Executive Director/Vice President, Analytical Development

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.

Keros Therapeutics is seeking an expert in Analytical Development and Protein Characterization to join our team as Executive Director/VP of Analytical Development. The ideal candidate will have a deep understanding of protein characterization hands-on experience in the laboratory, excellent organizational skills and attention to detail, a demonstrated ability for self-motivated and independent project execution, and a strong desire to learn. The incumbent will provide technical and strategic leadership for the development of analytical control strategies, methods, and specifications for Keros' pipeline of therapeutic proteins. This role will involve collaborating with various departments and leading a team of analytical professionals to ensure the successful execution of the company's analytical strategy throughout the product lifecycle. This position will play a critical role in bridging the gap between research, manufacturing, quality, and regulatory functions.

Primary Responsibilities:

• Lead and build a multi-level, high-functioning Analytical Development organization, capable of developing industry-leading, innovative, robust strategies across our pipeline
• Develop the strategic implementation of increasing levels of structural, physical, and advanced protein characterization in phase appropriate manner
• Manage technical and analytical method transfer for multiple analytical test methods for GMP manufacturing campaigns performed at CMOs
• Develop science-driven, phase appropriate, and risk-based analytical development control strategies to support programs at each stage of development from preclinical through commercialization
• Lead the analytical teams through process characterization, PPQ and BLA submissions
• Establish an effective department infrastructure and systems to enable efficient method development, specification setting, and method transfer by leveraging internal and external analytical expertise and capabilities
• Collaborate and manage CDMOs and CROs to develop and optimize a range of analytical assays for the release and characterization on a series of fusion proteins at each stage from preclinical to commercial launch
• Enhancing our product and process understanding by characterizing impurities, defining CQAs, process troubleshooting, supporting process control strategies
• Provide and develop laboratory based analytical support to upstream and downstream process development to drive new and improved processes for DS production
• Improve lab management and operations including lab safety, budget, quality systems, data reporting/management, productivity initiatives, etc
• Serve as a project core team member and communicate CMC strategy and project status to the key stakeholder cross-functionally and assist in driving decision-making
• Serve as part of a specifications committee to determine phase appropriate assays and release specifications
• Develop, mentor and coach the analytical staff to function effectively in cross-functional teams and collaborations
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Support cross-functional team coordinating efforts of the Technical Operations, Quality, and Regulatory to advance programs
• Write and review regulatory filings and briefing books; represent the company in regulatory interactions
• Author Analytical CMC sections of IND filings, internal SOPs, experimental procedures, training and safety documents
• Travel to CDMOs and/or CTLs for the vendor assessment and qualification, as well as analytical activities oversight as needed

Qualifications:

• Ph.D. degree in Biochemistry, Biology, Chemistry, or other relevant scientific disciplines with 10 to 14 years of experience or MS degree with 15+ years of analytical development experience in Pharmaceutical, Biotechnology with a minimum of 8 years leadership experience.
• Experience with biologics analytical support in late-stage activities (Phase 3 and commercialization)
• Strong background in protein characterization, analytical method development, qualification/validation, and physicochemical characterization of fusion proteins and protein therapeutics
• Demonstrated skills and experience in strategic planning and annual goal setting process, talent, and succession planning, OPEX and CAPEX process
• Deep understanding of analytical methods and data interpretation to evaluate protein structure, post translational modifications, and characterization
• Demonstrated expertise with a range of analytical techniques such as
  • CE (CSDS, CIEF and CGE DNA), qPCR, potency, MFI/HIAC, DSF, DLS, DSC, and LCMS/MS peptide mapping & subunit analysis
  • Chromatography: IA, SEC, RP, HIC and IEX
  • Glycosylation: monosaccharide, sialic acid characterization and N-linked Glycan analysis
  • Spectroscopy: UV/Vis, luminescence
• Experience in biochemistry techniques such as protein expression, gel electrophoresis, protein quantification assays, ELISA, cell-based assays, and enzyme kinetics
• Understanding of molecular biology, recombinant protein expression and construct design for affinity purification methods; familiarity with standard expression hosts such as mammalian, is a plus
• Innovative team-player with high energy for our dynamic company environment
• Thorough understanding and working experience of innovative drug development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA and associated regulatory requirements
• 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.