Scientist, Process 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.

This role is responsible for providing overall support in early stages of process development and acting as an interface with the Research and CMC organizations. The Senior Scientist is responsible for leading projects focused on developing, optimizing, and scaling cell lines and fed-batch processes for biologics manufacturing and other applications. The Sr. Scientist will also be responsible for tech transfer activities for external manufacturing.

Primary Responsibilities:

• Determination of critical process parameters, and developing robust, industrial processes for cell culture production of protein derived from mammalian cell lines for cGMP implementation
• Experience with and cell culture scale up/down and process characterization
• Experience delivering material suitable for toxicology studies to support regulatory filings
• Leading development, hands-on execution, and optimization of protein expression including cell culture from microplate to , familiarity with cell banking, comprehension of manufacturing processes (specifically batch and fed-batch) and harvest of material at required scales.
• Leading scale-up and tech transfer of protein expression processes for external manufacturing under various regulatory systems (e.g. ISO13485, cGMP).
• Executing, adapting, and troubleshooting analytical methods for protein characterization, including cell based assays
• Data analysis and authoring key documents such as development reports and technology transfer packages.
• Representing the Bioprocess Development team in cross-functional project teams and communicating data, results, and conclusions to scientists, project management, business development, and other stakeholders.
• Ensure a continuous improvement within Upstream process development activities
• Technical leader for equipment, technologies for Upstream process development
• Execute routine scale down protein expression using benchtop bioreactors to optimize protein expression processes
• Provide expertise and insight to guide development of appropriate expression methods
• Perform, develop and optimize robust, efficient, scalable strategies for improving process performance
• Activities will include small-scale studies and pilot scale expression studies
• Apply DOE methods to expression activities
• Mentoring junior Associates or Co-Ops and helping them in their planning and activities.
• Understand and keep current on key areas of science and technology, anticipate changes and new directions in the field
  
  

Qualifications:

• B.S. (Graduate degree preferred MS and PhD) in Biology, Biochemistry, Biomedical Engineering, or an equivalent engineering/science degree with 6+ years of experience working in the biopharma industry
• Strong hands-on experience in troubleshooting and routine instrument maintenance
• Upstream processes at the small to an intermediate scale of cGMP biologics production.
• Process scaling and/or technology transfer.
• Authoring and executing protocols, interpretation of data, and report generation.
• Operating and troubleshooting process equipment.
• Ability to work independently and as part of a cross-functional team
• Ability to adapt to frequent change and thrive in a dynamic early-stage environment
• Strong communication and organization skills, strong knowledge of MS Office, data plotting and graphing software. Must be able to communicate results effectively. Experience using electronic lab notebooks preferred.
  
  
  
  

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.