Head of Analytical Development and Quality Control
2 days ago
We are seeking an experienced and visionary leader to head our Analytical Sciences and Quality Control (ASQC) function. As the Head of Analytical Development and Quality Control, you will be responsible for developing and implementing phase-appropriate analytical methods and testing strategies for complex biologicals, including plasmid DNA, mRNA, lipid nanoparticles, proteins, and viral vectors.
Key Responsibilities- Strategic Leadership: Establish and lead the ASQC strategy, including tactics, timelines, budgets, and resource allocation. Build and mentor high-performing teams, proactively identify and resolve critical analytical issues, and support talent development and engagement.
- Analytical Development: Develop and qualify phase-appropriate methods for release, characterization, and stability of complex biologicals, utilizing state-of-the-art technologies and approaches. Oversee the qualification, transfer, and execution of analytical and bioanalytical assays, ensuring compliance with cGMP regulations and ICH guidelines.
- Lifecycle Management: Provide strategic oversight for the design, establishment, and execution of processes and procedures for the lifecycle management of analytical methods for clinical and commercial product testing. Drive the strategy for product quality assessment, analytical comparability, and characterization.
- Regulatory Expertise: Author and review relevant CMC sections of regulatory submissions, serving as an analytical subject matter expert in regulatory interactions. Draft guidelines and set release and stability specifications for clinical-stage and commercial programs.
- Cross-functional Collaboration: Partner with internal and external stakeholders to lead Quality Target Product Profile and product characterization strategy, enhancing process-to-product understanding and supporting process development and characterization.
- Ph.D. in Biochemistry, Analytical Chemistry, Microbiology, Genetics, or a related life sciences discipline.
- At least 15 years of experience in analytical development and quality control within the biotech industry.
- Industry experience managing scientific teams with a proven ability to lead and grow strong technical teams.
- Extensive industry experience with nucleic acids, viral vectors, lipid nanoparticles, and complex biologicals.
- Demonstrated expertise in cGMP regulations, ICH guidelines, and USP standards, and their application in clinical development and commercialization.
- Proven ability to build and lead masterful and impactful teams.
- Advanced strategic thinking with a focus on product quality assessment, analytical comparability, and characterization.
- Proven project management skills, including managing timelines, budgets, and resources.
- Excellent communication skills, both written and verbal, with experience in authoring and reviewing regulatory submissions, SOPs, and technical documents.
- Strong problem-solving skills, with the ability to resolve complex issues and drive innovative solutions.
-
Emeryville, California, United States 4D Molecular Therapeutics Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...
-
Emeryville, California, United States Prolific Machines Full timeAbout Prolific MachinesProlific Machines is revolutionizing the biomanufacturing industry with its cutting-edge proprietary platform. This innovative technology enables unparalleled control over cell functions, with far-reaching applications in food and pharmaceuticals. We are seeking a talented and mission-driven individual to join our team and contribute...
-
Head of Safety Science
2 weeks ago
Emeryville, California, United States BeiGene Full timeGeneral Overview:The Head of Safety Science plays a pivotal role in overseeing the safety evaluation of assigned compounds, collaborating closely with Product Safety Leads (PSLs). This position requires leveraging clinical and scientific knowledge to identify safety signals, assess safety data, and respond to regulatory inquiries while ensuring compliance...
-
Analytical Scientist
2 months ago
Emeryville, California, United States Totus Medicines Full timeThis role provides exposure to multiple phases of drug discovery and development with a mission to characterize covalent small molecule-protein interactions and develop new sample workflows for chemoproteomics.Lead protein mass spectrometry campaigns across a multidisciplinary Platform Team in pursuit of enabling covalent drug discoveryPropose, implement,...
-
Clinical Budget Development Specialist
2 weeks ago
Emeryville, California, United States BeiGene Full timeAbout the RoleWe are seeking a highly skilled Clinical Budget Development Specialist to join our team at BeiGene. As an Associate Site Budget Development and Investigator Payment Management Expert, you will play a critical role in supporting the creation of site budget templates leveraging Fair Market Value (FMV) analysis.Key ResponsibilitiesDevelop Global...
-
Clinical Budget Development Specialist
2 weeks ago
Emeryville, California, United States BeiGene Full timeAbout the RoleWe are seeking a highly skilled Clinical Budget Development Specialist to join our team at BeiGene. As an Associate Site Budget Development and Investigator Payment Management Expert, you will play a critical role in supporting the creation of site budget templates leveraging Fair Market Value (FMV) analysis.Key ResponsibilitiesDevelop Global...
-
Research and Development Scientist
2 weeks ago
Emeryville, California, United States Kelly Science, Engineering, Technology & Telecom Full timeJob SummaryWe are seeking a highly skilled Research and Development Scientist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our R&D team, you will be responsible for developing and implementing new product formulations, leading cross-functional projects, and collaborating with suppliers to drive innovation and...
