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Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF- signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
Job Summary:
We are seeking a Sr. Manager/Associate Director MSAT Drug Substance to join our team. The ideal candidate will have a deep understanding of biologics drug substance production (upstream and downstream), tech transfer, and regulatory submission support. The candidate will engage and work with external partners (CDMOs) to ensure successful cGMP manufacturing campaigns and provide technical leadership of deviations, investigations, and change controls. The individual will also serve as a key process owner by evaluating process performance in order to drive continuous improvements. The individual will work closely with regulatory in preparation of regulatory filings and RTQs.
Primary Responsibilities:
- Collaborate cross-functionally with process development to deliver manufacturing processes that meet the speed, yield, and product quality requirements of the development programs
- Provide key technical upstream and downstream leadership for development programs including technology transfer, process design, manufacturing support, and person-in-plant
- Lead technology transfer activities, including process fit and facility design at external CDMO, ensuring gap analyses and risks assessments are performed technical mitigations are in place for early stage MFG (Phase 1 and Phase 2)
- Review and approve technical documentation including protocols, master batch records, and reports related to engineering and GMP runs
- Support continuous process improvement and scale up activities using data analysis to increase yield while maintaining quality attributes for manufacturing process lifecycle management
- Collaborate cross-functionally to support clinical drug substance manufacturing processes, tech transfer, supply chain, quality compliance, change management and product life cycle management
- Provide guidance and author content for CMC regulatory submissions and ensure technical compliance with regional regulatory requirements
- Partner with product development, manufacturing, quality and regulatory, lead quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place
- Cultivate excellent working relationship with CMC stakeholders to deliver successful manufacturing campaigns
Qualifications:
- MS with 8+ years or PhD with 5+ years of experience in biologics process development (upstream and/or downstream); process scale-up; technology transfer; cGMP manufacturing support; and regulatory submissions for protein therapeutics
- Experience working with CDMOs for facility fit and tech transfer
- Experience with cell culture and/or purification and scale-up
- Experience with process data analysis and trending and statistical analysis preferred
- Experience with technical support of commercial products in external cGMP manufacturing including investigations and change management
- Understanding of regulatory requirements and experience with authoring and reviewing CMC documents for multiple regulatory submissions
- Excellent collaboration skills and ability to work cross functionally to achieve objectives
- Strong work ethic, motivation, and scientific curiosity
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.