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.

Supply Chain Operations Team Lead – 12 Month Assignment

Closing Date 17th April

• People management of direct reports of Warehouse Technicians, Biotechnicians and Shift Leads.
• Coach, mentor and train Shift Leads and Biotechnicians on materials operations processes, use of operational excellence tools, and high-performance team behaviours.
• Lead and support daily material operations under cGMP conditions.
• Lead and support business process excellence implementation within Supply Chian Operations (e.g. Daily Management System (DMS), 5S, SMED, Leader Standard Work, Cross training, PPM & Standard work).
• Strong focus of visibility boards for Supply Chain Operations metrics and daily operations.
• Ensure schedule adherence, assist in troubleshooting and facilitate appropriate escalation.
• Effectively and consistently prioritise and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
• Support and partner closely with the Supply Chain Operations Managers, shift leads and biotechnicians, Drug Substance, Drug Product and Packaging colleagues.
• Ensure training, SOPs and other documents are current and compliant under cGMP conditions – ensure training, manufacturing systems and practices are consistent throughout Supply Chain Operations.
• Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Participate and support inventory optimization that helps create a strong value proposition for future investment.
• Lead and implement continuous improvement initiatives and productivity and value enhancement projects for Supply Chain Operations.
• Lead the execution of Supply Chain Operations readiness plans for manufacturing campaigns for new and existing products.
• Support and partner closely with internal customers to ensure all operational activities are current and comply with cGMP conditions. 
• Own, investigate, write and approve associated deviations as well as supporting and coaching Biotechnicians in these functions.
• Ensure areas meet compliance standards and highlight any issues and work proactively with the area team and others to ensure resolution.

• Demonstrated experience working with MFG processes, device assembly and secondary packaging operations in a cGMP environment.
• Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred.
• Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
• Demonstrate strong communication skills and the ability to interact across cross-functional teams.
• Track record of embedding a strong Quality and Safety culture.
• Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
• Strong process knowledge of supply chain operations.
• Excellent project management skills.
• Proven ability to lead and deliver on multiple and agile and flexible to work on multiple initiatives.
• Strong continuous improvement focus.
• Strong collaboration skills.
• Experience with regulatory inspections and direct interaction with regulatory inspectors.
• Highly developed organizational and leadership skills.

• Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience in a GMP environment is preferred.
• Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).

• At least 3 years experience in a regulated manufacturing environment with excellent knowledge of material operations.
• Demonstrated ability to partner with other functional groups to achieve business objectives.
• Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to material operations in a pharmaceutical production facility.
• Strong communication and interpersonal skills – oral, written and formal presentation skills.
• Creative problem solving 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.