Manager - Manufacturing API

At Elanco (NYCE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Position Description: The Manager, Manufacturing acts as a Process Team Leader, and is responsible for leading day-to-day manufacturing operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. Reporting to the Director, Manufacturing, this position will manage the operations team, as well as have functional responsibility for leadership of the cross-functional mAb bioprocessing Process Team. The Manager, Manufacturing will drive production activities to a defined production schedule, following cGMP and regulatory guidelines, and reinforcing a strong “Safety First Quality Always” mindset. Functions, Duties, Tasks: Drive execution of production activities in compliance with company quality and safety standards, enforcing a ”safety first, quality always” mindset. Ensures production operations comply with safety requirements, cGMP, SOPs, and manufacturing documentation. Drive & model behaviors in alignment with company principles with a particular emphasis on speaking up for safety & quality. Provides technical and operational leadership to a cross-functional Process Team. Demonstrates Operational Excellence leadership and adherence to standard calendar work, including daily Huddles and shop-floor Gemba’s. Facilitates the daily huddle meeting, ensures cross-functional attendance, metrics delivery and action completion / accountability. Provides routine update to site control tower on key issues, mitigations, and schedule adherence. Facilitates cross-functional team meetings, including routine balanced scorecard review, continuous improvement project prioritization and improvement delivery accountability. Works with cross-functional Process Team to deliver one schedule including all production and maintenance activities. Works with Supply Chain to manage raw material issues / BOM improvements. Accountable for quality performance of the function and delivery against site quality targets. Leads significant deviation investigations using structured root cause analysis tools - documents investigations and outcomes in the quality management system. Reviews revisions to batch records, SOPs, qualification documents for the production operations. Implements small operational changes including writing change controls as required, ensuring compliance to local and global procedures. Provides input to URS documents for key capital projects. Acts as production lead for CAPEX projects ensuring the operational readiness plan is defined and completed on time. Escalates significant issues and potential solutions to the Director, Manufacturing. Build and grow the Manufacturing function, recruiting and developing talent in alignment with the site’s strategic needs. Develop and review operational objectives with direct reports, establish appropriate talent development plans, and conduct staff performance management reviews as required. Ensure all Manufacturing staff are properly trained for their roles and operate in adherence with corporate and regulatory standards. Minimum Qualification: 5 years’ experience in a regulated, commercial manufacturing environment, including 2 years demonstrating successful leadership and/or supervisory experience. Understanding of cGMP standards for manufacture of veterinary biologics. Demonstrated success operating within a matrixed organization. Experienced in preparation and execution of production documents (batch records, SOPs, deviations, CAPAs, change controls). Strong problem-solving skills, and experience performing / leading root cause investigations. Excellent interpersonal, written, and verbal communication skills (English). Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas. Additional Preferences: Bachelor’s degree in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.) Experience in monoclonal antibody, vaccine and/or recombinant protein manufacturing. Experience in biological manufacturing including cell culture, purification (separation technologies, chromatography, tangential flow filtration), viral inactivation and cleaning / sterilization processes in a biological environment. Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics. Strong mentoring and coaching skills. Lean Manufacturing or Six Sigma experience. Experience with SAP production execution. Other Information: Location: Elwood, KS (Onsite). Relocation provided for qualified candidates. Shift: Role will be available for contact 12 hours a day 7 days a week to address any urgent needs that may impact production operations. Travel: Minimal < 5%. 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 Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.