Job was saved successfully.
Job was removed from Saved Jobs.

Scientist, Technical Service Manufacturing Science

Elanco

Last Updated: 1/28/23

Job Description

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.

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 as well as design and delivery of local and major capital 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 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.
  • 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, risk assessments, investigations, technical studies, protocols, and reports.
  • 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.

Project Delivery

  • Provide technical support to project teams, including delivery of local and major capital projects.
  • Participate in design, development, execution, commissioning, qualification, and validation activities for major projects. This includes, but is not limited to; definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, support of commissioning and qualification programs, design and execution of cleaning validation / process validation activities, etc.
  • Act as product and process subject matter expert in project teams and committees.
  • Create, review and revise relevant documentation including user requirement specifications, PFDs, safety and environmental assessments, commissioning and qualification documents, SOPs, validation documents, etc
  • Prepare change management plans and complete corresponding action items.
  • Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and likelihood of technical success.

Basic 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.
  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

  • Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.

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 in capital project design, development, and execution.
  • 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:

  • Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
  • Minimal travel requirements < 10%.
  • Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

  • Completion of Post Offer Exam (POE), Completion of Work Simulation (SIM) or Completion of Administrative Skills Testing if applicable.

#LI-JH1

Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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



Company Details

Greenfield, Indiana, United States
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...