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 Associate Scientist is responsible for executing and developing stage appropriate downstream processes for novel protein therapeutics. Developing downstream purification processes for expression scales that range from shake flasks to pilot scale bioreactors. The Associate Scientist will also be involved in providing and analyzing data and relevant information for reports supporting tech transfer activities for external manufacturing.

Responsibilities:

Hands-on execution, and optimization of protein purification processes including primary recovery unit operations (centrifugation, homogenization, flocculation, tangential-flow filtration (TFF), and depth filtration), chromatography (ion-exchange, affinity, hydrophobic interaction), and pre-formulation (TFF, dialysis).
Generating and analyzing process and analytical data supporting key documents such as development reports, regulatory submissions, and technology transfer packages.
Execute routine scale down protein purification with affinity, size exclusion, ion exchange, and hydrophobic interaction chromatography using AKTA systems (Unicorn software)
Perform analyses including but not limited to UV-Vis Spectroscopy, SDS-PAGE, SE-HPLC, LAL, host cell-DNA, host cell protein, as necessary
Buffer preparation and aseptic technique
Drug substance and protein intermediate inventory management
Work within the DSP group to explore novel purification processes as well as using standard methods to purify proteins
Activities will include small-scale studies and pilot scale purification studies
Apply DOE methods to purification activities
Working with Co-Ops and helping them in their planning and activities as needed.
Maintain laboratory notebooks and digital records
Present data at process development and CMC department meetings

Qualifications

B.S. (Graduate degree preferred MS and PhD) in Chemical Engineering, Biochemical Engineering, or an equivalent engineering/science degree with 1-3+ years of experience working in the Biopharma industry.
Experience in protein purification, scale up/down, process and analytical characterization
Hands-on experience with purification unit operations including filtration, chromatography, TFF, UF/DF, AKTA, UNICORN and HPLC systems is a plus
Comprehension of downstream processes at the small to an intermediate scale of cGMP biologics production.
Chromatography, TFF including, UD/DF, micro filtration, nano filtration, and filtration
Process scaling and/or technology transfer
Familiarity with automated chromatography platforms (e.g., Cytiva AKTA)
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
Good oral and written communication skills
Ability to adapt to frequent change and thrive in a dynamic early-stage environment
Strong communication and organization skills, knowledge of MS Office, data plotting and graphing software. Must be able to communicate results effectively

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.

Keros Therapeutics

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Associate Scientist, Process Development