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CMC Project Manager

Location Novato, California Workstyle Remote Only
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 CMC Project Manager role is critical for coordination-based responsibilities in support of BioMarin’s product portfolio within Technical Operations (TOPS) and within the Program and Portfolio Management department.  Under minimal supervision this position supports cross-functional partnerships across BioMarin to ensure the availability of our portfolio of products to external partners, customers and patients.  You will support cross functional alignment on product and portfolio strategies and their execution and will serve as a key point of contact for collaborations with CMC team colleagues. You will serve as a subject matter expert and strategic partner to educate on how we operationalize a strategy and support leadership decision making and develop solutions to complex problems.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

  • Support the CMC Team Leader(s) with product strategy development, deployment, and maintenance.
  • Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items.
  • Be responsible for the preparation of routine status reports and communicate project progress to stakeholders, supervisors, site leadership, and various governance forums as needed.
  • Responsible for collecting CMC program resource allocations and validating with partner team leads and cost center managers. This position works with team members to create and maintain project plans and timelines, which may include budget, definition, scope, supply chain management, risk definition and analysis, financial resources allocation, dependencies, and target dates.
  • Identifies project issues such as resource, technical or scheduling constraints and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options, and proposed solutions with impact statements.
  • Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
  • Serve as a member of sub-teams, tracking timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards.
  • Support identifying cross-project synergies to leverage efficiencies and ensure consistencies where appropriate.
  • Contributes to best practices and improvements.

QUALIFICATIONS AND EXPERIENCE

  • Minimum of 4-8 years total relevant experience (including industry, project management, or private/government institution), with at least 2-4 years in a project management role
  • Minimum Bachelors’ degree in scientific/technical discipline.
  • Demonstrated ability to organize and update a complex schedule
  • Proven track record in a fast-paced, challenging, and complex matrixed team environment.
  • High degree of demonstrated learning agility.
  • Action-oriented with strong follow through.
  • Strong interpersonal skills; fluent and able to influence others in spoken and written English.
  • Strong risk management analysis and project management skills.
  • Ability to understand the big picture and focus on execution details to CMC product strategies.
  • Strong computer skills, MS Office, MS Word, MS PowerPoint. MS-Project is preferred.
  • Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment

Nice to Have Skills/Experience:
  • Lean-DMAIC expertise, Green belt or higher certification.
  • Strong regulatory and GMP acumen, specifically ICH8-12.
  • PMP Certification
  • Understanding of biotech or drug product development and of multi-project planning and coordination is required.

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. 



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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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