customer sites via mass transportation, personal car, and air travel., • Ability to travel internationally to major regions around the globe with limited restrictions (sales meetings, customer visits, training and customer audits) Salary Range: $125,000 - $150,000/yr. The position is full-time, Monday-Friday, 8 a.m.- 5 p.m., with overtime as needed. • Excellent full time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job Description Summary #LI-Remote This is a field-based and remote opportunity supporting key accounts in an assigned geography. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible to you. Company will not sponsor visas for this position. As the Director, Oncology Priority Accounts at Novartis, your role is customer-facing, leading major accounts and improving market access for our product portfolio by implementing brand strategies with key national and regional customers to achieve targets and gain market share. Your duties include managing relationships with senior partners at target accounts, comprehending their needs, and fostering mutually advantageous solutions through crafting and carrying out business plans for those accounts. Job Description Key Responsibilities: • Understand the needs of the customer at all levels from departments to C-suite, while utilizing insights to proactively anticipate, leveraging and navigating the trends that are impacting the business and has ability to clearly articulate business insights and priorities to deliver appropriate outcomes., • Craft strategic approaches to further Novartis goals, catering to the account's interests and needs, and fostering key customer relationships that enhance Novartis' interaction with the account., • Leads strategy and execution prior to and during launch, by coordinating collaboration among headquarters, account, and regional leadership teams., • Pinpoint chances to collaborate and interact with account executives at the C-suite and D-suite levels, acting as the main oncology contact for Novartis account partners to facilitate exchanges with executives and headquarters., • Foster teamwork across different departments to enhance involvement from various functional areas and establish connections with stakeholders in different roles to proactively solve problems and remove obstacles., • Owns account performance with care and accountability, bringing a performance-driven mindset to achieving meaningful results., • Facilitate efficient communication between Novartis and key accounts, along with internal team coordination, Customer Engagement executives, and other sectors within Novartis. This entails predicting and actively relaying strategic changes that align with the company's objectives and vision, thereby inspiring teams to adjust positively and assuredly., • Tasked with several high-priority accounts, at least one will be notably complex, highly visible, and have a major influence on Novartis Oncology. Essential Requirements: • Bachelor's degree required from 4-year college or university., • 10+ years' experience in pharmaceutical, biotech, healthcare, or similarly structured industries with large, geographically dispersed teams; inclusive of at least 2 different types of cross-functional roles and / or experiences. We also welcome candidates from other complex environments such as medical devices, diagnostics, life sciences services, insurance, consumer health, or B2B sectors, especially where strong field leadership and customer engagement are central to success., • 2+ years in project management and translation of strategy into execution., • 2+ years leading complex projects requiring cross-functional and national alignment., • Track record of exceptional performance and execution that drives results, embodies strong influencing skills, and the ability to exercise tact and diplomacy in stressful situations., • Candidate must reside within territory, or within a reasonable daily commuting distance of 100 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license. Desirable Requirements: • 3+ years in account management covering Academic Medical Centers, Integrated Health Systems, GPOs, and/or large community oncology integrated networks., • Experience working within the oncology therapeutic area, bringing insight and expertise to support meaningful impact for patients and partners. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to ___. For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Novartis Compensation Summary: The salary for this position is expected to range between $185,500.00 and $344,500.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $185,500.00 - $344,500.00 Skills Desired Accountability, Commercial Excellence, Competitive Intelligence, Complexity Management, Compliance, Cross-Functional Collaboration Leadership, Customer Engagement, customer relationship management, Enterprise Sales, health care industry, Integrated Marketing, Key Account Management, Market Development, problem solving techniques, Professional Ethics, Revenue Growth, Sales Strategy, Selling Skills, Strategic Leadership, Value Propositions

Number ICIMS-2026-10209 Job function QA&RA Job type Full-time Location Werfen - San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 1st Introduction Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary The Document Control Supervisor is responsible for overseeing the daily activities of the Document Control group. Oversees all activities associated with change orders, SAP training sessions, quality plan tasks, document and record processing, metrics, artwork for labeling, and other tasks that help to achieve department objectives. Works closely with other Quality & Regulatory teams, other departments, and management to ensure activities effective operations. Resolves procedural and process issues as well as recommends ares for improvement. Manages direct reports to comply with company policies and meet department goals. This position is the subject matter expert in document control processes and procedures. Ensures all work is completed in accordance with Inova Quality Management System. Responsibilities Key Accountabilities The main responsibilities of this role include: • Regulatory Compliance & Quality Management: Maintains a strong understanding of document control requirements within Quality Management Systems (QMS) and ensures compliance with changing regulations. Includes overseeing the document lifecycle and ensuring all Change Orders (CO) meet established requirements for accurate completion and implementation. Responsible for maintaining compliance with relevant regulations and procedures. Supports and represents department during audits and regulatory inspections, collaborating with Regulatory Affairs to ensure submissions meet all requirements., • Document Control Processes: Manages and optimizes document control processes, including efficient handling of Cos to ensure errors, inconsistencies, and delays are minimized. Drafts, updates, and trains staff on Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains expertise in SAP for document-related transactions, including those related to the Material Master. Determines appropriate document types, manages document formats, and provides administrative guidance to ensure accuracy and efficiency of document management across various platforms, including Word, Excel, and PDFs. With stakeholders, manages the creation and maintenance of document control processes related to Product Lifecycle. Overees scheduling and organizing SAP training and Quality related training plans and ensures training records are maintained. Develops, maintains and reports document control and SAP and Quality related training metrics., • Labeling and Translation Processes: Responsible for the product labeling processes to ensure all labeling materials meet regulatory requirements and align with company branding. Collaborates with R&D, Marketing, and Regulatory Affairs to align labeling with product specifications. Provides training and guidance to team members on labeling standards and procedures. Manages timelines and deliverables for labeling requests., • Process Improvement & Technology: Drives process improvements by promoting technological solutions, identifying bottlenecks, and implementing processes to enhance efficiency. With department management, develops and maintains an electronic document strategy, manages metrics, and may participate in or lead Quality Process Programs (QPPs) to ensure continuous improvement. Assesses current processes, implements feedback mechanisms, assess risks, and establishes disaster recovery processes to mitigate document control risks. The goal is to create a streamlined and resilient document control system that adapts to evolving business needs., • Collaboration & Communication: Effective communication and collaboration are critical in this role. Collaborates with internal customers to understand their needs and ensure seamless processes, including other departments and Werfen Technology Centers. Communicates process changes clearly to stakeholders and provides formal training to ensure all departments are aligned. With department leadership, partcipates in discussions regarding transformational strategies to ensure document control processes support broader business objectives, while also prioritizing and addressing urgent or critical issues as they arise., • Administrative Tasks: Responsible for administrative activities including, but not limited to, determining document storage requirements, and overseeing the secure destruction of documents when necessary. Audits internal processes to ensure accuracy, completeness, and adherence to quality standards, ensuring document control activities are thoroughly documented and compliant with both internal and external requirements. Networking/Key Relationships • Quality Teams (Quality Assurance, Quality Engineering, Quality Production Support), • Regulatory Team, • Manufacturing Teams, • Operations and Supply Chain Teams, • Marketing Teams, • Human Resources and Legal, • Research and Development Teams, • Werfen Manufacturing Sites and Affiliates Qualifications Minimum Knowledge & Experience required for the position:Education: • Bachelor's degree in Quality Management, Engineering, Life Sciences, Business Administration, or related discipline required., • At least 5 years of experience in document control, quality management, or related field within the medical device, pharmaceutical, or biotech industries required. Skills & Capabilities • Strong understanding of regulatory requirements such as 21 CFR Part 820, ISO 13485, ISO 15223, ISO 20417, ISO 18113, and IVDR - Language requirements for manufacturers., • Proficiency in document control software and tools, including experience with electronic Document Management Systems (eDMS), SAP (for COs, Material Master, document storage), and general office software (e.g., Microsoft Word, Excel, PDFs, EasyLabel, Codesoft, Automated Labeling System)., • Experience in drafting, updating, and managing SOPs, COs, training records, product item masters, and labeling in a regulatory context., • Familiarity with industry standards for document control, including document formatting, naming conventions, and lifecycle management., • Basic business acumen, including understanding of employment law, administrative policy compliance, expense management and business communications., • Demonstrated ability to supervise operations and direct reports, with a focus on building high-performing teams and fostering a culture of accountability and continuous improvement., • Project management experience, with the ability to participate in and/or lead projects, prioritize tasks, and work efficiently under pressure to meet deadlines. Salary: $70K-$110K If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Salary range $70K-$110K. