Project Manager, CMC

AstraZeneca-posted 9 months ago

$108,914 - $160,975/Yr

Full-time • Entry Level

Gaithersburg, MD

Chemical Manufacturing

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Biopharmaceutical Development (BPD) at AstraZeneca is at the forefront of developing scientifically-advanced, high-quality processes and methodologies for the manufacture and supply of clinical products across our biologics portfolio. The CMC Project Management function within BPD plays a pivotal role in advancing projects in our pipeline through strategic CMC leadership and coordination of in/out-licensing activities. As a Project Manager (PM), you will work collaboratively with CMC Team Leaders and CMC Teams to ensure project goals and milestones are achieved. You will provide project management expertise to ensure smooth and efficient operational implementation of CMC strategy, enabling project delivery in line with time, financial, and quality requirements. This role requires a high level of independence and minimal supervision.

Ensure effective integration of science and project objectives.
Manage BPD activities for specified projects, interfacing with relevant functional groups and external suppliers to plan and coordinate timely execution of CMC activities and contingencies.
Lead and facilitate CMC Team meetings, responsible for project logistics and documentation.
Ensure key project management tools are used appropriately to enhance project delivery and information dissemination.
Produce and maintain requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
Interface internally and externally as required to evaluate clinical and nonclinical material demand, providing appropriate planning, coordination, and communication.
Enable communications to align project activities with GPT strategy, including planning necessary changes to CMC deliverables.
Collaborate with BPD functional representatives to develop risk mitigation and contingency scenarios for projects.
Communicate effectively with BPD, GPPM, interfacing functions, and relevant governance bodies.
Influence, develop, maintain, own, and deploy key project management tools.
Anticipate operational issues at the project level and influence solutions for similar issues in other projects.

Bachelor's, Master's, or equivalent industry experience in a relevant technical discipline such as Biochemistry, Molecular Biology, Microbiology, Genetics, Immunology or Chemical Engineering.
1+ years of project manager experience (preferable in CMC) is required.
Understanding of biologics CMC development and manufacturing.
Experience in planning and managing the cross-functional aspects of biopharmaceutical product development.
Demonstrated knowledge and application of Project Management tools, such as Risk Management.
High level of commitment, flexibility, and independence with strong skills for planning, coordination, teamwork, communication, and interpersonal relations.
Effective working knowledge relevant to management of the technical disciplines represented within the CMC team.
Comfortable with ambiguity.
Must be professional, dedicated, and detail-oriented.
Excellent oral and written communication, interpersonal, analytical, and computer skills.
Effective problem-solving and analytical skills to tackle and manage a broad range of issues and projects and deliver innovative solutions.
Highly organized and able to work independently on multiple tasks in a fast-paced environment.

Ability to understand scientific data.
Hands-on experience working in one of the CMC Functions.
Familiarity with Planisware (PLANIT) or other project & portfolio management systems is preferred.
Project Management Professional (PMP) or equivalent certification.
Relevant training (PMP or equivalent) or experience in project management is preferred.

401(k) plan
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

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