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Job Description POSITION SUMMARY: Reporting to the Chief Medical Officer (CMO), the Vice President, Clinical Development provides executive leadership for the company’s clinical research and development activities within designated therapeutic areas and/or programs. The Vice President is responsible for the strategic planning, execution, and oversight of clinical trials and related data generation activities in support of Rigel’s product development and regulatory objectives. The Vice President, Clinical Development serves as a senior leader within Clinical Development, accountable for clinical trial execution, data integrity, regulatory readiness, and cross-functional alignment. The role partners closely with Biometrics, Clinical Operations, Regulatory Affairs, Medical Affairs, and Drug Safety to ensure clinical programs are executed in accordance with corporate strategy, regulatory requirements, and medical standards. The Vice President, Clinical Development contributes to portfolio-level decision-making and represents Clinical Development in internal governance forums and selected external engagements. Salary Range: $336,000 to $405,000 ESSENTIAL DUTIES AND RESPONSIBILITIES: Clinical Strategy & Execution • Provide executive oversight for the design, planning, and execution of clinical development programs across assigned therapeutic areas or assets., • Lead the development and implementation of clinical development plans aligned with Rigel's product strategy, registration pathways, and lifecycle management objectives., • Ensure high-quality execution of clinical trials, including protocol development, data collection, analysis, and reporting in compliance with GCP, regulatory, and medical standards., • Oversee preparation and review of key clinical documents, including protocols, Investigator's Brochures, clinical study reports, and regulatory submission materials. Organizational & Cross-Functional Leadership • Serve as a senior Clinical Development representative on cross-functional project teams, governance committees, and internal review bodies., • Partner with Clinical Operations and external CROs to ensure efficient trial execution, appropriate medical monitoring, and adherence to safety and quality standards., • Collaborate with Drug Safety to ensure ongoing evaluation of safety data and integration of pharmacovigilance considerations into clinical programs., • Contribute to enterprise decision-making through participation in portfolio reviews, investment discussions, and development governance forums. Regulatory & External Engagement • Support interactions with global Health Authorities by contributing to briefing packages, responses, and strategic positioning for assigned programs., • Engage with external experts, investigators, key opinion leaders, and advisory boards to inform clinical strategy and execution., • Provide clinical development input to Business Development activities, including due diligence for potential in-licensing or partnering opportunities. Strategic Contribution • Translate emerging clinical data into actionable insights to inform development decisions and portfolio strategy., • Support the CMO in shaping long-term clinical development capabilities, processes, and talent. KNOWLEDGE AND SKILL REQUIREMENTS: • M.D. degree; advanced knowledge in hematology/oncology required. Board certification in hematology or oncology preferred, • Minimum of 8 years of experience in clinical research or drug development (Phase 1 through 4) in an academic or industry environment; =6 years in an industry (pharmaceutical or biotech) setting, • Experience leading or supporting interactions with global Health Authorities and contributing to regulatory strategy, • Demonstrated ability to evaluate, interpret, and communicate complex scientific and clinical data to inform development and portfolio decisions, • Thorough knowledge of Good Clinical Practice, statistics, and clinical trial design, • Proven executive-level leader with experience driving clinical development strategies and delivering high-quality outcomes across multiple stakeholders, • Significant experience working cross-functionally within a matrixed organization and establishing productive scientific partnerships with external experts, • Excellent executive communication (verbal and written) and presentation skills, with the ability to influence internal and external stakeholders WORKING CONDITIONS: • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus., • WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

Job Description POSITION SUMMARY: The Executive Director, Key Customer Strategy serves as Rigel’s senior leader and subject matter expert in KOL and key account strategy across the commercial portfolio. This role is responsible for shaping and executing customer engagement strategy across in-line products, lifecycle initiatives, and development-stage assets, with direct impact on brand performance, market understanding, and organizational alignment. This individual operates as a strategic advisor to Commercial Leadership, translating key customer insights into actionable recommendations that influence brand strategy, resource allocation, and long-range planning. The role leads a team of field-based marketers and is accountable for building a high-performing organization that delivers consistent, high-impact execution across key customer segments. The Executive Director will partner closely with Marketing, Sales, Medical Affairs, Market Access, and external stakeholders to ensure a coordinated and enterprise-aligned approach to customer engagement. Salary Range $268,000 to $320,000 ESSENTIAL DUTIES AND RESPONSIBILITIES: Strategic Leadership & Enterprise Impact • Serve as a strategic advisor to Commercial Leadership by translating key customer insights into recommendations that shape brand strategy, customer engagement models, and long-range planning, • Contribute to cross-portfolio strategy, identifying opportunities to improve customer engagement and commercial effectiveness, • Lead development of customer engagement strategies across in-line brands, lifecycle initiatives, and development assets Insight Leadership & Market Understanding • Own the prioritization, synthesis, and activation of key customer insights, • Ensure insights are translated into actionable recommendations that influence decision-making across the organization, • Maintain deep understanding of evolving clinical, competitive, and customer dynamics Key Customer & KOL Strategy • Develop and lead comprehensive KOL and key account strategies across academic, community, and network-based providers, • Build and maintain strong relationships with thought leaders, academic institutions, and key accounts, • Lead Commercial advisory board strategy, execution, and insight integration into brand planning Customer Engagement & Channel Strategy • Oversee development and execution of promotional speaker bureau and peer-to-peer programs, • Identify and deploy innovative engagement models and vendor partnerships to expand reach into high-value and limited-access accounts, • Ensure consistent and coordinated customer engagement across personal and non-personal channels Pre-Launch & Asset Development • Support pre-launch and launch readiness activities for new assets, • Contribute to early market shaping, KOL development, and customer engagement strategy leading up to key regulatory milestones (e.g., PDUFA), • Provide input into asset evaluation and commercial viability from a customer and market perspective Cross-Functional Leadership • Lead alignment for KOL/ key customer management across Commercial, • Ensure coordinated execution and consistent messaging across all customer-facing functions, • Serve as a key connector across functions to drive a unified “One Rigel” approach Team Leadership & Organizational Development • Build, develop, and retain a high-performing team of field-based Regional Marketers, • Strengthen technical expertise across the team to enable independent ownership and execution, • Drive a culture of accountability, empowerment, and operational excellence, • Scale team capabilities to support expanding portfolio and organizational needs Operational Excellence & Financial Stewardship • Manage budget with a disciplined, ROI-driven approach to resource allocation, • Evaluate effectiveness of customer engagement initiatives and optimize investment decisions, • Ensure strong execution across key initiatives including advisory boards, conferences, and speaker programs External Engagement & Partnerships • Collaborate with hematology/oncology societies, networks, and GPOs, • Partner with ex-US affiliates and global stakeholders on key customer and conference strategies, • Represent Rigel externally as a key commercial leader and relationship owner KNOWLEDGE AND SKILL REQUIREMENTS: • 17+ years of pharmaceutical/biotech experience; hematology/oncology experience required, • Strong commercial leadership experience across marketing, field engagement, or customer strategy, • Demonstrated ability to influence cross-functional stakeholders and senior leadership, • Experience in launch planning and/or lifecycle management preferred, • Strong analytical, strategic thinking, and decision-making capabilities, • Proven ability to build and lead high-performing teams, • Excellent communication and executive presence, • High ethical standards and professional integrity, • Bachelor’s degree in marketing or related fields (required); MBA (preferred) WORKING CONDITIONS: • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus., • WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Position will require significant travel pre-launch (e.g., key customer engagement, advisory boards, medical conferences, home office visits, etc.). Travel is approx. 35-50%. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

About Planisware: Planisware is a leading provider of Strategic Portfolio Management (SPM) solutions, helping organizations connect strategy to execution and drive better business outcomes. Our platform enables companies to plan, prioritize, and deliver complex initiatives across R&D, IT, and capital projects, with strong adoption across pharmaceutical, medical device, manufacturing, energy, and financial services industries. With a strong foundation, global presence, and continued growth, Planisware is uniquely positioned to shape the future of portfolio management. About the role: As an Associate Account Executive, you’ll play a key role in driving Planisware’s growth by finding new opportunities, engaging with prospects, and supporting account executives. Working with experienced sales leaders, you’ll gain deep expertise in the market, Planisware’s solutions, and how to generate interest from the very first conversation. What You’ll Do: • Accelerate pipeline growth through intelligent ABM campaigns, combining all channels available (social selling, emails, calls, etc.) with IT and Digital teams., • Drive attendance and engagement by promoting key events and webinars., • Generate excitement and interest during discovery calls with prospective customers., • Support Account Executives in preparing proposals, managing RFPs, and delivering demos., • Partner with Marketing to convert inbound leads effectively and efficiently., • Maintain clear, organized documentation and ensure CRM data is accurate as opportunities progress. What You Bring: • Excellent communication skills and enthusiasm for customer engagement., • Curiosity, adaptability, and the ability to quickly understand complex software., • A proactive, high-energy approach to teamwork and sales execution., • Grit, particularly the ability to embrace rejections while maintaining a confident, positive, and solution-oriented sales approach. Required Qualifications: • Minimum 1+ years of experience as a BDR, SDR, or similar role., • A bachelor’s degree in business, information technology, or a related field., • Experience performing outbound sales activities. Preferred Qualifications • Background in project or product management., • Exposure to IT, Finance, or Healthcare industries. Benefits and Perks: • 3 weeks paid vacation, • Paid holidays, • Up to 4 months maternity leave, • Paternity leave, • Life, short and long-term disability insurance, • Company annual kick-off trip, • 401(k) plan with company variable contribution, • Health, dental, and vision insurance, • FSA plan, including employer contribution, • Cell phone and internet allowances, • Quarterly events/monthly happy hour, • Company charitable donation match, • Community outreach, • Tuition assistance program, • Graduate program This role will be based out of our San Francisco, CA office. Planisware currently has a hybrid policy of working in-office four days per week, Monday-Thursday, with remote flexibility on Friday. This is subject to change as the company sees fit.

Since 1929, ESTEVE has been driven by a clear and powerful purpose: improve people’s lives. Headquartered in Barcelona, we are a global pharmaceutical company with affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA, as well as world-class production sites in Mexico and China supporting our global CMO business. We are on an exciting growth journey, transforming into a leading international specialty pharma company, focused on highly specialized medicines that address unmet medical needs. At the heart of everything we do are our core values: people matter, transparency, and accountability. We care, we do: Our commitment goes beyond medicine. We care about making a positive impact on people, the environment, and the way we do business. The Key Account Manager (KAM) is responsible for representing ESTEVE products to physicians and healthcare professionals, establishing product sales, and performing total territory account management. The KAM is also responsible for providing account management support to accounts within a specific geography with a focus on issues specific to patient access and reimbursement, and will serve as a resource to accounts and ESTEVE staff on reimbursement regulations and processes, and payer policies, as appropriate. Responsibilities • Develops a comprehensive and territory business plan aimed at achieving and exceeding annual sales goals established by Commercial Operations Management., • Promotes Company products within approved labeling in a comprehensive, fair and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines., • Addresses issues related to pull-through, and reimbursement of ESTEVE products., • Develops strong customer relationships by better understanding the customer’s needs and goals and communicating those needs and goals to other Company team members., • Serves as a resource to customers and ESTEVE staff regarding local, regional and national payer policies, reimbursement regulations and processes (i.e., eligibility and benefit verification, prior-authorization, billing, coding, claims, and appeals/denials), and HIPAA compliance as related to TerSera products., • Consistently meets or exceeds sales goals., • Communicates territory activity in an accurate and timely manner as directed by management., • Provides feedback to Commercial Operations Management, colleagues, Marketing, and other internal departments about changing environment and results., • Adheres to the Company's compliance policies and guidelines as well as any other applicable guidelines, including but not limited to the PhRMA code., • Successfully completes all Company training classes., • Completes administrative duties in an accurate and timely fashion. Manages efforts within assigned promotional and operational budget. Maximizes use of approved resources to achieve territory and account level goals, • Functions as a contributing member of a high performance team., • Attends medical congresses and society meetings as needed., • Responsible for completing the above duties and responsibilities in a timely and accurate manner, • Responsible for completing the above duties and responsibilities in accordance with the internal controls that make up the internal control framework for all the ESTEVE business operational, administrative or regulatory processes., • Responsible for becoming knowledgeable of the internal controls operating within this department and to comply with these control activities by (1) being aware of the key controls, risks and compensating controls in this business area and (2) by identifying and reporting changes in the operating and internal control environment to their supervisor. Qualifications • Bachelor's degree required, Business or Science discipline preferred, • Graduate business or healthcare related degree preferred, • 3+ years pharmaceutical sales experience required, • Biologic/biotech sales and reimbursement experience preferred, • Experience with injectable/infused buy and bill/Medicare part B reimbursed products preferred, • Oncology, Rare Disease, or Infusion experience preferred, • Experience working with institutions and integrated delivery networks preferred, • Experience working in a team environment which successfully partners with all Commercial Operations functions, • Work hours may includes meetings scheduled outside of normal working hours., • Territories may require some overnight travel depending on the geography., • Some domestic travel to corporate headquarters, training, and sales meetings will also be required on a periodic basis., • Must be able to perform all essential functions of the position, with or without reasonable accommodations. ESTEVE US is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals defined under VEVRAA and Section 503 of the Rehabilitation Act.

