Project Manager, CMC Operations
Location United States, RemoteWorkstyle Remote Only Apply
Who We Are
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.
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 CMC integration department. The CMC PM Provides Project Management Support to enable successful program execution and ensures alignment across partner team leads in partnership with the CMC Team Lead.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
- The CMC PM Provides Project Management Support to enable successful program execution and ensures alignment across partner team leads, in partnership with the CMC Team Lead.
- Responsible for driving, deploying, and maintaining the CMC Strategic plan in alignment with Product strategy and in partnership with CMC Team members.
- Responsible for maintaining program management and portfolio deliverables in partnership with CMC Team members (e.g maintaining risk registers and decision logs)
- Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and following up on action items.
- Responsible for preparing CMC Team communication materials to communicate project progress to stakeholders, supervisors, site leadership, and various governance forums as needed e.g., status reports, milestones reporting for diverse leadership groups etc.
- Responsible for facilitating dialogue as well as collation and maintenance of materials for CMC stage gate reviews
- Responsible for working with team members to create and maintain project plans and timelines, highlighting key areas of risks such as resource or budget gaps, dependencies, and target dates
- Responsible for identifying and communicating dependencies and cross-project synergies to leverage efficiencies and ensure consistencies and standardization where appropriate within CMC team
- Identify project issues such as resource, technical or scheduling constraints and drives resolution of these issues with the CMC Team and with external stakeholders by developing program-level 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.
- Tracks program 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.
- Supports training and roll out of portfolio standard and guidance.
- Manages projects supporting continuous improvements of best program management practices.
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, experience with project management software such as Microsoft project, P6 Primavera or other
- Ability to understand the big picture and focus on execution details
- Experience in early-stage CMC development is a plus
- 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
- 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:
- Understanding of biotech or drug product development and of multi-project planning and coordination is required.
- Experience with CMC activities for development programs (Clinical stage) a plus
- Exposure to portfolio management a plus
- Lean-DMAIC expertise, Green belt or higher certification.
- Strong regulatory and GMP acumen, specifically ICH8-12.
- PMP Certification
Fully remote workstyle for candidates who are not local to the Marin County area.
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.
In the U.S., the salary range for this position is $ 104,000 to $ 156,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.