Manager - Manufacturing API

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.  

Your Responsibilities:  

• Sets and shapes cultural standard for safety and quality driving compliance (cGMP, SOPs, manufacturing documentation) and a “safety first quality always” mindset.

• Leads the cross functional Process Team through technical and operational excellence principles to achieve site performance, compliance, and technical objectives.

• Engages in documentation process for review, approval, authorship, in systems for change/deviation management, personnel performance, and standard production execution.

• Manages and owns business processes for financial scorecards, safety performance, personnel performance, production and maintenance coordination, etc.

• Actively engages in personnel development, organizational development, and capacity and capability modeling for staffing

What You Need to Succeed (minimum qualifications): 

• Education: High School Diploma or GED

• Experience: 5 years’ experience in a regulated, commercial manufacturing environment, including 2 years demonstrating successful leadership and/or supervisory experience.

• Experience with cGMP standards.
• Experienced in preparation and execution of production documents (batch records, SOPs, deviations, CAPAs, change controls). 

What will give you a competitive edge (preferred qualifications): 

• Bachelor’s degree in a biomanufacturing related discipline (eg. biology, chemistry, engineering, etc.)
• Experience in monoclonal antibody, vaccine and/or recombinant protein manufacturing and/or 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 problem-solving skills, and experience performing / leading root cause investigations.
• Demonstrated success operating within a matrixed organization.
• Excellent interpersonal, written, and verbal communication skills (English).
• Strong mentoring and coaching skills.
• Lean Manufacturing or Six Sigma experience.
• Experience with SAP production execution.

Additional Information:  

• Location: Elwood, KS (Onsite). Relocation provided for qualified candidates.
• Shift: Role adheres to standard site day shift, but will be available to address urgent notifications 24hr/7d that may impact production operations
• Must be able to wear appropriate gowning and personal protective equipment (PPE) in production and manufacturing support areas.
• Travel: Minimal < 5%.

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!  

Elanco Benefits and Perks: 

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: 

• Multiple relocation packages 

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) 

• 8-week parental leave 

• 9 Employee Resource Groups 

• Annual bonus offering 

• Flexible work arrangements 

• Up to 6% 401K matching