The 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. The CMC PM may contribute on behalf of CMC Team Management to operational process development initiatives and may deputize for other managers. This role may line manage, mentor or supervise other CMC project managers. This role has a high job complexity and the successful candidate must have a high level of independence to meet requirements outlined above with minimal supervision.
* Leads translation of strategy into project plans and deliverables, communicates plans to the team as well as BPD leadership and Key stake holders as appropriate
* Challenges team and functional BPD representatives on project assumptions relating to time, cost and quality
* Contributes actively to the creation of development options evaluating risk and benefit and ensuring BPD activities are not on the critical path for product development.
* Leads the CMC in preparing for BPD leadership reviews based on BPD guidance.
* With the CMC TL, drives the development of key CMC aspects of governance pre-reads and presentations pulling together CMC information in a cohesive story/presentation. Ensures the governance presentations have a professional look and feel.
* Ensures CMC team presentations are reviewed by BPD Sr. Management as appropriate.
* Understands, communicates and drives CMC team to meet the deliverables & goals and challenges appropriately
* Brings lessons learned from other projects to effectively drive project strategy
* Facilitates communications involving team members and external partners.
* Recognizes team members' contributions and accomplishments.
* Partners with the BPD functions to elevate and raise concerns regarding adequacy of resources & prioritization.
Assessing and Managing Issues and Risks
* Monitors risks in real time to ensure team engagement and mitigation plans are activated as required.
* Works with team to refresh risks & mitigation as needed.
Alliance Management (AM) & External Collaborations
* Acts as the Alliance Manager for the program and is responsible for the effective management of the alliance/ collaboration.
* Partners with legal, BD, and finance representatives to serves as the knowledge experts on contractual obligations with the partner.
* Ensures necessary infrastructure needs are met for interactions with the partner/collaborator.
* Maintains regular communications with the alliance partner/collaborator ensuring lines of communication are open:
o Establishes and agrees to standard practices for alliance/collaboration communications
o Maintains files in an electronic collaborative space as appropriate for the alliance/collaboration
o Plans agenda for the alliance/collaboration meetings in conjunction with the partner/collaborator
o Ensures appropriate review & approval of steering committee material and/or reports/payments
* To ensure effective integration of science and project objectives.
* To manage 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.
* To influence, develop, maintain, own and deploy all key project management tools. Ensure tools are used appropriately to enhance project delivery and information dissemination to the business.
* To ensure the production and maintenance of requisite project documentation to ensure delivery of the overall CMC Plan and milestones.
* To interface 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..
* To enable communications to align project activities with PDT strategy, including planning of any necessary changes to the CMC deliverables, and aiding activities to secure PDT and BPD Leadership team support.
* To represent CMC Team Management in cross functional initiatives of business impact, such as would benefit the design and establishment of organization processes.
* To collaborate with BPD functional representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects.
* To anticipate operational issues at the project level, and, working within the cross project community, to influence solutions for similar issues in other projects
* To mentor, coach and train other project managers, and where required, to act as line manager.
* To communicate effectively with BPD, PPSM, and with all interfacing functions and relevant governance bodies as required.
Education: 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 or experience in project management (PMP or equivalent) required.
Successful candidate must have experience in planning and managing the cross functional aspects of biopharmaceutical product development. In particular, experience in managing CMC teams responsible for development of biopharmaceutical products is required. The candidate must have technical understanding of the development of material to be used in either clinical studies or commercial product (clinical preferred). The candidate will have demonstrated knowledge and application of Project Management tools, such as Risk Management.
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
My company shares my passion for helping to improve human health around the world.
This is My MedImmune
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.