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role QuidelOrtho is looking for a Supply Chain Intern that wants to spend their summer working towards our mission: Advancing the power of diagnostics for a healthier future for all. Interns will have the opportunity to gain knowledge and develop their skills all while contributing to key company projects and initiatives. Our team will help students apply their educational background and broaden their knowledge base within their role and learn more about working in the medical device/biotech industry. Interns will work with a mentor(s) on a guided and impactful project and will be able to collaborate with and be part of a supportive and dedicated team. This Internship is a full-time (40 hours per week) paid program for 10-12 weeks. Session 1: June 1st through August 14th Session 2: July 6th through September 18th NOTE: There are two positions available - both will be onsite in San Diego, CA. WORK LOCATION: Carlsbad, CA and Sorrento Valley (Summers Ridge), CA The Responsibilities • Analyze demand, lead time, and variability to calculate ROP and safety stock levels., • Develop ROP recommendations for manufacturing parts and validate with planners., • Document assumptions, methodology, and calculation logic., • Monitor early performance of ROP settings and identify improvement opportunities., • Translate ROP strategies into ERP system parameters and ensure accurate setup., • Validate master data fields related to inventory planning., • Support testing cycles (SIT/UAT) for planning related functionality., • Assist with data cleansing, mapping, and cutover preparation., • Create process flows and documentation for ROP methodology and ERP integration steps., • Perform other work-related duties as assigned. The Individual Required: • Must be at least 18 years old., • Must be currently enrolled as a full-time student in a Bachelor's or Master's program in the Fall Semester 2026 at an accredited university or college., • Field of study: Supply Chain Management, Industrial Engineering, or a related., • Minimum GPA 3.0 or higher., • Understanding of inventory management concepts:, • Reorder Point (ROP), Safety stock, Lead time demand, Demand variability, Service level targets,, • Ability to analyze historical demand and lead time data to calculate ROP and safety stock., • Interest in ERP systems (SAP APO, S/4HANA, or similar)., • Able to start on either June 1st or July 6th., • Ability to complete a consecutive 10-12 week internship., • Rising Junior or Senior at an accredited university or college., • Strong analytical mindset; comfortable working with datasets and process flows., • Proficiency in Excel (pivot tables, VLOOKUP/XLOOKUP, charts)., • Familiarity with ERP / MRP systems preferred (SAP experience is a plus)., • Strong communication skills; able to work cross-functionally in a regulated environment., • Ability to organize priorities and work independently with guidance. The Work Environment No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. The salary range for current Freshman, rising Sophomore is 18.00/hour; Sophomore, rising Junior is 20/hour; Junior, rising senior is $23.00/hour to $26.00/hour; Senior, enrolled in school for fall 2024 is 25.00/hour to 28.00/hour; or currently enrolled Graduate, MBD, PhD program is 28.00/hour to 30.00/hour. At QuidelOrtho, compensation decisions are dependent on the facts and circumstances of each case. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at ___.

Description You are an expert facilitator: you open doors, foster communication, and bridge the gap. The Patient Access Liaison (PAL) will be responsible for the management of defined accounts in a specified geography. The Patient Access Liaison will execute the collaborative territory strategic plan through partnership with internal and external stakeholders, which may include sales, market access, and other collaboration partners. Responsibilities include ensuring understanding of reimbursement process, field reimbursement services, and patient support programs. The Patient Access Liaison will also work on patient-level reimbursement issue resolution. • Educate HCPs on reimbursement processes, claims submissions, procedures, and coding requirements of payer organizations (local payers, government payers, etc.), • Collaborate with field support team members such as sales representatives and key account managers and serve as reimbursement expert for the local team, • Act with a sense of urgency to address critical access and affordability issues for patients, • Analyze reimbursement and access issues and act as the local access and reimbursement resource for other field force personnel and region management, • Proactively provide approved education to defined accounts within a given territory on matters related to reimbursement, access and coverage to facilitate appropriate patient access, • BA/BS degree required, • 4+ years of pharmaceutical, biotech, or medical device experience, • 2+ years of experience in reimbursement is required, • Neurology/CNS disease experience is required, • Ability to solve access issues related to both specialty pharmacy and medical benefit products At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our ___ to stay connected to additional career opportunities. Why Syneos Health? Here, the work is challenging, and the pace is exhilarating. By joining one of our commercial teams, you're empowered to succeed with the support, resources, and autonomy that you need. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Syneos Health has launched more sales teams in the last 5 years across all major therapeutic areas than the top 25 pharma companies combined. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world. Work Here Matters Everywhere | How are you inspired to change lives? Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements. 400005588

Job Description Summary: The Senior Laboratory Technician is responsible for the day-to-day planning and coordinating of manufacturing. To have a solid understanding of the range of products made in the department and how they are produced. To manufacture human and animal serum products on time and according to customer and in-house specifications. The role of a Senior Laboratory Technician is to develop and optimize methods for the lab processes. Must possess strong problem-solving skills and the ability to think critically. They must be able to work independently and as part of a team and have excellent communication and interpersonal skills. Essential Duties: • Meet daily to overview production plans for the day., • Meet with supervisors from other departments if the need arises for work to be carried on into 2nd shift, establish priorities and divert available manpower., • Meet with Manager to communicate status of ongoing projects to ensure an efficient and accurate transition between shifts., • Involve in R&D projects in Bulk., • Involve heavily in K2 Ascites productions in Bulk., • Responsible for ensuring their areas and all items within them are clean, including, but not limited to: workbench, cabinets, buckets, tanks and accessories used during the manufacturing lot process., • General cleaning as necessary., • Review manufacturing documents for Bulk production for clarity and completeness., • Organize product packets for final release., • Review and update Standard BOM and Routing for Bulk Productions., • Update the percentage yield for Bulk production for QMR, • Regular, reliable and predictable attendance., • Light to moderate lifting (up to 50 pounds)., • May perform other job related duties as assigned., • May be assigned to any Scantibodies location for any period of time., • May be required to perform other duties as assigned by supervisor. This may include duties in another department or outside your normal scope of work. Equipment used: Personal computer and other general office equipment. General laboratory equipment, such as columns, UV spectrophotometer, centrifuge, Foxy 200, Foxy Junior, balance, pH and conductivity meters, HPLC, UF system, filtration apparatus, and other general equipment used in protein purification. Company vehicle. Job Specifications: • Minimum 5 years hands on, bench experience, • Bi-lingual speaking, reading and writing Spanish is required., • Must have a valid passport., • In addition to Santee the position requires working in Mexico and the Ramona Ranch., • Occasional Domestic and International Travel to Customers, Trade Shows, etc. Industry experience in the purification of monoclonal and polyclonal antibodies and proteins, • Experience with downstream processing for monoclonal and polyclonal antibodies and other biologics, • Familiarity with cGMPs and ISO regulatory requirements for biopharmaceutical production, • Strong experience with protein purification techniques, including column chromatography, Ultrafiltration, Ammonium Sulfate Precipitation, DEAE, Protein A, G, A/G, L, MabSelect, Agarose Resins, Affinity Chromatography, Small and Process-Scale Column Packing, Ligand Attachment Chemistry, Dialysis, Lyophilization, Buffer preparation, conjugating antibodies for ELISA, Chemiluminescent,, Lateral Flow immunoassays, • Hybridoma, Cell Culture and Mab production and purification, • Experience with analytical techniques, including HPLC, UV-Vis spectroscopy, SDS-PAGE, BioCore (instrumentation by Cytiva to characterize the binding characteristics of antibodies to its target), Electrophoresis,, • Excellent written and verbal communication skills, • Strong problem-solving and critical thinking skills, • Ability to work independently and as part of a teamCompany DescriptionWe are a 49 Year old Privately owned Biotech company located in the East County of San Diego. Proud to be producers of testing kits supporting the medical community.We are a 49 Year old Privately owned Biotech company located in the East County of San Diego. Proud to be producers of testing kits supporting the medical community.