We’re hiring a high-performing specialty pharmaceutical sales professional with a client of ours to own and grow a Northern CA territory. This is a performance-driven role for someone who thrives in an entrepreneurial environment and wants to be paid at the top of the market for top results. This is a direct hire with our client. Can reside in the San Francisco Bay Area or Sacramento area What you’ll do: • Drive prescription growth with targeted specialty HCPs, • Build and execute a smart, data-driven territory plan, • Influence prescribing through clinical knowledge and strong relationships, • Work closely with specialty pharmacies and navigate the payer landscape, • Calling on physician offices and surgeons Who we’re looking for: • 2-5 years of proven medical sales experience, • Strong track record of exceeding goals, • Open to high performers with any healthcare sales background., • Self-starter mindset Highly competitive compensation for high performers • Base salary, quarterly commission - uncapped, monthly car allowance, full benefits, 401k match 🚀 Opportunity to make a real impact with a fast-growing product

About ProcDNA ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 400+ across 8 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey? What we are looking for We are seeking a highly skilled Associate Engagement Lead – Technology with a strong understanding of the pharmaceutical industry and hands-on experience working with complex datasets (e.g., LAAD, DDD, XPO). In this role, you will deliver data-driven insights to solve real-world business problems, enhance performance, and manage risk. You will also lead transformation initiatives, including software modernization and cloud infrastructure migration projects. What you will do • Lead cloud transformation initiatives by assessing client IT landscapes, building business cases, and executing software modernization and infrastructure migrations across AWS, Azure, and GCP., • Drive end-to-end project delivery, managing cross functional teams and overseeing all phases from planning to execution with a focus on scalability and impact., • Design and implement secure, compliant cloud solutions, staying ahead of emerging technologies and aligning architectures with industry best practices., • Translate business requirements into technical strategies, delivering actionable solutions that address real-world challenges and maximize business value., • Build and maintain strong client partnerships, ensuring high-quality service delivery while aligning solutions with strategic goals. Must Have • 3–5 years in pharma technology consulting, with at least 2 years in the U.S., • 2+ years of experience in cloud platforms (AWS, GCP, Azure) and client service delivery., • Strong programming skills in Java, C#, Spark, PySpark, and Unix shell/Perl scripting; DevOps experience on AWS., • AWS Solutions Architect – Professional certification (preferred), along with AWS Big Data and AI/ML certifications., • Advanced degree (MBA or Master’s in Engineering) with a strong academic record, plus expertise in metadata management tools (Data Governance, MDM, etc.

Data Scientist (#40352) W2 ONLY Onsite in South San Francisco No C2C. No 3rd Party Contact On Site/In Person interview is required Master's Degree or higher required We are seeking a Senior Data Scientist (Level II) to support high-impact AI/ML initiatives within a regulated environment. About the Role Contract Data Scientist role Onsite/Hybrid in South San Francisco. This is a Hybrid role requiring 3 days a week ONSITE in South San Francisco from Day 1. An ONSITE interview is also required. If you are available and interested in being submitted for this role please get back to me with the following: • Your resume attached as a Word Document, • Your Desired W2 Pay Rate, • Your current location, • I also need the Month and Day of your Birthday for their resume submittal system. Required • Master’s or PhD in Data Science, Computer Science, Statistics, or a related field, • Minimum 5+ years of hands-on experience in data science and machine learning model development, • Proven track record of taking models from ideation through production deployment, • Strong proficiency in Python, SQL, and AWS, • Deep expertise in Machine Learning and/or Deep Learning techniques, • Experience working with large-scale, complex datasets in collaborative environments Preferred • Experience within healthcare, pharmaceutical, or other highly regulated industries, • Hands-on experience with claims data or similarly complex, regulated datasets, • Strong understanding of data privacy, compliance, and governance requirements, • Experience with MLOps practices, including pipeline automation, deployment, and monitoring Responsibilities • Model Development & Optimization, • Lead the design, development, and optimization of machine learning models to improve targeting accuracy and business performance, • Apply advanced Machine Learning and Deep Learning techniques to refine existing models and develop new solutions as needed, • Feature Engineering & Data Preparation, • Design and build scalable feature pipelines, transforming raw and complex datasets into high-quality model inputs, • Work with large, messy datasets (e.g., claims data) while ensuring data integrity and usability, • Production & Pipeline Scalability, • Transition analytical models and scripts into robust, production-ready pipelines, • Ensure code quality, documentation, and adherence to engineering and data science best practices, • Support model deployment, monitoring, and ongoing performance improvements, • Cross-Functional Collaboration & Insight Translation, • Partner with data science, analytics, and business teams to translate business problems into technical solutions Data Scientist W2 Contract role: Data Scientist II ROCGJP00040352 We are seeking a Senior Data Scientist (Level II) to support high-impact AI/ML initiatives within a regulated environment. This role will focus on advancing targeting models and delivering scalable, production-ready solutions that drive business outcomes. The ideal candidate brings strong technical depth, hands-on model development experience, and the ability to operate independently while collaborating across cross-functional teams. What We’re Looking For • A self-driven, senior-level contributor who can lead model development efforts and influence technical direction, • Someone who thrives in a team environment and contributes to shared goals without needing sole ownership, • A candidate who balances technical excellence with business impact, delivering solutions that are both scalable and meaningful Additional Notes This is a Level II role, requiring demonstrated depth in both technical execution and real-world application of AI/ML solutions. Candidates must be comfortable working in a fast-paced, collaborative, and regulated environment. Please email resume to Ellen at elerner@csi-it.com

Job Title: CMC Project Manager Duration: 8 months contract Location: Foster City, CA 94404 Type of Position: Only on W2 basis Foster City Hybrid role 3 days/week FOCUS AREAS • Lead integrated CMC planning across Drug Substance, Drug Product, Analytical, Quality, Regulatory, and Supply Chain, aligning deliverables, timelines, and priorities with clinical and regulatory objectives., • Drive execution of CMC plans to ensure alignment with program milestones and overall development timelines., • Provide end-to-end project management support across the product lifecycle, from development through commercialization and commercial manufacturing., • Develop, maintain, and manage integrated project timelines in Planisware or Smartsheet, clearly defining dependencies, milestones, and critical path activities., • Facilitate cross-functional Product Team meetings, including agenda development, decision documentation, and action item tracking., • Proactively identify, assess, and manage program risks and issues; maintain risk registers and ensure timely mitigation and corrective actions., • Coordinate preparation of high-quality governance materials in collaboration with Product Teams., • Translate complex technical input from subject matter experts into clear, actionable insights to support strategic decision-making., • Ensure clear, timely communication of program status and key updates to all stakeholders., • Partner with Product Teams and Finance on budget planning, tracking, and forecasting., • Ensure compliance with established processes and practices; identify and share best practices across Product Teams and PMs., • Integrating emerging AI and digital technologies into project management practices, • Minimum 5-8 years of relevant experience and a BA or BS in Life Sciences or related disciplines preferred., • Relevant experience consists of cross-functional work in biopharmaceutical /pharmaceutical CMC development and commercial teams, GMP environment and regulatory affairs, • Prior experience in project management required; PMP certification desirable, • Solid understanding of project management methodologies, tools, and techniques (Planisware familiarity is a plus) The pay rate range for this role is $80 - $88/hr on w2 Regards Satya S Sr. Operations Manager Phone #: 408-755-3025 Satyanathan.s@acldigital.com

Job Title: Model N Specialist/SME(Pharma) Location: San Francisco, CA Mode: Remote Employment type: Contract Role Summary We are seeking a highly experienced Model N Business Analyst / Project Lead with deep expertise in Revenue Management solutions, specifically across Validate, GP (Government Pricing), Medicaid, and Rebates modules. The ideal candidate will drive end-to-end implementations, enhancements, and production support, while acting as a bridge between business stakeholders and technical teams. Key Responsibilities • Strong expertise in Model N (Validate, GP, Medicaid, Rebates), • Experience in Revenue Management & pricing workflows, • Deep understanding of pharma & clinical domain processes, • Knowledge of AMP, ASP, Best Price, Medicaid compliance, • Hands-on with SQL, data analysis, reporting, • Experience with SAP/Oracle integrations & APIs, • Strong business analysis & stakeholder management, • Proven experience in Model N implementations/upgrades Required Skills & Qualifications • Strong hands-on experience in Model N Revenue Management suite., • Deep knowledge of: Validate module Government Pricing (GP) Medicaid Rebates Revenue Management workflows • Understanding of US pharmaceutical pricing and compliance regulations: AMP, ASP, Best Price Medicaid rebate calculations • Experience with SQL, data analysis, and reporting tools., • Familiarity with integration tools and APIs. Project & Domain Expertise • Proven experience in leading Model N implementations or upgrades., • Strong understanding of pharma/life sciences commercial operations., • Experience working in Agile / Waterfall methodologies.

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline. Summary: The Associate Contracts Manager will report into the Research Contracts Group organization within Research. The Associate Contracts Manager works under supervision of a manager to process/complete a high volume of Material Transfer Agreements (MTAs) (up to 400/year). The Associate Contracts Manager will communicate with Research scientists, leadership, internal legal counsel, outside technology transfer offices, academic scientists, and internal shipping/material supply teams under supervision of the manager. Job Responsibilities: • Process entire lifecycle for the Outgoing MTA Program, with an active queue of 70-110 MTAs at any one time., • Ability to interact and articulate salient points and status of MTAs to internal stakeholders, leadership, Legal, outside technology transfer offices and academic scientists., • Proactively manage, prioritize, and resolve a high influx of daily email correspondence. This role requires an exceptional ability to maintain rapid response times without sacrificing accuracy or professional tone., • Required understanding of scientific nomenclature, including lab reagents and genetically modified animal models and relevant associated terms - eg. antibodies, plasmids, DNA, genetically modified mice, progeny, derivatives, etc., • Basic understanding of legal agreement structure and concepts - eg. amendments, obligations, parties, etc., • Organizes and processes signatures for Outgoing Material Transfer Agreements following approved procedures., • Handles post execution tasks to complete agreements, including sending fully executed agreements to counterparty, filing agreements with Legal Records, completing data records in databases, initiating shipments, including organizing necessary import/ export paperwork, and addressing any shipping issues., • Tracks status and accurately maintains records in real time in MTA Database , including proper identification of party names, effective date and expiration date.., • General administrative responsibilities are required, including: Filing agreements with Legal Records; Coordinating meetings; Data entry in the MTA Database. Job Requirements: • Bachelors degree in scientific discipline; legal experience or education a plus., • Preferred 2-4 years relevant work experience;, • Preferred work experience in a pharmaceutical, biotech and/or university setting, • Experience drafting and managing agreements., • Ability to handle multiple priorities in a fast-paced environment., • Must be able to follow existing processes to solve problems in addition to independently proposing solutions., • Excellent interpersonal, verbal and written communication skills., • Excellent time management, prioritization and organizational skills., • Detail oriented, team player attitude, high work ethic, and reliable., • Comfortable working with databases and enterprise business systems., • Comfortable with standard office suites such as Microsoft Office (Word, Excel, etc.) and Google Applications (Mail, Calendar, Documents, etc.)., • Demonstrated Critical Thinking Skills: Must be able to use independent thinking to solve problems and propose solutions independently, even if they moderately deviate from protocols and guidance.

The Senior Associate Engineer will join the Upstream Process Development group within the Protein Development and CMC team. This is an exciting opportunity to join an outstanding team pursuing bacterial fermentation development. This is a 12-month contract based in San Carlos, CA. Responsibilities • Lead and collaborate in operational activities related to bioreactor set-up, monitoring, harvest, and maintenance., • Develop, test, and implement recipe scripting for fed-batch fermentation feeding controls., • Provide engineering support for design, implementation, and qualification of scale-down models., • Author SOPs (standard operating procedure), process flow diagrams and batch records., • Analyze and present fermentation data at internal project meetings., • Participate in upstream database management and documentation in electronic notebooks. Qualifications • BS in Chemical Engineering or a related discipline with 5+ years of relevant Pharma/Biotech industry experience, or MS with 2+ years of relevant Pharma/Biotech industry experience., • Hands-on experience operating and maintaining bioreactors, including Ambr® 250, at laboratory scale., • Experience with pilot scale fermentation and recovery equipment is a plus., • Skillful in analyzing and presenting data for process improvements, troubleshooting, and optimization., • Hands-on experience with fermentation and/or primary recovery unit operations., • Good understanding in fundamentals of bioreactor design, operation and controls., • Mechanical and technical knowledge of primary recovery unit operations such as homogenization, centrifugation, and depth filtration, is a plus., • Understanding of fermentation scale up and development of scale down models., • Familiarity with DoE (Design of Experiments) principles and software., • Familiarity with regulatory requirements of biotherapeutics. Late-stage process characterization experience is a plus., • Strong knowledge of aseptic techniques., • An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to achieve company goals, • Strong organizational and planning skills. Salary • $118,560-$131,040 Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

Molecular Biology Research Associate (RA) 12-month contract On-site South San Francisco About our Client: Our client is a late series A gene therapy organization using the emerging tools of genetic medicine to engineer cures for human diseases. They believe these powerful new approaches can be used to treat, or cure, common diseases that afflict large numbers of patients. To realize this vision, they are building therapeutics that modify and control multiple genes at the DNA, RNA, and protein level in vivo. Our client has a vibrant, collaborative workplace that supports their team in performing great science while bringing their whole selves to work. They are seeking a highly motivated, detail-oriented individual to join their growing Molecular Biology (MolBio) team on a 12-month contract basis. About the Role: As a Research Associate in the MolBio team, you will advance our client's genetic medicine technologies, enabling the discovery and development of new therapeutics. Working with a diverse team of cell biologists, protein and RNA engineers, computational scientists, molecular biologists, and translational biologists, you will: • Execute arrayed and pooled molecular cloning workflows, including T4 ligation, Gibson Assembly, Golden Gate Assembly, and PCR-based cloning, following established SOPs., • Perform high-throughput plasmid preparation using 96-well column-based miniprep protocols, as well as low-throughput midiprep and maxiprep workflows., • Utilize laboratory instrumentation — including the QPix automated colony picker and Integra VIAFLO liquid handler — to increase cloning and prep throughput and consistency., • Accurately register, track, and hand off samples and reagents using Benchling and internal LIMS tools, maintaining high standards for sample tracking and record keeping., • Support plasmid quantification and normalization using instruments such as the Lunatic/Stunner and Mantis., • Contribute to the maintenance and organization of the molecular biology lab workspace, including reagent inventory, cold storage, and shared equipment., • Participate in company-wide experimental campaigns, adapting to shifting experimental needs and priorities with flexibility and a positive attitude. Requirements: • A Bachelor’s degree in Molecular Biology, Biochemistry, Biotechnology, Bioengineering, or a related field., • Minimum of 2-3 years of laboratory experience, with a focus on molecular cloning and/or plasmid preparation., • Proficiency with common molecular cloning techniques, including Gibson Assembly, T4 ligation, and/or Golden Gate Assembly., • Experience with plasmid DNA purification., • Ability to follow SOPs rigorously and document experimental results accurately and completely., • Excellent organizational skills and attention to detail, with the ability to manage multiple concurrent tasks and maintain accurate records., • Experience with high-throughput plasmid DNA purification., • Strong communication skills and a collaborative, team-oriented demeanor. A creative thinker with a track record of high-quality data generation. Preferred Qualifications: • Preference for candidates with experienced in high-throughput workflows and laboratory automation including Agilent Bravo and Integra VIAFLO instruments., • Extensive undergraduate or post graduate laboratory experience and in-depth understanding of underlying molecular biology/biochemical concepts., • Familiarity with LIMS platforms, Benchling, or similar tools for sample and data management., • Prior experience in a fast-paced biotech or pharmaceutical research environment., • Positive, flexible, and proactive approach to work, with a demonstrated ability to adapt to changing experimental needs., • Working knowledge of tools such as GraphPad Prism, Dotmatics Geneious Prime, and other software tools. What You’ll Be Part Of: You will join a close-knit MolBio team that is central to the organization's research engine. Our team supports multiple high-priority programs simultaneously, executing hundreds of plasmid builds per year. We take pride in our rigorous processes, collaborative culture, and commitment to enabling great science across the company. This contract role offers meaningful hands-on experience in a cutting-edge genetic medicine environment, with the opportunity to contribute to work that directly advances therapeutic development.

