Senior/Executive Director, MSAT - Keros Therapeutics
Lexington, MA
About the Job
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-ß, 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-ß 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.
The Senior/Executive Director, MSAT, reporting to the SVP of CMC, will be responsible for managing activities related to the GMP production of early and late phase clinical materials produced at contract development and manufacturing organizations (CDMOs) for Keros Therapeutics' fusion proteins. The candidate will engage and work with external partners (CDMOs) to provide end-to-end technical support of GMP manufacturing of biologics and ensure successful cGMP manufacturing campaigns. Candidate has extensive experience with biologics manufacturing in a GMP setting, technology transfer, managing and mentoring staff, regulatory filings, and working within highly matrixed cross-functional teams. This individual will lead the MSAT department to provide manufacturing support, technology transfer, scale up, process characterization, validation, technical and continuous improvement support to ensure robust production and the timely release of cost-effective, compliant, and high-quality products. This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Quality, QC, Process/Analytical Development, Supply Chain, Finance, and Senior Management. As such, the role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups and external vendors. The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Primary Responsibilities:
- Provide key technical leadership for clinical programs across all aspects of the product lifecycle including technology transfer, process fit, process design, manufacturing support, and person-in-plant. Launch business process and structure for process data reviews in collaboration with internal and external stakeholders
- Plan and execute the MSAT departments strategy for technology transfer and manufacturing from process development through to commercial manufacturing
- Lead the evaluation and selection process for all future manufacturing CDMOs.
- Create and launch process monitoring/trending, process characterization, process validation, and process performance qualification programs (PPQ)
- Ensure successful delivery of GMP material in partnership with Supply Chain, Quality and supporting functions by providing technical oversight of manufacturing batch execution, deviation management, troubleshooting, and batch release
- 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
- Lead the evaluation process performance to drive continuous improvements
- Review and approve technical documentation including protocols, master batch records, and reports related to non-GMP 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
- Scientific and technical oversight of drug product formulation and manufacturing processes from pre-clinical development through late-stage clinical development
- Develop strategies and oversee the execution of activities associated with drug product development and manufacturing, supporting clinical development and regulatory filings
- Cultivate excellent working relationship with CMC stakeholders to deliver successful manufacturing campaigns
Qualifications:
- PhD in Chemistry, Bioengineering, or a related discipline preferred, with deep technical experience in biomanufacturing/ biotech/ pharmaceutical
- 15+ years of experience in biopharmaceutical drug development
- Must have a strong scientific background with deep knowledge of biologics
- Experience working with CDMOs for facility fit and tech transfer
- Experience with cell culture and/or purification, Drug Product, and scale-up
- Experience with process data analysis and trending and statistical analysis required
- 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
- Ability to work in a dynamic environment, multi-task, and prioritize work
- Demonstrated critical thinking and problem-solving skills
- Must have full working knowledge of cGMP regulations
- 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.
