As part of Nektar's Biologics CMC organization, the Associate Director, Biologics will support Nektar drug candidates in pre-clinical and clinical development. Knowledge and hands-on experience with development, qualification, and validation of cell-based bioassay for potency measurement to support GMP manufacture, product characterization, lot release, and stability testing are required.
Extensive experience in GMP, CMO/CRO management, and interaction with regulatory and quality is required. Prior experience with late stage drug development and regulatory filing is desirable. Management experience, excellent written and verbal communication skills are required. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
The successful candidate will be responsible for:
Establish and implement bioassay strategy to support Nektar biologics portfolio.
Guide the team to develop mechanism of action relevant bioassay to understand and characterize Nektar's biologics molecules.
Lead efforts for in house method qualification testing, and transfer methods to CRO for drug substance and drug product release and stability testing.
Direct technical project leaders and scientists in preparing and updating project work plans.
Develop tasks and maintain timelines to support development of manufacturing technology processes.
Communicate cross-functionally with groups such as research, process development, formulation development, manufacturing, QC group and CRO/CMO to ensure appropriate project support.
Write technical reports and CMC section for IND and BLA regulatory filings.
Ensure budgets, schedules and performance requirements are met. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
Ensure staff members are appropriately trained and training records are maintained at current required levels.
Provides regular performance feedback, development and coaching to direct reports.
Assesses utilization of resources and identifies when, and where additional resources may be needed. Serves as an in-house consultant.
Regularly interacts with senior management.
A minimum of a bachelor's degree in a biology/biochemistry discipline is required. An advanced degree is preferred.
Equivalent experience may be accepted. A minimum of 10 years' experience in the pharmaceutical or other related industry is required. A minimum of 8 years' previous biotechnology/pharmaceutical industry experience, preferably in a process development FDA and EMA regulated environment, is required.
Good track record in advancing Biologics drug candidates in clinical development and Regulatory agency (FDA, EMA) interaction required. A thorough knowledge and experience working in a GMP environment is essential. Prior experience with technology transfer and providing oversight to contract manufacturing organizations (CMO) desirable.
Excellent written and verbal communications and team work skills are essential. Must have experience within R&D and/or biologics CMC that includes method development, stage appropriate validation, method transfer to CRO and routine sample testing for lot release and stability evaluation. Strong verbal and written communication skills are required.
Must be goal-oriented, quality-conscientious, and customer-focused. Good compliance and safety practices are a must. Must be experienced in working in a team-focused environment.
A proven track record in developing and managing process development organizations is a must. Must have a thorough working knowledge of FDA and cGMP requirements for areas of responsibilities. Project management experience is a plus. A proven ability to work within budget and timeline.