Senior Scientists (Analytical Development) - Cell Based Assays
Job Title: Senior Scientist, Cell-Based Assays Location: San Francisco, California Company: They are an innovative biotechnology company dedicated to advancing the field of Gene and Cell Therapy. Their mission is to develop groundbreaking therapies that improve the lives of patients worldwide. They are driven by a commitment to scientific excellence, collaboration, and innovation. Position Overview: They are seeking a highly skilled and motivated Senior Scientist with extensive experience in cell-based assays to join their dynamic research team. The successful candidate will play a critical role in the development and implementation of cell-based assays to support their drug discovery and development programs. Key Responsibilities: Design, develop, and optimize cell-based assays to evaluate the efficacy, potency, and mechanism of action of therapeutic candidates. Perform high-throughput screening and validation of compounds using cell-based assays. Analyze and interpret complex data sets, and present findings to cross-functional teams. Collaborate with other scientists and departments to integrate cell-based assay data into broader research and development efforts. Maintain detailed and accurate records of experimental procedures and results. Stay current with advancements in cell-based assay technologies and methodologies. Mentor and train junior scientists and research associates. Qualifications: Ph.D. in Cell Biology, Molecular Biology, Biochemistry, or a related field with 5+ years of relevant experience; or M.S. with 8+ years of relevant experience. Proven expertise in designing and conducting cell-based assays, including but not limited to viability, proliferation, cytotoxicity, and reporter gene assays. Experience with high-throughput screening and automation technologies. Strong analytical skills and proficiency in data analysis software (e.g., GraphPad Prism, Excel). Excellent problem-solving abilities and attention to detail. Strong communication and presentation skills. Ability to work independently and collaboratively in a fast-paced, multidisciplinary environment. Preferred Qualifications: Experience in the pharmaceutical or biotechnology industry. Knowledge of regulatory requirements and guidelines for cell-based assays. Familiarity with CRISPR/Cas9 gene editing and other advanced molecular biology techniques. Benefits: Competitive salary and benefits package. Opportunities for professional development and career advancement. Collaborative and inclusive work environment. Access to state-of-the-art facilities and resources.
US$140000 - US$180000 per year
San Francisco
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Associate Director Radiopharmaceutical Development-
Associate Director, Radiopharmaceutical Process Development Our client is a pioneering biotechnology firm specializing in the development of cutting-edge radiopharmaceutical therapies. Their rapid growth is fueled by a robust pipeline of successful projects and strategic investments. They are seeking an Associate Director of Radiopharmaceutical Process Development to drive the CMC radiopharmaceutical process development for all novel clinical programs. The Associate Director will execute the CMC development plan and IND enabling activities, leading to the clinical manufacturing of the Drug Product. In this role, you will translate pre-clinical/research methods and data to develop cGMP compliant processes and clinical drug product specifications, manage the execution of CMC studies, and author drug substance/product IND sections. Additionally, you will provide technical support and assessment to clinical manufacturing, including root cause analysis, change control, and process optimization. This role will serve as the main liaison between Tech Ops and research as well as the CDMO development team. Principal Responsibilities Process Development of Radiopharmaceutical Drug Product (DP) Lead the process development of radiopharmaceuticals for phase 1 clinical trials with a multidisciplinary team. Participate in the selection team to review RFPs, assess technical fit, and select the appropriate CDMO for development and manufacturing of novel products. Develop DP from DC selection to IND submission, including creating technology transfer packages, defining and managing development timelines, designing studies to determine suitable process conditions, and leading process qualification and validation campaigns. Write relevant CMC sections and supporting reports for regulatory submissions. Execute clinical readiness activities to enable clinical manufacturing. Technical Support of Clinical Manufacturing Provide technical direction to external CDMOs to draft manufacturing documentation. Partner with Quality to review manufacturing data and identify opportunities for risk reduction and continuous improvement. Support Quality/Regulatory assessments, including batch release, change control, deviations, OOs, and CAPAs. Liaison Between Research/Pre-Clinical and CMC Support the setup and ongoing function of the radiochemistry laboratory. Act as the liaison to partner with research radiochemistry and in vivo teams to share best practices and facilitate knowledge exchange. Qualifications, Education & Experience MSc or PhD in scientific fields with 10+ years of experience in the pharmaceutical industry, including radiopharmaceuticals. Knowledge of cGMP requirements, aseptic processes, and equipment qualification. Experience in writing CMC sections of regulatory submissions and clinical development and manufacturing. Experience with antibodies and bioconjugation is a plus. Good understanding of radiation regulations and guidelines preferred. Skills and Abilities Strong understanding of cGMP and FDA regulations. Excellent written and verbal communication skills. Strong analytical capabilities and critical thinking skills. Ability to troubleshoot complex problems and build rapport with all levels of the organization. Team-oriented, innovative thinker who enjoys a fast-paced, multidisciplinary environment.
