Director, Technical Services Manufacturing Science

Elanco•Elwood, KS

22h•Onsite

About The Position

The Director, Technical Services Manufacturing Science (TSMS) is responsible for technical aspects of product and process performance at Elanco’s monoclonal antibody manufacturing facility in Elwood, Kansas. The role maintains and improves scientific oversight of manufacturing processes and technical changes and ensures product stewardship across process units and functions. Working directly with Manufacturing Operations and functions such as Quality, Engineering, and IT, the Director provides direction and expertise to maintain robust, validated manufacturing and packaging processes throughout the product lifecycle. The Director supports and leads process optimization using sound scientific reasoning and integrated process and technology strategies, applies best practices in training and process changes, and oversees discrepancy and investigation resolution. The role also coaches and develops TSMS team members and leads the function’s technical, quality, safety, financial, and talent-development activities.

Requirements

Bachelor’s degree in a biomanufacturing-related discipline, such as biology, chemistry, or engineering.
10 years of related work experience.
At least 5 years of experience in a technical management position.
At least 5 years of experience in (bio)pharmaceutical formulation, process development, or manufacturing technology.
Ability to lead and develop a team.
Fundamental understanding of (bio)pharmaceutical analytical testing.
Demonstrated understanding of quality culture, cGMP standards, and regulatory regulations.

Nice To Haves

MSc in Science, Pharmacy, Mechanical or Chemical Engineering, or Pharmaceutical Technology.
Proficiency in applied statistics or Lean Six Sigma methodologies.
Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
Demonstrated problem-solving experience, including identifying and understanding issues, problems, and opportunities.
Ability to network and build strong collaborative relationships across functions and geographies.
Excellent verbal and written communication skills in English.
Strong mentoring and coaching skills.

Responsibilities

Ensure technical competencies and knowledge are in place for the site’s monoclonal antibody processes, raw materials, sterile processes, and primary packaging components, as applicable.
Advise, guide, and coach TSMS associates in routine operational support, solution development, improvement, problem-solving, decision-making, communication, and written reporting.
Ensure adherence to cGMP requirements, guidelines, SOPs, local laws, the Elanco Red Book, company policies, and Health, Safety & Environment requirements.
Ensure mAb products and processes remain in control and capable, with appropriate control strategies that meet Elanco Global Quality and Manufacturing standards and maintain continuity of supply.
Develop and lead continuous improvement initiatives that improve cycle time, productivity, process robustness, gross margin, and production capacity.
Partner with Commercialization, R&D, Manufacturing, Engineering, Supply Chain, and Quality to transfer new mAb products on time with appropriate process and product control strategies.
Lead cross-functional teams conducting root-cause investigations.
Promote knowledge sharing and transfer among site manufacturing groups and Technical R&D.
Drive the product control strategy, including developing and applying KPIs for CPP/CQA trending, key process data reporting, and early identification of changing quality trends and issues.
Develop TSMS expense and capital planning budgets with the Sr. Director, Commercialization and the site leadership team, and ensure delivery meets or exceeds financial commitments.
Design and deliver TSMS-owned technical training programs and appropriate technical onboarding to ensure associate competency.
Monitor technological, regulatory, and industry developments, including through internal and external benchmarking.
Build and grow the TSMS function by recruiting and developing talent aligned with site strategic needs.
Maintain a safe work environment and establish a strong safety culture in compliance with Elanco standards and applicable government requirements.
Ensure TSMS staff comply with applicable Quality and cGMP requirements; be accountable for the function’s quality performance and delivery against site quality targets.
Develop and review operational objectives with direct reports, establish talent development plans, and conduct staff performance-management reviews.
Perform other duties as required.