Sr. Scientist - Technical Services & Manufacturing Science, M&Q

Responsibilities

• Partner with Manufacturing, Development, and Quality teams to execute technical and development studies, investigations, validation activities, and technical transfer programs.
• Collaborate with cross-functional teams to identify risks, sources of variability, improvement opportunities, and value engineering opportunities to maximize project return and technical success.
• Apply scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes remain capable and in a state of control, and identify opportunities for process improvement.
• Participate in the design, development, execution, commissioning, qualification, and validation of major projects.
• Support project scope definition, development and analysis of design options, establishment of user requirements, equipment selection, and commissioning and qualification activities.
• Design and execute cleaning validation and process validation activities.
• Author and provide critical review of technical documentation, including batch records, SOPs, PFDs, risk assessments, investigations, technical studies, and commissioning and qualification protocols and reports.
• Support a strong safety, quality, compliance, and continuous improvement culture within the manufacturing organization.

Requirements

• Education: Bachelor’s degree or equivalent in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• Experience: 3+ years of experience in the Biotechnology or Pharmaceutical industry.
• Detailed understanding of biopharmaceutical production processes and technologies.
• Working knowledge of cGMP standards and experience working in a regulated environment.

Qualifications

• MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.
• 5+ years of experience in the Biotechnology or Pharmaceutical industry.
• Demonstrated experience with commercial monoclonal antibody or recombinant protein manufacturing processes.
• Experience in tech transfer, scale-up, and validation of biopharmaceutical processes.
• Experience with capital project design, development, validation, and execution.
• Strong scientific and statistical analysis capabilities.
• Experience identifying process variability, technical risks, and continuous improvement opportunities.

Benefits

Elanco offers a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose!

• Multiple relocation packages
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching