Senior Scientist, Bioanalytical Assay Development
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: December 1, 2021
Company
Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are planning to advance to a Phase 3 trial by year-end. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
At Scholar Rock, our mission is to help patients with serious illnesses through innovative thinking, cutting edge science, and a passion for discovering and developing novel therapeutics. We’re seeking an outstanding, motivated scientist with assay development experience to join our R&D team. This person will play a hands-on role in establishing pharmacokinetic, pharmacodynamic, and immunogenicity assays to evaluate novel therapeutic antibodies. The role provides exposure across the drug discovery process, as the successful candidate will support characterization and development of potential drugs at the research, preclinical, and clinical stages, playing a critical role in each.
Position Responsibilities:
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- Contribute to developing and executing a broad range of bioanalytical assays, including pharmacokinetic, immunogenicity, pharmacodynamic assays.
- Lead and coordinate assay development, sample analysis and reporting data generated by external CROs
- Understanding of regulatory requirements and approval processes (IND, CTA, BLA etc.)
- Coordinate bioanalytical timelines, workflow, and documentation between internal program teams (discovery, toxicology, clinical operations, regulatory etc.) and external vendors.
- Maintain detailed records of experimental protocols and data in laboratory notebooks in accordance with company policy.
- Analyze, interpret, and report experimental results in a small and large group settings.
Candidate Requirements:
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- Ph.D with 3+ years is industry experience or BS/MS with 6+ years’ experience in drug discovery research.
- Candidates must have experience with development of bioanalytical assays for biologics or antibodies (PK, PD, ADA, biomarker, etc.) for drug discovery programs.
- Extensive knowledge of assay development, qualification, validation, and regulatory requirements for PK, immunogenicity, PD assays
- Experience with developing cell-based functional and/or potency assays is desirable.
- Demonstrated ability to work independently, including experimental design and execution, in a fast-paced team-oriented environment.
- Be able to troubleshoot problems and propose creative solutions.
- Strong communication skills, written and oral.
- Ability to succeed in a small, interactive, ambitious, and entrepreneurial drug-discovery environment.
- Have a strong work ethic and high level of motivation.
- Have flexibility and the ability to work in a matrix-managed research environment.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.