This position is responsible for leading upstream development projects by applying scientific knowledge and QbD principles to develop efficient and robust upstream manufacturing processes and establish product/process knowledge. They will be accountable for timely development and successful transfer of these processes to either internal or external manufacturing partners to satisfy CMC deliverables. Furthermore, this position will contribute to establishing department infrastructure and efficient business processes to support process development from discovery through commercial launch through identification, evaluation, and implementation of innovative solutions. Key requirements for this individual are a strong capability to resolve complex technical issues, consistent delivery on objectives without appreciable direction, and excellent communication skills in multi-disciplinary environments.
Job Function and Description
- Apply QbD principles to lead/implement phase appropriate upstream bioprocess development
- Lead upstream activities to align with overall CMC project plans and to achieve completion of CMC milestones on schedule.
- Interact with CMO organizations to ensure deliverables are executed on time/budget with acceptable quality.
- Author or approve written study proposals, development reports, CMC sections of regulatory filing documents, and responses to regulatory agency questions.
- Provide technical leadership and report project progress in various governance committee and functional/program decision making bodies
- Guide junior team members to ensure sound experimental design, flawless execution, and ultimately, timely completion of deliverables based on sound scientific and engineering methodology.
- Mentor junior team members in QbD principles and phase appropriate process development / characterization.
- Maintain group awareness of state-of-the-art principles and theories and ensure group contributes to BioEngineering scientific knowledge base through literature review, conference attendance, and publication.
- Lead/Contribute to upstream platform development and improvement
- Identify innovative solutions that maximize IP protection
- Evaluate and support new technologies for bioprocess operation
Education and Experience Requirements
Degree in Chemical Engineering, Biochemical Engineering or other related discipline with minimum years of relevant industry experiences in process development.
- Ph.D. : 4+ years
- MS: 6+ years
- BS: 8+ years
Recognized expert by peers both within and outside the company in microbial and/or cell culture bioprocess development, medium and feed development, scale-up, tech transfer; and manufacturing support.
Preferred qualification: Ph.D. in engineering or biological sciences with microbial process development and commercial product support
Key Skills, Abilities, and Competencies
- Fundamental knowledge of engineering and bioprocessing principles related to microbial and/or cell culture process development
- Expert understanding of process scale-up, tech. transfer, and GMP manufacturing support
- Familiarity of industry trends, practices, technical standards, and applicable regulatory guidelines to support development and regulatory filings
- Adept at planning, designing, and executing experiments, as well as providing succinct summaries/conclusions based on data analysis
- Strong oral and written communication skills
- Solid track record of collaboration and stakeholder relationship management.
- Excellent people management skills. Takes responsibility for developing people.
Complexity and Problem Solving
- Identify and analyze complex technical problems and implement solutions.
- Strong track record of guiding upstream teams to deliver on technical objectives.
- Demonstrate the ability to work in a matrix environment and motivate/influence key stakeholders and cross-functional teams to complete CMC deliverables.
- Work closely with his/her supervisor and coworkers in managing multiple work streams and projects.
- Provide expert input to departmental and senior management towards making strategic & functional decisions.
- Deal with a high level of ambiguity while making sound and timely decisions based on project priorities and risks.
Location/Region: Lexington, MA