Biologics Process Development Lead

Keros Therapeutics; Lexington (MA); On-site; USD 200,000 - 230,000; Full time

Job summary

Keros Therapeutics is seeking a senior leader to manage the Process Development group focused on biologics. You will lead Process Scientists and Engineers, directing bench-to-pilot scale development and tech transfer across programs, coordinating with Quality, Manufacturing, Analytical Development, and non-Clinical teams.

The role emphasizes building scalable, robust upstream and downstream processes, guiding budgets and headcount, and mentoring staff to advance career paths in a fast‑paced,

Qualifications

• Bachelor of Science in a scientific discipline with 10+ years of technical management experience.
• Master's or Doctorate in scientific/biochemical engineering with 5+ years in a managerial role.
• Experience with process development of biologics and cGMP is preferred.

Responsibilities

• Serve as Process Development department head overseeing planning, execution, and project delivery in a fast-paced environment.
• Manage, mentor and facilitate the development of staff in Upstream and Downstream Process Development.
• Provide hands-on expertise for bench-scale to pilot-scale bioreactor operations and scalable processes.
• Design and execute studies to optimize culture conditions for growth and product quality.
• Drive innovation in process technologies to increase efficiency and purity.
• Partner with downstream teams to ensure seamless interface between cell culture harvest and purification steps.
• Coordinate with Quality, Manufacturing, Analytical Development, and other functions for successful tech transfer.
• Lead programs to supply material for bioanalytical, tox, and other groups; establish production processes for biologics in cGMP settings.
• Develop budgets, headcount plans and capital requirements for the process development group.

Skills

Team leadership

Cross-functional collaboration

Regulatory knowledge

cGMP knowledge

Process development

Biologics

Tech transfer

Upstream/downstream

Education

BS in science

MS/PhD in biochemical engineering

5+ years managerial experience

Tools

CMC documentation

Regulatory submissions

Bioprocess scale-up

Job description

Keros Therapeutics is seeking a senior leader to manage the Process Development group focused on biologics. You will lead Process Scientists and Engineers, directing bench-to-pilot scale development and tech transfer across programs, coordinating with Quality, Manufacturing, Analytical Development, and non-Clinical teams.

The role emphasizes building scalable, robust upstream and downstream processes, guiding budgets and headcount, and mentoring staff to advance career paths in a fast‑paced,