What are the responsibilities and job description for the Senior Scientist, Analytical Development position at Keros Therapeutics?
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-, 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- 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.
JOB SUMMARY: The successful candidate will have experience in various phases of analytical method development and product characterization and support the GMP manufacture of biopharmaceuticals. This position will serve as the project-based analytical leader to provide analytical guidance and support manufacturing collaboration with contract manufacturing organizations and quality control groups. Additionally, this role will provide in-house analytical testing for the development of novel protein therapeutics.
Responsibilities
- Provides input for analytical method development and biochemical characterization for all phases of process development from first in human to late clinical phase and commercial filings.
- Collaborates within cross-functional teams (Research, Development, Manufacturing, Quality, Regulatory), to provide analytical expertise for biotherapeutics.
- Supports the method development, qualification, and validation of methods at CMO or CRO for GMP biotherapeutic manufacturing, including the review and approval of protocols and reports.
- Provides in-house analytical testing capabilities for development activities.
- Contributes to the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).
- Ensures that all developed methods are compatible with quality requirements including regulations, policies, applicable guidelines, and procedures.
Qualifications
- PhD 2 , MS 7 , BS 10 years related experience in the pharmaceutical field, preferably with mAbs and Fc-fusion proteins, and a degree in analytical science, biochemistry, or biophysics.
- The final job title (Scientist or Senior Scientist) will depend on the years and breadth of relevant experience in the biopharmaceutical industry.
- Experience with chromatography, capillary electrophoresis, cell-based bioassay, ELISA and /or other analytical techniques is desired.
- Excellent oral and writing skills are a must.
- Self-motivated, yet aware of limitations and a willingness to seek clarification.
- Familiarity with regulatory guidelines for method qualification/validation and experience authoring regulatory sections for IND through BLA filings is 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.