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Operations Vaccine Manufacturing Manager

52380
Operations Vaccine Manufacturing Manager
Winslow
Maine
United States
North America
Local
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
Provide leadership and oversight for autogenous and tissue culture production operations at the Winslow vaccine manufacturing site, integrating all functional requirements to ensure customer, quality, and safety requirements are met.

Key Objectives/Deliverables:

The Autogenous Manager provides leadership, oversight and direction to the autogenous and tissue culture manufacturing operations areas of the Winslow site.

Site Leader
  • Leadership to direct reports including employee development.
  • Strong partnership and communication with Operations, QA, QC, TS/MS, Regulatory, Supply Chain, Sales and Marketing and other support areas.
  • Proper documentation and use of HR processes.
  • Member of the Plant lead team
  • Participate in site reviews, strategic planning, and business planning
  • Drive a culture of Safety first - Quality always
  • Coaching, development, and feedback of direct reports
  • Benchmarking with other Elanco sites to learn and apply best practices
  • Site and community engagement
Autogenous Operations Manager
  • Ensure vaccine operations are conducted in compliance with regulatory and corporate requirements in a safe and consistent manner, in well-maintained and clean facilities according to documented instructions.
  • Deliver departmental results as required as part of metric reporting, business plan and annual site objectives.
  • Ensure compliance with quality systems, including proper documentation, change control, and incident or deviation investigation.
  • Ensure personnel conducting and supporting operations are capable and performing at high level.
  • Operational area shall conform to all SOP, policies, and regulations.
  • Foster a cross functional process improvement mindset
  • Foster safe operations and safety focused culture
  • Leadership towards Operational Excellence
  • Leadership and sponsorship of Autogenous Steering Team and Process Teams.
  • Technical service support, including root cause analysis, process improvements, and leading projects.
  • Liaison between autogenous manufacturing and the autogenous commercial team. Active member of the commercial Autogenous Steering Team.
  • Facilitate Project management and Change Management processes for capital improvements and maintenance activities
  • Usage of capacity planning and continuous improvement to ensure growth is maintained and productivity is achieved.
  • Leadership to direct and indirect reports to ensure alignment of all resources to deliver business needs.
  • Participation in audits and assessments, and successful implementation of operations related action plan
52380BR
  • Bachelor’s degree in Biology, Microbiology or other scientific or engineering field
  • 5+ Years of demonstrated leadership within a production environment, and understanding of production quality systems in a GMP or USDA regulated environment
  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
  • Strong leadership skills
  • Strong interpersonal/communication skill: verbal and written
  • Ability to lead through complex technical issues
  • Customer focus
  • Cross-functional networking and influencing ability
  • Scientific data collection and documentation skills
  • Efficient approach to trouble shooting/problem solving
  • Ability to prioritize and respond to changing priorities
  • Must be able to wear required PPE and be able to comply and follow all gowning requirements.
  • Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
  • Six Sigma experience
  • Experience in Autogenous
  • Position will require occasional travel (approximately 10%)
  • Position is located in Winslow, Maine
  • Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status