Job DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The In‑House Legal Counsel provides broad commercial and corporate legal support for Capricor’s growing operations, with a focus on contract negotiation, vendor management, commercialization readiness, and day‑to‑day legal advisory work across the business. Reporting to the General Counsel, EVP, this role partners closely with Commercial, Clinical, CMC, Quality, Regulatory, Operations, and Finance to ensure Capricor’s activities align with applicable legal, contractual, and industry standards. The ideal candidate is a motivated junior–mid level attorney with strong law‑firm training and experience supporting pharmaceutical or biotech clients, particularly in commercial contracting and product‑launch environments.Responsibilities • responsibilities include but are not limited to Commercial & Corporate Contracting, • Draft, review, and negotiate a wide variety of commercial agreements, including master service agreements (MSAs), CRO/vendor agreements, confidentiality agreements, supply and manufacturing agreements, consulting agreements, quality agreements, and technology-related contracts., • Provide day-to-day contract management, including issue spotting, risk assessments, and coordination with internal stakeholders., • Maintain and improve contract templates and contracting processes to support scalability and compliance., • Support contract lifecycle management systems and ensure timely routing, review, and execution. Commercialization & Pre-Launch Legal Support, • Provide legal guidance for commercialization planning including distribution, supply, marketing operations, and patient support programs., • Review commercial and vendor-related materials to ensure compliance with relevant industry standards and applicable laws. Vendor & Cross-Functional Support, • Provide legal support to ensure vendor obligations are contractually clear and aligned with operational needs. Corporate, Operational, & Compliance Support, • Provide legal support for internal reviews, investigations, and compliance initiatives in collaboration with the General Counsel and Compliance teams., • Support audit readiness and respond to legal document needs related to inspections or third-party assessments. General Legal Advisory, • Monitor relevant legal developments in pharma/biotech, including commercial, contracting, privacy, and healthcare law trends, and communicate implications to stakeholders., • Support special projects and new initiatives as Capricor scales toward commercial launch.Requirements, • J.D. from an accredited law school; active license to practice in California., • 5+ years of experience working in both a law firm and in‑house, supporting pharmaceutical and/or biotechnology companies., • Experience negotiating and reviewing contracts common to the life sciences sector (e.g., MSAs, CRO/vendor agreements, supply and manufacturing agreements, consulting agreements)., • Familiarity with commercialization activities in the pharmaceutical or biotech industry, including pre-launch and launch-stage considerations., • Ability to translate complex legal issues into practical, business-oriented guidance., • Strong communication, collaboration, and organizational skills. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job Description Job Title: QA Consultant (GxP) Location: San Diego, CA (On-site) Position Type: Contract / Consultant Department: Quality Assurance Reports To: Site Quality Head / Director, QA This is for the Poseida location in San Diego, CA. Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed About Us Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need. Position Summary The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions. You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams. Key Responsibilities • Support concurrent activities for legacy Quality systems during QMS integration and system migration phases., • Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems., • Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls., • Operate and support legacy Quality systems during the transition to new platforms., • Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records., • Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA)., • Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records., • Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS)., • Support continuous improvement efforts for events within EDMS and LMS., • Work with document owners to ensure timely periodic review of procedures., • Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools., • Generate and trend quality metrics, communicating findings to leadership., • Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans., • Review and approve paper-based quality documentation and electronic quality records., • Promote a culture of quality, teamwork, and accountability with a patient-first mindset., • Align daily activities with department goals and company values. Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred). Technical Skills: • Strong knowledge of Quality Management Systems in a cGxP manufacturing environment., • Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training., • Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio., • Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word). Competencies:, • Exceptional written and verbal communication skills., • Strong attention to detail and ability to manage multiple projects simultaneously., • Proven ability to work independently and collaboratively in a fast-paced, dynamic environment., • Experience developing training materials and delivering training to employees., • Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents. #TB_PH #ZRHC Why TalentBurst? At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce. Company DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CAFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Job DescriptionAbout the role: The Quality Assurance (QA) Specialist is responsible for supporting quality planning and ensuring compliance across production and operational processes within a regulated environment. This role works closely with manufacturing, engineering, and cross-functional teams to establish and maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11. The QA Specialist oversees quality processes throughout the product lifecycle, including reviewing and approving validation and quality documentation, managing deviations, CAPAs, and change controls, and ensuring that production activities meet defined quality standards. The role also supports internal and external audits, participates in vendor qualification activities, and helps maintain compliance with regulatory and industry requirements. In addition, the position contributes to continuous improvement initiatives by monitoring quality metrics, supporting LEAN initiatives, and providing guidance and training on quality processes and compliance. The ideal candidate is detail-oriented, collaborative, and experienced in quality assurance within regulated manufacturing or life sciences environments, with a strong ability to ensure quality is built into planning, production, and operational workflows. Key Responsibilities: • Ensure compliance with applicable standards and regulations (ISO 9001, GAMP 5, EU GMP Annex 11, 21 CFR Part 11)., • Review and approve validation documentation (e.g., URS, FRS, test protocols, test scripts)., • Conduct and support internal and external audits, including regulatory inspections., • Develop, implement, and maintain QA policies, procedures, and SOPs., • Perform risk assessments and support risk-based decision-making., • Monitor and report on quality metrics and KPIs., • Provide training and guidance on quality and compliance topics to cross-functional teams., • Manage deviations, CAPAs, change controls, and other quality records., • Participate in vendor qualification and software supplier audits., • Stay current with regulatory developments and industry best practices., • Minimum 5 years of experience in QA within a regulated software development environment., • Experience working with LEAN, • Strong knowledge of ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11., • Experience with validation of computerized systems and software quality assurance., • Excellent understanding of SDLC and software testing methodologies., • Strong analytical, problem-solving, and communication skills., • Ability to work independently and collaboratively in a fast-paced environment., • Bachelor’s or master’s degree in Life Sciences, Computer Science, Engineering, or related field., • Experience with electronic quality management systems (eQMS)., • Familiarity with Agile and DevOps environments., • Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) is a plus. 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 30K9e5ebwk

Job DescriptionDescription: The Clinical Contracts and Budgets Manager will be responsible for managing the lifecycle of clinical contracting and site budgeting. This role requires strong financial acumen and hands-on expertise with Master Service Agreements (MSAs), Clinical Trial Agreements (CTAs) Statements of Work (SOWs), and related clinical agreements. Working in close partnership with Clinical Operations, Clinical Development, Legal, and Finance as well as external vendors, this role ensures that budgets and contracts are aligned with protocol requirements, study timelines, and financial objectives. The ideal candidate is a detail-oriented professional who proactively assesses risk, challenges assumptions, and helps ensure agreements are legally compliant, and operationally executable. Essential Duties and Responsibilities The main responsibilities of this role include: • Partner with Clinical Operations, Clinical Development, Finance and external vendors to develop study-specific site budget templates and negotiation parameters., • Review and support negotiation of clinical trial site budgets in alignment with fair market value (FMV) guidelines and study specific parameters., • Support contract negotiations within approved financial and legal parameters., • Manage the end-to-end contract lifecycle, including Clinical Trial Agreements (CTA), Master Services Agreements (MSA), Statements of Work (SOW), amendments, and change orders., • Partner with Clinical Operations and Legal to develop site contracting timelines, documents, track progress and provide regular updates to study teams and internal stakeholders., • Support the site clinical trial agreement (CTA) development timeline., • Partner closely with Clinical Operations and Legal on contract review, redlines, risk assessment, and resolution of contractual issues., • Review and analyze budgets, payment terms, milestones, and pass-through costs to ensure accuracy and alignment between executed contracts, approved budgets, and forecasts., • Monitor and track contract and budget changes that impact scope, cost, or timelines; escalate risks and issues as appropriate., • Utilize internal and external benchmarking data to perform site budget analyses and support negotiation recommendations., • Responsible for Clinical Operations vendor sourcing and evaluation activities including drafting, submitting, and managing RFI/RFP, proposal comparison and analysis, coordination of bid defenses and proposal review meetings, and communication of vendor award and non-award notifications., • Partner with Clinical Compliance, QA, and Clinical Development to ensure vendor selection processes are efficient and compliant with ICH GCP E6, and oversee vendor risk mitigation per ICH GCP E6 guidelines., • Responsible for partnering with Finance, Legal, and Clinical Operations to manage clinical vendor contract lifecycle, including Statement of Work (SOW), Change Orders, Rate Cards, and Functional Service Provider (FSP) models., • Partner with Legal and Finance colleagues to establish Confidentiality Agreements and Master Service Agreements., • Support study-level budgeting, forecasting, and variance management activities as needed., • BS/BA degree and a minimum of 6 years of relevant and progressive experience., • Deep understanding of the drug development process and cross-functional responsibilities., • Knowledgeable in the use of industry benchmarking data sets (e.g., Grantplan, etc.)., • Proven track record of supporting financial processes, including budgeting/forecasting and variance management., • Effective and collaborative problem-solving skills., • Ability to multi-task within and across projects and prioritize and manage timelines effectively., • Strong interpersonal, communication and presentation skills to be able to engage with all levels both internally and externally., • Able to apply good judgement and professional expertise in new situations., • Experience in pharmaceutical/biotech industry required., • Experience with complex trial designs preferred., • Highly accountable, adaptable, and detail-oriented., • Able to work independently or on teams in a fast-paced environment. VIKING THERAPEUTICS 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 DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. As a Manufacturing Supervisor, you will oversee the manufacturing team, ensuring cGMP-compliant production of biologic products for clinical trials. You will supervise daily operations, mentor staff, and collaborate with the Associate Director of Manufacturing to drive efficiency, quality, and regulatory adherence. Responsibilities · Supervise the manufacturing team, including Technicians, Associates (I-II, III, III-Lead), to ensure seamless execution of production tasks such as cell culture, media preparation, formulation, centrifugation, and freezing. · Ensure all manufacturing activities comply with cGMP standards, overseeing proper documentation, inventory management, and cleanroom operations. · Review and approve cGMP documentation, including batch records, logs, forms, and protocols, ensuring accuracy and adherence to Good Documentation Practices (GDP). · Monitor production processes, analyze data, and report on performance metrics to identify areas for improvement and ensure quality goals are met. · Coordinate with the Associate Director of Manufacturing to develop production schedules, allocate resources, and address operational challenges. · Lead training and mentoring of manufacturing staff, ensuring team competency in aseptic techniques, cGMP standards, and manufacturing procedures. · Oversee the initiation, investigation, and closure of deviations, CAPAs, and process improvements, ensuring timely resolution and documentation. · Author, review, and update standard operating procedures (SOPs) and other manufacturing documentation using the document change system. · Manage inventory, material transfers, and cleanroom setup/shutdown activities to support continuous manufacturing operations. · Facilitate cross-functional collaboration with Quality Control, Materials Management, and other departments to ensure production alignment with company objectives. · Lead special manufacturing and development projects as assigned by the Associate Director of Manufacturing. · Perform other duties as assigned to support manufacturing operations and company goals. Requirements · Bachelor’s degree in Biological Sciences, Biomedical Engineering, or related field; advanced degree preferred. · 6+ years of experience in a cGMP manufacturing environment, with at least 2-3 years in a supervisory or leadership role. · In-depth knowledge of cell culture, aseptic techniques, cGMP standards, and regulatory compliance in a biotech/pharma setting. · Proven expertise in Good Documentation Practices (GDP) and managing manufacturing documentation. · Experience leading deviation investigations, CAPAs, and process improvement initiatives. · Strong leadership and mentoring skills, with the ability to guide and develop a diverse manufacturing team. · Excellent organizational and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment. · Effective communication skills for cross-functional collaboration, training, and reporting to senior management. · Proficiency in data analysis, technical report writing, and presenting production metrics. · Ability to gown and work in classified cleanroom areas, ensuring compliance with ISO 7 standards. Work Environment / Physical Demands · Primarily cleanroom-based with required time in GMP spaces overseeing manufacturing operations and team activities. · Requires prolonged periods of standing, computer use for documentation and reporting, and full gowning in ISO 7 cleanroom. · May involve lifting materials or equipment up to 20 pounds. · Ability to navigate cleanroom and GMP environments for production oversight and staff training. Why Capricor?Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough. Come Work With Us!At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason. Notice to Recruiting AgenciesCapricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionAbout GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBio: ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. Job Description: The role of the (Sr.) BD is to drive and support sales efforts in a given territory by implementing the sales/marketing strategies for ProBio's world class discovery services that are both extensive in breath of offerings, and state-of-the-art in their latest technologies. The Sales Manager will use their knowledge of science and the business including corporate contacts to develop and deliver profitable initiatives and build sales. Key Responsibilities: • Conduct and coordinate opportunity assessment, financial justification, due diligence, transaction design, contract negotiation, and completion of the discovery deals covering both antibodies and cell & gene therapies, • Create and execute programs for new prospective clients to increase awareness of Probio's service offerings and provide key differentiators from our competition, • Serve clients with a consultative mindset with good scientific knowledge to garner and uphold trust from them to win deals, • Provide insights to the scientific requirements for the transaction process and work in close collaboration with internal stakeholders to help prepare project designs and proposals, • Understand customer's research application and match Probio services and products to align with the customer's research project requirements, • Remain current on customers' news, pipeline development, and funding status, as well as industry news, trends, regulatory guidelines, and key technology to be able to serve as consultants to customers., • Stay current on all Probio's internal trainings on discovery services and technologies, and provide mentorship and coaching to new team members as needed, • Work with Head of Discovery Sales (HDS) to develop and implement territory sales strategies and tactics for products/services, new markets and new applications, • Work together with the HDS and technical account managers (TAM) to ensure all possible actions have been taken to secure business in a competitive environment, • Responsible to understand the customer's research application and match Probio services and products to align with the customer's research project requirements, • Share market knowledge with HDS, Sales, TAM and Marketing teams, driving business expansion with them, • Bachelor's degree or above in scientific disciplines preferably in life science or working at a pre-clinical or discovery CDMO, • Relevant sales experience around 2+ years and a high level of technical and professional expertise, • Good knowledge of biopharmaceutical discovery and CDMO market as well as biotech industry, • Ability to work in international and multicultural environments, • Ability of work in a fast paced and challenging environment with the ability to handle multiple projects simultaneously and meet deadlines, • Proven track records to meet and surpass goals, • Ability to accurately forecast sales within territory on a weekly basis, • Team player. Strong analytical and time management skills. #LW #PB GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. GenScript USA Inc./ProBio Inc. maintains a drug-free workplace. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Job Description Targeted dates: Early June 2026 - Mid/Late August 2026 Salary: $20/Hour - $25/Hour About the Internship We are seeking a collaborative intern to join our team for the summer. This internship offers the opportunity to contribute to real-time projects, develop technical and analytical skills, and gain insight into the biotech industry. We are looking for a motivated and detail-oriented Human Resources Intern to support HR initiatives across compliance, talent management, and people programs, working on high-impact projects that help shape the employee experience, organizational effectiveness, and HR operations. The ideal candidate is analytical, organized, and eager to learn how HR programs are designed, evaluated, and optimized within a growing organization. Key Responsibilities HR Operations & Compliance • Conduct audits of employee files and HR documentation to ensure accuracy, completeness, and compliance, • Review and recommend improvements to HR file structure and recordkeeping processes, • Assist in the design, organization, and rollout of talent management and training programs, • Support development of materials for performance management, goal setting, and employee development, • Review the current employee recognition program and benchmark against market practices, • Provide recommendations to enhance engagement, participation, and impact, • Support development of HR dashboards and reports (e.g., headcount, turnover, program participation), • Analyze HR data to identify trends and surface actionable insights, • Currently pursuing a Bachelor's or Master's degree in Human Resources, Business Administration, Psychology, or a related field, • Strong organizational skills and attention to detail, • Ability to manage multiple tasks in a fast-paced environment, • Proficiency in Microsoft Excel (pivot tables and basic formulas preferred), • Interest in HR operations, talent development, or people analytics, • Experience with data analysis, reporting, or project work (academic or internship), • Familiarity with HRIS systems or survey tools, • Problem-solving mindset and willingness to learn, • Ability to work cross-functionally with diverse teams, • Strong ownership and accountability, • Adaptability in a fast-paced, evolving environment, • Hands-on experience with core HR functions and strategic projects in a biotech environment, • Exposure to HR program design and organizational development practices, • Opportunity to present findings and recommendations directly to senior leadership We are a science-driven biotechnology company focused on advancing targeted protein degradation therapies. Passionate about discovery, collaboration, and translating innovative research into impactful medicines, our interns work alongside experienced scientists and professionals, gaining real-world experience while contributing to meaningful projects. Powered by JazzHR txkZt6iWct

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our Clinical Department as a Clinical Trial Manager (CTM) and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team. The CTM will support ongoing RNA-based drug discovery projects in several therapeutic areas. The Clinical Trial Manager (CTM) is responsible for supporting the effective planning and conduct of one or more ADARx Pharmaceuticals clinical trials in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and applicable regulatory requirements. Essential Responsibilities: • Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives., • Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines., • Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., core labs, independent contractors) to execute clinical trials., • Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to Clinical Team Members as appropriate., • Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention., • May perform clinical data review of patient profiles, data listings and summary tables, including query generation., • Develop and/or provide input to trial plans, such as Project Management Plan, Enrollment Plan, Monitoring Plan, Study Guides/Manuals, Protocol Deviation Plan, etc., • Develop or provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc., • Review and/or approve of IP release packages., • Reviewing monitoring reports and other study documentation as required., • Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF)., • Participation in team meetings and collaborate with other functional groups within the company and project team (e.g., Medical, Data Management, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals., • Following up on assigned team action items and identification, escalation, and resolution of issues as needed., • Collaboration with contracts specialist/Legal to review and negotiate Clinical Trial Agreements and site specific study budgets., • Assessment of adequacy/feasibility of potential clinical investigators and sites including evaluating facilities, personnel, patient referral base, and adherence to GCP., • Conduct site visits (e.g., training visits, site initiation visits, monitoring visits), as required., • Managing investigational product accountability and reconciliation process., • Assist with the preparation of safety, interim and final clinical study reports, and resolution of data discrepancies., • Providing clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies., • Serving as primary clinical operations contact for internal and external (clinical sites, vendors, etc.) teams for assigned studies., • Review protocol deviations and data listings., • Support safety reporting., • Support the management, tracking and oversight of clinical site budgets/payments in relation to conduct of a clinical trial., • Manage IRB/IEC and regulatory submissions, as needed., • Establish vendor management plans and review quality metrics., • 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: • BS/MS in life and health sciences., • 6+ years of combined managing/monitoring Phase 1-3 clinical trials., • Ability to work across global time zones (including EU, APAC)., • Experience in performing clinical site monitoring visits, including remote visits., • Experience in CRO/Vendor management (domestic/international), • Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements., • Proficiency working with Microsoft Office Suite Products, EDC, IRT., • Ability to travel domestically and internationally if necessary., • 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., • Global clinical trial experience preferred., • Must be able to work independently with supervision as needed., • 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., • Strong problem-solving skills and a proactive attitude towards exploring new approaches., • Understanding of project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders., • 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., • 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 DescriptionCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Quality Control Associate for Environmental Monitoring (EM) plays a critical role in maintaining the environmental conditions required for GMP manufacturing. This position is responsible for performing routine and specialized sampling, analyzing trends, documenting results, and ensuring controlled areas maintain compliance with regulatory and internal quality standards. As part of the QC EM team, you will perform hands-on monitoring of air, surfaces, and personnel, as well as water system and utility testing to ensure facility integrity. You will be responsible for maintaining accurate, real-time documentation and supporting investigations into any environmental excursions or anomalies. Working closely with QC, QA, and Production, this role ensures that manufacturing and testing environments remain in a constant state of control to support the production of high-quality therapeutic products.Responsibilities • Conduct routine environmental monitoring in controlled and classified areas in alignment with GMP, ISO, and regulatory requirements., • Perform sampling of air, surfaces, water, and equipment using approved methods., • Document sampling activities and results accurately in accordance with GMP and data integrity standards., • Analyze environmental monitoring data to identify trends, excursions, and required corrective or preventive actions., • Escalate atypical results promptly and support the investigation, documentation, and closure of deviations and CAPAs., • Maintain calibration, readiness, and routine upkeep of environmental monitoring equipment., • Support audit and inspection readiness through compliant documentation and area oversight., • Collaborate with QC, QA, and Production to address findings, implement improvements, and maintain a state of control., • Follow gowning and cleanroom entry procedures consistently and perform duties in full cleanroom attire., • Participate in continual learning, safety programs, and ongoing process improvements.Required Qualifications, • Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field., • 2–5 years of experience in environmental monitoring or quality control within a regulated environment (pharmaceutical, biotech, medical device, or similar)., • Knowledge of GMP, ISO, FDA expectations, and environmental monitoring standards., • Experience performing environmental sampling and handling EM equipment., • Strong documentation, data integrity, and analytical skills., • Ability to work effectively in controlled environments, including cleanrooms., • Strong organizational and time‑management skills for handling multiple priorities.Preferred Qualifications (Nice‑to‑Haves), • Experience with viable and non‑viable particle monitoring, active air sampling, and cleanroom incubation workflows., • Familiarity with LIMS or other laboratory information systems., • Experience supporting audits, inspections, or EM program review., • Strong communication and cross‑functional collaboration skills., • Experience with troubleshooting trends or environmental anomalies.Work Environment & Physical Demands, • Significant time spent in GMP cleanrooms, including full gowning., • Prolonged standing during sampling activities and extended computer use for documentation and trending., • May require lifting of equipment or materials up to 20 pounds., • Ability to work within laboratory, cleanroom, and manufacturing environments as part of routine monitoring.Shift/Schedule, • Primary shift options:Sunday through Thursday \u007C Tuesday through Saturday, • Typical hours: 12:00 PM to 9:00 PM (may vary based on business needs), • Flexibility is required, and occasional adjustments to shift times or days may be necessary. Notice to Recruiting Agencies Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.

