Associate Director, External Partner Management, Secondary Packaging, GEO

Novato, CA

Employer:

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.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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.
Associate Director, External Partner Management, Secondary packaging, GEONovato - Hybrid 2-3 days per week onsite

The role of Associate Director, External Partner Management for Secondary Packaging will have responsibility for partnership enablement with all contract manufacturing organizations (CMOs) that support BioMarin's clinical pipeline and commercial secondary packaging portfolio. The core focus of the role is to develop & foster relationships with CMOs to enable seamless supply of products. Our CMO operations span multiple sites globally (US, EU and Japan) and multiple technology platforms namely, Biologic Drug Substance, Synthetic Drug Substance, Oral Solid Dose, Sterile Drug Product, Combination Products, and Devices.

The Associate Director, External Partner Management (EPM) is accountable for overall relationship management and operational oversight of one or more contract manufacturing organizations (CMOs) or contract development manufacturing organizations (CDMOs) used in the manufacture of materials and products. A primary focus is leadership of matrix teams that interface closely with the external manufacturing network and internal stakeholders, to ensure flawless execution of the product supply. The EPM acts as a manufacturing site lead and is accountable for the overall performance of the team and activities under their responsibility. Furthermore, the Associate Director, EPM is accountable for ensuring that external partners, CMOs, CDMOs, meet BioMarin's long term strategic growth requirements. The Associate Director, EPM will sit as part of External Partner Management Organization, reporting through the Sr. Director of External Partner Management in Global External Operations.

Primary Activities:

Secondary Packaging EPM responsible for all secondary packaging CMOs within the BioMarin external network - both clinical and commercial.
Clinical and Commercial packaging operations are spread over the US, EU and Japan.
Accountable for the VPT (Virtual Plant Team) for Packaging in the external network - an internal business unit team that manages the strategic direction for our external network
Accountable for overall CMO partnership / relationship management activities including day-to-day supply / supporting escalations management, driving alignment between internal & external stakeholders
Accountable for ensuring long-term strategic plan & objectives are considered & addressed in the CMO selection, contract development, and long-term partnership commitments
Partners with external operation & external quality to deliver quality product on time from our CMO network to support clinical and commercial supply plans, proactively resolving issues that escalate from Process Teams
Has a deep understanding of overall CMO performance and develop the CMO relationship through routine cycle of Business Review Meetings (BRMs), Quality Review Meetings (QRM), and Joint Steering Committee (JSCs) Meetings as well as ad hoc visits as needed
Lead the CMO selection process by evaluating CMO capabilities against applicable manufacturing, quality and compliance requirements and needs of BioMarin - both operational capabilities & strategic objectives
Partner with Global Supply Chain to develop and maintain CMO Network Strategies which will ensure capacity is in place for long term product supply
Accountable for long term strategic agenda at CMOs and support development of strategic partnerships with CMOs
Develop detailed understanding of external partners / CMO's needs & strategic direction in relation to BioMarin strategic objects & near-term supply requirements
Establishment and maintenance of CMO governance programs through a formal CMO assessment and tiering framework.
Accountable for ensuring seamless supply of product(s) from the CMO leveraging GEO tiered escalation structure.
Proactively manage and communicate operational risks across the CMO network and develop mitigation plans in partnership with other functional leaders
Execute CMO visits as required by governance program.
Lead matrixed Virtual Plant Team comprised of internal stakeholders e.g. External Quality, MMSAT, Supply Chain, Global Sourcing & Procurement (GSP)
Act as single point of contact with CMO for significant issues & communications, and for new business opportunities.
Drives adherence & accountability with partnership goals & expectations across internal & external stakeholders
Partner with Legal, Compliance and Global Sourcing & Procurement (GSP) to ensure that contracts with CMO are favourable for BioMarin.
Sponsorship of Operation Readiness Planning (ORP) at CMOs as required.
Drive value realization/cost saving efforts
Other duties as assigned.

Qualifications/Experience:

Bachelor's degree in a Life Sciences, Chemistry, Chemical Engineering or Pharmaceutical Engineering discipline required.
Minimum of 10 years of relevant biotechnology or pharmaceutical industry (operations, quality, supply chain).
10+ years of direct experience in a GMP manufacturing environment and 3+ years of team leadership preferable.
5+ years of supplier oversight / relationship management in the pharmaceutical industry.
Experience overseeing multiple product launch / NPI / Tech Transfer programs.
Experience with regulatory agency inspections (e.g., FDA, TGA).
Previous experience leading/influencing global teams in multiple locations preferable.
Strong leadership track record and experience in operations management with CMOs or internal operations.
Track record of delivery on operational improvements across Quality, Cost, Delivery, and Customer Service.
Strong leadership track record especially in the areas of leading in a global and matrix environment, and working cross functionally
Excellent written and verbal communication skills at all levels in the organization.
Direct and broad experience in GMP manufacturing across multiple platforms preferred (biologics; synthetics; oral dose; parenteral manufacturing; packaging).
Ability to travel 25-50%, when required

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.

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 $ 149,000 to $ 223,400 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.

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