Summary
Reporting to the Director of Upstream Process Development and Manufacture, the Senior Manager, Upstream Process Development and Manufacture will have responsibility for managing and supporting upstream development and manufacturing activities of late-stage programs, including: phase 3 process development, GMP manufacturing, tech transfer, on floor support, process validation, process characterization and BLA-enabling studies. It extends further to the preparation of CMC content for regulatory correspondences and submissions. The job level can be flexible depending on the qualifications of the candidate.
The candidate will have oversight of the planning and execution of external CMC activities, and work proactively with service providers to define project scope and make sure of successful delivery with regard to technical quality and timeline. The candidate will assist in the identification and selection of CDMOs and CROs and establishing/maintaining strong working relationships with their respective technical staff and management. The candidate will also manage the tech transfer activities between various manufacturing sites, provide on floor support during GMP manufacturing operations and collaborate with internal lab to design and implement development studies.
Responsibilities (including but not limited to):
- Manage and assist upstream development and manufacturing activities of late stage programs, including phase 3 process development, tech transfer, GMP manufacturing, process validation, process characterization and BLA-enabling studies
- Manage and assist tech transfer activities between various manufacturing sites and provide on floor assistance during GMP manufacturing operations
- Cooperate with internal lab to design and implement development studies
- Provide technical input for the development and scale up of robust upstream processes
- Write and review CMC documentation for regulatory filings
- Establish and maintain an understanding of current trends and up and coming upstream process technologies to make sure that team is at the spearhead of biologics development
- Apply innovative technical ability and knowledge to critically analyze experimental data and findings
- Set clear objectives/goals to ensure delivery of high-quality results
- Provide clear communication to functional line management and cross-functional teams with progress against technical objectives/milestones
- Ensure well-organized, clear and complete records of all activities across areas of responsibility
- Approximately 5-10% of local and/or international travel
Qualifications:
- PhD in chemistry, biochemistry, (bio)chemical engineering (or other relevant physical or life sciences discipline) with 3+ years , or MS with equivalent education with 5+ years of biologics drug development experience in biotech/pharma industry
- Experience in the areas of upstream process development and process characterization based on quality by design (QbD) principles
- Experience in tech transfer, scale up, process validation, GMP operation, and BLA-enabling activities
- Knowledge of and experience with production of recombinant proteins using mammalian cell lines
- Experience in managing outsourced manufacturers and vendors is a plus
- Comprehension of cGMP regulations
- Familiarity with preparing and defending regulatory documents (BLAs/NDSs/MAAs) is a plus
- Knowledge and experience in process validation highly desired
- Excellent team building, management and leadership skills
- Excellent communication and interpersonal skills promoting team spirit
- Strong technical/analytical skills to identify and solve problems
- Self-driven, assertive, and self-confident with the ability to act with passion and urgency
- Proven ability to manage projects and work with a high level of accuracy, precision, and integrity
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on time and on budget
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company
- Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making
- Resourceful, creative, enthusiastic, and results-oriented