Job DescriptionThe Clinical Trial Manager/Sr. CTM will play a pivotal role in the strategic implementation and execution of clinical trials from study start-up to close-out. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs., • Ensure inspection readiness by maintaining comprehensive study documentation and files., • Organize and lead study and departmental meetings, including minute-taking and document archiving., • Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings)., • Ensure team compliance with study-specific training and perform TMF reviews for completeness., • Support clinical sites in audit and inspection preparation., • Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements., • Monitor subject and site activity/metrics and perform quality checks across study components., • Proactively identify, troubleshoot, and escalate issues impacting deliverables., • Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation., • Collaborate with CROs to ensure timely collection and archiving of TMF documents., • Partner with regulatory affairs on essential document submissions., • Support study close-out activities including TMF and drug reconciliation and CSR readiness., • Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads., • Participate in process improvement and quality initiatives related to study execution., • Other duties as deemed necessary.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • Bachelor’s degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered., • Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out., • Global clinical trial management experience, especially in the EU, highly desirable., • Strong working knowledge of ICH/GCP regulations., • Proficiency with electronic systems such as eTMF, CTMS, EDC, etc., • Ability to work independently and thrive in a collaborative team environment., • Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset., • Excellent interpersonal, written, and verbal communication skills., • Proficiency in MS Office and comfort with technology.

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, CA Position Type: 5 days Onsite Exempt Position 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., • Required Qualifications:, • 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., • 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 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 Description We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body requirements. Job Type: Full time Job Title: Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities · Prepare and submit 510(k) applications for IVD products to ensure timely market entry. · Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory bodies, as needed. · Conduct regulatory risk assessments and develop mitigation strategies for IVD products. · Stay updated with regulatory changes and ensure all IVD products comply with current regulations. · Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions. · Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization. · Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance. · Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company’s products. Requirements · Bachelor’s degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field. · Minimum of 5 years of experience in relevant industry with min or 3 year hands on experience in 510(k) preparations and submissions. · Strong understanding of FDA regulations, guidance documents, and processes related to IVD products. · Experience in interacting with regulatory agencies, particularly the FDA. · Excellent analytical, organizational, and communication skills. · Detail-oriented with the ability to manage multiple projects simultaneously. Preferred Skills RAC certification or similar. Benefits • Health Care Plan (Medical), • 401K, • Paid Time Off and Paid Sick Leave

Job DescriptionJanux Therapeutics is seeking a hands-on, execution-driven Head of Clinical Pharmacology to support the design, analysis, and interpretation of clinical pharmacology strategies across our development programs. This role is ideal for a scientific contributor who thrives on working directly with data, ensuring high-quality PK analysis, and enabling data-informed decisions for dose selection and regulatory filings.This position is focused on executional excellence and strategy. The key will be producing internal strategic alignment and scientific rigor in deliverables.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES • Serve as both the Head of Clinical Pharmacology and Clinical Pharmacology SME/Lead across multiple programs, on both the oncology and immunology side, setting and owning the execution of clinical pharmacology plans from IND through early clinical development (POC)., • Design and oversee PK, PD, and exposure-response analyses to support dose selection, study design, and benefit-risk assessments., • Propose and lead the development and execution of clinical pharmacology components of studies, including food effect, drug-drug interaction, organ impairment, and QT assessments., • Author and review clinical pharmacology sections of regulatory documents (e.g., INDs, NDAs, briefing books) and support regulatory interactions., • Collaborate with Translational Medicine and Biomarker teams to integrate mechanistic and biomarker data into PK/PD interpretation., • Work closely with Biometrics and external modeling partners to support population PK and exposure-response modeling., • Contribute to program-level planning and prioritization based on pharmacological insights and development risk.REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES, • M.D., Pharm.D., or equivalent in Clinical Pharmacology, Pharmaceutical Sciences, or a related field., • 12+ years of experience in clinical pharmacology and/or pharmacometrics in the biotech or pharmaceutical industry., • Direct experience designing and executing early-phase clinical studies, including healthy volunteer studies., • Strong expertise in PK analysis and exposure-response interpretation; experience in oncology or immnology preferred., • Experience managing external Clinical Pharmacology resources., • Proven track record of contributing to regulatory submissions and engaging with health authorities., • Excellent communication, collaboration, and organizational skills., • Ability to work independently and in a fast-paced, matrixed environment., • Ability to travel up to 15%.In addition to a competitive base salary ranging from $260,000 to $320,000, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available.Please note that the hourly rate range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity.Job Type: Full-time Benefits:· Annual bonus program· Incentive stock option plan· 401k plan with flat non-elective employer contribution · Comprehensive medical insurance with 90-100% employer-paid premiums · Dental and vision insurance· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity) · Unlimited PTO · Generous holiday schedule; includes summer and winter company shutdown · Relocation assistance Schedule:· Monday to Friday Work authorization:· United States (Required) Additional Compensation:· Annual targeted bonus % Work Location:· On site (San Diego, CA) EQUAL OPPORTUNITY EMPLOYER:Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity. Notice to Recruiters and Third-Party AgenciesThe Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

If you are a current Jazz employee please apply via the Internal Career site. \n Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to \ntransform the lives of patients and their families. We are dedicated to developing \nlife-changing medicines for people with serious diseases — often with limited or no \ntherapeutic options. We have a diverse portfolio of marketed medicines, including leading \ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. \nOur patient-focused and science-driven approach powers pioneering research and development \nadvancements across our robust pipeline of innovative therapeutics in oncology and \nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development \nlaboratories, manufacturing facilities and employees in multiple countries committed to \nserving patients worldwide. Please visit\n more information. \n Associate Director, Analytics & Insights Role Overview Jazz is dedicated to delivering a differentiated customer experience, and the Associate Director, Analytics & Insights plays a pivotal role as a strategic thought partner and analytical expert—driving actionable insights that inform strategy, lifecycle planning, forecasting, and senior leadership decision‑making. This role sets the strategic direction for Therapeutic Area analytics, advancing the use of secondary data analytics, predictive modeling, and analytical approaches to surface new insights and enable forward‑looking actions. The Associate Director oversees performance analytics, ensuring the organization clearly understands the key drivers, barriers, and opportunities shaping performance. This individual synthesizes insights from a wide range of data sources and collaborates closely with cross‑functional partners to translate analytics into meaningful business impact. The Associate Director operates in a highly matrixed environment, partnering with Analytics colleagues and cross‑functional stakeholders across Field Leadership, Marketing, Market Access, Business