Our client is a clinical-stage biotech company founded by industry veterans and backed by leading venture capital funds. The company is focused on the development of novel cell-based cancer therapies using proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

As a member of the Protein Sciences team, the Associate Director will be responsible for the design and hands-on execution of Protein purification to support process development, tech transfer, characterization, process validation, and other developments activities of bio therapeutics drug candidates at all stages of clinical development. Activities will be performed internally or with external vendors. Other responsibilities will include cross-functional team membership, authoring and/or reviewing technical reports.

Essential Functions

• Manage and perform development, scale-up, production and tech transfer of processes within or between CMO's.
• Debottleneck and rationalize processes to optimize processes consistency, yield, and robustness.
• Ensure all experiments and activities are documented appropriately to ensure full traceability of work performed at the CMO/CRO.
• Contribute to preparation and submission of CMC portions of regulatory submissions and updates (IND)
• Work effectively with team members and contractors both in person and remotely.Provide direction, support, and corrective action as needed.
• Ensure that all processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
• Have a high level of scientific curiosity and keep informed of technical developments

Required Knowledge, Skills, and Abilities

• Over seven years of relevant biological process development and manufacturing experience with a strong record of achievement.
• Hands-on experience with purification techniques including operation of AKTA and UF/DF systems as well as analytical methodologies (SDS-PAGE, HPLC, spectrophotometry).
• In depth understanding of charge based separation mechanisms and manipulation of operating conditions for optimal separation of target protein from process and product related impurities.
• Knowledge and experience of working with statistical programs (JMP) for design and analysis of experiments.
• Experience with small scale process validation studies to support BLA filings
• Manage and execute lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
• Execute and Support process scale-up activities, clinical and commercial manufacturing sites.
• Maintain awareness of current process control strategies, critical parameter identification and assessment as applied to downstream operations
• Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
• Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development as well as practical application of principles of QbD.
• Demonstrated proficiency in oral and written communication, an innovative problem solver and proven ability to recognize and recommend areas for improvement.
• Ability to deliver objectives on time in pressurized, fast-paced environment, whilst also meeting all compliance, quality and cost targets.
• Ability to perform campaign monitoring and support, performance analysis and interpretation, investigation support, and authoring campaign summary report.
• Knowledge of quality systems and FDA regulations as they relate to process / product development and manufacturing of biologics.
  

Qualifications and Experience

• Degree in Chemical/Biochemical Engineering, Biochemistry or equivalent
• PhD and a minimum of 7 years industry experience or M.S. with a minimum of 10 years industry experience in protein purification.