Associate Principal Scientist, Engineering

Associate Principal Scientist, Biologics, Sterile Drug Product Commercialization Responsibilities

• Lead and/or serve on cross-functional biologics drug product working groups; manage DP activities through filing and Process Performance Qualification (PPQ), including registration stability study execution, process characterization, tech transfer control strategy, process development, PPQ readiness, PAI readiness, approval, launch, and post-launch support.
• Ensure commercialization programs meet science, quality, reliability, schedule, and cost requirements.
• Drive technical/business process strategic initiatives to enable faster commercialization of innovative products.
• Provide mentorship, technical oversight, and guidance for non-routine/difficult scientific/technical issues.
• Develop process and product development plans; influence primary packaging and combination product design.
• Design and execute DP development/commercialization studies, new product introduction, and process validation at commercial sites.
• Ensure fit-for-purpose scale-down models; establish and validate platform engineering/scientific models.
• Innovate and drive best practices for tech transfer, facility fit, and DP control strategy (process parameter classification, performance parameters, operating ranges, in-process controls); drive PPQ and shelf-life strategies.
• Influence CMC regulatory strategy; author/review DP CMC sections and regulatory submissions; support agency meetings.
• Drive continuous, phase-appropriate process optimization for liquid, lyophilized, and combination product presentations.

• Travel up to 25%.
• Education:
  
  BS (10 years) or MS (8 years) or PhD (4 years) in Chemical/Biochemical Engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field.

• Biologics drug product process development/optimization/process characterization.
• At-scale biologics drug product manufacturing and fill-finish experience.
• Sterile drug product fill-finish unit-operations expertise; lab/fundamental models.
• Technology transfer and scale-up to pilot/manufacturing scales.
• Excellent oral/written communication; ability to articulate process science to drive decisions and study design.

• Biologics fill-finish process optimization, scale-up, and sterile tech transfer to pilot/commercial.
• Manufacturing experience with potent/sterile products (pilot/commercial).Late-stage biologics commercialization experience.
• Knowledge of sterile product regulatory requirements/QbD; cGMPs and ICH Quality norms.
• DOE/statistics, SPC, MVA and/or PAT; data analytics/modeling/digital applications.
• Analytical methods to characterize biologics/sterile drug products.

• Adaptability;
  Bioprocessing;
  Data analysis;
  Decision making;
  Detail-oriented;
  Manufacturing process validation/quality control/scale-up;
  Mentorship;
  Process improvements;
  Regulatory submissions;
  Technical writing;
  Technology transfer.