Senior Associate / Manager, CMC Operations jobs in United States
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Relay Therapeutics · 1 month ago

Senior Associate / Manager, CMC Operations

Relay Therapeutics is a clinical-stage precision medicines company focused on transforming the drug discovery process. The Senior Associate / Manager, CMC Operations will support CMC financial and operational activities, collaborating with internal teams and external partners to ensure timely delivery of clinical materials and documentation.

BiotechnologyHealth CareTherapeutics
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Growth Opportunities

Responsibilities

Collaborate with CMC, Accounting, and Finance teams to support the creation and maintenance of department budgets and forecasts
Generate and finalize all departmental Purchase Orders (POs) within the Coupa system; track progress to ensure timely approval
Confirm that all PO requests are accurately captured in the budget; escalate and obtain approval for any items not previously included
Ensure contracts contain appropriate legal language, milestones, and payment terms
Track CMC operational expenses against budget by conducting monthly reviews of accruals in partnership with CMC functional leads (Drug Substance, Drug Product, Analytical Development, Quality, and Clinical Supply) and Finance
Support the onboarding of new CMC and supply chain vendors
Meet with vendors monthly (or as needed) to monitor spending against approved contracts
Coordinate internal and external vendor communications and action items, including contract and PO management, budget and accrual oversight, material transfers, and inventory system support
Support the execution of CMC activities across Drug Substance, Drug Product, Analytical Development/Manufacturing, and Clinical Supply Chain, including scheduling and project management tasks
Assist in the development and alignment of CMC project plans, risk assessments, and timelines with overall program goals; ensure timely communication of project status, timeline changes, cost updates, and risks to team members and functional leaders
Facilitate internal CMC team meetings, track action items, and maintain documentation to drive operational excellence
Contribute to continuous improvement efforts across CMC processes, tools, and data management systems

Qualification

CMC operations experienceBudget managementProject managementGMP knowledgeRegulatory complianceCommunication skillsOrganizational skillsDetail-orientedCollaborative mindset

Required

Bachelor's degree in life sciences, engineering, business, or a related field required
3 to 5 years of experience in CMC operations, technical operations, or pharmaceutical manufacturing within a biotech or pharmaceutical company
Experience supporting clinical-stage programs and working with CDMOs
Working knowledge of GMP, ICH guidelines, and regulatory expectations for CMC development
Strong project management, organizational, and communication skills
Detail-oriented and proactive, with the ability to anticipate and resolve issues
Collaborative mindset with the ability to work effectively within cross-functional teams
Comfortable operating in a dynamic environment with evolving priorities

Company

Relay Therapeutics

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Relay therapeutics is a developer of an allosteric drug-discovery platform intended to apply computational techniques to protein motion.

Funding

Current Stage
Public Company
Total Funding
$1.4B
Key Investors
Nextech InvestSoftBank Vision FundBiotechnology Value Fund
2024-09-10Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $30M
2022-09-12Post Ipo Equity· $300M

Leadership Team

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Sanjiv Patel
President and CEO
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Imogen Pryce
Chief Operating Officer, R&D
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Company data provided by crunchbase