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. 

RESPONSIBILITIES

List the major responsibilities of the job.

• Interface with internal stakeholders including Process Development, Quality Assurance, Validation, and Quality Control on technical process details
• Coordinate work across departments to support tech transfer to CMOs

• With the Process Development, Regulatory Affairs and Quality departments, support technology transfer and the final stages of process development.  Optimize the inclusion and contributions from the Contract Manufacturing Staff, Process Development, Quality and Contractor staffs. 

• Troubleshoot equipment and process failures. Follow-up on variance reports generated during production efforts.

• Communicate with members of the CMC team, and with other departments, as needed to optimize the production schedule.
• Write and review regulatory documentation as assigned.
• Contribute to the development of formal systems and procedures for the selection of CMOs
• Contribute to the selection contract manufacturers for audit; initiate and implement necessary control systems within budget and to reduce cost of goods.
• With the Corporate Compliance and Quality departments, ensure that the physical contract facility is compliant with cGMPs.
• Manage contract and confidentiality agreements with the contract manufacturers, ensuring consistency between sites
• Customarily and regularly exercises discretion and independent judgment in the performance of the duties described above.
• 50% or more of time is spent in work directly and closely related to carrying out exempt functions.
• Other duties as assigned.

SCOPE

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. 

EDUCATION

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.

EXPERIENCE

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

• Working knowledge of manufacturing processes
• Working knowledge of desktop computers.

• Highly developed organizational and leadership skills.
• Process development or technology transfer experience preferred.
• Excellent written and verbal communication skills.

• Negotiation skills.
• Experience working with biologics, gene therapy products, and/or orphan drugs

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.

EQUIPMENT

Describe any equipment required to perform the job.

None

CONTACTS

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. 

SUPERVISOR RESPONSIBILITY

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

CAREER DEVELOPMENT

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.