What are the responsibilities and job description for the Director, Operations - Global External Operations position at Initial Therapeutics, Inc.?
Who We Are
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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.
Global External Operations (GEO), Operations Lead
The GEO Operations Lead will report to the Senior Director, Head of External Operations and is responsible for the supply of product(s) from contract manufacturing organizations (CMO) by management of the business relationship and supply contracts. The position will be expected to own one or more business relationships in the form of Process Teams and manage Operations professionals to ensure quality product is delivered as required.
Key Responsibilities
- Ensure delivery of quality product on time from our CMO network to support clinical and commercial supply plans, as direct management of GEO Process Teams (Make – Assess – Release and Ready – Run – Release processes).
- Partner with Technical Development & Services, External Quality, and External Partner Management teams to oversee & support product launch programs, tech transfers, technical changes, labelling updates, etc.
- Recruit, onboard, & train operations professionals to ensure the team has the appropriate experience & capabilities to provide oversight across the E2E pharmaceutical value chain.
- Manage career development & succession planning for direct reports.
- Manage the CMO meeting schedule in conjunction with your cross functional colleagues to ensure an engaging and collaborative environment.
- Identify any supply constraints and negotiate / resolve with the CMO any issues to meet the supply plan.
- Manage escalations and communications within the process team / GEO site from an operations perspective.
- Collaborate with a cross functional team to ensure uninterrupted supply of product. This will involve both process team and non-process team colleagues.
- Perform root cause analysis, or equivalent, to understand issues and implement corrective actions as appropriate.
- Manage material movement between CMO sites with various internal partners.
- Attend at CMO to monitor production campaigns and develop an in-depth knowledge of the manufacturing process and systems at the CMO.
- Manage and maintain with cross functional team a visual metric / dashboard to provide an oversight of the GEO business.
- Coordinate as required BioMarin activities in the evaluation of process changes, change requests and deviations to ensure timely resolution without impacting on supply.
- Act as the focus and conduit for communications between the CMO and with members of BioMarin manufacturing group and other departments to meet the supply plan.
- Lead and / or participate in technology transfers, new product launches, validation activities with the CMO and internal cross functional teams including Process Development, Regulatory Affairs and Quality departments.
- Contribute to the development of formal systems and procedures for the selection of CMO.
- Initiate and implement necessary control systems within budget and to reduce cost of goods.
- Ensure that the CMO is compliant with cGMPs.
- Support contracts and negotiations with CMO.
- Support Process Team Leads, associates and specialists as required.
EXPERIENCE : Minimum requirement of 10 years in Operations, Supply Chain or Quality. BS / BA degree; life sciences, business, or supply chain management.
Required skills needed to accomplish the responsibilities / essential functions include :
Work is hybrid, which requires 2-4 days per week onsite in Novato, CA. In addition, ability to travel approximately 25%, when required as CMO oversight may include US, India and other locations as assigned.
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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