Analytical Development Group Leader
2 weeks ago
PRIMARY RESPONSIBILITY
We are looking for an Analytical Development Group Leader to join the Process and Analytical Development group to lead early-stage and late-stage analytical assays development/optimization and tech transfer of release and characterization testing for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness. Additional responsibilities will include authorship and/or review of CMC sections of regulatory filings and supporting documents. You will collaborate in a cross functional manner to support successful testing of manufactured T Cell drug products for clinical trials. As a subject matter expert in analytical assays development of novel T cell products with familiarity of CMC cross-functional dynamics, you will be expected to demonstrate leadership while you provide strategic direction of analytical development activities and tactical scientific assistance to a team of Scientists and Associates, based on CMC needs. As Analytical Development Group Leader, you will be accountable for the team’s performance and development. Additionally, you will be expected to collaborate closely with our UK process and analytical development team. This is an excellent opportunity for career development, working closely with the Process Development team and cross-functional CMC groups, as an Analytical Development Group Leader of a team of high performing Scientists and Associates in a fast-paced and highly collaborative environment. Performance in this role will be monitored through group performance and stakeholder feedback from peers, senior management, and project team members.
KEY RESPONSIBILITIES Lead analytical assay development, optimization, qualification, and tech transfer to QC team, CRO or CMO partners for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness (30%) Effectively manage, train and mentor a diverse team of Scientists and Associates by communicating clearly, assigning responsibilities, providing oversight of projects, and career development opportunities (30%) Write protocols, reports, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use (20%) Collaborate with cross-functional teams across CMC, Quality, Regulatory, Translational and Research and interact with contract manufacturing organizations (CMOs) to ensure appropriate release assays implementation and conduct of analytical methods (10%) Author and review CMC content for IND submissions, amendments and BLA filing (10%) QUALIFICATIONS & EXPERIENCE
Required Ph.D., M.Sc. or B.Sc. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 6 years (PhD), 8 years (M.S.) or 10 years (B.S.) of industry experience. Experience in working in cross-functional teams, familiar with CMC team matrix environment and internal/external collaborations to support successful manufacturing of T Cell drug products for clinical trials. Excellent track record of people management and career development support. Experience with analytical assay development, including bioassays, qPCR/ddPCR and flow cytometry. Experience with method qualification and/or validation, experience with analytical comparability a plus Strong technical skills with industry experience in writing regulatory documents, including CMC sections of INDs and BLA. Additional experience writing technical protocols, reports, and procedures required. Experience in transferring analytical assays into cGMP facility and serving as an SME with external CRO/CDMO. Outstanding critical thinking, collaborative mindset and organizational skills, leadership, and attention to details. Comfortable in a fast-paced environment. Desirable Prior experience with cell and gene therapy products and processes.
OTHER REQUIREMENTS Potential travel to other office locations for the company and CMOs to assist with tech transfer and troubleshooting activities.
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