Associate Director, Clinical CMC Team Leader
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.
The Chemistry, Manufacturing and Controls (CMC) Team Leader (individual contributor role) will be a project lead on cross functional teams tasked with the many CMC-related activities on a product-by-product basis for clinical programs.
What will you do?
- Act as the single point person responsible for understanding the CMC-related activities and will track key activities consistently and in detail.
- 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.
- Contribute to developing and sustaining effective Program Management business processes within Technical Operations.
- Facilitate 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.
- 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.
- Strategically coordinates CMC program plans with global company plans; ex: Galli and Shanbally production and contract manufacturing production.
- Bachelor’s Degree in a scientific/engineering discipline required. Advanced degree in science/engineering or MBA preferred
- 8 or more years of relevant industry experience, particularly in the development of protein-based, AAV, oligonucleotide, and/or synthetic chemical entity therapeutics.
- Must have experience with managing clinical pharmaceutical products from a project management and supply chain perspective.
- 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.
- Strong communication skills and demonstrated leadership experience.
- A demonstrated ability of facilitating and influencing large cross-functional meetings within a pharmaceutical setting is required.
- Excellent interpersonal skills and proven ability to foster important relationships with customers and key stakeholders.
- 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.
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.