Process Development Associate II
About The Position
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. Job Summary: 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 Scientist is responsible for projects focused on developing, optimizing, and scaling cell lines and fed-batch processes for biologics manufacturing and other applications. The Scientist will also be involved in tech transfer activities for external manufacturing.
Requirements
- B.S. in Biology, Biochemistry, Biomedical Engineering, or an equivalent engineering/science degree with 2-5 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
Responsibilities
- Understanding 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
- Performing and and operation 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
- Data analysis and authoring key documents such as development reports
- Participating in cross-functional project teams and communicating data, results, and conclusions to scientists, project management, business development, and other stakeholders.
- Execute routine scale down protein expression using benchtop bioreactors to optimize protein expression processes
- 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 Co-Ops and helping them in their planning and activities.
- Maintain laboratory notebooks and digital records
- Present data at process development and CMC department meetings
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
