Manager, Clinical Packaging OperationsLocation Novato, California Apply
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. Come join our team and make a meaningful impact on patients’ lives.
The Clinical Packaging Operation Manager is responsible for supporting clinical packaging manufacturing operations at Contract manufacturing facilities. S/he will help coordinate clinical material needs between contract manufacturers and the internal project teams to ensure that all clinical product needs are defined and met. This role is primarily responsible for coordinating contract packaging activities, across multiple external sites, to ensure clinical product supply needs are defined and met.
- Execute with the CMO the production plan to deliver an uninterrupted supply of clinical & commercial product.
- 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, MSAT, 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.
- With the Corporate Compliance and Quality departments, ensure that the CMO is compliant with cGMPs.
- Support contracts and negotiations with CMO.
- Support/lead business optimization efforts for the BioMarin Clinical Operations processes.
- Other duties as assigned.
EXPERIENCE & Skills:
Minimum requirement of 3-5 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:
- Will have a strong understanding of the processes/unit operations assigned to the team.
- Demonstrated ability in leading/managing cross functional, multi-disciplinary teams.
- Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
- Excellent people management, organizational, written and verbal communication, commercial acumen and negotiation skills.
- A high level of initiative, influencing, coaching and questioning skills are key role requirements, as well as excellent organizational skills.
- Experience in supply planning or inventory management.
- Organizational and time management skills.
- Working knowledge of GXP regulations.
Desired skills to accomplish the responsibilities/essential functions include:
- Clinical Packaging Operations/Supply Chain
- Cold chain logistics knowledge.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.