Operations, Digital Enterprise Capabilities, and Learning & Development to deliver objective, strategic insights on brand and market performance. A successful candidate will bring a growth mindset, demonstrating curiosity, resilience, and a willingness to learn from failure, experiment with new approaches, and continuously evolve how analytics are applied to business decisions. Key Responsibilities Strategic Analytics & Insights Leadership * Define and advance the analytics vision and operating approach for the Therapeutic Area to strengthen data‑driven decision‑making across brands and the portfolio. * Serve as a senior analytics and insights advisor to leadership, influencing strategies, priorities, and tactics through objective, data‑backed recommendations. * Shape near‑ and mid‑term priorities in partnership with Marketing, Sales, and cross‑functional stakeholders, grounded in patient and provider experiences, outcomes, data and evolving market dynamics. * Represent analytics in planning cycles, business reviews, and leadership forums, contributing to enterprise‑level discussions and decisions. * Analytics & Decision Support * Lead the integration and triangulation of secondary data sources (e.g., claims, EHR/EMR, specialty pharmacy, Rx, CRM, internal performance data) to develop a unified view of patient journeys, treatment patterns, and competitive dynamics. * Apply predictive analytics and identify leading vs lagging indicators to inform forecasting, opportunity assessment, targeting, and risk evaluation. * Partner with cross‑functional teams to develop scalable analytical frameworks, metrics, and decision‑support tools that enable consistent, repeatable decision‑making. * Ensure delivery of high‑quality dashboards and executive‑level reporting, providing clear, actionable visibility into brand and portfolio performance. * Translate complex analyses into compelling, executive‑ready narratives that inform strategic choices and resource allocation. * Market Research & Voice of Customer * Lead the design and execution of qualitative and quantitative primary market research to address key strategic and tactical business questions. * Synthesize insights from primary research and secondary data to represent a holistic “voice of the customer” (physicians, patients, payers). * Facilitate insight‑sharing with brand and matrix teams to deepen understanding of product perceptions, usage drivers, market dynamics, and competitive context. * Cross‑Functional Collaboration & Influence * Build strong, trusted partnerships across functions, including Medical, Market Access, Sales Operations, Brand, Data Strategy, and IT. * Drive alignment on Therapeutic Area and cross‑portfolio analytics priorities, ensuring focus on the highest‑value business questions. * Act as a connective bridge across teams, translating insights into coordinated action and execution. * Influence without authority in a matrixed environment, balancing multiple perspectives while maintaining focus on enterprise and patient outcomes. * Innovation & Continuous Improvement * Continuously evaluate emerging data assets, analytical techniques, and technologies to ensure analytics capabilities evolve with the business. * Identify opportunities to streamline, standardize, and improve analytics processes to increase speed, quality, and impact. * Experiment thoughtfully with new approaches, incorporating learnings from both successes and failures to strengthen analytics over time. Required Qualifications & Experience Education & Experience * Bachelor’s degree in a quantitative, scientific, or business discipline; advanced degree (MBA, MS, PhD) strongly preferred. * 6+ years of progressive experience in commercial analytics, insights, strategy, or consulting within pharma/biotech; prior consulting experience preferred. * Experience supporting specialty or complex Therapeutic Areas preferred. * Analytics & Research Expertise * Strong experience with secondary data analytics, including claims, EHR/EMR, specialty pharmacy, prescriber‑level, and real‑world data. * Demonstrated ability to leverage predictive analytics to inform commercial and strategic decisions. * Solid familiarity with primary market research methodologies and translating research findings into actionable recommendations. * Proficiency with analytics and visualization tools (e.g., Power BI, Excel); exposure to Python, R, or SAS is a plus. * Stakeholder & Communication Skills * Exceptional stakeholder management and influencing skills, particularly with senior leaders and cross‑functional partners. * Strong storytelling and communication abilities, able to distill complex analyses into clear, persuasive insights. * Consulting‑style problem‑solving skills, with comfort navigating ambiguity and structuring work around decisions. * Additional Attributes * Strong project and initiative management capabilities, balancing multiple high‑impact efforts simultaneously. * Collaborative, adaptable mindset, effective in fast‑paced, evolving organizations. * High intellectual curiosity and continuous‑learning orientation, especially in analytics, data, and commercial best practices. * Exposure to advanced analytics or AI‑enabled insights is a plus, but not required. Description of Physical Demands * Occasional mobility within an office environment. * Routinely sitting for extended periods. * Constantly operating a computer, printer, telephone, and other similar office machinery. Description of Work Environment * Frequent computer use at workstation. * May move from one work location to another occasionally. * Responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands. * Occasional public contact requiring appropriate business apparel. #LI-Remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $167,200.00 - $250,800.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

Job Description Company Overview We are an innovative clinical-stage biotechnology company based in La Jolla, California, pioneering the development of oncolytic virus therapies to transform cancer treatment. Our platform harnesses engineered viruses to selectively target and destroy tumor cells while stimulating robust anti-tumor immune responses. With a promising pipeline in immuno-oncology, we are poised for significant growth and are seeking a dynamic leader to drive our business forward. Position Overview Reporting directly to the CEO, the Chief Business Officer (CBO) will be a key member of the executive team, responsible for shaping and executing the company's business strategy. The primary focus will be on leading capital raising efforts (including venture financing, non-dilutive funding, and potential public offerings) and forging strategic partnerships (such as collaborations, licensing deals, and co-development agreements with pharma and biotech partners). The CBO will play a pivotal role in maximizing the value of our oncolytic virus platform, building investor confidence, and positioning the company for long-term success. Key Responsibilities • Lead fundraising initiatives, including preparing compelling pitch materials, cultivating relationships with venture capital firms, strategic investors, and institutional funds, and closing financing rounds to support pipeline advancement., • Identify, evaluate, negotiate, and execute strategic partnerships, licensing agreements, and collaborations with pharmaceutical companies, academic institutions, and other stakeholders to accelerate development and expand the reach of our oncolytic therapies., • Develop and implement corporate strategy, including competitive intelligence, market analysis, and long-term planning in the immuno-oncology and viral therapy landscape., • Represent the company externally at investor meetings, scientific conferences, partnering events (e.g., BIO, JPMorgan Healthcare Conference), and industry forums to build visibility and networks., • Collaborate closely with R&D, clinical, and executive teams to align business development opportunities with scientific milestones and company goals., • Oversee alliance management for existing and future partnerships, ensuring value creation and smooth execution., • A scientific background in life sciences, immunology, virology, or oncology is highly desirable., • 10+ years of progressive experience in biotechnology or pharmaceutical industries, with at least 7 years in business development, corporate strategy, or investment roles., • Proven track record of successfully leading capital raises (Series A/B/C or beyond) and closing high-value strategic partnerships/licensing deals in biotech., • Experience with oncolytic virus therapies, viral vectors, or immuno-oncology companies is a significant plus., • Established network in the biotech investor community (VCs, pharma BD teams) and a history of building productive relationships., • Exceptional negotiation, communication, and presentation skills, with the ability to articulate complex scientific and business concepts to diverse audiences., • Strategic thinker with strong analytical skills, financial acumen, and a results-oriented mindset., • Competitive compensation package, including significant equity participation., • Comprehensive benefits, including health insurance, 401(k), and relocation assistance if needed., • Opportunity to join a cutting-edge oncolytic biotech at an exciting growth stage in the vibrant La Jolla/San Diego life sciences ecosystem.

