Manager, CMC Portfolio Management -- REMOTE
SRG is looking for a Manager, CMC Portfolio Management for our client that will be responsible for the execution and deliverables of the assigned CMC programs. Reporting to the Sr. Director, CMC Portfolio Manager, this person would also be responsible for integrating and understanding Formulation & Process Development activities by developing and maintaining product project timelines across the commercialization lifecycle. You would have the opportunity to be the single point of contact for communication with the CMC team and other internal, cross-functional teams. You would drive the multiple CMC project consistency with the stakeholders and ensure all projects have accurate timelines and project teams have clear goals, objectives, and milestones consistent with the priorities of the business.
- Work closely with cross-functional project team to direct the team to assure the successful completion of projects according to rigorous scientific and regulatory standards within agreed upon timelines.
- Partner with cross-functional groups and lead project discussion and actively directs the projects for completion of CMC milestones and actively addresses any deviations from the plan that would trigger review of the project by the appropriate management committees.
- Coordinates the preparation of the CMC project timelines, budgets, clinical supplies, tracking CMC filing documentation and possible contingency plans and coordinate the presentation to management committees.
- Facilitate the project team meeting schedule, discussion, meeting minutes preparation et al.
- Generate and maintain CMC section of the Integrated Program Development Plan (IPDPs) that serve as a single source of cross-functional inter-dependencies.
- Challenge team to think about and anticipate risks, proactively manage risks, and develop mitigation strategies.
- Ensure effective communication within teams, across functions, through sub-teams, and to key stakeholders throughout the organization, including senior management.
- Coordinate activities with external business partners and alliances, where applicable.
- Required: English / Chinese language fluency both written and oral.
- Bachelor’s degree in Life Sciences or a relevant field; Masters and/or PhD is preferred.3+ years of CMC project management experience in the Pharmaceutical and/or Biotechnology industry.
- 1+ years’ experience managing and/or leading cross-functional drug development teams.
- Prior experience and working knowledge in Product Development of Therapeutic Biologics and Vaccines is a plus including Drug substance, Drug Product, Formulation, Process, Packaging, Clinical and/or late stage/Commercial manufacturing, Supply Chain, Regulatory affairs, Clinical Operations, Lifecycle Management.
- Proven capability to lead, motivate, inspire without authority in a diverse, global, cross functional structure.
- Quick learner, details orientated, organized, strategic thinking, Open minded, creative problem-solving skills, positive thinking, result driven.
- Ability to work and communicate effectively in cross-cultural environments.
- Utilization of Project Management tools (e.g. MS Project), practices, and infrastructure, as related to the biopharmaceutical industry.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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