US$160000 - US$200000 per year
San Francisco
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Director/Senior Director, Analytical Development
Director/Senior Director, Analytical Operations About The Job We are seeking an exceptional leader to develop and implement innovative analytical technologies and testing strategies from preclinical and IND-enabling studies through clinical development and commercialization. Who We Are We are an early-stage biotechnology company pioneering a new class of medicines for individuals, especially children, living with genetically driven diseases. Powered by a non-viral DNA vector system, our mission is to develop novel therapeutics that bypass the current limitations of gene therapy and achieve higher standards for potency, durability, redosability, and safety. Funded by leading investors and led by seasoned experts in gene delivery, protein sciences, and clinical translation. The Impact You Will Make This leader will be responsible for driving analytical technology innovation and development strategies for non-viral DNA-based gene therapy drug products, along with fostering a culture of inclusion, empowerment, scientific excellence, collaboration, and engagement. You will create a comprehensive roadmap for product analytics, contribute to long-term technology and operational strategies, drive rapid implementation of new technologies, and ensure functional excellence for regulatory strategies and operational efficiencies leveraging automation and state-of-the-art data management. This is a leadership position with critical accountabilities and influence on the pipeline product portfolio from pre-candidate nomination through research, development, commercialization, and beyond. The position requires strong technical partnership and collaboration with multiple stakeholders including Early Research, Gene Delivery Technology, CMC and Process Development, and Quality. This role is based in Southern California. What You'll Bring Technical Demonstrate technical leadership while collaborating closely with leaders from other functional areas and potential external partners. Serve as a thought leader for analytical technology innovation, integrated process and analytical control strategies, and integrated technical development and regulatory strategies for DNA-based vectors and non-viral DNA delivery technologies. Create a comprehensive roadmap for drug product and DNA vector analytics, as well as critical raw materials, process, and product residuals. Drive rapid implementation of new analytical technologies into CMC and clinical programs, ensure functional excellence for regulatory strategies for INDs and BLAs, and ensure operational efficiencies leveraging automation as well as state-of-the-art data analysis and management. Provide key strategic compliance and analytical development input to projects and cross-functional teams, including early research, and process development and manufacturing. Ensure scientific integrity and quality of regulatory submissions and support interactions with the global health authorities. Contribute Program Development Strategy including risk identification and mitigation plans, program development activities, timelines, and resource allocation. Leadership Build and strengthen a cohesive and motivated department that understands its issues, challenges, and opportunities. Engage and retain talent by understanding individuals' development needs and aligning with business requirements. As part of the R&D Leadership Team, drive technical vision, strategy, and programs to meet corporate objectives. As part of the R&D Leadership Team, help define and effectively communicate a compelling scientific vision internally and externally. As part of the R&D Leadership Team, contribute to gene therapy insights and technology through publications and external partnerships to deliver best-in-class therapies to patients. Education and Experience Required MS/Ph.D. degree in Immunology, Life Sciences, Chemistry, Pharmacology, or Engineering or similar. 5 years (>10 years for Senior Director) of experience in the development of gene therapy products or biologics. Knowledge and direct experience in developing analytical technology and methods, characterization and release of gene therapy drug products, including lipid nanoparticle (LNP) and/or polymer nanoparticle (PNP) formulation, is strongly desired. Experience with regulatory filings of rare disease products is preferred. Demonstrated excellence in developing, mentoring, and managing staff. Proven leadership and ability to positively influence colleagues and key decision-makers. Demonstrated collaboration skills working cross-functionally, maintaining strong stakeholder relationships, influencing direction, voicing opinion, and communicating. Benefits & Additional Information Compensation range: $145,000-$230,000 annually plus additional bonus, benefits and relocation support If you are interested please apply to be considered.