About ProcDNA ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 400+ across 8 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey? What we are looking for We are seeking a Senior Engagement Lead – Analytics to join our team. You are someone with a strong understanding of the pharmaceutical industry, in-depth knowledge of datasets such as LAAD, DDD, XPO, etc., and a passion for working with complex data to solve real-world business challenges. In this role, you will help clients drive performance, manage risk, and develop practical, data-driven strategies that deliver measurable impact. What you will do • Leveraging data and emerging technologies: Build advanced analytics tools using Tableau, SAS, R, Alteryx, etc., to solve complex problems in healthcare and pharma., • Driving strategic client partnerships: Act as a trusted advisor to client leadership, delivering innovative, high-impact solutions that unlock growth for clients and ProcDNA., • Structuring and modelling data: Analyze complex datasets, implement statistical models, and design BI tools to support data-driven decision-making., • Leading and mentoring teams: Guide team leads, streamline recurring tasks, and ensure smooth execution and capability development., • Building internal capabilities: Contribute to internal initiatives and ideate new offerings that enhance team and company growth beyond client work. Must Have • 8–10 years of experience in healthcare/pharma consulting, with at least 6+ years in the U.S. market., • Bachelor’s or Master’s degree in Engineering, with strong academic performance., • Proven ability to manage multiple projects for various stakeholders with a focus on quality., • Excellent communication skills—verbal, written, and collaborative—able to clearly articulate results and issues to internal and client teams., • Strong problem-solving skills with the ability to work independently in a creative and analytical environment., • Experience in areas such as IC, Ops, Design, Implementation, Goal Setting, Sales Crediting, Eligibility, Contests, Awards, Targeting, Call Planning, Sizing, Alignment, and Segmentation.

Are you looking for an exciting new challenge in Project Management? MIGSO-PCUBED is looking for an experienced and passionate Project Management Consultant with biotechnology industry experience to join our team and support our engagements. This position is onsite and requires you to commute throughout the San Francisco Bay Area. Who We Are MIGSO-PCUBED (MP) is a global management consulting firm focused on delivering project, program, & portfolio management as a service. We are a global team of about 2,000 expert Consultants operating in Europe, North America, Asia, and Australia. We are industry agnostic, working across Aerospace, Automotive, Rail, Defense, Energy, Financial Services, Telecom, Technology & Media, and Public Sector. Every day, we support our clients by steering major Projects and Programs, managing Project Portfolios, improving maturity and efficiency of PM Organizations, and addressing business transformation and change management initiatives. Experiencing a growth period in San Francisco, we are looking for a passionate individual to join the team. What You’ll Do As a Project Management Consultant, you will work within our global team of Project Management Consultants to deliver value. You will engage with key stakeholders and represent the MP brand. This role will have a strong focus on client delivery, with the opportunity to vary your experience and support our top engagements as part of our San Francisco hub. Your responsibilities will be to: • Deliver project management execution and be involved at every scope of the project, • Develop schedules/timelines/cost plans that support the business objectives, established budgets, resources, and project deliverables for each project, • Initiate and manage creative and dynamic solutions for clients facing challenges in delivery, • Lead project level communications and prepare executive level updates. Communicate effectively across all mediums, • Assess risks and establish contingency plans, • Manage work and inputs from variety of stakeholders As a consultant, you will deliver expertise, adapt to new environments, and be able to work within a team. You will represent our brand on client-sites and, thanks to the materials that we provide, you will be prepared to support our engagements. We are expanding rapidly this year, so if you think you would be a good fit to join our team, do not hesitate to apply! Who You Are You should hold a Bachelor's Degree or a Master's degree. For this position, we are looking for someone with 3 to 8 years of experience in biotechnology or pharmaceutical project management. You should have a background in biotechnology, pharmaceuticals, or medical devices as well as knowledge in Software Development Lifecycles. Ideally, you hold a PMP certification. All in all, we are looking for someone who is eager to learn, grow, and develop their skills in the project management industry. If you recognize yourself in this description, please do not hesitate to apply. We cannot wait to meet you! Why You’ll Love M|P At MP, we know that our people are our greatest strength. That’s why we care about what we can do for YOU and your career. Here are a few reasons why you’ll love working with us: • Network with diverse team of project managers around the globe, • Expand your skillset across countless industries and departments, • Join our culture of continuous learning including certification trainings and support, internal seminars on the latest in the PM field!, • Career development framework, • Culture of respect, team spirit, excellence, and commitment Compensation MIGSO PCUBED believes in fair and equitable compensation. The reasonable estimate of the current total compensatory salary range for this role is $80,000 - $110,000 annually for San Francisco. In addition to base salary, employees will participate in an annual performance-based incentive program. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; certifications; and other business and organizational needs. Benefits and Perks: MP offers comprehensive contributions to medical, dental, and vision for you and your dependents. We also include a notable PTO plan, paid holidays, a 401k with company match, and professional development opportunities. Equal Opportunity Statement MIGSO-PCUBED recognizes the civil right of every person to obtain and maintain employment without discrimination. We have a longstanding policy that no individual may be refused a job, discharged, or discriminated against in any way due to any protected characteristics established by local, state and Federal law. In all respects, MIGSO-PCUBED is committed to a policy of full and fair equal employment under the law and applies this in all employment decisions, including recruitment, hiring, compensation, engagement staffing, training, promotion, transfer, and termination

About ProcDNA ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 400+ across 8 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey? What we are looking for We are seeking a Senior Engagement Lead - Technology to join our team. You are someone with a strong understanding of the pharmaceutical industry, in-depth knowledge of datasets like LAAD, DDD, XPO, and enjoy working with complex data sets to help clients solve real-world problems. You will play a key role in driving business performance, navigating risks, and developing pragmatic strategies through data-driven insights. What you’ll do ▪ Lead Data Management Projects: Drive end-to-end data engineering and BI solution delivery for multiple clients, ensuring timely execution and adherence to project plans ▪ Data Integration & Visualization: Build integrated data solutions and visualizations using tools like Tableau/Power BI to support impactful business storytelling. ▪ Client Engagement & Solution Design: Collaborate with clients to understand business challenges and deliver customized analytics solutions with high-quality UX/UI design. ▪ Data Governance & Security Compliance: Ensure analytics solutions align with data governance, quality, and security frameworks. ▪ Cross-Functional Collaboration: Work closely with internal teams to align technical implementations with business goals and ensure seamless solution delivery. Must have ▪ Experience: 8–10 years in pharma technology consulting, with at least 6 years of U.S. project exposure and direct client interaction. ▪ Technical Expertise: Proficient with ETL tools (ADF, Databricks, Informatica), data workflow tools (Airflow, Azkaban), and storage systems (SQL/NoSQL, Snowflake, Redshift). ▪ BI Tools & Visualization: Strong hands-on experience in building dashboards and BI solutions using Tableau and Power BI. ▪ Data Strategy Knowledge: Solid understanding of data governance, quality frameworks, and experience designing enterprise data warehouse solutions. ▪ Communication & Problem-Solving: Excellent presentation, analytical thinking, and stakeholder management skills

About Planisware Planisware is a global provider of software solutions for project portfolio management. Planisware solutions are specifically designed to support product development, engineering, and IT business processes. For more than 25 years, Planisware has been helping its customers to achieve strategic and innovative excellence, make valid business decisions, and increase portfolio value. Today, over 1,000 companies worldwide rely on Planisware products to manage their projects, resources, and portfolios. The Role As an Implementation Consultant, your mission is to design, configure, and deploy Planisware solutions to client organizations. Working as part of a team, you will interact regularly with clients to learn their internal processes and understand the needs of their organization. As you gain experience, you will begin to take direct responsibility for critical aspects of the implementation. You will be able to apply your experience and understanding of Planisware's capabilities to transform business requirements first into a comprehensive system design, and then into a functional, high-quality implementation of the Planisware solution. Key Responsibilities • Configure, test, deploy, and support Planisware applications for client organizations., • Support the configuration of standard Planisware modules under supervision., • Assist with data migration, validation, and analysis tasks., • Participate in internal and client-facing meetings to learn and observe., • Help prepare documentation, training content, and system walkthroughs., • Provide post-go-live support, troubleshoot basic issues, and escalate appropriately., • You will be part of a project team, learning directly from experienced consultants and participating in key meetings., • You will become deeply familiar with the business needs and processes of clients. As you become more skilled at understanding business needs and applying Planisware capabilities, you will be able to propose solutions that both meet requirements and facilitate the client's long-term success. What We Expect From You • Curiosity and eagerness to learn Planisware and project delivery practices., • Ability to follow instructions and complete assigned tasks on time., • Willingness to ask questions, receive feedback, and improve continuously., • Dependable collaboration with team members and proactive support on delivery needs. Location This position will be based out of our San Francisco, CA office. Planisware currently has a hybrid policy of working in the office four days per week, with Monday-Thursdays as mandatory days, and remote work allowed on Friday. This is subject to change as the company sees fit. Your Qualifications • BA or BS degree with 2 to 5 years of experience preferred, • Computer programming experience (object-oriented preferred), • Willing to travel (US & International), • Quick learner, efficient multi-tasker, and team player, • Strong written and oral communication skills Preferred Qualifications • Knowledge of portfolio and/or project management, • Working knowledge of database management, • Previous experience in software implementation, • Interest in Pharmaceutical/Biotech/NPD industries Benefits • 3 weeks paid vacation, • Paid holidays, • Up to 4 months maternity leave, • Paternity leave, • Health, dental, and vision insurance, • Life, short and long-term disability insurance, • 401(k) plan with company variable contribution, • Profit sharing, • FSA plan, including employer contribution, • Cell phone and internet allowances, • Company annual kick-off trip, • Quarterly events/monthly happy hour, • Company charitable donation match, • Community outreach, • Tuition assistance program, • Graduate program

Job Description Senior Research Associate, Flow Cytometry (3 Month Contract) Position Overview We are seeking a highly motivated Senior Research Associate with deep expertise in flow cytometry to join our team on a 3 month contract basis. This individual will play a key role in supporting immunology and/or cell biology research initiatives through the design, execution, and analysis of complex flow cytometry experiments. The ideal candidate is hands-on, detail-oriented, and experienced operating independently in a fast-paced research environment. Duration 3 Month Contract Location San Francisco Bay Area Key Responsibilities • Design, optimize, and execute multicolor flow cytometry assays for cell phenotyping, functional analysis, and biomarker characterization, • Perform sample preparation including PBMC isolation, cell staining, viability assessments, and compensation controls, • Operate, maintain, and troubleshoot flow cytometry instruments including BD FACSCanto, LSRFortessa, Cytek Aurora, FACSymphony, or similar platforms, • Analyze and interpret flow cytometry data using FlowJo and other relevant software platforms, • Develop gating strategies and generate high-quality datasets and summary reports for internal teams, • Collaborate cross-functionally with research scientists and project teams to support experimental objectives and timelines, • Maintain accurate laboratory records and ensure compliance with SOPs and regulatory standards, • Assist in assay validation, protocol development, and continuous process improvement initiatives, • Support additional laboratory activities as needed in a dynamic R&D environment Required Qualifications • Bachelor’s or Master’s degree in Immunology, Cell Biology, Molecular Biology, Biomedical Sciences, or related scientific discipline, • 4+ years of hands-on flow cytometry experience in biotech, pharmaceutical, academic, or CRO environments, • Strong experience with multicolor panel design, assay optimization, and flow cytometry troubleshooting, • Proficiency with FlowJo and flow cytometry data analysis workflows, • Experience handling human primary cells, PBMCs, or immune cell populations preferred, • Strong understanding of immunophenotyping and cell-based assay development, • Excellent organizational skills and attention to detail, • Ability to work independently while managing multiple priorities and deadlines Preferred Qualifications • Experience with spectral flow cytometry platforms such as Cytek Aurora, • Prior experience supporting immuno-oncology, cell therapy, or translational research programs, • Familiarity with GMP/GLP environments is a plus, • Experience with cell sorting or FACS instrumentation preferred

