Lead the analytical lifecycle that enables cutting-edge cell therapies to reach patients safely and at speed, setting strategy and standards for complex analytical methods from late-stage development through commercialization and post-approval.
Locations (3)
Gaithersburg, Maryland, United States
Rockville, Maryland, United States
Tarzana, California, United States
Compensation
The annual base pay for this position ranges from $138,393 to $207,589. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Responsibilities
Own the product-level analytical lifecycle strategy and network-level governance standards for late-stage and commercial cell therapy products
Define and govern the analytical lifecycle handover from Analytical Development to QC
Assess analytical impact of process, material, equipment, method and/or site changes
Define transfer and validation strategies across internal and external networks
Define network method-performance monitoring and assess cross-site trends, drift, and lifecycle risks
Requirements
BS in analytical sciences, biotechnology, biochemistry, cell or molecular biology, pharmaceutical sciences, engineering, or a related discipline with 10+ years of experience
MS in analytical sciences, biotechnology, biochemistry, cell or molecular biology, pharmaceutical sciences, engineering, or a related discipline with 5+ years of experience
PhD in analytical sciences, biotechnology, biochemistry, cell or molecular biology, pharmaceutical sciences, engineering, or a related discipline with 3+ years of experience
Manager, Quality Control External Operation, responsible for assisting with the continued implementation, and management of Quality Control activities at contract manufacturers and contract testing laboratories for LNP and other drug product components for early development stages.
Compensation
The anticipated wage for this position is $72,000 - $169,400
Responsibilities
Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories
Run day-to-day Quality Control Operations at external partners
Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments
Lead the review and approval of Quality Control data and CoA/CoTs
Manage material specifications for excipients, drug substances and drug products
Requirements
B.S. degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field
MS degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field
Manager, Quality Control External Operation, responsible for assisting with the continued implementation, and management of Quality Control activities at contract manufacturers and contract testing laboratories for LNP and other drug product components for early development stages.
Compensation
The anticipated wage for this position is $72,000 - $169,400
Responsibilities
Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories
Run day-to-day Quality Control Operations at external partners
Manage laboratory investigations, deviations, change controls, CAPAs and risk assessments
Lead the review and approval of Quality Control data and CoA/CoTs
Manage material specifications for excipients, drug substances and drug products
Requirements
B.S. degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field
MS degree in chemistry, biochemistry, biological sciences, pharmaceutical sciences, or related field
Lead a team of analytical scientists to develop and optimize potency assays for lentiviral vector gene therapy products, ensuring robust analytical methods and supporting regulatory submissions.
Compensation
Compensation: $38.00-$46.00 per hour based on education and relatable industry and leadership experience.
Responsibilities
Develop, optimize, and qualify analytical methods with emphasis on potency assays, cell-based assays, and advanced characterization methods.
Support design and execution of experiments to improve assay performance, establish method readiness, and support analytical control strategy development.
Support analytical method transfer activities by preparing technical documentation, supporting partner training, reviewing transferred data, and troubleshooting assay performance.
Generate, analyze, and present scientific data to cross-functional stakeholders to support product characterization, process changes, comparability assessments, and regulatory submissions.
Contribute to authoring technical reports, protocols, method transfer packages, and analytical development documentation while serving as a technical resource for potency assay and analytical development activities.
Requirements
B.S. in Biology, Biochemistry, Cell Biology, Molecular Biology or a related field
M.S. in Biology, Biochemistry, Cell Biology, Molecular Biology or a related field
Provide analytical support for GMP manufacturing, process development, and stability studies, developing, qualifying, and executing immunoassays and cell-based potency assays for pharmaceutical products.
Responsibilities
Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines
Work with management and vendors to acquire, install, and qualify new equipment
Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically
Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment
Develop and execute ELISA, cell-based, other types of immunoassays, and plate based analytical methods for small molecules, proteins, and antibody drug conjugates with minimal supervision
The Senior Manager, Analytical Sciences will provide scientific and technical leadership for analytical activities supporting our gene therapy product portfolio across internal and external development and testing networks.
Compensation
$150,000—$175,000 USD
Responsibilities
Serve as the analytical lead for external testing laboratories, providing scientific oversight of analytical execution, method performance, lifecycle management activities, and continuous improvement initiatives.
Develop and maintain strong working relationships with CDMO, CRO, and contract testing partners to ensure consistent method execution and analytical performance.
Lead governance activities related to analytical methods including transfers, validations, investigations, method revisions, trend monitoring, and change assessments.
Evaluate assay suitability throughout the product lifecycle and identify opportunities for optimization, modernization, or platform replacement.
Support analytical strategy and long-term control strategy development for clinical and commercial programs.
Requirements
Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related scientific discipline
M.S.
Nice to have: Experience managing analytical activities across multiple external testing organizations
Nice to have: Prior hands-on experience with CD34+ cell lineages
Quality Control Manager (External Operation)NewLilly · Boston, US
Sr. Manager, Analytical SciencesGenetix Biotherapeutics · Somerville, US