Viral/Renogen Supervisor

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Functions, Duties, Tasks:

• Adhere to, and ensures Viral team adheres to the principles of “safety first, quality always”.
• Comply with safety requirements, cGMP, SOP, and manufacturing documentation including maintenance of training records.
• Ensures the product produced according to their approved Outline of Product/Product Dossiers and to cGMP guidelines to meet market demand for the Aqua products.
• Drive and model behaviours in alignment with company principles with a particular emphasis on speaking up for safety and quality.
• Provide leadership to Viral team by demonstrating knowledge, expertise and implementing process improvements.
• Routine shop floor presence ensuring that required standards are met in a timely manner. Ensure that aseptic best practices are embedded within the team through all stages of manufacturing.
• Facility owner with ownership of all activities occurring in the Viral/Renogen areas, representative for the cross functional team for the Viral/Renogen areas.
• Manage and track adherence to production planning, scheduling, and team shift cover plan including short term absences.
• Manage and track Viral team training including sterile gowning and aseptic qualifications. Ensure operations is completed by trained and competent people.
• Equipment owner for Viral/Renogen equipment: ensure production equipment remain in an appropriate state of maintenance, calibration, and validation. Collaborate with relevant support groups to ensure compliance is maintained.
• Review and ensure batch documentation and batch records are completed accurately and in a timely manner according to the Outline of Production. Feedback will be provided to technicians to drive standards.
• Ensure timely completion of SAP related items including material consumption in production.
• Write and review batch records, SOPs, qualification documents for viral/Renogen operations.
• Document and own operational events, investigations, change controls, CAPAs, tasks, etc. in Veeva using structured root cause analysis tools as required to address issues and implement small operational changes.
• Review and provide input to documents for key capital projects and technical projects.
• Escalate significant issues and potential solutions to Process Team leader.
• Liaises with other Process Team members (engineering, TS/MS, quality, supply chain) as necessary to adhere to schedule and solve issues.
• Update daily huddle board and routine meetings (e.g. Supply chain, Quality) with assigned data prior to meetings. Facilitate Viral team and cross functional team huddles.
• Coach, mentor and complete performance management for Viral team members via routine 1:1’s to drive accountability versus essential wins and ensure development discussions are held.
• Other duties as required.

Minimum Qualifications (education, experience and/or training, required certifications):

• Must have a bachelor’s degree in a life science (e.g., Biochemistry, biotechnology, Biology). 
• 3-5 years of experience in the GMP bio manufacturing industry, including sterile manufacturing.
• Previous Supervisory experience is preferred.
• Thorough technical understanding of quality systems and regulatory requirements.
• Experience performing investigations and writing deviations.
• Experience in completing production documentation (i.e. deviations, SOPs, CAPAs, etc.).
• Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point). SAP and experience in Unicorn software is required.
• Excellent interpersonal skills, both communications and written.

Other Information:

• Role will be available for contact 12 hours a day 7 days a week for emergency situations.
• Must be able to read, write, understand, and comply with appropriate standard operating procedures.

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