Manufacturing Associate 📍 Location: On-site: Richmond, CA 🕒 Type: Full-Time, Hourly, OnSite 🏢 Company: Confidential (Drug Testing Organization – Stealth Mode) Peoplework LLC is hiring for our client, a rapidly growing drug testing organization operating in stealth mode, developing next-generation laboratory testing solutions. We are seeking a Manufacturing Associate to contribute to the commercial production of novel, medical diagnostic devices. You will operate equipment and assemble products in a clean or dry room environment while adhering to strict quality policies and procedures. Immediate Needs · Support build-out and setup of the AC line in H2 and base station line in SR1 (cleaning, staging, construction). · Complete onboarding and training on core commercial processes (gowning/cleanroom, ESD, traceability, documentation, safety). · Provide hands-on production support: kitting, basic assembly, in-process checks, packaging/labeling, and rework to meet early build schedules. · Assist receiving and inventory organization: unpacking, labeling, cycle counts, sorting/disposing of legacy inventory, and accurate transactions. · Perform miscellaneous lab/manufacturing support tasks as assigned (basic measurements, fixture setup, material prep). Long-Term Needs · Execute routine commercial manufacturing across H2, SR1, and TRT, meeting throughput, quality, and documentation requirements. · Own daily inventory management (receiving support, material moves, cycle counts, Kanban/min-max restocking) to ensure uninterrupted production. · Contribute to continuous improvement: propose/implement process and fixture improvements, participate in CAPA/deviation investigations, and support validation/scale-up. · Cross-train across product lines and stations to provide flexible staffing and support future expansion. · Experience · 2+ years of hands-on experience in a regulated manufacturing environment (medical device, diagnostics, biotech, or pharmaceutical). · Experience performing assembly, kitting, labeling/packaging, and basic in-process inspection activities while meeting production schedules. · Working knowledge of Good Manufacturing Practices (GMP) and/or Good Documentation Practices (GDP); experience completing batch records, travelers, or device history records (DHR) is a plus. · Experience working in controlled environments (cleanroom, dry room, ESD-controlled area) and following gowning, line clearance, and contamination-control procedures. · Comfortable using basic hand tools and measurement equipment (e.g., torque drivers, calipers, scales) and following work instructions/SOPs. Knowledge & Skills · Proficient in computer systems: Windows, Microsoft Word, Excel, PowerPoint and various file repositories. · Ability to read and follow detailed instructions, maintain accurate records, and complete product inspections that meet all requirements. · Understands and adheres to applicable production controls including but not limited to line clearance, gowning, ESD controls, PPE, etc. · Good communication skills (written and verbal [English]), good penmanship, is detail oriented and ability to perform basic arithmetic. · Understanding basic principles and function of common electronic and mechanical components. Why Join Us • Join a confidential, high-impact drug testing organization, • Play a key role in building manufacturing and validation processes from the ground up, • Work in a collaborative, fast-paced, and technically challenging environment, • Competitive compensation and benefits Salary range: $25-$30/hour depending on experience 🔒 Due to the confidential nature of our work, additional details will be shared during the interview process. Apply here or contact us directly to learn more.

Senior Manager, Regulatory Affairs Clinical-Stage Precision Medicine Biotech | Bay Area We’re supporting an innovative, clinical-stage biotech focused on translating human genetics into precision small-molecule therapies targeting renal, cardiovascular, and metabolic diseases. This is an excellent opportunity for an experienced Regulatory Affairs professional seeking a highly visible, hands-on role with significant ownership across global development programs. The position offers close collaboration with Clinical, CMC, Biometrics, and executive leadership teams, alongside direct interaction with international Health Authorities. The Opportunity • Lead regulatory activities for designated clinical-stage programs, • Develop and execute global regulatory strategies, • Prepare and manage INDs, CTAs, amendments, and agency communications, • Partner cross-functionally to support program advancement and key milestones, • Contribute strategically within a collaborative, science-led environment Ideal Background • Approximately 7+ years of Regulatory Affairs experience within biotech or pharmaceutical environments, • Strong understanding of US and EU regulatory frameworks, including ICH guidelines, • Demonstrated experience authoring and managing IND/CTA submissions, • Background supporting clinical development programs preferred What’s on Offer • Base salary up to $220,000, depending on experience, • Annual bonus and equity participation, • Comprehensive healthcare coverage including medical, dental, and vision, • 401(k) with company match, • Generous PTO and holiday allowance This is a fantastic opportunity to join a well-funded biotech with a growing pipeline and make a meaningful impact within a cutting-edge precision medicine environment. If this opportunity could be of interest, please apply with a copy of your CV to arrange a confidential discussion.

Director, Regulatory CMC (Hybrid – San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with a diversified pipeline spanning both biologics and small molecule therapeutics. The organization is advancing multiple programs across early and late-stage development and is building out its Regulatory CMC leadership to support global filings and accelerate programs toward commercialization. This is a high-impact, strategic leadership role for someone who thrives at the intersection of regulatory strategy, CMC development, and cross-functional program execution in a fast-paced, science-driven environment. The Director, Regulatory CMC will lead global CMC regulatory strategy and execution across multiple programs, including biologics and small molecules. This individual will serve as a key interface between Regulatory Affairs, CMC, Quality, Technical Operations, and external partners to ensure alignment with global regulatory expectations and successful IND/CTA, BLA, and NDA submissions. This is a hybrid role based in the San Francisco Bay Area, requiring on-site collaboration several days per week. Key Responsibilities • Lead global Regulatory CMC strategy across clinical and late-stage development programs (biologics and small molecules), • Author, review, and oversee high-quality CMC sections for INDs, IMPDs, CTAs, BLAs, and NDAs, • Provide strategic regulatory guidance on CMC development plans, comparability strategies, process changes, and lifecycle management, • Act as primary CMC regulatory liaison with global health authorities, including FDA and EMA, • Partner closely with Process Development, Manufacturing, Analytical, and Quality teams to ensure regulatory alignment, • Support regulatory responses to agency questions, deficiencies, and inspection readiness activities, • Drive regulatory risk assessments and mitigation strategies for complex CMC issues, • Contribute to development of regulatory policies, templates, and best practices across the organization, • Monitor evolving global regulatory guidance impacting CMC strategy and submissions Qualifications • Advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field (PhD preferred), • 10+ years of experience in Regulatory Affairs CMC within biotech or pharma, • Demonstrated experience supporting both biologics and small molecule development programs, • Strong track record of successful IND/CTA filings and NDA/BLA submissions, • Deep understanding of CMC regulatory requirements across US, EU, and other global regions, • Experience interacting directly with regulatory agencies (FDA, EMA, and/or other health authorities), • Strong cross-functional leadership skills in matrixed, fast-paced environments, • Excellent written and verbal communication skills with the ability to influence senior stakeholders Why This Role • Opportunity to shape CMC regulatory strategy across a dual-modality pipeline, • High visibility role reporting into senior regulatory leadership, • Strong pipeline momentum with multiple clinical-stage assets, • Collaborative, science-driven culture with significant growth trajectory If interested, please reach out to tanya.kochan@meetlifesciences.com

We are hiring a Senior Associate Scientist to review analytical data and electronic notebook entries for accuracy and adherence to SOPs. This is a fully remote part-time position with flexible working hours that requires strong organizational skills, clear communication, and a high level of attention to detail. This is a 12-month contract position offering 20-30 max hours per week. Responsibilities • Review analytical assay data for adherence to SOPs and accuracy., • Review electronic notebook entries for completeness and accuracy., • Track shipping details for vendor-supplied samples., • Draft and update data analysis templates to reflect new and updated analytical methods and for continuous improvement., • Maintain organized records of review status of notebook entries and analytical data., • Contribute to reports, certificates, and other documentation supporting process development., • Collaborate effectively with team members and contribute to cross-functional activities. Qualifications • BS degree in Chemistry, Biochemistry, or related field with minimum 5 years of industry experience, or MS degree with minimum 3 years of industry experience., • At least 2 years of experience in an analytical development or quality control role., • Prior experience running colorimetric assays is required., • Prior experience with SEC-MALS is required., • Prior experience with SDS-PAGE is required., • Excellent attention to detail, organizational skills, and record-keeping abilities., • Ability to work both independently and collaboratively in a fast-paced environment., • Commitment to integrity, professionalism, and safety in all aspects of work. Pay • $56.00-$62.00/hr R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

About ProcDNA: ProcDNA is a global rocket ship in life sciences consulting. We fuse design thinking with cutting-edge tech to create game-changing Commercial Analytics and Technology solutions for our clients. We're a passionate team of 400+ across 8 offices, all growing and learning together since our launch during the pandemic. Here, you won't be stuck in a cubicle - you'll be out in the open water, shaping the future with brilliant minds. Ready to join our epic growth journey? What we are looking for: We are seeking a Director - Analytics to join our team. You bring a deep understanding of the pharmaceutical industry, along with detailed expertise in datasets such as LAAD, DDD, XPO, and more. You thrive on working with complex data sets to help clients solve real-world challenges, drive business performance, manage risks, and develop practical strategies through data-driven insights. What you’ll do: • Own end-to-end delivery across multiple workstreams while fostering strong relationships with client leadership and acting as a strategic advisor., • Design and implement advanced analytics and business intelligence tools (e.g., Tableau, SAS, R, Alteryx) to support data-driven decision-making in the healthcare and pharma sectors., • Leverage emerging technologies and pharma data expertise to solve complex business problems, model data structures, and continuously optimize analytical solutions., • Guide and mentor team leads, promoting best practices in analytics, quality delivery, automation, and client communication., • Proactively identify and develop new business opportunities and internal offerings to support organizational growth beyond client projects. Must have: • 10+ years of relevant experience in healthcare/pharma consulting, with at least 8+ years focused on the U.S. market., • Proven ability to manage multiple concurrent projects for various stakeholders with a focus on quality., • Strong educational background in engineering (Bachelor’s or Master’s) with excellent academic performance., • Excellent communication skills—strong verbal, written, and collaboration abilities to articulate results and issues to senior leadership and client teams., • Creative and analytical problem-solving skills with the ability to work independently with minimal direction., • Experience in key areas of sales, commercial, and marketing operations, including expertise in Salesforce Sizing, Marketing Mix, IC & Call Plan design, Go-to-market strategy, Segmentation, etc., is preferred.

Kelly® Science & Clinical is seeking a Scientist for a future opportunity with a client in the Bay Area. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries. Workplace: Onsite in the San Francisco, Bay Area Position Title: Scientist Position Type: contract Pay rate: $45-65 per hour Overview A rapidly growing biotechnology start-up is seeking highly motivated scientists with advanced degrees (M.S. or Ph.D.) and 1–3 years of experience in the biotech or pharmaceutical industry. This is an exceptional opportunity for individuals passionate about technology-driven innovation to join a dynamic and collaborative team dedicated to advancing human stem cell applications. Qualifications • Demonstrated expertise in mammalian cell culture, including human and rodent cell lines, stem cells, primary cells, and their various workflows., • Hands-on experience designing, developing, and optimizing reporter assays to industry standards., • Proficiency in flow cytometry, cell sorting, quantitative PCR (qPCR), and immunocytochemistry (ICC) techniques., • Proven track record developing and executing in vitro cell-based assays across 2D, 3D, spheroid, and organoid models., • Meticulous technical writing skills and strong oral communication ability, complemented by excellent organizational acumen., • Thrives in a fast-paced, innovation-driven start-up environment; exhibits outstanding interpersonal skills and collaborates effectively with scientific and business stakeholders. Preferred • Significant experience with human stem cell research and stem cell culture techniques., • Comprehensive knowledge of cell-based assay design and data interpretation., • Familiarity with GMP/GLP laboratory practices and quality systems is advantageous., • Exposure to cell culture automation technologies is a strong plus. Ready to accelerate your biotech career in one of the world’s leading innovation hubs? Apply today! If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research

We are a fast-growing startup backed by an Nvidia VP, working alongside top AI labs and global tech companies to build the foundational data layer that will power the next generation of AI-driven drug discovery. We are conducting a confidential search for a senior scientific leader to oversee and execute our data strategy. We need a scientist who can lead—not just manage—and who brings a wealth of "big pharma" clinical experience to the table. The Role As our Principal Scientific Data Scientist, you will ensure our data is world-class, rigorous, and ready to train the AI models that will discover tomorrow's breakthrough therapeutics. You will: • Lead the day-to-day operations and strategic direction of our biological data layer across multiple concurrent projects., • Leverage your deep expertise in bioinformatics and Real-World Data (RWD) to translate complex clinical needs into precise data specifications., • Draw heavily on your background in global pharma clinical programs to personally examine, validate, and enforce the scientific rigor of our data generation pipelines., • Manage a distributed network of PhD-level expert contractors to recruit, brief, review, and iterate on scientific data generation. The Ideal Candidate • Education: Ph.D. in Bioinformatics, Computational Biology, Pharmacology, or a closely related life sciences field., • Domain Expertise: Extensive experience working within global pharmaceutical companies, with a strong focus on clinical programs and translational research., • Technical Skills: Deep bioinformatics expertise with a proven track record of handling Real-World Data (RWD), multi-omics datasets, and clinical trial data analysis pipelines., • Leadership: Demonstrated experience leading computational teams, managing complex data operations, and taking ownership of end-to-end data quality., • Mindset: Detail-obsessed, fast-moving, and possessing a "builder" mentality—you are a scientist first who understands the biology and can build the infrastructure to support it. Why Join? This is an opportunity to join a founding team with real equity and make a massive impact at the most exciting intersection in biotech today: AI and drug discovery. If you are a seasoned pharma scientist who is tired of big pharma bureaucracy and wants to build infrastructure that matters, we want to hear from you

