Bio Manufacturing Scientist - Tech Services

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.

Position Description: The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing technical and scientific support for commercial operations at the Charlottetown, PEI manufacturing facility. The position is a subject matter expert with respect to vaccine production and manufacturing 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 overseeing, planning and delivery of technical projects.

Functions, Duties, Tasks:

• Serve as a process capability specialist utilizing statistical modeling to advance site capabilities.
• Participate in site investigations; enhancing the site technical knowledge; understanding and problem solving.
• Participate in the manufacturability review process.
• Participate in the Process Quality Review.
• Partner with R&D to enable commercialization of new products.
• Ensure that the right technical capability (TS/MS) and control strategies are in place.
• Partnership with R&D to execute scale up, registration and validation activities.
• Conceive of and lead continuous improvement initiatives through Life Cycle Management.
• Lead technical transfer operations:
  • Serving as a subject matter expert (SME) for site specific projects.
  • Ensuring that the transfers are in accordance with the cGMP and respond to the requirements for the dossier submission.
  • Drive the execution of tech transfer to ensure that they are accomplished on time, with robust manufacturing control strategies implemented PEI’s site.
  • Other duties as required.

Minimum Qualifications

• Master’s degree in Bioengineering, Bio/Pharmaceutical Technology, Chemistry, Microbiology, Engineering or equivalent scientific degree.
• 3+ years’ bio manufacturing experience
• Experience with a variety of technologies: vaccine technologies, recombinant protein platform, protein-based, purification, fermentation technology, lyophilization and/or sterile filling technology.
• Experience in problem solving and tools available.
• Experience in statistical analysis.
• Ability to influence people.
• Ability to build collaborative relationship with areas inside and outside Elanco, to build the network.
• Familiarity with global Regulatory Standards (EU GMP, USDA, CFIA).
• Experience in lean approach/principles.

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