US$145000 - US$230000 per year + bonus, relocation support
Los Angeles
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Scientist, Analytical Development
We are seeking a highly skilled and motivated Analytical Scientist to join our team. The ideal candidate will be a SME in method development with extensive experience in injectable dosage forms. This role requires a Ph.D. in a relevant field and at least 2 years of experience working with Small Molecules. Key Responsibilities: Develop and validate analytical methods for injectable dosage forms. Conduct routine and non-routine analysis of pharmaceutical products using advanced analytical techniques. Collaborate with cross-functional teams to support product development and ensure compliance with regulatory standards. Troubleshoot and optimize analytical methods to improve efficiency and accuracy. Prepare and review technical documents, including protocols, reports, and standard operating procedures (SOPs). Stay current with industry trends and advancements in analytical technologies. Qualifications: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field. Minimum of 2 years of experience in small molecule analysis. Expertise in method development and validation for injectable dosage forms. Proficiency in using analytical instruments such as HPLC, GC, MS, and others. Strong problem-solving skills and attention to detail. Excellent written and verbal communication skills. Ability to work independently and as part of a team. Preferred Qualifications: Experience with regulatory submissions and compliance. Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
US$100000 - US$120000 per year
New Jersey
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Scientist, Analytical Development
We are seeking a highly skilled and motivated Analytical Scientist. The ideal candidate will be a SME in method development with extensive experience in injectable dosage forms. This role requires a Ph.D. in a relevant field and at least 2 years of experience working with Small Molecules. Key Responsibilities: Develop and validate analytical methods for injectable dosage forms. Conduct routine and non-routine analysis of pharmaceutical products using advanced analytical techniques. Collaborate with cross-functional teams to support product development and ensure compliance with regulatory standards. Troubleshoot and optimize analytical methods to improve efficiency and accuracy. Prepare and review technical documents, including protocols, reports, and standard operating procedures (SOPs). Stay current with industry trends and advancements in analytical technologies. Qualifications: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field. Minimum of 2 years of experience in small molecule analysis. Expertise in method development and validation for injectable dosage forms. Proficiency in using analytical instruments such as HPLC, GC, MS, and others. Strong problem-solving skills and attention to detail. Excellent written and verbal communication skills. Ability to work independently and as part of a team. Preferred Qualifications: Experience with regulatory submissions and compliance. Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
US$100000 - US$120000 per year
New Jersey
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Analytical Scientist
We are seeking a highly skilled and motivated Analytical Scientist. The ideal candidate will be a SME in method development with extensive experience in injectable dosage forms. This role requires a Ph.D. in a relevant field and at least 2 years of experience working with Small Molecules. Key Responsibilities: Develop and validate analytical methods for injectable dosage forms. Conduct routine and non-routine analysis of pharmaceutical products using advanced analytical techniques. Collaborate with cross-functional teams to support product development and ensure compliance with regulatory standards. Troubleshoot and optimize analytical methods to improve efficiency and accuracy. Prepare and review technical documents, including protocols, reports, and standard operating procedures (SOPs). Stay current with industry trends and advancements in analytical technologies. Qualifications: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field. Minimum of 2 years of experience in Small Molecule analysis. Expertise in method development and validation for injectable dosage forms. Proficiency in using analytical instruments such as HPLC, GC, MS, and others. Strong problem-solving skills and attention to detail. Excellent written and verbal communication skills. Ability to work independently and as part of a team. Preferred Qualifications: Experience with regulatory submissions and compliance. Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
US$100000 - US$120000 per year
New Jersey
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Associate Director, Process Management - Clinical R&D