We are hiring a Scientist to support our client's drug product development team. You will have have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, especially immunoassays and multiplexed immunoassay formats. Experience in analyzing vaccine and adjuvant-containing formulations is a plus. In addition, we are looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a lab-based scientific role and requires excellent scientific judgement, independence, rigor, and thorough record-keeping. This is a 12-month contract based in San Carlos, California. Responsibilities • Execute routine and non-routine analysis of internal release, development, and stability samples using a variety of analytical techniques across Drug Product working groups, ensuring high-quality data generation and reporting., • Support the execution, optimization, and continuous improvement of multiplex immunoassay (MSD) assay suite, including troubleshooting assay performance, improving robustness, and supporting assay lifecycle management., • Design, execute, and interpret experiments to support non-GxP stability studies including thermal, freeze/thaw, agitation, and container closure system evaluations., • Analyze and interpret complex assay data, identify trends or deviations, and communicate findings to project teams to support development decisions., • Contribute to method development, qualification, and technology transfer activities, including collaboration with external analytical laboratories and manufacturing CMOs., • Author and review technical documentation including assay protocols, SOPs, reports, study plans, and technical summaries in support of development and analytical activities. Qualifications • BS degree with minimum 8 years of relevant industry experience or MS degree in Chemistry, Biochemistry, or related field with minimum 5 years of relevant industry experience., • At least 2 years of experience in an analytical development or quality control role., • Prior experience running colorimetric assays is required., • Prior experience with SEC-MALS is required., • Prior experience with SDS-PAGE is required., • Excellent attention to detail, organizational skills, and record-keeping abilities., • Ability to work both independently and collaboratively in a fast-paced environment., • Commitment to integrity, professionalism, and safety in all aspects of work. Salary • $128,960-$141,440 Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

The Associate Scientist II will focus on the synthesis, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide protein conjugates. The successful candidate will apply a strong foundation in analytical chemistry and laboratory techniques to optimize and troubleshoot processes, while also supporting related areas such as analytical development and stability studies. This position requires strong organizational skills, clear communication, and the ability to work in a fast-paced, cross-functional environment. This is a 12-month contract based in San Carlos, CA. Responsibilities • Perform and optimize multi-step syntheses of protein-polysaccharide conjugates., • Purify polysaccharides and conjugates using methods including dialysis, size-exclusion chromatography, and tangential flow filtration (TFF)., • Analyze polysaccharides and conjugates using methods such as colorimetric assays, HPLC assays, SEC-MALS, and SDS-PAGE, and contribute to method bridging studies and qualification to ensure robustness and consistency., • Maintain accurate, well-organized experimental records and support data verification and analysis to enable process optimization and reproducibility., • Assist with troubleshooting of synthesis, purification, and analytical procedures., • Track inventory of critical reagents and assist with ordering as needed., • Support maintenance of assigned lab instruments, perform general lab duties, and contribute to training new team members., • Present experimental results and progress updates at group meetings., • Contribute to laboratory protocols, reports, and other documentation supporting process development., • Collaborate effectively with team members and contribute to cross-functional activities. Qualifications • BS degree in Chemistry, Biochemistry, or related field with minimum 2 years of industry experience, or MS degree with minimum 1 years of industry experience., • Experience with laboratory-scale protein purification methods such as dialysis, diafiltration, and size-exclusion chromatography; experience with TFF is desirable., • Working knowledge of analytical methods including colorimetric assays, HPLC, SEC, and SDS-PAGE., • Hands-on experience with protein conjugation reactions or chemical modification of polysaccharides is desirable., • Ability to work both independently and collaboratively in a fast-paced environment. Salary • $106,080-$116,480 Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

Title: Product Marketing Manager Location: Hybrid in Foster City, CA 94404 (3 Days Onsite) Duration: 6 Months Contract with possible extension PR: $50/hr - $60/hr on W2 Job duties and responsibilities • Background and experience in product management of digital platforms, • Must be proficient in MS Office tools. Specifically planning tools such as MS Project, Jira, Smartsheets., • Must have demonstrated ability to effectively manage multiple projects/priorities. Ideally omnichannel related., • Must have strong interpersonal and influencing skills., • Working knowledge and experience with pharmaceutical markets and customers., • Demonstrated strong verbal, written, and interpersonal skills required., • Demonstrated ability to contribute to the development and writing of use cases and user stories., • Knowledge of SalesForce Marketing Cloud, SiteCore Content Management system, & Google analytics would all be beneficial., • Proven ability to interact with employees from a variety of functional areas., • Understanding of the health care system and its influence on the pharmaceutical business and products preferred., • Specific education and experience requirements:, • 5+ years of experience., • Bachelor’s degree in marketing, tech or related fields required., • Therapeutic Area knowledge preferred.

We are hiring a Senior Scientist to support a growing biotechnology client’s late-stage clinical program. This role will demonstrate strong technical proficiency and cross-functional collaboration with External Manufacturing, Process Development, Analytical Development, and Quality to ensure robust, compliant drug product manufacturing processes and enable BLA submission. The Senior Scientist will provide scientific leadership across formulation development, process characterization, technology transfer, and GMP manufacturing while mentoring junior scientists. This is a 12-month contract based in Redwood City, California. Responsibilities • Demonstrates technical proficiency, cross-functional collaboration with External Manufacturing, Process Development, Analytical Development, Quality Control, and other relevant stakeholders to drive improvement, consistency and compliance for drug product manufacturing processes., • Establish internal Drug Product Development capabilities including:, • Design and conduct experiments to develop stable and effective drug formulations, including selection of excipients, and compatibility studies., • Conduct stability studies to assess the short- and long-term integrity of drug products under various storage conditions and identify potential degradation pathways., • Establish and qualify representative scale down models in support of drug product process design., • Design drug product process characterization (PC) strategies, engage cross-functional SMEs and execute PC activities to enable BLA submission., • Develop and scale-up manufacturing processes considering critical process parameters (CPPs) and critical quality attributes (CQAs). Utilize statistical analysis and experimental design to identify and improve process parameters, maximizing product yield and quality consistency., • Provide support for drug product process technology transfer and GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, lead risk assessment and serve as person-in-plant as required., • Manage, collaborate and provide scientific oversight of formulation and drug product process development and data generated by internal and contract labs., • Must think critically, ability to work independently and awareness on when to seek guidance and have strong organizational and planning skills., • Author and review technical development documents including study protocols, technical reports, and batch records. Qualifications • Ph.D. in Pharmaceutical Chemistry, Biochemistry, Chemistry, Chemical Engineering, Bioengineering or related discipline with 5-8 years of relevant experience in biologics or viral vector drug product development; or M.S. with 8-11 years of relevant experience. Job title is dependent on candidate’s experience level., • Must have proven experience with formulation development, drug product process development and optimization, statistical design and analysis of experiment, managing CROs, tech transfer to CDMOs., • Must have knowledge and hands-on experience with analytical instrumentation used in biologics/viral vector formulation and process development such as spectrometry, HPLC, CE, particle characterization techniques, calorimetry, light scattering etc., • Experience with fill-finish processes, clinical compatibility studies, scale-up and/or technology transfer., • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up., • Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing., • Must have excellent problem-solving skills, verbal and written communication skills., • Ability to work in a dynamic environment, with a willingness to adapt to shifting priorities and tasks., • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines., • Ability to work independently in a fast-paced startup environment as well as work collaboratively in a highly interactive team environment. Pay • $80-$90/hr Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

Senior Director, Global Regulatory Lead Location: South San Francisco, CA Base Salary: $270-285k range plus bonus and RSU’s Hybrid Onsite – Relocation Offered. Remote candidates will not be considered. Scientific Search has recently partnered with a commercial stage pharmaceutical company that is looking for a Senior Director, Global Regulatory Lead. This role is accountable for the development of global regulatory strategies for assigned products to meet business objectives. This position will be the primary regulatory interface within the organization for assigned projects/products and reports to SVP Global Regulatory Affairs. Responsibilities • Develops and oversees the global regulatory strategy for projects in assigned TA, in conjunction with and under the leadership of the SVP, Global Regulatory Affairs., • Leads the Global Regulatory Project Team meetings in collaboration with Regulatory Project Management when being the Global Regulatory Lead on a project., • Oversee the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with a Health Authority and provide guidance to their team., • Overseas/leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements., • Contributes to and reviews responses to global Health Authority questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy., • Provide global regulatory advice through the product life cycle by representing the regulatory function in the Program Team when being the Global Regulatory Lead on a project., • In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally in assigned TA., • Actively participates in Health Authority meetings., • Clearly articulate regulatory challenges/risks, identify potential solutions, and make a recommendation(s) on a path forward to Program Teams and Senior Management., • Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating regulatory changes to Program Teams., • Effectively manages direct report(s) and provide mentorship to junior professionals. Requirements • Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); an advanced degree is desirable., • A minimum of 15 years in the pharmaceutical industry with a minimum of 12 years in Global Regulatory Affairs, experience with major Health Authorities (US FDA, Health Canada, and EMA) is mandatory., • Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices., • Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), Pediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred., • Experience in all phases of development and post marketing activities is highly preferred. How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.

Senior Director, Regulatory Affairs – Permanent – San Francisco, CA Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the San Francisco Bay Area, California. Primary Responsibilities: In this role, you will lead global regulatory strategy and operations across the company’s development pipeline. This individual will be responsible for developing and executing regulatory strategies, overseeing submission activities (INDs, CTAs, NDAs/BLAs/MAAs), and partnering with internal stakeholders and external agencies to advance programs through clinical development and regulatory review. The position is based in the San Francisco Bay Area, California in a hybrid work environment. Skills & Requirements: • Advanced degree (PhD, PharmD, MD, MS) or BS in a scientific discipline with 10+ years of regulatory affairs experience in the biotech/pharmaceutical industry, including 5+ years at the Director level or above., • Demonstrated success developing and executing global regulatory strategies and leading submissions across multiple stages of drug development., • Deep knowledge of US regulatory requirements (FDA), with experience in ex-US markets (e.g., EMA, Health Canada, MHRA) preferred., • Hands-on experience with INDs, CTAs, NDAs, BLAs, MAAs, and regulatory agency meeting preparations., • Familiarity with special regulatory designations and accelerated pathways., • Experience in a fast-paced biotech or small company environment; adaptable, proactive, and collaborative., • Proficiency in regulatory operations, including working with publishing vendors and eCTD submissions. Experience with RIMS tools is a plus., • Experience in immunology, dermatology, or rare diseases is a plus. The Senior Director, Regulatory Affairs will: • Lead the development and execution of US and global regulatory strategies to support the advancement of their investigational products from preclinical through late-stage development., • Serve as the regulatory lead on cross-functional project teams, providing regulatory guidance to ensure alignment with clinical, CMC, nonclinical, and corporate goals., • Oversee preparation, submission, and maintenance of high-quality regulatory documents (e.g., INDs, CTAs, amendments, briefing books, meeting requests, and responses to health authority queries)., • Manage interactions with regulatory authorities (FDA and ex-US) including leading or supporting meeting preparations and correspondence., • Evaluate regulatory risks and provide mitigation strategies to support timely development and approvals., • Provide regulatory guidance on special designations (e.g., Orphan Drug, Fast Track, Breakthrough Therapy) and expedited pathways, as applicable., • Support regulatory activities related to CMC, nonclinical, and pharmacovigilance to ensure comprehensive submission packages. If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.

We are seeking a motivated and detail‑oriented Research Associate to join the Synthetic Molecule Analytical Chemistry Department. This role will support drug discovery and development activities through the characterization and analysis of synthetic molecule drug substances, including small molecules, peptides, and oligonucleotides. The successful candidate will contribute to method development, execution, and interpretation of analytical data while collaborating closely with cross‑functional teams in a fast‑paced, innovative research environment. This position offers hands‑on experience with advanced analytical technologies and the opportunity to impact pharmaceutical development. This is a 12-month contract based in South San Francisco, CA. Responsibilities • Responsibilities include characterization of synthetic molecule drug substance, including small molecules, peptides and oligonucleotides, and delivery systems, method development, execution of analytical methods, and new technology evaluation., • The candidate will develop chiral and achiral HPLC methods, conduct testing, document studies in notebooks, summarize and interpret the data, and troubleshoot technical problems., • The role is in a multi-functional environment supporting drug discovery, discovery pharmaceutics and process chemistry., • The successful candidate will accomplish our mission through innovation and teamwork, creative problem-solving, and use of state-of-the-art technology including UHPLC-MS, multidimensional HPLC, GC, KF, UV, and CAD. Qualifications • BS/MS in a relevant scientific discipline (chemistry, pharmaceutics or chemical engineering preferred)., • 1-3 years of experience in the pharmaceutical industry is strongly preferred., • Candidates must have good knowledge of analytical chemistry., • Practical experience in chromatography (HPLC and data handling/reporting) is required., • Knowledge of pharmaceutics, solid state characterization, and drug discovery is desirable., • Candidates should have good problem solving and communication skills, and the ability to work in a collaborative team environment., • The position requires good organizational skills and the ability to work well as part of a team. Salary • $80,891-$101,108 Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

We are hiring an Associate Engineer II to join the Drug Product Process development team. The primary responsibility will be to provide technical and engineering support across drug product process development activities, spanning late-stage clinical supply, process characterization, tech transfer, and commercial readiness. This is a 12-month contract based in San Carlos, CA. Responsibilities • Support the development, characterization, and qualification of robust Drug Product processes for late-stage clinical and commercial manufacturing., • Execute bench- and pilot-scale process development studies using down-scaled models, including compounding/mixing, sterile filtration (filter selection and sizing), fill/finish, hold time, and container/closure evaluations., • Perform in-process sample testing and analysis of drug product intermediates and finished product to support process monitoring, process characterization, and release., • Maintain accurate and timely data entry and documentation in Benchling (ELN) in accordance with Good Documentation Practices (GDP), ensuring accuracy, completeness, and compliance with established standards and regulatory requirements., • Analyze experimental and manufacturing data using statistical tools (e.g., JMP), identify trends, and summarize findings in technical reports and presentations., • Perform routine lab upkeep and housekeeping to ensure laboratory cleanliness standards are met and conduct regular inventory monitoring and reconciliation., • Work within a team environment and provide support as necessary to further the team’s initiatives. Qualifications • BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience., • Experience in, or exposure to, early- and/or late-stage clinical fill/finish manufacturing under GMP regulations preferred., • Working knowledge of Drug Product unit operations, such as compounding/mixing, sterile filtration, aseptic fill, and container/closure systems (vials, PFS, cartridges)., • Experience supporting technology transfer, scale-up/scale-down, process characterization, or CDMO-based manufacturing activities is preferred., • Familiarity with statistical analysis tools (e.g., JMP, Minitab) is preferred., • Experience using electronic lab notebook (ELN) systems, preferably Benchling, is a plus. Salary • $106,080-$116,480 Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

The Associate Scientist II will focus on the synthesis, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates. The successful candidate will apply a strong foundation in analytical chemistry and laboratory techniques to optimize and troubleshoot processes, while also supporting related areas such as analytical development and stability studies. This position requires strong organizational skills, clear communication, and the ability to work in a fast-paced, cross-functional environment. This is a 12-month contract based in San Carlos, California. Responsibilities • Perform and optimize multi-step syntheses of protein-polysaccharide conjugates., • Purify polysaccharides and conjugates using methods including dialysis, size-exclusion chromatography, and tangential flow filtration (TFF)., • Analyze polysaccharides and conjugates using methods such as colorimetric assays, HPLC assays, SEC-MALS, and SDS-PAGE, and contribute to method bridging studies and qualification to ensure robustness and consistency., • Maintain accurate, well-organized experimental records and support data verification and analysis to enable process optimization and reproducibility., • Assist with troubleshooting of synthesis, purification, and analytical procedures., • Track inventory of critical reagents and assist with ordering as needed., • Support maintenance of assigned lab instruments, perform general lab duties, and contribute to training new team members., • Present experimental results and progress updates at group meetings., • Contribute to laboratory protocols, reports, and other documentation supporting process development., • Collaborate effectively with team members and contribute to cross-functional activities. Qualifications • BS degree in Chemistry, Biochemistry, or related field with minimum 2 years of industry experience, or MS degree with minimum 1 years of industry experience., • Experience with laboratory-scale protein purification methods such as dialysis, diafiltration, and size-exclusion chromatography; experience with TFF is desirable., • Working knowledge of analytical methods including colorimetric assays, HPLC, SEC, and SDS-PAGE., • Hands-on experience with protein conjugation reactions or chemical modification of polysaccharides is desirable., • Strong attention to detail, organizational skills, and record-keeping abilities. Salary • $106,080-$116,480 Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO & HSA, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

Job DescriptionMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES: • Ability to assemble, install, test and maintain electrical or electronic wiring, equipment, appliances, apparatus and fixtures., • Maintain electrical equipment to meet regulatory codes at state and federal levels., • Demonstrate safe and proficient use of shop tools (both hand and power)., • Demonstrate mechanical knowledge., • Competent with programming of VFD’s., • Knowledge and ability to troubleshoot PLC’s., • Must be physically capable of performing work from ladders, scaffolds, and roofs to install, maintain or repair electrical wiring, equipment and fixtures., • Proficient in testing electrical systems and continuity of circuits in electrical wiring, equipment, and fixtures, using testing devices such as ohmmeters, voltmeters, and oscilloscopes, to ensure compatibility and safety of system., • Perform duties in a work environment that will be hot, cold, dirty and fast-paced., • Able to complete forms e.g. time sheets, works order request forms indicating materials used/required, times, work undertaken etc., • Work overtime when required (including weekends and/or holidays)., • Attend emergency calls outside of normal working, if available., • Perform all duties in a safe and proper manner and complying with the EHS policies., • Ensure that all documents are completed complying with the GMP’s practices when required., • Provide cover for other members of staff during holidays, sickness or other absences and in emergencies., • Be proactive with people, keeping them informed; maintain positive relations and demonstrate good customer care., • Execute preventive maintenance, troubleshooting and general repair work on specific assigned working area/site of mechanical, electrical system and equipment., • Perform effectively inspections, testing and emptying secondary containment systems (dams), • Correct deficiencies found in inspections., • Report any spills immediately to your supervisor., • Take reading of the hours of operation of boilers and fuel consumption, • Take reading of the hours of operation of generators and fire pumps, • Receive diesel for boilers and emergency generators., • Ensure that boilers flow meters are calibrated in the set frequency, • Ensure accuracy of generators and fire pumps data taking., • Monitor / document effectively routinely operational parameters to ensure optimum control and regulatory compliance., • Report any deviation, • Provide maintenance to critical measurement equipment and tools, reporting failures and repair if necessary., • Analyze fuel and water consumption to detect irregularities and take action if necessary., • Ensure that leak detection system of dikes is operating properly (buoy system), • Identify gaps in the utility systems and take action to repair and put into normal operation, • Strictly follow company’s safety and cGMP policies and procedures, • Able to work extra hours, at night or on weekends and irregular shifts., • Able to respond to emergency calls., • Maintain current electrician's license or identification card to meet governmental regulations., • Electricians should have direct experience with some or all of the following activities:, • Cable Terminations - 600 volts to 34 KV, • SF6 Breakers o Installation of Electrical Equipment, • Open air switches to 138 KV, • Transformers from 1 MVA to 100 MVA, • High Voltage CTs and PTs, • HV switches to 138 KV, • Switchgear - 480 V, 5 KV, 15 KV, • Aluminum bus in HV substations480 volt MCCs, • Grounding systems, • Cathodic Protection, • Control Panels, • Installation of Control wiring and equipment, • Installation and repair of Insulators, • Pulling and terminating of conductors and pilot wires, • Installation of Fiber Optic cable and terminations, • Installation of conduit and pulling cable - large sizes and from 480 volts to 35 KV, • Installation of Transmission and Distribution poles, • Complete installation of HV Electrical Substations to 138 KV, • Pole Line work - 15 KV to 138 KV 1. Other duties as assigned by supervisor. EDUCATIONAL or EQUIVALENT REQUIREMENTS: • Technical College Electrician Degree, • C-10 Contractor License awarded by the Contractor State License Board Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR BJPsWJtGFV

Director, GMP Quality Assurance Location: Remote EmploymentType: Contract (9-12 months+) Hourly Rate - $100-125HR Scientific Search has partnered with an innovative biotechnology organization seeking an experienced Director, GMP Quality Assurance to provide strategic and operational QA leadership supporting biologics manufacturing, analytical testing, stability programs, and external partner oversight. This individual will play a key role in ensuring GMP compliance, supporting quality systems, and driving cross-functional collaboration across manufacturing, quality control, regulatory, and supply chain activities within a fast-paced clinical-stage environment. Responsibilities Manufacturing & Analytical QA Oversight • Provide GMP QA oversight for drug substance and drug product manufacturing activities conducted at external CMOs, including batch record review and approval, • Review and approve GMP analytical methods, test protocols, and associated documentation generated at external contract laboratories, • Provide quality partnership and oversight for biologics manufacturing, testing, and product disposition activities, including combination products Stability Program QA Oversight • Provide QA oversight of stability programs for drug substance and drug product activities, including review and approval of stability protocols, reports, and supporting data, • Partner with Clinical QC teams to ensure stability study design and execution align with ICH guidelines and applicable regulatory commitments Reference Standard QA Oversight • Oversee QA activities related to reference standard qualification, characterization, and requalification, • Review and approve reference standard protocols and reports while ensuring proper chain of custody, storage, and release documentation General QA & Cross-Functional Collaboration • Support compliance within Quality Management Systems and external CDMO manufacturing/testing operations in accordance with FDA and global GMP regulations, including 21 CFR Parts 4, 210, 211, 820 and EU GMP guidelines, • Collaborate cross-functionally with CMC, Manufacturing, Analytical Testing, Quality Control, Regulatory CMC, Clinical Operations, and Supply Chain teams, • Review and verify quality-related documents, records, protocols, reports, and data supporting biologics programs and products, • Identify, assess, and escalate quality risks while driving compliant resolutions and continuous quality improvement initiatives, • Contribute to the development and refinement of quality processes, procedures, and organizational quality culture Requirements • Bachelor’s degree in scientific discipline or related field required, • 10–15 years of progressive GMP Quality Assurance experience within biotech, pharmaceutical, or biologics environments, • Strong experience overseeing external CDMO/CTO manufacturing and testing operations, • Hands-on expertise supporting QA oversight of QC operations, manufacturing, analytical testing, and supply chain activities, • Strong working knowledge of FDA and global GMP regulations and quality systems, • Experience supporting biologics and/or combination products strongly preferred, • Excellent communication, collaboration, and problem-solving skills within matrixed organizations, • Ability to support occasional evening meetings based on business needs How To Apply We’d love to see your resume, but we don’t need it to have a conversation. Email tom@scientificsearch.com or message me directly to learn more. • REMOTE

Job DescriptionJob Title: Pharmaceutical Manufacturing Technician I Reports to: Manufacturing Manager Summary: Responsible for the manufacturing of pharmaceutical products in a GMP environment. Duties and Responsibilities include the following. Other duties may be assigned. · Perform daily manufacturing tasks as assigned by supervisor. · Weigh materials, prepare solutions and production materials. · Perform manufacturing packaging and related tasks. · Document production activities in manufacturing batch records. · Clean up production equipment and production area. · Clean and prepare manufacturing equipment · Clean and maintain production areas Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education/Experience: Minimum High School Diploma or GED and three (3) to five (5) years related experience in a GMP pharmaceutical manufacturing environment. · Experience with analytical balances, weighing materials accurately. · Experience with handling of solids and liquids, pouring and filtering. Language and Communications Ability: Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to read, understand and legibly enter data in production batch records. Ability to read and understand equipment manuals. Math Ability: Ability to use a calculator to add, subtract, multiply, and divide different units of measure, using whole numbers, common fractions, and decimals. Reasoning Ability: Ability to recognize and communicate practical problems in the production environment. Ability to troubleshoot under supervision. Computer Skills: The individual should have a working knowledge of Microsoft Word and Microsoft Excel plus basic email and internet functions. Specialized Training: GMP Training in a pharmaceutical manufacturing environment. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. Appropriate personal protective equipment is provided. The noise level in the work environment is usually moderate. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, sit, use hands or talk/hear. The employee is occasionally required to reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 75 pounds, as well as rolling equipment that is over 100 lbs. Location: Must be located in the Bay Area or willing to relocate at own expense Medterials is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Our client is a destination law firm for talented, ambitious attorneys who value collaboration, teamwork, and commitment to excellence. They are known around the world not only for delivering innovative yet practical client service but also for serving as an incubator for our top-notch talent. Their Technology Transactions - Life Sciences Transactions + Licensing Team As part of our clients preeminent Technology Transactions Group, Our clients market-leading Life Sciences Transactions + Licensing team advises clients at every stage of product and company lifecycle – from discovery and development through commercialization and exit. They represent a broad spectrum of industry participants, including biotechnology and pharmaceutical companies, medical device and diagnostic innovators, research institutions, investors, and digital health companies. Our client’s Life Sciences Transactions + Licensing team advises clients with respect to a wide range of areas including the following: • License agreements, • Collaboration, research, and development agreements, • University and research institution licensing transactions, • Patent licensing and commercialization agreements and strategies, • Distribution, supply, commercialization, and manufacturing transactions, • Clinical trial arrangements including contract research, development, and manufacturing transactions, • Intellectual property management and audits, • Risk mitigation strategy in connection with licensing intellectual property, • Supporting corporate transactions (e.g., venture financings, M&A, joint ventures) by conducing IP and commercial contract due diligence, and preparing and reviewing key transaction documents, • Interfacing with clients, in-house counsel, and counterparties in a fast-paced, deal-drive environment, • Collaborating across practice areas (e.g. corporate, IP, regulatory, litigation) on multidisciplinary matters Joining our client’s Technology Transactions Group and Life Sciences + Licensing practice means working at the forefront of the industry on deals that drive innovation in biotech, pharma, medtech, and digital health. You’ll gain hands-on experience with high-impact transactions – including licensing, collaborations, and strategic partnerships – from a broad range of clients, from early-stage emerging growth companies to global public companies. Our practice offers unmatched exposure to complex, cross-border work and close collaboration with top-tier lawyers across IP, corporate, regulatory, and litigation disciplines. We’re a collegial, mentorship-driven team, committed to your growth and success. Who You Are • You have a J.D. from an accredited law school and are licensed to practice in Massachusetts., • You have 3-6 years of relevant experience at a top law firm or in-house legal department, with a strong preference for candidates who have worked extensively in the life sciences., • You have experience with the legal, regulatory, and business issues unique to the life sciences sector., • You have superior drafting, analytical, negotiation, and communication skills., • You have demonstrated an ability to manage multiple matters and clients simultaneously with a high level of responsiveness and attention to detail., • You have an undergraduate or advance degree in the biological sciences, chemistry, pharmacy, business, or similar areas (preferred but not required).

