Scientist, Analytical Development
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: August 29, 2021
Company
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, and fibrosis. 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 forms 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 first investigational product candidate, apitegromab (SRK-015), is a selective inhibitor of the activation of latent myostatin. We announced positive 12-month top-line data from the TOPAZ trial in April 2021, demonstrating that apitegromab has the potential to improve motor function in patients with Type 2 and Type 3 spinal muscular atrophy (SMA). We anticipate initiating a Phase 3 registrational trial by the end of 2021 and are moving steadfast towards our aim of bringing this potential first muscle-directed therapy to patients with SMA
Our second investigational product candidate, SRK-181, is a selective inhibitor of latent TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapies (CPIs), such as anti-PD-1 or anti-PD-L1 antibodies. Although CPIs have transformed the cancer treatment landscape, only approximately 20% of patients respond to treatment. We believe SRK-181 has the potential to meaningfully increase the number of patients who can benefit from CPIs. We are evaluating SRK-181 in the ongoing DRAGON Phase 1 proof-of-concept trial (NCT04291079) evaluating patients with locally advanced or metastatic solid tumors. We anticipate initial clinical response and safety data from Part A (dose escalation) portion of the trial by the end of 2021.
We continue to progress our scientific platform and preclinical programs as we apply our structural insights and protein science and antibody expertise to discover antibodies with differentiated therapeutic profiles and develop high-impact medicines for patients suffering from serious diseases.
Summary of Position:
Here is your opportunity to join a patient-inspired, creative, collaborative, fun and experienced team. Our mission is to help patients with serious illnesses by applying innovative thinking, explore cutting edge science, and drive our passion towards discovering and developing novel therapeutics. Playing a critical role within Scholar Rock, the Scientist, Analytical Development, will be responsible for analytical method development, and extended characterization activities supporting various programs from early phase to late phase. This position will be responsible for method development, qualification, and transfer. In addition, this position will be responsible for analyzing samples, day-to-day maintenance and operations of analytical instruments, generating data summary, and technical reports. This position will also be involved in regulatory submission including INDs and BLAs. This position requires a highly motivated and enthusiastic professional with hands-on lab expertise. We are interested in candidates with a proven track-record of technical excellence and product development. Key success factors for the position include biologics experience, creativity, integrity in thought and action, team-centric mindset, integrative thinking, ability to influence decision-making, exceptional communication skills, the ability to inspire, and being a “hands-on doer”.
Position Responsibilities:
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- Apply advanced scientific principles, theories, concepts, practices and standards to analytical development and product characterization
- Responsible for sample analysis, maintenance and operations of capillary electrophoresis, HPLC and other analytical instruments
- Write data summary and technical reports
- Participate in authoring, and reviewing IND, IMPD, BLA, and MAA sections
- Author method development and qualification reports and test methods.
- Actively participate in building an internal analytical team with the objective of being a center of excellence of monoclonal antibody characterization, including identification of posttranslational modifications, and establishing degradation pathways to support developability screening and formulation of early phase molecules and comparability of late stage molecules for drug candidate nomination, IND submission and BLA filing.
Candidate Requirements:
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- Ph. D. in a relevant discipline (chemistry, biochemistry, or related field) or MS with a minimum 3 years of relevant industry experience or BS with a minimum of 5 years of relevant industry experience.
- Hands-on experience and extensive knowledge in capillary electrophoresis, gel electrophoresis, HPLC mass spectrometry and other related analytical techniques for analyzing proteins and peptides
- Knowledge of analytical ultracentrifugation, differential scanning calorimetry and circular dichroism highly desirable
- Knowledge of protein modifications and degradation
- Demonstrated technical writing skill
- Understanding GLP, and GMP working environment
- Good balance between scientific thinking and compliance
- Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
- Working with the sense of urgency
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.