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Manager, CMO

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. 

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Job Title:

Manager, Contract Manufacturing

Department / Cost Center:

Contract Manufacturing / 647

Reports to (Job Title):

Senior Director, Contract Manufacturing

Location:

Novato

Date Prepared:

13st July 2018

 Full-Time      Part-Time

 Regular      Temporary

 Exempt      Non-Exempt

SUMMARY DESCRIPTION

The Manager is responsible for the supply of small molecule drug products from contract manufacturing organizations (CMO) by management of the business relationship and supply contracts. In particular the position will be expected to provide technical and project management expertise for oral solid dosage manufacturing activities including primary & secondary packaging. He/she will lead process investigations, process improvement efforts along with Formulations and QA.  He/she will lead the coordination for all clinical and commercial material needs between the various manufacturing groups and the project teams to ensure that all clinical and commercial product needs are defined and met. 

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.
  • Attend at CMO to monitor production campaigns 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 at CMO site.
  • Develop and manage a visual metric/dashboard to provide an oversight of the production plan.
  • Coordinate 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 CMOs
  • 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.
  • Manage contracts and negotiations with CMO.

SCOPE

While functioning as the person in the plant at the CMO, this person will ensure that the work has been completed as per BioMarin instructions. He/she will coordinate all clinical and commercial material needs between the various manufacturing groups and the project teams to ensure that all clinical and commercial product needs are defined and met.  As part of negotiating contracts for manufacturing this individual will evaluate the need for capital investments (in the form of dedicated equipment at contract manufacturing sites) and will have input into program budgets.

EDUCATION

Bachelor’s degree or higher in Science or Engineering is a requisite.

Qualification in any of the following is desireable: Lean Manufacturing, Supply Chain, Project Management.

EXPERIENCE

  • A minimum of 8 years experience in the pharmaceutical industry with a strong production management and/or supplier relationship management experience
  • Working knowledge of solid oral dosage manufacturing and packaging processes to enable problem solving and identification of process improvements.
  • Working knowledge of pharmaceutical regulatory requirements appropriate to level and solid cGMP skills required.
  • Ability to start up and lead cross functional teams in the resolution of short term issues or sustained performance for longterm goals.
  • Demonstrated ability to project manage technology transfer and/or new product launches.
  • Use of Lean Six Sigma tools in continuous improvement projects.
  • Familiarity with an ERP system and Trackwise documentation systems are desirable
  • Excellent organizational, written and verbal communication & negotiation skills.

WORK ENVIRONMENT / PHYSICAL DEMANDS

Travel:   20% - 50%

Candidate will be expected to travel to CMO facilities in US/EU.  Additional travel to BioMarin facilities in Marin County, US, Dublin Office and Shanbally, Co. Cork, may be required..

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

CONTACTS

Internally this person will need to interact with Quality Assurance, Quality Control, QP release, Validation, Process Development, Manufacturing, Supply Chain, Finance, Compliance, Legal, Clinical Operations and Regulatory.  He/she will also be one of the main contacts for all CMO (Contract Manufacturing Organizations) work and contracts. He/she will be responsible for optimizing the inclusion and contributions from the Contract Manufacturing Staff, Process Development, Quality and CMO staffs. 



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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