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Senior Project Manager / Project Manager - CMC - BPD

Lieu Gaithersburg, Maryland, États-Unis Job ID R-065651 Date de publication 11/11/2019

The CMC PM/Sr. CMC PM 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. This role also leverages and applies operational management experience where appropriate to support alliances and collaborations and maintains, promotes and influences CMC project information systems and tools. This role has a high job complexity and the successful candidate must have a high level of independence to meet requirements outlined below with minimal to no supervision.

Major Responsibilities:

CMC Project Manager:

  • Ensures effective integration of science and project objectives.
  • Manages BPD activities for specified projects at all development stages, 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.
  • Influences, develops, maintains, owns and deploys all 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.
  • 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.
  • Anticipates operational issues at the project level, and, working within the cross-project community, to influence solutions for similar issues in other projects
  • Communicates effectively with BPD, GPPM (Global Project & Portfolio Management), and with all interfacing functions and relevant governance bodies as required.

In addition to above listed requirements, Senior CMC Project Manager may

  • Contribute on behalf of CMC Team Management to operationalize process development initiatives and may deputize for CMC Team Lead at governance interactions.
  • Utilize technical knowledge to influence project direction
  • Leverage and apply operational management experience to support alliances and collaborations.
  • Lead to operational process development initiatives of moderate business impact (e.g. Program level).
  • Demonstrate the ability to work with and manage tactical departmental and functional business processes that impact project progression.
  • Work with minimal supervision to meet goals
  • Mentor, coach and help train other project managers.

Required Education and Experience:

  • Bachelor's, Master's, PhD 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 required.
  • In order to qualify for:
    • Senior Project Manager:  3 to 5 years of Project Management experience (preferably in CMC) is required.
    • Project Manager: 1 to 2 years of Project Management experience (preferably in CMC) 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 required.

Required Skills:

  • Requires an ability to assess 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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