- Develop Product a robust strategy for multiple products in conjunction with Supply Chain, MSAT, Quality, Regulatory and Finance.
- Plan for the Technical Operations related activities, manage and track key CMC activities, including identifying responsible individuals for completing; Coordinate CMC plans with global development and forecasted plans and contribute to the development of a product portfolio view within Technical Operations.
- Contribute to developing and sustaining effective Program Management business processes within Technical Operations.
- Facilitate Regulatory submissions; Provide and implement Facility, Equipment, IT systems requirements as needed where it impacts specific product timelines.
- Ensure the integrity and accuracy of the CMC program information to meet management requirements.
- Partner with the head of Tech Ops Planning Management Group in identifying, managing & communicating key project risks and leading risk management strategies.
- Develop and manage program data in tools that feed into a portfolio view of TOPS activities across CMC product programs.
- Must have experience with managin g pharmaceutical products from a project management and supply chain perspective.
- Must have strong financial acumen with an emphasis on the understanding of all elements in product costing.
- Experience with recent regulatory trends, and regulatory submissions is preferred.
- Project Management certification or equivalent is a plus ( ie : PMP or equivalent Experience with Risk management practices an advantage.
- A demonstrated ability of facilitating and influencing large cross-functional meetings within a pharmaceutical setting is required.
- Working knowledge of project management practices either from a formal PM background or from extensive experience in managing projects or programs
- Ability to work in a highly matrixed organization with strong influence management skills
- Extensive experience with MS Project or Primavera is preferred.
- Extensive experience with Microsoft Office package, especially Excel and PowerPoint is preferred.
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Lead Director - Novato, CA, United States - BioMarin Pharmaceutical Inc.
Description
Director, Commercial CMC Team Leader**
Location Novato, California
Workstyle Open to Hybrid BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
The Chemistry, Manufacturing and Controls (CMC) Team Leader (individual contributor role) will the leader of a cross functional team (s) tasked with the many CMC-related activities on a product-by-product basis for commercial programs.
Bachelors Degree in a scientific/engineering discipline required. Advanced degree in science/engineering or MBA preferred
PLEASE NOTE:
Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
**