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

Job Description Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is seeking an experienced Director of Thought Leader Liaison (TLL) with deep expertise in Dermatology. This role is a field-based commercial leadership role responsible for leading a team of field based TLLs, to develop and execute Key Opinion Leader (KOL) engagement strategies for the US launch of envudeucitinib for Psoriasis. The successful candidate will be a key member of the brand marketing team, working across multiple stakeholders at the intersection of marketing, medical, and field execution, with accountability for team leadership, KOL strategy and execution, and strategic insight generation to shape brand strategy. This role will require a deep understanding of medical science, excellent leadership capabilities, and a strong ability to drive the success of cross-functional teams. Key Responsibilities:Leadership & Team Management • Build, lead and manage a team of TLL reports with the responsibility for coaching, developing, assessing performance, delegation, prioritization and fostering a collaborative and high performing culture., • Collaborate with the Marketing leadership team to align TLL activities with organizational priorities and strategic initiatives., • Set the direction and manage the cross functional collaboration and coordination of the TLL team with key stakeholders for development and execution of key brand activities and tactics., • Conduct regular performance evaluations, identify skill gaps, and support TLL development through coaching, training, and career growth opportunities.Strategic Planning & Execution, • Design and implement an engagement strategy in partnership with Marketing and other key stakeholders to guide interactions between the TLL team and KOLs., • Oversee the identification, establishment, and maintenance of the TLL thought leader community, ensuring alignment with Medical Affairs and other key stakeholders., • Drive development and execution of key strategies and tactics to high standards whilst delivering exceptional customer experiences., • Initiates and pursues opportunities for commercial engagement at national and regional conferences, key advocacy or healthcare stakeholder meetings. and represent Alumis at these events.KOL Relationship Management, • Cultivate strong, long-lasting relationships with existing and new KOLs to gather feedback on market dynamics, competitive landscape, marketing strategy, and tactical execution., • Serve as a marketing resource and point of contact for KOLs., • Represent the company at scientific congresses, advisory boards, speaker bureau events and other relevant forums to enhance scientific and therapeutic understanding.Compliance & Reporting, • Ensure all TLL activities are conducted in compliance with regulatory, ethical, and company standards, HIPAA regulations., • Provide regular updates to Marketing management on team progress, KOL engagement, and other key initiatives, including metrics on impact and outcomes., • Stay abreast of the competitive landscape and emerging trends in dermatology, rheumatology, and neurology, ensuring TLL activities reflect the latest scientific advancements.Qualifications:Experience, • Minimum of 10 years of experience in TLL or related roles, with leadership experience in managing a team of TLLs., • Deep experience in therapeutic area of medical dermatology., • In-depth knowledge of medical dermatology, including clinical practice, research, and evolving treatment paradigms., • Proven track record of successful relationship-building with KOLs, HCPs, and key stakeholders within the medical community., • Experience working in cross-functional teams, with a demonstrated ability to collaborate effectively with medical affairs, clinical, and other business functions.Skills & Competencies, • Excellent leadership and team management skills, with the ability to inspire and develop a high-performing team., • Previous experience working in a leadership role within a biopharmaceutical company or a global pharmaceutical organization., • Comfort at presenting team activities to C-suite., • Strong communication, presentation, and interpersonal skills, with the ability to engage effectively with internal and external stakeholders., • Deep understanding of the pharmaceutical industry, including regulatory and compliance requirements, scientific data dissemination, and account or relationship management., • Ability to translate information including scientific, into actionable insights for diverse audiences, including KOLs, healthcare professionals, and internal teams., • Strong problem-solving, strategic thinking, analytical and decision-making skills., • Agile, solutions-oriented leader with a strong bias for action., • Bachelor's degree required.Travel, • This position is primarily remote with travel., • Willingness to travel extensively (50-75%) as required for KOL engagement, scientific meetings, brand activities and team management activities, • Regular travel to HQ expected Alumis Inc. is an equal opportunity employer. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. The salary range for this position is $215,000-$260,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company's compensation practices degree and background. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: • Health insurance premiums paid at 90% for employee, 80% for dependents, • 401k match, • Free access to Genentech Bus & Ferry Share program, • $100 monthly cell phone stipend, • Unlimited PTO, • Free onsite gym and a kitchen stocked with yummy snacks and drinks! We are a hard-working, collaborative team on a mission to transform patient's lives-- and we aspire to elevate, challenge and nurture one another along the way.

Job Description R&D Partners is seeking to hire a Research Associate I in Foster City, CA. Your main responsibilities as a Research Associate I: · Responsible for the expansion, maintenance, cryopreservation, and thawing of multiple cell lines. · Collaborate with team members to assess cell culture needs and provide necessary support for ongoing research activities. · Engage with various functional areas to evaluate cell culture and cell banking needs and deliver materials according to defined timelines. · Understand quality control procedures to validate cell lines as needed to ensure experimental integrity. · Maintain accurate, detailed laboratory notebooks and relevant documentation for all laboratory activities. What we are looking for in a Research Associate I: · B.S. degree in Molecular Biology, Cell Biology, Cancer Biology, or a related life science field, with a minimum of 3 years of hands-on experience working with cancer cell lines, primary cells, and genetically engineered cell lines. · Expertise in aseptic technique and mammalian cell culture, including handling multiple cell lines simultaneously and preparing media with complex supplements. · Excellent organizational skills, attention to detail, and proficiency in record keeping. · Familiarity with cell culture quality control practices such as mycoplasma testing and cell line authentication. · Proficiency in using electronic lab notebooks for experiment documentation, inventory management, and workflow execution (Preferred). Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: • Medical insurance – PPO, HMO &, • Dental & Vision insurance, • 401k plan, • Employee Assistance Program, • Long-term disability, • Weekly payroll, • Expense reimbursement, • Online timecard approval Pay Scale: $66,310 – $82,888 Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer. Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\n\nThe cornerstone of our success: a knowledgeable and experienced recruiting team.\n\nOur life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

Job Description Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan. We are building a mission-driven, collaborative team operating with speed, transparency, and adaptability. We are hiring a new member of the team who will lead analytical development and product quality strategy for RTR242, a small molecule in Phase I for the treatment of neurodegenerative diseases such as Alzheimer’s. In this role, you will provide hands-on leadership for analytical development while owning the end-to-end product quality strategy across CMC, manufacturing, and QC. You will work with our CDMO and CRO partners to achieve quality standards appropriate to stage and intended use. About You:You are a rigorous and pragmatic quality leader with deep expertise in small molecule analytical development. You know how to build scientifically sound, risk-based control strategies that are fit-for-stage. You are comfortable owning the details—from specifications and stability strategy to analytical methods, critical quality attributes, and acceptance criteria. You work effectively across internal teams and external partners, identify gaps early, and drive practical solutions with a high bar for quality, compliance, and execution. You are motivated by the opportunity to help advance therapies for age-related neurodegenerative disease and contribute to extending healthy lifespan. In This Role, You Will: Lead Quality Assurance for RTR242, providing end-to-end oversight of manufacturing and QC activities at CDMOs, including tech transfer, performance monitoring, deviation oversight, issue resolution, and continuous improvement and data integrity. Define and maintain a scientifically sound, risk-based, phase-appropriate control strategy across materials, manufacturing processes, analytical methods, and specifications to ensure product identity, strength, quality, purity, and stability in alignment with cGMP expectations. As part of the control strategy, define, justify, and maintain drug substance and drug product specifications, including critical quality attributes, acceptance criteria, scientific rationale, and lifecycle management. • Collaborate with QMS Chapter leads and document owners to define, refine, and standardize quality requirements. Lead the analytical method strategy across the product lifecycle, including QC release and stability methods supporting clinical development. Oversee analytical method development, qualification, and validation at CDMOs and CROs in alignment with ICH guidance and phase-appropriate regulatory expectations. Establish and oversee stability strategies, including protocol design, stability-indicating methods, data trending and interpretation, and shelf-life proposals. Serve as the product quality subject-matter expert for investigations, deviations, and CAPAs, ensuring robust root cause analysis and effective resolution. Identify and mitigate analytical, quality, and control strategy gaps and risks to support CMC readiness, compliant product release, and regulatory submissions. Serve as the primary analytical and product quality interface with CDMOs and CROs, establishing clear responsibilities, robust quality agreements, and governance to support effective oversight and sustained inspection readiness. Partner cross-functionally with Research, CMC, Regulatory Affairs, and QMS stakeholders to ensure analytical and quality strategies are scientifically sound, compliant, and clearly and defensibly documented. Contribute to global regulatory submissions and support health authority interactions in collaboration with Regulatory Affairs. You Will Excel In This Role If You: Bring 7+ years of experience in small-molecule analytical development, quality control, and/or product quality within a regulated pharmaceutical environment. Have hands-on experience with analytical method development, validation, and transfer, including techniques such as HPLC, GC, dissolution, impurity methods, and related assays. Have a strong working knowledge of ICH guidelines, GMP requirements, and regulatory expectations for clinical-stage small-molecule products. Have experience supporting IND-enabling or early clinical CMC activities. Have experience overseeing CDMO and/or CRO analytical activities, including method transfer, performance management, and external partner oversight. Demonstrate strong judgment in identifying and addressing CMC, quality, and regulatory risks before they affect timelines or development progress. Understand how analytical and quality expectations evolve across early clinical development and apply appropriate, phase-aligned rigor. Communicate clearly and effectively across technical teams, senior leadership, and external stakeholders. Have an advanced degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline, or equivalent experience. It's A Bonus If You: Have prior experience serving as a product quality or analytical lead within a matrixed organization. Have prior experience leading or providing technical oversight for impurity identification, metabolite or degradation pathway characterization, and root cause investigations, leveraging LC/MS and related techniques. Have experience supporting or leading formulation development activities. Have exposure to regulatory interactions or authoring CMC sections related to analytical control strategies. At Retro, we don’t use titles. New hires join as a “Member of X Team.” Depending on experience, this role could flex from Senior Manager to Associate Director or Director level, depending on company stage and size. Total compensation includes competitive base salary, generous equity, and benefits including: Medical, dental, and vision insurance for you and your family 401(k) plan with 4% matching Flexible time off and 10 company holidays per year Paid parental leave Annual learning & development stipend • Monthly longevity stipend Daily Retro-sponsored lunch and snacks We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionCorvus is a clinical-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer. Our lead program, soquelitinib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system. We are seeking an Executive Administrative Assistant to provide administrative support to Chief Executive Officer (CEO), Chief Financial Officer (CFO) and other executives as necessary. This is an on-site role with a minimum of 4 days on-site. Role and Responsibilities Tasks may include, but are not limited to: • Scheduling and coordinating meetings as requested by the CEO and CBO with internal and external team members including meetings related to business development activities, • Collects and prepares information for use in discussions/meetings of executive staff and outside individuals, including investors and board members, • Coordinate and schedule executive leadership team and board of director meetings and related phone or video calls, • Preparing materials and packages for executive leadership team, board of director meetings and other important company meetings, • Coordinate arrangements and meetings related to annual conferences such as ESMO, ASCO and AACR, • Coordinate the review, signing and filing of various contractual agreements., • Coordinate arrangements and meetings related to investor relation functions including meetings and related phone or video calls with existing and potential investors, • Support and act as backup for other administrative staff including Office Manager and Facilities Coordinator, • Must anticipate the needs of the CEO and CFO, • Handles details of a highly confidential and critical nature, • Makes high-level contacts of a sensitive nature inside and outside the company, • Represents CEO and CFO and Corvus with the highest level of professionalism, • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions, • Must be willing to work five days a week in Corvus’ South San Francisco OfficeQualifications and Education Requirements, • 5+ years’ experience in similar role with comparable responsibilities, • Bachelor’s degree a plus, • Expert level proficiency with Microsoft Office Suite required (Outlook, Word, Excel), • Experience in working with senior-level executives within and outside the company, customers, vendors, and visitors, • Excellent verbal and written communication skills, • Experience in working in pharmaceutical and/or biotechnology industryPreferred Skills, • Excellent teamwork and collaboration skills, • Proficient with Microsoft Office including creation of slides for technical and business presentations, • Strong project management skills, • Able to build effective working relationships throughout the organization internally and externally to achieve goals, • Flexibility and willingness to solve problems that fall outside of immediate area of expertise, • Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail, • Work independently in an interdisciplinary, fast-paced, often changing environment, • Committed to the values of integrity, accountability and driveSalary Range 140k – 170k Powered by JazzHR sK9ZqHOwPv

