Director/Sr. Director, Contract Manufacturing
Description Responsible for developing and implementing long term Contract Manufacturing strategies and networks that address the needs of Depomed's clinical and commercial products. Ultimately responsible for the supply of clinical and commercial products from Depomed's Contract Manufacturing Organizations (CMOs), and oversees a team of engineers/scientists as well as outside vendors that oversee the related manufacturing activities. In addition, acting in the capacity of a Project Management role, coordinates on-going CMC and manufacturing activities as well as leading the planning and execution of new programs working across the organization with Quality, Regulatory, Clinical and Marketing to introduce new products or changes to existing products. ESSENTIAL JOB FUNCTIONS
Develop vision and strategies for Contract Manufacturing management to ensure continuity of quality, supply & cost for the Commercial products.
Lead strategic planning efforts for Contract Manufacturing sourcing.
Develop strong Contract Manufacturing processes related to product development, Contract Manufacturing selection and Contract Manufacturing qualification. Design a proactive process for Contract Manufacturing selection, management, monitoring and development
Clinical Manufacturing - Manage all aspects of GMP manufacturing processes to produce clinical supplies to support clinical studies, including schedules and budgets. Ensure that processes comply with requirements of regulatory agencies. Coordinate Tech transfer and approve engineering, registration validation activities.
Commercial Manufacturing -Manage and oversight of CMOs to manufacture commercial products. Responsible for manufacturing processes and technical activities Ensure manufacturing demand is met. Participate in investigations associated with processes to bring them to timely resolution.
Implement CMC and Manufacturing activities to support lifecycle initiatives
Work with colleagues in the strategic planning and execution of the corporate goals for the Department (QC, QA, and Manufacturing) including the resources and timelines for carrying out those objectives. Formulate, monitor and control budgets.
Manage the Contract manufacturing and Project Management group. Provide direction and objectives to direct reports in Contract Manufacturing and Project Management, leading, training, and mentoring for effective performance
Develop and manage against the department budget
Ensure all required SOP's are in place and up to date
Ensure area is operating in a manner to withstand an audit
Strong influence management skills including comfort operating in a highly matrix-based environment
EDUCATION AND EXPERIENCE
BS or equivalent in Chemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. An advanced degree in sciences would be a plus.
A minimum of 10 years of pharmaceutical or biotech industry experience, including late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environments
Prior experience related to managing external CMOs is required.
Prior experience in working at a commercial manufacturing site is a plus
SKILLS AND ABILITIES
Ability to articulate and communicate vision and strategic direction.
Collaborative - is successful in delivering through influence.
Excellent interpersonal, negotiation, and organizational skills.
Able to travel up to 30%.
DEPOMED COMPETENCIES INCLUDE
Able to work in a team, get direction and give direction
Responsive, sincere, loyal, good work ethics
Able to cope with business limitations and challenges
Excellent decision making skills
Sitting 80%; walking / standing 20%
Able to see and read PC screens; detect color coding, read fine print, and/or normal type size print
Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints
Ability to organize and prioritize work on long-term basis
Ability to make decisions which have significant impact on the department's credibility, operations, and services
Ability to compose materials such as detailed reports, work-related manuals, publications of limited scope or impact, etc., and/or to make presentations outside the immediate work area
Ability to compute, analyze, and interpret numerical data for reporting purposes