Study Supply Manager Introduction to role The Study Supply Manager will support Radioconjugates ... CMC, ensuring alignment on study needs and timelines. * Ensure key project milestones are met by ...
Study Supply Manager Introduction to role The Study Supply Manager will support Radioconjugates ... CMC, ensuring alignment on study needs and timelines. * Ensure key project milestones are met by ...
Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of ... Proven project management skills to support the planning and coordination of regulatory submissions ...
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Regulatory Strategy, CMC, Labeling, Ad Promo, Medical Review, and Medical Information. Our team of ... Proven project management skills to support the planning and coordination of regulatory submissions ...
Support and guide TO NPL team members to achieve defined project outcomes as required. * Act as a ... Prepare, review, and approve CMC sections for NDAs, ANDAs, supplements, and lifecycle management ...
Support and guide TO NPL team members to achieve defined project outcomes as required. * Act as a ... Prepare, review, and approve CMC sections for NDAs, ANDAs, supplements, and lifecycle management ...
Author, review, and manage technical and regulatory documentation, including: * Drug product ... CMC sections * Technical reports, protocols, and summaries * Collaborate cross-functionally with ...
Author, review, and manage technical and regulatory documentation, including: * Drug product ... CMC sections * Technical reports, protocols, and summaries * Collaborate cross-functionally with ...
Cmc Project Manager information
What are the key skills and qualifications needed to thrive as a CMC Project Manager, and why are they important?
A CMC Project Manager needs strong expertise in Chemistry, Manufacturing, and Controls (CMC) processes, project management certifications (such as PMP), and a background in pharmaceutical or biotech industries. Familiarity with regulatory submission systems, quality management software, and documentation tools is highly valued. Exceptional organizational skills, problem-solving ability, and effective cross-functional communication help candidates excel in this role. These capabilities are critical for ensuring project milestones are met, regulatory requirements are satisfied, and product development remains on track.
What are the typical responsibilities of a CMC Project Manager in a pharmaceutical company?
A CMC Project Manager is responsible for coordinating cross-functional teams to ensure successful delivery of project milestones related to product development, manufacturing, and regulatory submissions. Their daily tasks often include developing project timelines, managing risk assessments, overseeing documentation, and facilitating communication between technical, regulatory, and quality departments. They play a pivotal role in preparing CMC sections for regulatory filings, supporting process optimization, and troubleshooting manufacturing challenges. This position requires excellent multitasking abilities and close collaboration with internal stakeholders and external partners throughout the product lifecycle.
What is a CMC Project Manager?
A CMC (Chemistry, Manufacturing, and Controls) Project Manager oversees the development, manufacturing, and regulatory aspects of pharmaceutical products. They coordinate cross-functional teams, manage timelines, and ensure compliance with regulatory requirements. Their role is critical in guiding drug development from early stages to commercialization while maintaining quality and efficiency.

AstraZeneca rating
8.4
Based on 45 frontline employees who took The Breakroom Quiz
22nd of 86 rated pharmaceutical
Job description
Study Supply Manager
Introduction to role
The Study Supply Manager will support Radioconjugates clinical studies, collaborating with Global Study Teams and external vendors to ensure clinical drug product needs are met across multiple programs. This role builds strong relationships, acts as a key resource and escalation point, and contributes to the creation of strategy for clinical drug supply, translating strategic objectives into clear, actionable plans. Working both within clinical drug supply and cross-functionally, the Study Supply Manager helps develop consistent practices, routinely identifies risks in the supply chain, recommends mitigation plans to management, and implements effective solutions. Ready to help shape how life-changing radioconjugate studies are supplied and delivered?
Accountabilities
Develop and maintain strong, collaborative relationships with key stakeholders across Global Study Teams, Quality, Radiation Science and CMC, ensuring alignment on study needs and timelines.
Ensure key project milestones are met by defining, negotiating and communicating clinical supply plan timelines to internal and external stakeholders and partners.
Serve as an escalation point to Clinical Logistics, Clinical Operations, CMC and/or CROs, resolving issues quickly and effectively.
Participate in functional initiatives, including process development and review, and system/process improvement to drive operational excellence.
Support the creation and maintenance of Radioconjugates pharmacy manuals to enable safe and compliant handling at clinical sites.
Oversee ordering, tracking, delivery and receipt of clinical supplies and drug to clinical sites, ensuring availability for patients when needed.
Lead monthly network capacity planning so that supply plans are aligned with clinical programs, manufacturing schedules and quality capabilities.
Collaborate with Radio Pharm Manufacturing and Quality to manage any issues arising during shipping and/or receipt, communicating delays to the clinical team and, when applicable, managing deviations and corrective/preventive actions.
Continuously monitor supply chain risks across multiple programs, propose mitigation strategies and implement agreed actions to protect study continuity.
Essential Skills/Experience
Bachelor's Degree with 5+ years of relevant experience OR a MS, PhD, or PharmD with 2+ years of relevant experience
Knowledge of ICH GCP Guidelines and local and international regulatory requirements.
Demand planning, forecasting and analytical skills.
Advanced problem-solving ability
Flexibility in working hours to deal with Global supply activities.
Have excellent written, verbal and interpersonal communication skills and comfort working with multiple internal and external stakeholders.
Must have sense of urgency and be comfortable pulling together stakeholders to make quick decisions as needed.
Desirable Skills/Experience
Certification in Supply Chain and Operations Management (i.e. - CSCP, CPIM) preferred
Prior experience in radiopharmaceutical/pharmaceutical product distribution of Class 7 Dangerous goods including import/export
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca offers the chance to follow the science in Oncology, working with radioconjugates at the forefront of innovation, supported by an ambitious pipeline and significant investment. Here, bold ideas turn into real impact as teams combine cutting-edge technology, integrated data and collaborative research with leading academic and clinical partners. Curiosity is encouraged, smart risk-taking is supported, and every role contributes directly to advancing new molecular entities that aim to transform outcomes for people living with cancer.
If this Study Supply Manager opportunity sounds like the next step in your journey, apply now and help drive the future of radioconjugate clinical development!
Annual base salary for this position ranges from 99,552.80 to 130,663.05.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
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