Director, Process Development

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

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

Job Summary

This role is responsible for providing overall management of the Process Development group with a focus on biologics. The position will lead a group of Process Scientists and Engineers in the development and tech transfer of processes for different stages of multiple biologics programs. The candidate will also coordinate with multiple internal teams to support successful, early program transition from Research to Development, internal process development studies, and production of material for toxicology studies.

Primary Responsibilities

• Serves as Process Development department head overseeing planning, execution, and project delivery in a fast-paced environment
• Manage, mentor and facilitate the development of the staff in Upstream and Downstream Process Development
• Strong working knowledge of upstream and downstream process technologies
• Provide hands‑on expertise and strategic guidance for bench‑scale to pilot‑scale bioreactor operations, ensuring scalable and robust processes
• Design and execute studies to evaluate critical culture conditions (e.g., pH, DO, feeding profiles, shear stress) to optimize growth, viability, and product quality
• Drive innovation and development of process technologies that can result in significant increases in efficiency and purity
• Partner closely with downstream teams to ensure seamless interface between cell culture harvest and purification steps
• Operate within a cross‑functional project team environment and coordinate efforts with all relevant internal functional areas including Quality, Manufacturing, Analytical Development, Program Management, Formulation Development, Research, non‑Clinical (Tox)
• Lead group in successful operations for supply of material for use by other groups (Bioanalytical, Tox, etc) and process development studies
• Have direct experience with establishing production processes for biologics in cGMP manufacturing settings
• Determine areas for gaining efficiency, coordinates with individual groups and ensure harmonized implementation of best practices
• Support the development and maintenance of budgets, manpower and capital requirements for process development group
• Actively provides career path and development for team members
• Execution of process development studies, review of the data, and documentation of all activities according to the appropriate laboratory procedure
• Experience throughout the biopharmaceutical product life‑cycle including process characterization studies, in‑process control strategy and process validation is preferred but not required

Preferred Skills

• Management experience must include managing a team of at least 5
• Experience reviewing and/or authoring CMC sections for regulatory submissions
• Demonstrated ability to work cross functionally to achieve goals
• Knowledge of upstream and downstream process development for biologics
• Proven track record of running, programming, and scaling bench‑to‑pilot scale bioreactor systems
• Ability to multi‑task and handle successful execution of multiple parallel programs
• Knowledge of cGMP and manufacturing operations
• Knowledge of tech transfer
• Knowledge of good lab practices including hands‑on implementation
• Knowledge of regulatory guidelines, particularly those for IND filing

Education Requirements

• Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 10 years of technical management experience; a Master's degree with 8 years or a Doctorate degree in a scientific or biochemical engineering area (or equivalent. Additionally, at least 5 years’ experience serving in a relevant managerial capacity required

This pay range represents the base hourly rate or base annual full‑time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.

Potential base pay range

$200,000 — $230,000 USD

Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.