-
Senior Manager of Cell Therapy Development
7 days ago
Emeryville, California, United States BeiGene Full timeAbout the RoleWe are seeking an exceptional and highly motivated leader to join our Cell Therapy team at BeiGene. As the Director of Cell Therapy Operations, you will play a critical role in enabling the development of our cell therapy programs.Key ResponsibilitiesStrengthen our internal cell therapy capability by working with internal stakeholders and...
-
Senior SAP Finance Control Specialist
2 weeks ago
Emeryville, California, United States Tranzeal Incorporated Full timePosition: SAP FI/CO Functional SpecialistCompany: Tranzeal IncorporatedOverview: We are seeking a knowledgeable professional with extensive experience in SAP Finance (FI) and Controlling (CO) modules to enhance our financial operations and drive process optimization.Key Responsibilities:Customize and configure SAP FI/CO modules to align with organizational...
-
Inventory Control Specialist
2 weeks ago
Emeryville, California, United States Grocery Outlet Full timeAbout Grocery Outlet: Our Mission: Enhancing lives positivelyOur Vision: Becoming the preferred choice for value-conscious shoppers in the U.S.Our Values & Behaviors: Achievement, Diversity, Entrepreneurship, Family, Fun, Integrity & ServiceAbout the Team: The Finance team is dedicated to fostering efficiency while supporting our organization and business...
-
Product Development Specialist
2 weeks ago
Emeryville, California, United States Kelly Science, Engineering, Technology & Telecom Full timeJob SummaryWe are seeking a highly skilled Research and Development Scientist to join our team at Kelly Science, Engineering, Technology & Telecom. As a key member of our product development team, you will be responsible for driving innovation and delivering high-quality products to the market.Key ResponsibilitiesDevelop and execute product development...
-
City Manager
5 days ago
Emeryville, California, United States City of Emeryville, CA Full timeAbout the Role:The City Manager serves as the Administrative Head of the City of Emeryville government, playing a pivotal role in shaping and realizing the City's vision for the future. This position ensures efficient and effective delivery of public services while upholding the principles of accountability and transparency.Key Responsibilities:Foster an...
-
Strategic Business Development Manager
5 days ago
Emeryville, California, United States Grocery Outlet Full timeAbout Grocery OutletGrocery Outlet is a leading retail company that operates with a unique business model, focusing on providing high-quality products at discounted prices to its customers.About the TeamOur Strategy team is responsible for identifying and analyzing key business problems, including innovation, long-term business strategy, advertising, and...
-
Head of Intellectual Property and Licensing
2 weeks ago
Emeryville, California, United States OmniAb Full timeAbout OmniAbOmniAb stands at the forefront of delivering access to a wide array of antibody repertoires and innovative screening technologies tailored for the pharmaceutical sector. Our enthusiastic team is dedicated to advancing drug discovery and enhancing global health through pioneering research initiatives.Position Overview: Director of Intellectual...
-
Associate Director, Early-Stage Product Development
2 months ago
Emeryville, California, United States 4D Molecular Therapeutics Full timeAttention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to...
-
Strategic Business Development Manager
1 day ago
Emeryville, California, United States Grocery Outlet Full timeAbout Grocery OutletGrocery Outlet is a leading retailer in the United States, known for its unique business model and commitment to providing high-quality products at affordable prices.About the TeamOur Strategy team is a dynamic and entrepreneurial group of professionals who are passionate about identifying and analyzing key business problems to create...
-
Executive Director of Municipal Services
7 days ago
Emeryville, California, United States City of Emeryville Full timeAbout the Role:The City of Emeryville is seeking a visionary and strategic leader to serve as its Chief Administrative Officer. As the Administrative Head of the City government, the successful candidate will play a pivotal role in shaping and realizing the City's vision for the future.Key Responsibilities:Ensure the efficient and effective delivery of...
-
Chief Administrative Officer
5 hours ago
Emeryville, California, United States City of Emeryville, CA Full timeAbout the Role:The City Manager serves as the Administrative Head of the government of the City of Emeryville, playing a pivotal role in shaping and realizing the City's vision for the future. This position ensures efficient and effective delivery of public services while upholding the principles of accountability and transparency.Key Responsibilities:Foster...
-
City Manager
6 days ago
Emeryville, California, United States National League of Cities Full timeAbout the RoleThe City Manager serves as the Administrative Head of the government of the National League of Cities, playing a pivotal role in shaping and realizing the organization's vision for the future. This key position ensures the efficient and effective delivery of public services while upholding the principles of accountability and transparency.Key...
-
Restaurant Operations Manager
2 days ago
Emeryville, California, United States PRP Full timeAbout the RoleThe IHOP Restaurant General Manager is a key member of the PRP team, responsible for overseeing the daily operations of our restaurant. This role requires a strong leader who can manage a team, drive sales growth, and maintain high standards of quality and service.Key ResponsibilitiesOperations Management: Manage all aspects of restaurant...