Manager, Clinical Supply Operations
Immunome, Inc.Bothell, Washington, United States · Posted 25 days agoDescription
Company Overview
Position Overview
The Manager, Clinical Supply Operations, is responsible for meeting Immunome’s supply requirements by enabling and overseeing cGMP operations performed at Contract Development and Manufacturing Organizations (CDMOs). This role centers on managing the supply of finished drug products (FDP) and may support a wide range of projects, including biologics and small molecule programs.
Responsibilities
- Serve as the Supplier Relationship Manager (SRM) for specified CDMOs offering clinical packaging and distribution services. Serve as the primary liaison between the CDMO and Immunome.
- Lead one or more Virtual Management Teams (VMTs) ensuring Immunome’s deliverables stay on track, and internal alignment on priorities and key communications with the CDMO.
- Conduct well-organized meetings with CDMOs. Ensure CDMO progress is tracking to plan (e.g., label development, production readiness, batch operations, release activities and logistics, etc.). Proactively address delays to avoid impact on supply.
- Participate in Clinical Operations study team(s) to stay current on trial design, demand parameters and protocol amendments. May support the development of randomization schemes for open and blind clinical studies.
- Partner with Supply Chain Planning to analyze inventory levels and plan batch production. Recommend changes to labeling and packaging schedules based on study progress.
- Support technical reviews of master and executed batch records, specifications, investigations, and change requests as required.
- Work with Global Logistics and Materials Management to ensure on-time shipments and drug availability at all clinical sites.
- Collaborate with department management and Legal to support the development and negotiation of proposals and service agreements.
- Monitor and track spending against budget. Ensure CDMO invoicing is accurate and aligned with contractual terms. Ensure that unexpected cost variances are communicated quickly.
- Maintain comprehensive knowledge of the CDMO’s systems, capabilities, capacities, requirements, and business practices.
- Monitor CDMO performance through Key Performance Indicators (KPIs) and drive improvements aligned with Immunome’s expectations. Lead or participate in periodic Business Review Meetings.
- Support sourcing efforts, and the audit and qualification of new CDMOs.
- Support technology transfers, process improvements, process validations, and regulatory submission reviews.
- Support network risk assessments and the development and implementation of measures to mitigate supply risks.
Qualifications
- Minimum of 5 years of experience with direct responsibility overseeing outsourced cGMP clinical packaging and labeling operations withing the biotech or pharmaceutical industry, or equivalent.
- APICS certification a plus.
- Position will require domestic and international travel (up to 25%) and occasional evening and/or weekend commitment.
Knowledge and Skills
- Strong organizational, communication, and collaboration skills.
- Closely familiar with cGMP clinical labeling and packaging operations. Experience with highly potent products is a plus.
Similar jobs
Est. 120,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 165,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 250,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 140,000 USD
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medic…
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medic…
Est. 165,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 85,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 250,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 250,000 USD
Position Summary What if... We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner? Pioneering Medicines, an initiative of Flagship Pioneering,…
Est. 120,000 USD
Company Description Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in ca…
Est. 140,000 USD
GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-s…
Est. 120,000 USD
Company Description Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in ca…
Est. 140,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 120,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 120,000 USD
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop diffe…
Est. 250,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 120,000 USD
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, w…
Est. 85,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 160,000 USD
Company Overview: Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nerv…
Est. 250,000 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 140,000 USD
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, suppor…
Est. 120,000 USD
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Est. 128,200 USD
Clinical Pharmacy Specialist Join our Shields team today! Shields Health Solutions is redefining patient care through health-system integrated specialty pharmacy. We’re hiring an Ambulatory Clinical Pharmacy Specialist w…
Est. 128,200 USD
Clinical Pharmacy Specialist Join our Shields team today! Shields Health Solutions is redefining patient care through health-system integrated specialty pharmacy. We’re hiring an Ambulatory Clinical Pharmacy Specialist w…