{"schemaVersion":"jobsearcher.job.v1","id":"f0c50eaafcaedfa1cfbd547f","url":"https://jobsearcher.com/jobs/f0c50eaafcaedfa1cfbd547f","canonicalUrl":"https://jobsearcher.com/jobs/f0c50eaafcaedfa1cfbd547f","title":"Director, Process Development","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.\nJob Summary\nThis 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.\nPrimary Responsibilities\nServes as Process Development department head overseeing planning, execution, and project delivery in a fast-paced environment\nManage, mentor and facilitate the development of the staff in Upstream and Downstream Process Development\nStrong working knowledge of upstream and downstream process technologies\nProvide hands-on expertise and strategic guidance for bench-scale to pilot-scale bioreactor operations, ensuring scalable and robust processes\nDesign and execute studies to evaluate critical culture conditions (e.g., pH, DO, feeding profiles, shear stress) to optimize growth, viability, and product quality\nDrive innovation and development of process technologies that can result in significant increases in efficiency and purity\nPartner closely with downstream teams to ensure seamless interface between cell culture harvest and purification steps\nOperate 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)\nLead group in successful operations for supply of material for use by other groups (Bioanalytical, Tox, etc) and process development studies\nHave direct experience with establishing production processes for biologics in cGMP manufacturing settings\nDetermine areas for gaining efficiency, coordinates with individual groups and ensure harmonized implementation of best practices\nSupport the development and maintenance of budgets, manpower and capital requirements for process development group\nActively provides career path and development for team members\nExecution of process development studies, review of the data, and documentation of all activities according to the appropriate laboratory procedure\nExperience throughout the biopharmaceutical product life-cycle including process characterization studies, in-process control strategy and process validation is preferred but not required\nPreferred Skills\nManagement experience must include managing a team of at least 5\nExperience reviewing and/or authoring CMC sections for regulatory submissions\nDemonstrated ability to work cross functionally to achieve goals\nKnowledge of upstream and downstream process development for biologics\nProven track record of running, programming, and scaling bench-to-pilot scale bioreactor systems\nAbility to multi-task and handle successful execution of multiple parallel programs\nKnowledge of cGMP and manufacturing operations\nKnowledge of tech transfer\nKnowledge of good lab practices including hands-on implementation\nKnowledge of regulatory guidelines, particularly those for IND filing\nEducation Requirements\nMinimum 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\n\nOur 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.\nKeros 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.\nRecruitment & Staffing Agencies:\nKeros 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.","company":"Kerostherapeutics","rawCompany":"kerostherapeutics","city":"Lexington","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-03T23:32:38.220Z","occupations":[{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"11-1021.00","title":"General and Operations Managers","slug":"general-and-operations-managers"},{"code":"11-9041.00","title":"Architectural and Engineering Managers","slug":"architectural-and-engineering-managers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Director, Process Development","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.\nJob Summary\nThis 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.\nPrimary Responsibilities\nServes as Process Development department head overseeing planning, execution, and project delivery in a fast-paced environment\nManage, mentor and facilitate the development of the staff in Upstream and Downstream Process Development\nStrong working knowledge of upstream and downstream process technologies\nProvide hands-on expertise and strategic guidance for bench-scale to pilot-scale bioreactor operations, ensuring scalable and robust processes\nDesign and execute studies to evaluate critical culture conditions (e.g., pH, DO, feeding profiles, shear stress) to optimize growth, viability, and product quality\nDrive innovation and development of process technologies that can result in significant increases in efficiency and purity\nPartner closely with downstream teams to ensure seamless interface between cell culture harvest and purification steps\nOperate 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)\nLead group in successful operations for supply of material for use by other groups (Bioanalytical, Tox, etc) and process development studies\nHave direct experience with establishing production processes for biologics in cGMP manufacturing settings\nDetermine areas for gaining efficiency, coordinates with individual groups and ensure harmonized implementation of best practices\nSupport the development and maintenance of budgets, manpower and capital requirements for process development group\nActively provides career path and development for team members\nExecution of process development studies, review of the data, and documentation of all activities according to the appropriate laboratory procedure\nExperience throughout the biopharmaceutical product life-cycle including process characterization studies, in-process control strategy and process validation is preferred but not required\nPreferred Skills\nManagement experience must include managing a team of at least 5\nExperience reviewing and/or authoring CMC sections for regulatory submissions\nDemonstrated ability to work cross functionally to achieve goals\nKnowledge of upstream and downstream process development for biologics\nProven track record of running, programming, and scaling bench-to-pilot scale bioreactor systems\nAbility to multi-task and handle successful execution of multiple parallel programs\nKnowledge of cGMP and manufacturing operations\nKnowledge of tech transfer\nKnowledge of good lab practices including hands-on implementation\nKnowledge of regulatory guidelines, particularly those for IND filing\nEducation Requirements\nMinimum 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\n\nOur 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.\nKeros 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.\nRecruitment & Staffing Agencies:\nKeros 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.","datePosted":"2026-08-03T23:32:38.220Z","dateModified":"2026-08-03T23:32:38.220Z","hiringOrganization":{"@type":"Organization","name":"Kerostherapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Lexington","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f0c50eaafcaedfa1cfbd547f"},"url":"https://jobsearcher.com/jobs/f0c50eaafcaedfa1cfbd547f"}}