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Associate Project Manager/ Project Manager -CMC - BPD

Location Gaithersburg, Maryland, United States Job ID R-083763 Date posted 06/08/2020

The Associate Project Manager (APM) works collaboratively with CMC Team Leaders and CMC Teams to ensure Biopharmaceutical Development (BPD) project goals and milestones are achieved by providing project management expertise to CMC Teams ensuring smooth and efficient operational implementation of CMC strategy, and enabling project delivery in line with time, financial and quality requirements. The APM may also contribute to departmental or functional initiatives or projects.  This role has a moderate job complexity and the successful candidate must have a high level of independence to meet requirements outlined below with minimal supervision.

Major Responsibilities:

  • Ensures effective integration of science and project objectives.
  • Manages BPD activities for specified projects, interfacing with relevant functional groups, and with external suppliers as necessary, to plan and coordinate the timely execution of CMC activities and contingencies.
  • Leads and facilitates CMC Team meetings and is responsible for project logistics and documentation.
  • Ensures key project management tools are used appropriately to enhance project delivery and information dissemination to the business.
  • Responsible for the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
  • Interfaces internally and externally as required in evaluation of clinical and nonclinical material demand and to provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.
  • Enables communications to align project activities with PDT strategy, including planning of any necessary changes to the CMC deliverables, and aiding activities to secure PDT (Product Development Team) and BPD Leadership Team support.
  • Collaborates with BPD functional representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects.
  • Communicates effectively with BPD, GPPM (Global Project & Portfolio Management), and with all interfacing functions and relevant governance bodies as required.
  • In addition to the above requirements, a Project Manager will also be responsible for:
  • Influences, develops, maintains, owns and deploys key project management tools. Ensure tools are used appropriately to enhance project delivery and information dissemination to the business.
  • Ensures the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
  • Anticipates operational issues at the project level, and, working within the cross-project community, to influence solutions for similar issues in other projects

Required Education and Experience:

Bachelor's, Master's, or equivalent industry experience in a relevant technical discipline such as Biochemistry, Molecular Biology, Microbiology, Genetics, Immunology or Chemical Engineering. Relevant training (PMP or equivalent) or experience in project management is preferred.

Associate Project Manager: 1 year of Project Management experience (preferably in CMC) is preferred.

Project manager: 1-2 years of project manager experience (preferable in CMC) is required.

Understanding of biologics CMC development and manufacturing is required.

  • Successful candidate must have experience in planning and managing the cross functional aspects of biopharmaceutical product development.
  • The candidate will have demonstrated knowledge and application of Project Management tools, such as Risk Management.
  • This position requires a 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 is expected.
  • Familiarity with Planisware 5 (Opal) or other project & portfolio management system is preferred.

Required Skills:

  • Requires an ability to understand scientific data.
  • Comfortable with ambiguity
  • Must be professional, dedicated, and detail-orientated.
  • 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
  • Strong organizational skills required, including good time management skills.
  • Highly organized and able to work independently on multiple tasks in a fast-paced environment.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.