This job is archived
(Archived) Director – Biological Drug Product Manufacturing
Job Description
Position Summary
Lead, manage and directly support specific manufacturing functions related to Lincoln Operations Biological Manufacturing. Direct the manufacturing of biological assembly, filling, lyophilization, capping and related manufacturing support to ensure production of therapeutic, safe, pure, and high-quality vaccines.
Position Responsibilities
- Plans and directs manufacturing resources to produce vaccines in accordance with GMS requirements and approved budgets.
- Plans and implements long range manufacturing plans, policies and procedures, consistent with strategic goals of the company.
- Develops and reviews operational objectives with all reporting managers. Ensures objectives and goals are clearly understood by all managers/supervisors and biological manufacturing organization.
- Ensures all products produced meet company quality standards. Also, ensures that the facility is operated in conformance with current APHIS Regulations (USDA), European cGMP, US FDA cGMP, Zoetis Quality System Policies (ZQS), and Zoetis SOP’s.
- Ensures leadership and clear, concise communication inside and outside the division or departments within the company. Directs the development and training of personnel to enhance effectiveness, coverage, production efficiency, morale, and teamwork.
- Directs the development and implementation of new and innovative manufacturing processes to improve safety, quality, cost, or supply.
- Accountable for pilot scale-up and manufacturing feasibility efforts for new products and improved processes.
- Interfaces with Global Manufacturing Technology (GMT) and Quality Operations (QO) for the transfer of new products to Manufacturing.
- Ensures facilities are operated in a safe, environmentally acceptable manner, and ensures all colleagues are properly trained to work in a safe manner.
- Proposes strategic initiatives to sustain a high performing organization including succession planning and development of colleagues.
Resources Managed
Financial Accountability
- Expense Budget: $9MM
- Capital Budget: $20MM
Supervision
Responsible for supervision of 75+ colleagues, in a multi-discipline, 24/7 operation.
Directly Supervises 5 – 8 colleagues
Education and Experience
B.S. / B.A.in Life Sciences or Engineering. Minimum of 10 years’ experience, five years leading a large manufacturing, engineering, or quality organization with demonstrated ability to develop and achieve long range/operational plans, effectively resolve complex technical issues in a timely manner, prepare and achieve budgets and financial forecasts. Prior experience managing in a biological and/or pharmaceutical manufacturing environment, with increasing levels of leadership responsibility.
Preferred Qualifications:
MBA or Master’s Degree in Microbiology, Immunology, Virology or other relevant advanced technical degree.
Minimum of three years leading a biological manufacturing operation (including aseptic manufacturing
and support systems). Preference given to applicants with vaccine experience
Technical Skills and Competencies Required
Demonstrated creativity and proven capability to effectively lead and develop others,
optimize team and organizational performance, execute strategic and operational plans, lead and
manage change, deal with ambiguity, analyze complex issues resulting in appropriate & timely
decisions, and promote innovation. Strong commitment to Product Quality, Customer Supply and
Operational Excellence. Strong written and verbal communication skills. Demonstrated ability to lead,
motivate and develop diverse groups to meet network, site and departmental objectives. Demonstrated
commitment to the Zoetis Cor Beliefs and leadership competencies. Demonstrated ability to interact
positively with senior management and related support groups (i.e. Global Manufacturing & Supply (GMS), Supply Chain Management (SCM), Veterinary Medicine Research & Development (VMRD), Human Resources (HR), Quality Operations (QO), etc.) as well as international regulatory authorities (including FDA, USDA, VMD, EPA, OSHA).
Preferred Qualifications:
Prior experience managing a large multi-shift operation (50+), with responsibility for directing a significant number of colleagues. Successful experience and application of LEAN and Six Sigma Operational Excellence tools.
Physical Position Requirements
- This position requires sitting, standing, and walking with occasional overtime/weekend work.
- Must wear appropriate gowning and PPE (Personal Protective Equipment) in manufacturing/production areas.
- The work conditions for the position are greater than 50% stationary with periodic standing and walking through out the workday(s).
- The colleague(s) may be required to travel and or work greater than 40 hours per week, including weekends and holidays to support the business.