Job DescriptionThe Position At Maze Therapeutics, we believe that precision medicine has the power to transform the lives of patients with both common and rare diseases. As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you'll play a key role in supporting our Clinical Operations team as we deliver an exciting clinical trial in the rare disease, Phenylketonuria (PKU). You'll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is best suited for someone who is organized, detail-oriented, and proactive. The ideal candidate enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management. The Impact You'll Have You'll be a critical part of our clinical team, ensuring our trials are executed with precision, efficiency, and the highest standards of quality. Your contributions will include: • Driving Study Execution: Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 PKU study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary., • Site, Vendor Management & Oversight:, • Lead site management oversight (e.g., reviewing reports, conducting QC checks, escalating trends to Global Site Manager) to ensure CRO activities align with the study plans and protocol. Facilitate any deviation discussions for quick resolution. Identify site trends, opportunities for training, and creating tracking tools to ensure sponsor oversight., • Manage one or more clinical trial vendors from study-start to close-out, including day-to-day management, budget oversight, and escalating to Study Lead as, appropriate., • Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner., • Ensuring compliance & Best Practices: Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs., • Supporting Key Study Materials: Assist in the design, development, and review of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials., • Collaboration & Leadership: Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners., • Tracking & Documentation: Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed., • Sample & Data Management: Work with study team to coordinate and track sample shipments, sample analysis, and data reconciliation efforts., • Cross-Functional Collaboration: Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team., • Process & SOP Development: Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) and process documents to optimize study execution. What We're Looking For We're looking for someone who's not just checking the boxes but is truly passionate about bringing high quality clinical trials to life. You might be a great fit if you have: • A strong clinical operations background: Bachelor's degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment., • A systematic and problem-solving mindset: You enjoy solving complex challenges and thinking critically to improve processes., • Exceptional organizational skills: You can manage multiple priorities, staying detail-oriented, and keep trials on track., • A proactive and collaborative approach: You're a strong team player who takes initiative and builds meaningful relationships with internal and external partners., • Hands-on experience with trial systems: Familiarity with clinical trial databases such as Medidata Rave, Veeva, or similar platforms., • Flexibility and adaptability: You thrive in a fast-paced, evolving environment and willing to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed., • Willingness to travel: Up to 10-15% travel, with the possibility of more based on project needs as necessary., • Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook). This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least two days per week. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $125,000 to $152,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job Description OPPORTUNITY Mammoth Biosciences seeks an experienced Senior Clinical Scientist to advance pre-clinical research into clinical trials. This role encompasses both tactical and strategic responsibilities, including the design and execution of clinical trials, as well as meticulous monitoring of data for accuracy and integrity to ensure regulatory compliance. The incumbent will collaborate closely with the medical monitor, operations team, CRO partner, and study sites to ensure an efficient recruitment and follow-up of subjects in accordance with study protocols. Reporting to the VP, Clinical Development, the Senior Clinical Scientist will be responsible for the compilation and analysis of study data for various internal and external reports, as well as for key meetings. KEY RESPONSIBILITIES Trial Design and Execution: participate in protocol development, develop study CRFs, ICFs and databases Data Analyses and Monitoring: monitor clinical trial data for accuracy and integrity Compliance: ensure all study activities adhere to regulatory and ethical guidelines Collaboration: act as a bridge between medical monitor, operations, CRO and study sites to ensure efficient communications, subject recruitment and trial management Reports: write study reports, plans, and make data presentations for internal and external meetings Other duties as assigned REQUIRED QUALIFICATIONS Master’s degree/PharmD/PhD in a relevant life science field Minimum of 5 years experience in the pharmaceutical or biotechnology industry, with at least 2 years experience in clinical science/clinical development Demonstrated experience in the design, execution, and reporting of global Phase 1-3 clinical trials Strong proficiency in data analysis, interpretation of clinical trial results, and presenting data Deep knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements for clinical trials (FDA, EMA, etc.) Excellent verbal, written, and presentation skills with proven ability to communicate with multiple stakeholders Ability to travel internationally for site visits as needed PREFERRED QUALIFICATIONS Experience managing or directly overseeing clinical monitoring and data management processes Prior experience in a clinical scientist role within a high-growth, fast-paced biotechnology environment Demonstrated success in leading cross-functional teams and managing external partners (CROs) Strong collaborator with strategic planning and independent problem-solving skills Experienced in patient safety guidelines Knowledgeable about clinical trial ethics and regulatory standards Strong follow-up skills Ability to manage multiple conflicting priorities BENEFITS Company-paid health/vision/dental benefits Unlimited vacation and generous sick time Company-sponsored meals and snacks Wellness, caregiver and ergonomics benefits 401(k) with company matching Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity. COMPANY Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company’s ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth’s deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies. It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation. Mammoth Biosciences requires that all employees be vaccinated against COVID as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job DescriptionDescriptionCodexis, a biotechnology company based in Redwood City, CA, is looking to hire an Associate Director of Program Management . Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis enzymes can drive improvements, such as higher yields, reduced energy usage and waste generation, improve efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications. To meet the goals we’ve set for ourselves, we look for individuals who are driven, eager to grow and ready to embrace meaningful challenges. We empower employees to be authentic, ambitious, agile and have the courage to take action where they can make a positive impact. Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health. About the Opportunity: Associate Director of Program Management within our RNA Manufacturing team is responsible for partnering with all areas of the business to help advance customer assets into and through the clinic using ECO Synthesis™ technology. In this role you will be responsible for overseeing both Codexis internal R&D Programs and customer programs centered on RNA manufacturing. Working directly with ECO Synthesis™ Innovation colleagues to develop the enzymatic platform and implement its use in customer programs. The Associate Director of Program Management will support customer programs for siRNA manufacturing via the ECO Innovation lab through GMP manufacturing in support pre-clinical and clinical studies for our customers. The Associate Director of Program Management is responsible for understanding all aspects and interdependencies of the internal R&D and customer programs and is accountable for managing timelines and key deliverables by working with subject matter experts and departmental representatives to coordinate operational activities. The Associate Director of Program Management will lead the process to ensure all client goals and stage gates are met, identifying and elevating risks and opportunities to achieve success. If any of the below describes you, we would love to meet you! • Highly goal- and result oriented, • Strong interpersonal skills, • Strong, effective communication (verbal and written), • Highly organized, • Attention to detail In this role you will be responsible for: • Engage with Business Development (BD) and customers during opportunity qualification and development of proposals and business cases, including cost/margin analysis., • Lead multiple complex projects for both internal R&D and customer programs, working closely with commercial, technical, and quality/regulatory counterparts:, • Act as the key liaison between internal Codexis teams within research, development, and operations., • Drive the definition, stakeholder alignment, and documentation of deliverables for development and commercialization projects., • Develop budgets, schedules, project plans, and resource requirements, identifying critical path, milestones, and interdependencies., • Ensure that projects are executed on time and within budget, and/or that exceptions are appropriately escalated and managed., • Lead teams in risk identification and assessment processes to effectively balance risk and reward, and identify and escalate when mitigation actions are needed., • Support prioritization across programs based on resource needs (FTE and budget), timelines, and complexity., • Lead customer projects from concept to completion, partnering with both internal and external cross-functional teams and stakeholders:, • Manage client programs to manufacture siRNA drug substances and oversee projects through scale-up at CDMO and future clinical trials., • Collaborate with Business Development to review new proposals and address scope changes., • Submit milestone invoices to Finance and provide revenue updates., • Promptly share project documentation (e.g., minutes, emails, data) capturing critical information for relevant stakeholders., • Ensure communication is clear, timely, and sensitive, especially in the case of deviations., • Develop team members to continuously improve performance to meet business needs., • Lead efforts to identify and evaluate areas for improvement in project processes:, • Collaborate with other departments to improve support for changing business needs., • Contribute recommendations for process and administrative improvements to address inefficiencies. The essential requirements of the job include: • Bachelor's degree in sciences or related field required, with an Advanced degree (PhD or MBA)., • Advanced understanding of CDMO industry, Codexis capabilities, and siRNA pharmaceutical life cycle., • 10+ years' experience in pharmaceutical or biotechnology industry with at minimum of 4 year in project or program management. Strong preference for experience in drug development programs on pre-clinical and clinical stage programs., • Self-starter who can manage ambiguity, handle multiple stakeholder priorities while performing job responsibilities accurately., • Ability to understand program objectives and risks across the entire API development, regulatory submission, and commercialization landscape., • Skilled in the use of Project Management tools (Smartsheet, MS Projects, etc.)Additional Experience:, • Therapeutic oligonucleotide e.g. ASO, siRNA, aptamer API CDMO / drug innovator experience. CODEXIS PAY TRANSPARENCY: The anticipated salary range for candidates who will work in Redwood City is $170,000 to $200,000. 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. Codexis is a multi-state employer, and this salary range may not reflect positions that work in other states. What can Codexis offer you? • Medical, Dental and Vision Insurance, • Basic Life, AD&D, Short- and Long-Term Disability Insurance, • 401k with Company Match up to 4%, • Company Equity, • Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time, • Annual Lifestyle Account for reimbursement of fitness programs, equipment and more, • Employee Stock Purchase Program (ESPP), • Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare), • Student Debt Program (Company Contribution to Loans), • Mental Health Wellness Program, • Subsidized onsite lunch program, • Onsite Gym Facilities, • Paid Parental Leave, • And More!

Job Description Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance Director, (CONTRACTOR) reporting to the Executive Director, GCPQA. The role works closely with the Quality leadership and Study Execution Team members to provide ICH-GCP/GVP support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Data Management, Pharmacovigilance, Medical Affairs, Regulatory, Legal, and other teams across Alumis. The Clinical QA Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools, auditing and risk mitigations. The Director will assist with establishing Key Performance Indicators and Metrics to trend and track on the health of the clinical trials. The role is responsible for providing the operational quality guidance for the development teams and supporting the Executive Director of GCP Quality in building the Alumis Quality organization strategy and vision. This position requires expertise in Good Clinical and Pharmacovigilance Practices (ICH-GCP & GVP) and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management. The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities. ESSENTIAL DUTIES & RESPONSIBILITIES • Establish and maintain the ICH-GCP Clinical QA programs, policies, and procedures., • Ensure ongoing clinical programs are in compliance with applicable health authority regulations, guidelines and internal Standard Operating Procedures., • Act as the primary ICH-GCP Clinical QA subject matter expert and point of contact for all ICH-GCP/GVP related matters and issues for the assigned studies and initiatives., • Establish/maintain the study specific audit plan; perform audits and lead a team of external quality auditors as needed., • Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and Clinical QA to Clinical QA meetings., • Provide quality oversight and review of key Clinical and IND/NDA enabling documents., • Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues., • Support inspection readiness, plans and activities. Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs., • Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports. EDUCATION & EXPERIENCE • Bachelor's or advanced degree in Biology, Chemistry, or related field., • Minimum 10 years of ICH-GCP/GVP Quality Assurance experience., • Experience with auditing (e.g. Investigator Sites, Clinical Trial Vendors, Processes), • Strong understanding of small molecule products with direct experience in solid oral dosage forms. KNOWLEDGE/ SKILLS/ ABILITIES • Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices., • Hands-on experience in drug life cycle management., • A successful track record of working with service providers and CROs., • Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity., • Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry., • Excellent verbal and written communication skills., • Collaborative, analytical and interpretative skills., • Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required., • Previous experience in successfully leading assigned activities within cross-functional teams., • Approximately 15% travel required. The salary range for this position is $193,000 USD to $242,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company's compensation practices. This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Alumis Inc. is an equal opportunity employer.

Job DescriptionThe Opportunity As Senior Director of Pharmaceutical Development, you lead all small molecule drug product activities and serve as a technical expert overseeing processes at CDMOs. You guide formulation and process development, manage scaleups, and proactively identify risks, gaps, and solutions across CMC. You'll dig into process and analytical data to resolve key challenges and advise on the best path forward. You bring strong cGMP expertise, support regulatory submissions, and collaborate across research, development, and technical operations. You coach teams for excellence, fuel intellectual curiosity, and champion inclusive, impactful leadership. This position reports to Vice President, Technical Operations. The Impact You'll Have • Lead small molecule drug product formulation, process development, and manufacturing activities with external CDMOs., • Ensure drug products meet quality, cost, time, safety, and operational goals., • Evaluate CDMO capabilities and recommend approaches for development and manufacturing., • Drive formulation, process development, scaleup, and tech transfer from initiation through regulatory approval., • Shape and optimize CMC strategy, project plans, and execution., • Monitor daily CMC activities, resolve challenges, and ensure cGMP compliance., • Ensure CDMO processes meet needs across formulation development, tox studies, clinical trials, and commercial launch., • Assess and implement new methods, tools, and technologies that elevate program success., • Analyze scientific data, review batch documentation, and contribute to regulatory filings (IND/IMPD/CTA/NDA)., • Review and approve master and executed batch records; lead process improvements and drive solutions., • Lead technical investigations, identify root causes, and implement corrective actions for deviations., • Collaborate effectively across teams with integrity, impact, and a values-driven mindset., • Represent Tech Ops and CMC in cross-functional settings. As a Senior Director, we also expect you to demonstrate the following Leadership Competencies: Leadership Competencies • Communication and Influence, • Role models clear communication and open two-way conversations., • Reinforces an environment where people feel heard and their opinions are valued., • Inspires followership despite differing initial opinions., • Teamwork and Collaboration, • Champions collaborations and connections across Maze., • Establishes team norms and expectations., • Seeks opportunities to spotlight team and individual contributions in public forums., • Execution and Results, • Develops recommendations to seize on opportunities and mitigate obstacles that could impact long-term success., • Coaches others on resource management and work distribution/delegation., • Aligns work to Maze's strategy, mission, and vision., • Develop Others and Self, • Develops staff capabilities to handle delegation of responsibilities., • Encourages staff to develop and execute personal stretch goals., • Identifies and recommends ways to increase inclusive leadership. What We're Looking For, • PhD/MS/BS in Pharmacy, Pharmaceutics, Chemical Engineering, or related field., • 15+ years of experience in Drug Product CMC development and manufacturing., • Deep expertise in small molecule Drug Product CMC from preclinical through commercial stages., • Experience leading Drug Product functions in biotech/pharma across multiple programs., • Strong knowledge of GMP and ICH guidelines; experience authoring regulatory submissions is a plus., • Direct manufacturing experience preferred., • Proven success in tech transfer and scaleup., • Ability to strategically and pragmatically partner with CDMOs to optimize quality and operations., • Handson formulation development experience and the ability to share knowledge with external partners., • Strong attention to detail and a talent for building robust Drug Product processes., • Comfort navigating fast-paced, evolving startup environments., • A self-starter mindset with strong leadership, communication, and decision-making skills., • Willingness to travel as needed to support CMC goals with external partners. This role follows a hybrid schedule, with an expectation to be onsite at our South San Francisco headquarters at least three days per week About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which allows it to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process it refers to as variant functionalization. The company's pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease. Maze is based in South San Francisco. Our People Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases. We are fostering a culture that encourages vision, initiative and the development of talent. Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work. While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients. Our Core Values Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we'll achieve our mission. Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others. Stand True – Our integrity is foundational; it guides us no matter the obstacle. The expected annual salary range for employees located in the San Francisco Bay Area is $257,000 - $315,000. Additionally, this position is eligible for an annual performance bonus. Maze performs position-based compensation benchmarking to industry market data to ensure we pay competitive wages. Determination of starting salary will depend upon a variety of job-related factors, which may include professional experience, skills, and job location. The expected salary range for this role may be modified in the future. Maze offers a robust benefits package to our eligible employees including competitive medical, dental, and vision insurance, mental health offerings, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy. #LI-Hybrid

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific / Medical Director, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities for AbbVie’s Oncology portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives, scientific communications, value propositioning, and safeguarding patient safety (risk minimization activities and safety surveillance activities). The Scientific / Medical Director works closely with commercial and research and development teams to provide critical medical input into evolving core medical, brand (product), and value and access strategies to support our evolving on-market and therapeutic area needs. Responsibilities • In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory, HEOR and other functional areas, provides leadership and support for assigned indications/projects., • Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and is responsible for executing medical support/launch activities for gynecologic oncology initiatives., • Conducts promotional review and assists in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia., • Serves as Medical expert for internal and external stakeholders regarding asset clinical profile, value, and appropriates; and provides Medical review for cross-functional deliverables, ensuring compliance and scientific accuracy., • Develops innovative research concepts, generates evidence, and drives execution of scientific communication plans, including high-quality publications, presentations, and educational programs., • Engages and cultivates relationships with key opinion leaders, scientific advisors, and advocacy groups within the gynecologic oncology community., • Monitors the evolving relevant therapeutic landscape to inform business decisions and anticipate future needs., • Leads the development and execution of advisory boards., • May lead delivery of medical functional plan, brand plan, and/or integrated evidence plan.Qualifications Position will be commensurate with education and experience. For Scientific Director: • Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Substantial understanding of relevant therapeutic area required., • Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred. For Medical Director: • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred. Other • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Ability to run a clinical study independently with little supervision., • Proven strategic leadership, influencing, and collaboration skills in cross-functional environments. Ability to interact externally and internally to support global business strategy., • Expertise in evidence generation, scientific communication, and health economics/outcomes research., • Must possess excellent presentation, organizational, and written/oral communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html