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GEO Clinical Packaging Operations Specialist

Location Novato, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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 GEO Clinical Operations Specialist will serve as an integral member of the Global External Manufacturing Operations team who have responsibility for and play a key role in supporting external Contract Manufacturing Operation (CMO) activities relating to Clinical drug products. He/she will help coordinate starting material and drug product and finished packaged goods supply needs between CMOs and internal BioMarin teams to ensure that all product supply needs are defined and met. The candidate will be required to work closely with a cross-functional team and coordinate activities between Supply Chain, Quality, MSAT and the CMO. TheGEO Clinical OperationsSpecialist will report to the Process Team Owner, GEO.

KEY RESPONSIBILITIES

  • Execute with the CMO the production plan to deliver an uninterrupted supply of clinical & commercial product.
  • Identify any supply constraints and negotiate/resolve with the CMO any issues to meet the supply plan.
  • Maintain a visual metric/dashboard to provide an oversight of the production plan.
  • Act as the focus and conduit for communications between the CMO and with members of BioMarin Process Team and other departments to meet the supply plan.
  • Attend periodically at the CMO to monitor production and develop an in-depth knowledge of the manufacturing process and systems at the CMO.
  • Manage ERP aspects at BioMarin for production efforts at CMO & Monitor and manage inventory levels of drug substance, drug product, finish goods and components as applicable at CMO site.
  • Coordinate BioMarin activities in the evaluation/execution of issues, process changes, change requests and deviations to ensure timely resolution without impacting on supply.
  • PO and Invoice Management – generation, receipt and coordination of POs
  • Shipment Management – Form completion, shipment coordination, inbound & outbound, DS/DP/bulk packs & samples
  • Inventory Reconciliation – manage monthly reconciliation process for relevant CMOs, prepare for and be primary SME/point of contact for inventory audits
  • Support generation of annual documents including APRs,YBPRs and Product Specifications
  • Coordination of reference standard supply with the relevant CMOs
  • Coordination of annual stability samples with Novato and the relevant CMOs.


EXPERIENCE

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 good understanding of the processes/unit operations assigned to the team.

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.

Strong written and verbal communication, commercial acumen.

A high level of initiativeand questioning skills are key role requirements, as well as strong organizational skills.

Experience in supply planning or inventory management.

Experience in inventory reconciliation.

Working knowledge of GXP regulations.

Desired Skills:

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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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