CMC Program Manager
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s 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 BioMarin’s 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. Come join our team and make a meaningful impact on patients’ lives.
CMC Program Manager
The CMC Program Manager will act as the single point person or single repository that tracks the many CMC-related activities on a product-by-product basis for clinical product programs. CMC-related activities will track activities consistently and in detail. The Program Manager will plan for the Technical Operations related activities, manage and track key CMC activities, including identifying responsible individuals for completing; anticipate, resolve, and escalate issues; coordinate CMC plans with global development and forecasted plans and contribute to the development of a product portfolio view within Technical Operations.
- Plan/manage/track key CMC activities, including identifying responsible individuals
- DS, DP, API labeling/packaging
- Regulatory submissions – including the tracking of INDs (and the comparable filings on a country-by-country basis) approved in particular countries and the timing for introduction of clinical products
- Facility, equipment, IT systems requirements – in cases where implementation impacts specific product timelines
- Global distribution plans
- Partner commitments, as appropriate
- Contractor status – including the tracking-to-closure of CMO deviations
- Develop a consistent methodology for managing CMC teams
- Roles/responsibilities for team members, including defining appropriate membership
- Define decision-making authority for team and when to escalate
- Consistent meeting management: agendas, desired outcomes, read-ahead documents, minutes, etc.
- Consistent use of project tracking tools (e.g., Primavera, MS Project, dashboards, etc.)
- Anticipate, resolve, escalate issues as appropriate
- Scheduling conflicts
- Technical issues
- Processing issues
- Compliance issues
- Resource issues
- Facility and equipment issues
- Coordinate CMC program plans with global company plans
- Galli and Shanbally production plans
- Contract manufacturing production plans
- Clinical development plans
- CMC regulatory filings meeting
- Assist with tracking program costs to be consistent with company budget
- Develop and manage program data in tools that feed into a portfolio view of TOPS activities across CMC product programs.
- Allows for prioritization discussions across projects
- Bachelor’s Degree in a scientific/engineering discipline required. Advanced degree in science/engineering or MBA preferred
- Project Management certification or equivalent is a plus (ie: PMP or equivalent Experience with Risk management practices an advantage.
- 5+ years of experience with managing clinical pharmaceutical products from a project management and supply chain perspective.
- 5+ years of experience within a Pharmaceutical CMC Operations group is required.
- A demonstrated ability of facilitating large cross-functional meetings within a pharmaceutical setting is a must.
- Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
- Ensuring the integrity and accuracy of CMC program information to meet management requirements.
- Partnering with the head of Tech Ops Planning Management Group in identifying, managing & communicating key project risks and leading risk management strategies
- Working knowledge of project management practices either from a formal PM background or from extensive experience in managing projects or programs
- Strong influence, negotiation, analytical and presentation skills.
- Ability to work effectively with cross-functional teams
- 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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.