Job Title: Manager, CMC Stability and QC
Reports To: Associate Director, Analytical Development
Functional Area: CMC
Position Location: Remote – Possibly Hybrid
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
We are a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts with a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead program has completed multiple Phase 1 and Phase 2 clinical trials. We launched our Phase 2b clinical trial in Thyroid Eye Disease (TED) in 2023 and our Phase 2 clinical trial in cardiovascular disease in Q2 2024. We plan to initiate our Phase 3 clinical trial in TED later in 2024. More information about Tourmaline can be found at www.tourmalinebio.com.
General Responsibilities:
The Manager, CMC Stability and Quality Control (QC) reports to the Associate Director of Analytical Development and is responsible for the oversight of the drug substance, drug product, and placebo release and stability programs for Tourmaline products. Primary responsibilities of this position include providing sponsor oversite of testing performed at the Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTLs) that manufacture and /or test Tourmaline products. This position will also provide oversight of a variety of analytical functions related to Analytical Development and Quality Control.
Responsibilities:
- Manage stability studies on development and clinical projects at Contract Research Organizations (CROs)/CMOs/CTLs
- Manage tracking and trending of release and stability data
- Maintain schedule of stability pulls, testing timelines, and reporting deadlines at CROs/CMOs/CTLs and ensure timely pulls per protocol
- Manage reference standard and critical reagents at CROs/CMOs/CTLs and coordinate with project teams for re-testing activities
- Work with CROs/CMOs/CTLs in the design and execution of stability studies for DS and DP that justify retest/expiry period, storage, and shipping conditions
- Author, review and approve data packages, protocols, change controls, and reports that are ICH-compliant
- Participate in out of specification (OOS)/out of trend (OOT) investigations and deviations
- Act as the primary representative for Stability function in vendor meetings and on cross-functional project teams
- Support regulatory submissions by reviewing relevant CMC sections (e.g., INDs, BLAs), coordinate data requests, compilation, and management of internally and externally generated data
- Coordinate the shipment of samples as required, with the Supply Chain team
- Perform other duties as assigned
Education and Licensure:
- BS/MS or Ph.D. in chemistry, biochemistry, analytical science, biophysics, biochemistry, or related field
Experience and Attributes:
- 6+ years’ experience (BS/MS) or 3+ years’ (Ph.D.) biotech or pharmaceutical industry experience with biologics preferably with monoclonal antibodies or related proteins
- Experience in protein analytics and with the overall Drug Development process within the pharmaceutical industry (e.g., bioassays, biochemical and biophysical)
- Working understanding of cGMP, ICH, FDA and USP guidelines, including the ability to apply the guidelines in context of the stage of pharmaceutical development
- Familiarity with lyophilized products and pre-filled syringe / auto-injector manufacturing is a plus
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Demonstrated ability to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines
- Self-starter with ability to work autonomously in a dynamic environment with changing priorities.
- High level of integrity, ethics and discretion
- A good team player with solid record of collaboration within and across functional areas
- Availability to travel to corporate headquarters and/or to vendor sites domestically and internationally as needed (not to exceed 20% of time)
Base Salary Range:
$122,000 – $159,000 based on candidate professional experience level.
Note:
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.
