TSMS Pilot Plant Manager

Elanco•Elwood, KS

1d•Onsite

About The Position

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: TSMS Pilot Plant Manager Your day-to-day will include: Responsible for optimization of new product processes within the Elwood, Kansas monoclonal antibody (mAb) pilot plant. Present finding of experiments with cross functional groups for advancement of product pipeline. Facilitate the transition of products to commercial scale production in collaboration with Operations and Primary TSMS teams. Collaborate with other functions (Quality, Engineering, IT, etc.) to trouble shoot processes and recommend data driven solutions. Pilot Plant Manager provides the necessary expertise to support and where appropriate lead optimization of bio‐pharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies. Identify and continuously apply best practices specifically in training, process changes and handling of discrepancy and investigation resolution. Recommend continuous improvement initiatives which positively impact cycle time, productivity, process robustness, gross margin and production capacity. Ensure that manufacturing and maintenance operations carried out within the pilot unit are in compliance with current procedures, safety/environmental rules, and Good Manufacturing Practices. Committed to knowledge sharing/transfer inside site manufacturing groups such as Technical R&D. Supervises 3 subordinates: TSMS Scientists.

Requirements

Education Requirement – Bachelor’s degree in Biotechnology, Pharmaceutical Technology, Microbiology, a related field, or a foreign equivalent
Relevant experience – 3 years of progressively responsible post-baccalaureate experience in job offered or any engineering related job titles.
Applicants must have 3 years of experience in the following: (1) biopharmaceutical production processes and technologies; (2) working in a cGMP standards regulated environment; (3) capital project design, development and execution; (4) tech transfer, scale up, and validation of biopharmaceutical processes; (5) SAP, JMP, Veeva Vault; (6) application of RCI, FMEA and QRM tools; and (7) USDA or EU GMP regulations for veterinary biologics.
10% domestic travel required for site visits, vendor visits, training and trade shows.

Responsibilities

Responsible for optimization of new product processes within the Elwood, Kansas monoclonal antibody (mAb) pilot plant.
Present finding of experiments with cross functional groups for advancement of product pipeline.
Facilitate the transition of products to commercial scale production in collaboration with Operations and Primary TSMS teams.
Collaborate with other functions (Quality, Engineering, IT, etc.) to trouble shoot processes and recommend data driven solutions.
Pilot Plant Manager provides the necessary expertise to support and where appropriate lead optimization of bio‐pharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies.
Identify and continuously apply best practices specifically in training, process changes and handling of discrepancy and investigation resolution.
Recommend continuous improvement initiatives which positively impact cycle time, productivity, process robustness, gross margin and production capacity.
Ensure that manufacturing and maintenance operations carried out within the pilot unit are in compliance with current procedures, safety/environmental rules, and Good Manufacturing Practices.
Committed to knowledge sharing/transfer inside site manufacturing groups such as Technical R&D.
Supervises 3 subordinates: TSMS Scientists.