Job Description About the Company Protego focuses on the discovery and development of first-in-class small molecule therapeutics that aim to reprogram protein folding for the treatment of various diseases. We are exploring monogenic protein misfolding diseases that cause myopathy, cardiomyopathy, stroke, renal disease, retinal diseases, channelopathies, and various degenerative diseases. Our approach builds on the proven pharmacological chaperones approach previously exemplified by tafamidis, which was discovered and developed by our cofounders Dr. Jeffery W. Kelly and Dr. Richard Labaudinière, for the treatment of transthyretin amyloidosis. About the job The incumbent will be responsible for independently managing operational aspects of assigned clinical trials. This includes oversight of contract research organizations (CROs), vendors, and clinical sites across both U.S. and international regions. The role requires a deep understanding of clinical trial processes, regulatory compliance (GCP, FDA, ICH), and the ability to lead cross-functional teams to ensure high-quality, timely, and cost-effective trial execution. The ideal candidate will bring an in-depth understanding of managing clinical trials at a sponsor biotech. Essential Functions And Responsibilities • Lead the planning, initiation, execution, and close-out of complex Phase 3 trials. Ensure all trial activities are conducted in accordance with the protocol, SOPs, GCP, and applicable regulations., • Manage the day to day operations of clinical studies, including oversight of CROs, central labs, biometrics, safety vendors, eTMF providers, and others. Ensure deliverables are met on time, within budget, and to quality standards., • Manage, mentor, and support direct reports, fostering professional development and team performance., • Participate in site selection, feasibility assessments, and initiation visits.., • Oversee the development and review of essential study documents such as protocols, informed consent forms, monitoring report, case report forms (CRFs), monitoring plans, and study manuals., • Review monitoring reports and ensure timely resolution of issues. Provide guidance to CRO study monitors; review a subset of monitoring reports to ensure consistency and quality, and to provide sponsor oversight., • Oversee ongoing data reviews and support data cleaning activities., • Ensure inspection readiness at all times, including regular review of the Trial Master File (TMF)., • Collaborate with finance and legal teams to manage study budgets, review vendor invoices, and negotiate contracts and change orders., • Work closely with internal stakeholders including Clinical Development, Regulatory Affairs, Quality, and CMC to ensure alignment and smooth execution of clinical programs., • Provide guidance and mentorship to junior team members and cross-functional colleagues. Share best practices and contribute to continuous process improvement., • Prepare and deliver study updates, metrics, and presentations to senior leadership. Represent Clinical Operations in internal and external meetings., • Contribute to the development and implementation of SOPs, work instructions, and operational tools to enhance team efficiency and compliance., • Willingness to travel up to 10% for site visits, investigator meetings, , and conferences. Required Education, Experience, Skills, And Abilities • Bachelor’s Degree in related scientific field with a minimum of 10 years of experience in clinical research, with at least 5 years in clinical trial management., • Proven track record of leading trials from start-up through close-out, including protocol development, site initiation, vendor management, and data review., • Strong knowledge of ICH GCP, FDA regulations, and global clinical research guidelines., • Proficiency in MS Office and clinical trial systems (e.g., CTMS, eTMF, EDC)., • Ability to interpret and analyze clinical data and metrics., • Excellent communication, leadership, and interpersonal skills., • Strong organizational and time management abilities., • High level of accountability, adaptability, and attention to detail., • Ability to work independently and collaboratively in a fast-paced, matrixed environment. Salary Range: $155,000 - $215,000 a year In addition to a competitive base salary ranging from $155,000 to $215,000 dependent on level and experience, we offer stock options and a target bonus. Protego also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. Please note that the salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and internal equity. Job Type: Full-time Benefits • Annual bonus program, • Incentive stock option plan, • 401k plan with employer contribution, • Comprehensive medical insurance, • Dental and vision insurance, • HSA, FSA, and supplemental insurance plans, • Paid Time Off, • Company paid holidays

Job Description Senior Accounting Technician – TalentZok OVERVIEW Are you looking for a new career opportunity with an exciting company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Senior Accounting Technician in La Mesa, CA who possesses: • Perform difficult and complex technical accounting work involved in the preparation of payroll, accounts payable, fixed asset accounting, accounts receivable, financial reporting and/or budget monitoring., • Prepare and process the payroll, verify and process time sheets, add new employees, monitor and reconcile position control with adopted budgeted and Human Resources, process involuntary deductions such as levies and garnishments, calculate and prepare general ledger entries, prepare related reports, inspect automated system output such as registers and standard reports, determine and correct out-of-balance conditions, and document and update procedures. Navigate and interpret the payroll system, • Utilize various computer programs; enter data, maintain and generate reports from a database or in-house system; create spreadsheets, enter data and generate reports using spreadsheet software. Email resumes to or call 858.633.2357. FULL DESCRIPTION: The selected candidate will be responsible for: • Create special reports using report writer software., • Updating reference tables and codes when needed, and prepare various schedules,, • Prepare, reconcile, and file quarterly tax filings, W-2's, and pension reports. Research and prepare special reports for management as requested., • Prepare and process the payroll; verify and process time sheets; prepare related reports and journal entries; prepare and distribute W-2 forms and 1099 forms., • Prepare and process the accounts payable and file records., • Confer with the departments and individuals regarding changes and corrections., • Provide technical information and instruction to departmental personnel regarding procedures and methods; interpret and explain rules and regulations., • Reconcile bank statements., • Process accounts receivable; prepare invoices; log receipts; coordinate accounts receivable activities with other departments; prepare the daily bank deposit., • Identify and resolve problems and inconsistencies, determining corrective entries involved in maintaining accounting controls., • Prepare a variety of statements, reports and tax returns from a variety of data and records., • Prepare and submit account information for input into computerized system; reconcile differences between accounting records and computerized reports., • Coordinate accounting activities with other departments, divisions and sections; provide statistical data upon request., • Prepare, reconcile, balance and submit a variety of monthly, quarterly and annual reports; maintain necessary records and logs., • Respond to inquiries from internal and external sources in a courteous manner; provide information within the area of assignment; resolve complaints in an efficient and timely manner., • Assist in supervision of lower-level accounting clerical staff; provide training in procedures; answer questions; assist in resolution of more difficult problems., • Perform related duties as required. The selected candidate will also possess: • Standard office procedures, methods, and equipment including computers and related software applications., • Principles and practices of financial record keeping and reporting., • Principles, procedures and methods of technical accounting including payroll, accounts payable, receivables, general ledger, etc., • Basic accounting principles., • Mathematical principles including business mathematics., • Pertinent federal state and local laws, codes and regulations. Salary Range: $35.00 - $45.00/hour For immediate and confidential consideration, please email your resume to or call 858.633.2357. More information can be found at Company DescriptionTalentZok was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.TalentZok was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.