Fill/Finish Scientist- Technical Services Manufacturing Scientist

Your Role: Fill/Finish Scientist- Technical Services Manufacturing Scientist

The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial operations, specifically for primary and secondary packaging, at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, aseptic fill/finish, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects, relating to primary and secondary packaging.

Your Responsibilities:  Technical Ownership of Product and Process

• Provide technical and on-floor support for commercialization, manufacture, media filling simulation, and life-cycle management of monoclonal antibody products, provide on-floor support to the Manufacturing fill/finish teams regarding product and process troubleshooting, and provide support in resolution of technical and compliance issues. Prepare technical assessments and responses for site quality, internal inspection bodies, and relevant Health Authorities.

• Work with R&D, Manufacturing, and Quality teams in execution of technical / development studies, validation activities and technical transfer programs for fill/finish and participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.

• Ensure issues are identified and captured in the relevant quality management system and that proper root cause analysis is performed with appropriate corrective and preventative actions

  assigned and ensure process operations comply with all health, safety, and environmental policies and procedures. Participate in Hazard and Operability (Haz-ops) studies and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment.

• Act as product and aspectic filling process subject matter expert in Process Teams, project teams and committees and use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.

• Develop / execute projects to address process performance issues and deliver improvement opportunities and establish and deliver training / coaching on core processes and technologies to operational teams.

• Author and provide critical review of technical documents including, but not limited to, batch records, SOPs, PFDs, risk assessments, investigations, technical studies, protocols, and reports and demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures. Exemplify “Safety First and Quality Always” mind-set.

What You Need to Succeed (minimum qualifications): 

• Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.

• Experience: 3+ years’ experience in the Biotech / Pharmaceutical industry.

• Detailed understanding of biopharmaceutical fill/finish production processes and technologies, working knowledge of cGMP standards and experience working in a regulated environment, proven analytical thinking and problem-solving skills, demonstrated success operating in cross-functional teams self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.

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

• MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.

• 5+ years’ experience in the Biotech / Pharmaceutical industry.

• Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes, with emphasis in primary and secondary packaging operations.

• Experience in tech transfer, aseptic media filling simulation, qualification, and validation of biopharmaceutical fill/finish line.

• Experience with SAP, JMP, Veeva Vault.

• Excellent technical writing skills.

• Understanding and application of RCI, FMEA and QRM tools.

• Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

Additional Information:  

• Travel: Minimal travel requirements < 10%

• Day shift position. Weekend (and potential evening work) on a rotation to provide process support to ongoing operations.

• Location: Elwood, Kansas

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