A global pharmaceutical company located in Lexington, MA is looking for a Manager/Senior Manager of Downstream Process Development and Manufacturing to join their team! The Manager/Sr. Manager will be responsible for managing and supporting the downstream development and manufacturing activities of the late-stage programs, including process characterization, process validation, tech transfer, GMP manufacturing, supporting on floor work, and BLA-enabling studies.
The successful candidate will help identify and select CROs and CDMOs, as well as develop and maintain excellent working relationships with their technical team and management. This position will also oversee tech transfer across production facilities and collaborate with the internal lab to create and conduct development projects.
RESPONSIBILITIES:
- Manage and support downstream development and manufacturing activities of late stage programs, including process development, tech transfer, GMP manufacturing, process characterization, process validation and BLA-enabling studies
- Manage and support tech transfer activities between various manufacturing sites and provide on floor support during GMP manufacturing operations
- Collaborate with internal lab to design and execute development studies
- Provide technical input for the development and scale up of robust downstream processes
- Author and review CMC documentation for regulatory filings, as needed
- Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development
- Apply innovative technical ability and knowledge to critically analyze experimental data and results
- Set clearly defined goals/objectives to ensure delivery of high-quality results
- Provide clear communication to functional line management and cross-functional teams regarding progress against technical objectives/milestones
- Ensure well-organized, clear and complete records of all activities across areas of responsibility
- Approximately 5-10% of domestic and/or international travel
WHAT YOU NEED:
- Bachelors in relevant physical or life sciences discipline with 4+ years of biologics drug development experience in pharma/biotech, or MS (preferred) with equivalent education or experience
- Experience in downstream process development and process characterization based on quality by design (QbD) principles
- Expert knowledge of protein purification unit operations and process technologies (e.g., centrifugation, filtration, chromatography, etc.) and experience in advancing biologics processes through clinical development to successful regulatory approval/licensing
- Knowledge of and experience with production of recombinant proteins using mammalian cell lines
- Experience and knowledge in process validation preferred
- Excellent communication and interpersonal skills fostering team spirit
- Strong technical/analytical skills to identify and solve problems
- Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
- Proven ability to manage projects and work with a high level of integrity, accuracy, and attention to detail
- 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