Sr Manager, Manufacturing Operations (PDS)
About the Job
Plans, manages, leads and controls the activities necessary to produce products that: meets quality specifications; complies with the regulatory and customer requirements; are produced at optimum production costs; and meets customer demands in a timely fashion. Ensures supervisory and operative staff are well trained.
Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
Manages staff ensuring that these groups are adequately trained, motivated, and developed, and that responsibility and accountability are assigned at the proper levels.
Ensures that all unit indicators support company’s objectives and that favorable results are being achieved or appropriate action is being taken, that all operations are performed in the most economical manner practical and that the department is in position to deliver new products or product extensions to the customer in minimal periods after approval.
Budgets and ensures that the division has adequate resources in facilities, equipment, and personnel to produce the customer demand. Establishes direction for the department by developing goals that support O&T and company goals and strategies.
Ensures that all operations are validated and fully comply with all Current Good Manufacturing Practices (cGMP’s). Responsible for area compliance in the face of internal, customer, and regulatory inspections.
Establishes/approves the technical requirements for production documentation including equipment and systems specifications, manufacturing formulas, POMS procedures, filling and packaging work orders, SOP’s, Environmental Procedures, PM’s, etc.
Uses input from Operations Planning, plans, schedules, and executes production workload to ensure product availability when demanded, while maintaining product inventory at its lowest level.
Works in a safe manner in order to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Reviews, proposes plans and makes recommendations for acquisition of new equipment and/or modification/expansion of the facility to enable the function of the department and growth of the PDS business.
Provides technical support to business development and actively participate in procuring new business.
Performs other duties as assigned.
Participates in establishing strategic plans and objectives, making final decisions on administrative or operational matters and ensuring effective achievement of objectives. Erroneous decisions will have a serious impact on the overall success of functional, divisional, or company operations.
Manages the coordination of the activities of a section or department with responsibility for results.
Share responsibilities with other MSsenior management; provides technical direction and leadership to staff in connection with current projects; within the team, authority to move staff to ensure projects run smoothly; can recommend role changes as necessary. Functions independently, with support from the Director - PDS.
Bachelor’s degree in pharmaceutical science or related technology is required.
Minimum of twelve years of previous drug development experience with emphasis on late stage development and transfer technology and at least five years in a significant management role is required. Experience in a large Pharma company in product development would be preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Proven interpersonal and communication skills (both oral and written), leadership ability, and organizational skills.Possesses a highly developed quality, regulatory, and production mindset including an appreciation for client service and the contract manufacturing industry. Strategic thinker and planner. Decisive. Coaching and staff development experience. Effective at networking.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.