Director / Sr. Director, Quality Control
Cambridge, MA /
Technical Operations /
Scholar Rock is a clinical-stage biopharmaceutical company creating a robust pipeline of therapeutics with the potential to transform the lives of patients suffering from serious diseases, including neuromuscular disorders, cancer, fibrosis, and anemia. Our proprietary platform is rooted in our structural biology insights into the activation of latent growth factor precursors and drives the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By exploiting structural differences in the precursor, or latent form of growth factors, Scholar Rock intends to avoid the historical dose-limiting safety challenges associated with inhibiting the mature form of growth factors for therapeutic effect.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
Our second product candidate, SRK-181, is a potent and highly selective inhibitor of latent TGFβ1 activation. A Phase 1 proof-of-concept trial was initiated in April 2020 in patients with solid tumors. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from checkpoint inhibitor therapy by overcoming primary resistance to anti-PD-(L)1 antibodies.
Summary of Position:
Scholar Rock is seeking an enthusiastic and highly motivated Senior Director/Director, Quality Control. The successful candidate will be responsible for: helping to define, communicate and implement the company’s quality control strategy and vision. This role will develop strong relationships, collaborate, and interact with our development, clinical and operations teams to accomplish the company’s objectives. This individual will also collaborate and develop strong relationships with external CTL’s/CMO to ensure the appropriate testing, systems, processes, and activities are in place for Scholar Rock’s products. The successful candidate will utilize strong communication and relationship building skills to oversee Quality Control functions through external services.
A successful candidate will possess extensive experience in analytical CMC, including interactions with the FDA and other agencies. Experience interacting with and managing external resources (CTO’s/CMO’s). Ability to exert influence diplomatically and have a positive impact inside and outside of the organization. Demonstrated interpersonal, organizational, negotiation and communication skills. Excellent oral and written communication skills and computer skills. Ability to travel as needed.
- Working with the Analytical team in methodologies to support testing of drug substances and products.
- Working closely with collaboration partners to ensure project needs are met.
- Identifying and overseeing CTL’s/CMO’s to ensure stability and product release goals are met.
- Providing analytical support to development studies and troubleshooting analytical issues arising during product development and manufacture.
- Overseeing appropriate sections of regulatory filings (IND, BLA) as well as regulatory responses.
- EXPERIENCE AND QUALIFICATIONS ·
- 10+ years of experience in overseeing QC laboratory functions
- Masters’ or PhD level candidates with 10+ years of experience in analytical chemistry with a focus on biologics preferably in the CMC area.
- Demonstrated experience in developing strong relationships both internally and externally
- Strong technical understanding of complex analytical techniques
- Strong understanding of GXP functions
- Demonstrated ability to work in a virtual quality control testing environment.
- Experience and confidence in managing remote testing facilities.
- Able to deliver a concise message to management and other stakeholders related to quality control matters.
- Must have strong communication and influencing skills
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.