Biologics Process Sciences Leader

2 days ago

Rockville, Maryland, United States GSK Full time
Biologics Process Sciences Leader

GSK is seeking a highly skilled Biologics Process Sciences Leader to join our team. As a key member of our process sciences team, you will be responsible for leading the technical aspects of product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.

Key Responsibilities:

  • Lead the technical aspects of product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.
  • Develop and implement innovative approaches to process development, characterization, and validation studies.
  • Plan, execute, and report process or viral clearance studies through process sciences, CROs, internal NPI or commercial DS sites or strategic CDMOs.
  • Author regulatory submissions, respond to health authority information requests, and present at pre-approval & cGMP inspections as necessary.
  • Participate in deviation, change & continuous improvement evaluations in support of continued lifecycle verification.
  • Participate in the development & implementation of new process and analytical manufacturing technologies in support of biologics DS processes.
  • Manage CRO or CDMO contracts, and the effective management of expenditure and effort in support of process or viral clearance studies.
  • Provide technical leadership and establish key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D.

Requirements:

  • BSc in Scientific Discipline
  • Minimum 5 years' demonstrated experience in the Pharmaceutical Industry in leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.

Preferred Qualifications:

  • Experienced in process development, characterization, and validation at commercial scale and bench scale.
  • Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
  • Excellent problem solver and ability to think and work creatively.
  • Demonstrated knowledge of Quality by Design and risk management approaches.
  • Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.
  • Broad and integrated knowledge that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.
  • Must have excellent verbal and written communication skills, and ability to influence, lead, and drive change.
  • Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.
  • Ability to support due diligences.

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