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The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing technical support for commercial operations 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, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects.
Functions, Duties, Tasks:
Technical Ownership of Product and Process
Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products.
Work with R&D, Manufacturing, and Quality teams in execution of technical / development studies, validation activities and technical transfer programs.
Provide on-floor support to the Manufacturing teams regarding product and process troubleshooting. 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.
Act as product and process subject matter expert in Process Teams, project teams and committees.
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 on improvement opportunities.
Provide support in resolution of technical and compliance issues. Prepare technical assessments and responses for site quality, internal inspection bodies, and relevant Health Authorities.
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.
Establish and deliver training / coaching on core processes and technologies to operational teams.
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.
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.
Attend and complete necessary training as required in order to stay current with industry standards.
Other duties as required.
Minimum Qualifications:
Bachelor’s degree (or equivalent) in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.
3+ years’ experience in the Biotech / Pharmaceutical industry.
Detailed understanding of biopharmaceutical 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.
Strong verbal, written and interpersonal communication skills.
Strong organizational and computer skills.
Additional Preferences:
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.
Experience in tech transfer, scale up, and validation of biopharmaceutical processes.
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.
Other Information:
Location: Elwood, KS (Relocation can be provided for qualified candidates)
Shift: Day shift. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
Travel: Up to 10%.
Post offer Requirements: Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.
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