We are seeking a dynamic and strategic Associate Director, Process Management to create and drive business process optimization and continuous improvement in support of the growth and organizational effectiveness of our Clinical Research & Development team. This role requires a minimum of 3 days a week of onsite presence in either our California or New Jersey offices. About You: The ideal candidate is a collaborative and dynamic individual with a strong background in developing and executing robust business processes to improve efficiency, optimize resources, and reduce errors and compliance risks. You have experience engaging and organizing subject matter experts and cross-functional groups to identify gaps and inefficiencies and taking action to bridge these gaps through process optimization. Additionally, you have a strong background in the end-to-end clinical drug development process. Key Responsibilities: Lead project teams in creating, reviewing, and maintaining procedural documents (e.g., SOPs, policies, job aids), process maps, and personnel qualification strategies. Partner with Business Process Owners to ensure processes integrate with the end-to-end clinical drug development process, delivering efficiencies and mitigating compliance risks. Identify gaps and inefficiencies in current business processes and opportunities for improvement. Implement tools to collect and measure relevant data, identify key performance indicators (KPIs), and produce data-driven analyses of critical functions. Define and evaluate metrics to monitor the effectiveness of existing business processes. Collaborate with Business Process Owners and IT System Owners in the design, implementation, and release management of clinical systems (e.g., Clinical Trial Management System, electronic Trial Master File). Work with functional leaders, SMEs, and Clinical Quality Assurance to define compliance and business requirements, prioritizing core business processes based on strategic importance, regulatory requirements, and business impact. Develop and implement strategies to ensure ongoing inspection readiness for clinical trials. Support GCP audits and inspections by regulatory authorities and business partners. Develop and deliver training programs for new/updated operational procedures or clinical systems, including documentation, tools, and training to support adoption. Stay informed about changes in regulations, industry standards, and best practices. Qualifications: 10+ years of clinical drug development experience with a Bachelor's degree or 8+ years with a postgraduate degree. Experience in the biotechnology or pharmaceutical industry is required. In-depth knowledge of ICH-GCP, EMEA guidelines, and other relevant regulations and guidelines. Demonstrated ability to lead and influence change in process development and system implementation. Ability to collaborate effectively with cross-functional teams and subject matter experts. Proven ability to synthesize information from multiple sources and make risk-based decisions. Experience with Veeva Quality Vault and Veeva Clinical Platform is preferred. Excellent written, organizational, and interpersonal skills. Ability to work onsite at least 3 days a week. Compensation and Benefits: At Biopharmaceutical Company, employee compensation includes bonus and equity compensation, along with several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Biopharma company at 95%), dental, and vision insurance (premiums covered by Biopharma company at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Biopharma company at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site Join Biopharma company and be part of a team dedicated to advancing clinical research and development through innovative process management!
US$122000 - US$190000 per year
Hayward
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Scientist III Formulation Biologics
Summary: This growing Biotech is looking for a strong drug product development scientist to join their CMC team. This role involves formulation development, analytical testing, drug product manufacturing, and support for pre-clinical and clinical studies. The ideal candidate should be highly motivated, able to multitask, and thrive in a dynamic environment. Responsibilities: Lead formulation development and drug product manufacturing activities. Act as an SME in developing stable formulations for clinical-stage biotherapeutics. Design and evaluate formulations through stability studies. Perform analytical testing to assess product stability. Oversee DP container selection and Fill/Finish processes with CDMOs. Ensure GMP compliance during manufacturing. Lead compatibility studies of clinical administration components. Collaborate with internal teams and external partners. Contribute to regulatory filings and technical reports. Manage day-to-day lab activities and maintain equipment. Engage in scientific discussions and present findings. Qualifications: MS/PhD in Biochemistry, Biophysics, Chemical Engineering, or related field. Minimum of 8 years of biotech industry experience in formulation development and GMP DP Fill/Finish manufacturing. Expertise in formulation development methodologies and analytical techniques for mAbs, ADC's, Bispecifics, or fusion proteins is highly desired. Strong understanding of cGMP regulations. Excellent communication and multitasking skills.
US$100000 - US$130000 per year
Maryland
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Associate Director/Director, CMC
Associate Director / Director - CMC (Chemistry, Manufacturing, and Controls) Location: Brisbane, CA Department: R&D Employment Type: Full-Time, On-site OPPORTUNITY We are seeking an Associate Director / Director, CMC to be a key player in our product development teams, providing support across all developmental and clinical programs. The successful candidate will manage a network of CDMOs for Drug Substance and Drug Product manufacturing for our pipeline. KEY RESPONSIBILITIES Associate Director Level: Design, develop, and validate analytical methodologies for our pipeline. Identify opportunities to improve productivity and efficiency in projects and analytical science. Collaborate with diverse teams, including CDMO analytical science teams. Lead analytical science in project teams, ensuring alignment and fostering productive relationships with other core functions. Ensure data integrity and promote knowledge sharing throughout the medicine development lifecycle. Ensure compliance with regulatory standards including GMP, ICH, EMA, and FDA guidelines. Support the preparation of global regulatory submissions, scientific reports, and patents. Develop phase-appropriate quality control strategies for drug substance and drug product. Manage drug substance and drug product stability study programs. Develop scientifically sound and data-driven specifications. Oversee analytical and QC activities at CDMOs and Contract Testing Laboratories, including the review and approval of test records, forms, methods, protocols, and reports. Identify and develop suitable analytical methods for comprehensive characterization of drug substances, drug products, associated impurities, and excipients. Maintain documentation within the quality management system. Experience with various cultures, as CDMOs are global, with potential for global travel. Director Level: Provide broad CMC support for internal programs from GLP tox through IND clinical programs. Ensure timely Drug Substance/Drug Product supply for non-clinical and clinical studies. Assist in the preparation and review of CMC sections of regulatory submissions, including IND, BLA, NDA, and MAA. Manage CMOs for process development and manufacturing of Drug Substances and Drug Products for toxicology and cGMP supplies. Develop and execute CMC strategies for early and late phase Drug Substance/Drug Product clinical supplies. Implement processes and controls for regulatory materials, intermediates, and drug substances and products. Coordinate with internal and external analytical/quality control, quality assurance, and regulatory team members to resolve technical issues or deviations during cGMP production. Create and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturing. Ensure activities align with established Quality Agreements. Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed. Work closely with cross-functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers. Develop and maintain collaborative relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality, Finance, etc.) to deliver on internal goals and objectives. REQUIRED QUALIFICATIONS Master's Degree in a relevant scientific discipline. Prior experience with CMC development in gene therapy is highly desired. Minimum of 10 years of experience in biotech for large and small molecules (Director); minimum of 8 years of experience (Associate Director). Strong process understanding in one or more of the following: biologics, oligonucleotide, cell therapy, viral vectors, gene therapy, or LNP. Experience in managing external CDMOs for DS/DP production. Strong understanding of phase-appropriate analytical development and manufacturing strategies for large and small molecules. Experience with US and EU CMC regulatory expectations, technical transfers, and complex development & manufacturing activities. Excellent people manager and cross-functional leader, able to lead diverse and complex teams with demonstrated success. Ability to travel both domestically and internationally, as needed. PREFERRED QUALIFICATIONS Previous experience with CMC development in gene therapy. Previous experience managing CDMOs for outsourced manufacturing. Extensive understanding of cGMP regulations. Previous experience working in small to midsize biotech. Previous experience in CMC development of gene therapy products. Previous experience in small molecule and biologics manufacturing. Previous experience in formulation development for complex products like lipid nanoparticles. Experience with various cultures, as CDMOs are global, with potential for global travel. 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. Base Salary Range: $170,000 - $215,000 Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity. Would you like any further modifications or additional details?
US$170000 - US$215000 per year
San Francisco
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Clinical Scientist
Title: Clinical Scientist (Contract Position) Introduction: A renowned biotechnology firm based in Redwood City, United States is seeking an experienced and dedicated Clinical Scientist. This contract position offers a challenging yet rewarding opportunity to contribute significantly within the immunology space while managing clinical sites efficiently. Key Responsibilities: -Collaborate with the physician lead to plan and oversee clinical studies focusing on mast cell and stem cell diseases, providing support for medical monitoring activities. -Gather, analyze, interpret, and review clinical data from assigned studies. -Support clinical data review and cleaning processes for key studies in the urticaria and stem cell programs, including generating and resolving queries. -Engage directly with study sites to facilitate effective communication and exchange of information. -Prepare study reports, presentations, and publications to share findings with internal and external stakeholders. -Actively participate in weekly study execution, clinical study team, and data review meetings. -Partner with cross-functional teams, including clinical operations, medical affairs, regulatory affairs, and biostatistics, to ensure the successful execution of assigned programs. Requirements: Education and Experience Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical field required. 0-3 years of pharmaceutical industry experience, preferably in immunology. Strong understanding of clinical trial design, methodology, and regulatory standards (e.g., GCP, ICH). Proficient in data analysis, interpretation, and statistical methods. Excellent written and verbal communication skills for diverse audiences. Experience in hematological malignancies, transplant studies, immunological, or dermatological research is a plus. Title commensurate with experience. Skills and Competencies Strong project management, organizational, and analytical skills. Exceptional problem-solving and communication abilities. Ability to collaborate effectively in a matrixed environment. Proficiency in statistics, data interpretation, and relevant tools. Bay Area location preferred. Experience with electronic data capture systems is a plus. Apply now if meeting these criteria aligns with where you envision taking your expertise next!
Negotiable
Redwood City
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