Manager/Senior Manager, Quality Control
Obsidian Therapeutics
About Us…
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors.
We’re proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Development, Manufacturing, and Quality team is based in our brand-new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
Our Opportunity…
We’re looking for a highly motivated Manger or Senior Manger of Quality Control to support our Drug Product CDMO(s) for analytical method transfer and validation, DP release and stability, and QC investigation.
This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
You will...
- Support analytical method transfer and validation at Obsidian’s drug product CDMO.
- Support the drug product stability program; analyze data trends and identify issues requiring investigation.
- Support QC investigations of quality events, including laboratory investigations, OOS/OOT results, deviations, and manufacturing investigations.
- Author and review test methods, protocols, SOPs, reports, and associated documents; coordinate cross-functional processes and integrate feedback.
- Support QC Person-In-Plant activities at Obsidian’s CDMO facilities as needed.
- Manage QC data trending and metrics for reporting to the Quality Council.
- Contribute to regulatory submission activities, including authoring and review.
- Collaborate closely with QA, Regulatory, Supply Chain, MSAT, Analytical Development (AD), and Process Development (PD) groups, as well as external partners.
- Assist with continuous improvement initiatives to enhance quality and compliance.
- Support drug product release as needed.
- Be available and willing to engage after hours or on weekends when required for batch release to deliver product to a patient.
- Up to 30% U.S. travel required.
You bring...
Core Qualifications:
- Bachelor’s degree in Biology, Chemistry, Life Sciences, or a related field, and 8+ years of analytical experience in biologics or cell and gene therapy, including at least 5 years in GMP QC (or an M.S. and 6+ years of experience with 3 years of relevant GMP QC experience).
- Expertise in analytical method transfer and phase-appropriate validation.
- Experience in QC analytical method optimization and troubleshooting for biologics or cell and gene therapy drug products. A solid background in microbiology and environmental monitoring is preferred.
- Experience supporting late-phase to commercial programs.
- Exceptional oral and written communication skills; able to communicate effectively with scientific and technical colleagues in a dynamic, cross-functional environment.
- Experience with flow potency assays is a plus.
- Regulatory experience is a plus.
Obsidian is committed to equitable and transparent pay practices.
The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location.
Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities.
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.