Manager, Contract ManufacturingLocation Novato, California Apply
Manager, Contract Manufacturing
Department / Cost Center:
Contract Manufacturing / 607
Reports to (Job Title):
Director, Contract Manufacturing
The Manager, Contract Manufacturing is responsible for bulk biologic manufacturing for early to late phase products and supporting outsourced gene therapy programs. 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.
List the major responsibilities of the job.
Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
While functioning as the person in the plant at contract manufacturing activities, this person will ensure that the work has been completed as per BioMarin instructions and is, therefore, within the scope of the contract. 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. 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.
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelors degree in science with 8 years of directly related experience GMP manufacturing experience, including at least 3 years of management/ supervisory experience.
Masters degree in science with 4 years of directly related GMP manufacturing experience, including at least 3 years of management/ supervisory experience.
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.
Travel: 40% - 50%
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.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Describe any equipment required to perform the job.
List the key positions, internal and external, with which the job incumbent must interact.
Internally this person will need to interact with Quality Assurance, Quality Control, 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 Contractor staffs.
List the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a “dotted-line” basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others.
None at this time
List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.
Proven ability to set-up contracts and transfer processes to CMO organizations. Ability to manage external manufacturing projects by leading technology transfer and optimizing the inclusion and contributions from the Contract Manufacturing Staff, Process Development, Quality and Contractor staffs. Ability to turn program goals into achievable results. Coordinating all clinical and commercial material needs between the CMO and the project teams to ensure that all clinical and commercial product needs are defined and met. Achieve a high level of project management and negotiation skills.