Director, Process Development
Keros Therapeutics
August 14, 2026
Remote friendly (Lexington, MA)
United States
Operations
Job Summary
This role provides overall management of the Process Development group (biologics). Leads Process Scientists and Engineers in development and tech transfer of processes across stages of multiple biologics programs. Coordinates internal teams to support early transition from Research to Development, internal process development studies, and toxicology material production.
Primary Responsibilities
- Oversee planning, execution, and project delivery in a fast-paced environment.
- Manage, mentor, and facilitate Upstream and Downstream Process Development staff.
- Use strong upstream/downstream process knowledge.
- Provide hands-on expertise and strategic guidance for bench-to-pilot bioreactor operations; ensure scalable, robust processes.
- Design and execute studies to optimize culture conditions (pH, DO, feeding, shear) for growth, viability, and product quality.
- Drive innovation to improve efficiency and purity.
- Partner with downstream teams to ensure seamless harvest-to-purification interfaces.
- Coordinate cross-functionally with Quality, Manufacturing, Analytical Development, Program Management, Formulation Development, Research, and non-clinical (Tox).
- Lead operations to supply material for other groups and process development studies.
- Establish biologics production processes in cGMP manufacturing settings.
- Identify efficiency opportunities and harmonize best practices implementation.
- Support budgets, manpower, and capital needs for process development.
- Provide career path and development for team members.
- Execute studies, review data, and document work per lab procedures.
Preferred Skills
- Management experience (team of at least 5).
- Experience reviewing/authoring CMC sections for regulatory submissions.
- Cross-functional collaboration.
- Upstream/downstream biologics process development knowledge.
- Bench-to-pilot bioreactor scaling/programming experience.
- Multi-tasking across parallel programs.
- cGMP/manufacturing operations; tech transfer.
- Good lab practices (hands-on).
- Regulatory guideline knowledge, especially IND filing.
Education Requirements
- BS in a scientific discipline + at least 10 years technical management experience; or MS with 8 years; or Doctorate in scientific/biochemical engineering area (or equivalent) + at least 5 years in a relevant managerial capacity.
This role provides overall management of the Process Development group (biologics). Leads Process Scientists and Engineers in development and tech transfer of processes across stages of multiple biologics programs. Coordinates internal teams to support early transition from Research to Development, internal process development studies, and toxicology material production.
Primary Responsibilities
- Oversee planning, execution, and project delivery in a fast-paced environment.
- Manage, mentor, and facilitate Upstream and Downstream Process Development staff.
- Use strong upstream/downstream process knowledge.
- Provide hands-on expertise and strategic guidance for bench-to-pilot bioreactor operations; ensure scalable, robust processes.
- Design and execute studies to optimize culture conditions (pH, DO, feeding, shear) for growth, viability, and product quality.
- Drive innovation to improve efficiency and purity.
- Partner with downstream teams to ensure seamless harvest-to-purification interfaces.
- Coordinate cross-functionally with Quality, Manufacturing, Analytical Development, Program Management, Formulation Development, Research, and non-clinical (Tox).
- Lead operations to supply material for other groups and process development studies.
- Establish biologics production processes in cGMP manufacturing settings.
- Identify efficiency opportunities and harmonize best practices implementation.
- Support budgets, manpower, and capital needs for process development.
- Provide career path and development for team members.
- Execute studies, review data, and document work per lab procedures.
Preferred Skills
- Management experience (team of at least 5).
- Experience reviewing/authoring CMC sections for regulatory submissions.
- Cross-functional collaboration.
- Upstream/downstream biologics process development knowledge.
- Bench-to-pilot bioreactor scaling/programming experience.
- Multi-tasking across parallel programs.
- cGMP/manufacturing operations; tech transfer.
- Good lab practices (hands-on).
- Regulatory guideline knowledge, especially IND filing.
Education Requirements
- BS in a scientific discipline + at least 10 years technical management experience; or MS with 8 years; or Doctorate in scientific/biochemical engineering area (or equivalent) + at least 5 years in a relevant managerial capacity.