Description
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
SUMMARY:
The Associate Director, Site Technical Lead shall provide technical and scientific leadership through partnerships with site functions, global functions, and third parties to introduce and maintain commercially viable and robust products and processes. The Site Technical Lead will lead the Novato Technical Services (NTS) team, part of our Technical Develop and Services group and be accountable for front line technical support of all commercial products produced at Novato, CA site with the potential to support contract development and manufacturing organization (CDMO) operations in tech transfers and routine operations. The Lead will drive process performance optimizations to increase process robustness, reduce process variability, and ensure delivery of consistent quality product.
The lead will serve as a member of the Novato site Leadership Team (NLT) and contribute to the overall strategy, performance and direction of the site in the development of the Site Business plans, Site Facility Master Plans, and long term site strategy. The lead will be the primary point of contact between the site and Technical Development and Services (TDS).
The lead will contribute to the technical strategy for the development of new programs and next generation evolution of existing commercial products. As a member of NLT, the Lead will be expected to lead and support the development of business cases for the application of new technologies and processes to the Site.
The Associate Director, Site Technical Lead will be responsible for leading and developing a highly engaged, diverse, and inclusive team which is committed to the development of technical experts and leaders in our organization – while consistently delivering exceptional team performance and meeting.
INFORMATION:
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 Novato Technical Services (NTS) team, part of our Technical Develop and Services group, supports the commercial drug production at the Novato, CA site. The NTS team owns the technical manufacturing process on site and is accountable for its performance. We support production through the development and implementation of process improvement, constant monitoring of process improvement, and process investigation and impact assessment when necessary. We ensure consistent high quality supply of product to our patients and our mission is to lead the way in process science through innovation and excellence while maintaining the highest standards of quality and compliance.
Key Responsibilities
- Lead the team of scientists and process engineers for technical oversight of the commercial drug substance manufacturing at the Novato, CA site.
- Responsible for the introduction of products and for technical transfers from Process Sciences to Manufacturing at the Novato, CA site as well as sending site responsibilities for tech transfers from Novato to CDMOs or internal sites.
- Ensures the process control strategy is translated commercially and maintained for the safety and quality of our manufactured products.
- Support and lead optimization of pharmaceutical processes by applying sound scientific reasoning and following integrated process and technology strategies.
- Support continuous improvement in TDS processes using Operational Excellence principles and relevant tools.
- Works with the global TDS team, including global Drug Substance Technology and Analytical Sciences teams, to drive robustness and productivity initiatives for BioMarin’s commercial products.
- Lead a lab-based group of scientists capable of performing scale-down models of cell culture and purification processes with their associated analytical methods to support on-going process investigations, changes, validation, and process improvement initiatives.
- Leads the from line manufacturing interface team responsible for the continuous application of the process control strategy as integral members of the site process teams.
- Work closely with Process Sciences to provide input during development and lead knowledge transfer from Process Sciences to production regarding product and manufacturing process.
- Identify, recruit, develop and retain qualified individuals to provide technical support to the site.
- Creates and maintains an environment of teamwork and collaboration while developing and motivating a diverse, high performing team that models the organization values and attributes.
- Serve as an influential member of the leadership team who impacts decision making and takes an active role in promoting initiatives, teamwork and collaboration across functions.
- Other duties as assigned.
REQUIREMENTS
- Bachelor's degree in a Life Sciences, Chemistry, Chemical Engineering or Pharmaceutical Engineering discipline required. Advanced degrees are preferred
- Minimum of 10 years of relevant biotechnology or pharmaceutical industry (operations, process development, MSAT)
- 5+ years of direct experience in a GMP manufacturing environment and 5+ years of team leadership
- Demonstrated ability to hire, coach and grow technical talent
- High business acumen with focus on financial acumen
- Ability to communicate effectively across levels, cultures, and mediums
- Ability to develop a compelling vision with measurable objectives and proven ability to lead a team on delivering these objectives for the business
- CMC experience a plus
- Strong analytical, problem-solving, and critical thinking skills
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
In the U.S., the salary range for this position is $ X to $X, 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.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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