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.
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.
Recruitment & Staffing Agencies:
Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.
Skills Required
- Manage and lead Process Development department including mentoring staff in Upstream and Downstream Process Development
- Strong working knowledge of upstream and downstream process technologies for biologics (cell culture, purification)
- Hands-on expertise with bench-scale to pilot-scale bioreactor operations and scalable process development
- Design and execute studies to optimize culture conditions (pH, DO, feeding profiles, shear) and review data
- Experience establishing production processes for biologics in cGMP manufacturing settings
- Execute process development studies, document activities per laboratory procedures, and support supply of material for other groups
- Coordinate cross-functionally with Quality, Manufacturing, Analytical Development, Program Management, Formulation, Research, and Non-Clinical (Tox)
- Bachelor of Science with minimum 10 years technical management experience; OR Master's with 8 years; OR Doctorate (or equivalent) with relevant experience; plus at least 5 years managerial experience
- Management experience must include managing a team of at least 5
- Experience reviewing and/or authoring CMC sections for regulatory submissions (IND filing knowledge)
- Knowledge of tech transfer and ability to support tech transfer activities
- Knowledge of good lab practices and hands-on lab implementation
- Proven ability to run, program, and scale bench-to-pilot scale bioreactor systems and manage multiple parallel programs
What We Do
Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from rare hematologic and musculoskeletal disorders with high unmet medical need
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