Sterility Assurance Advisor – Technical Services/manufacturing Science (ts/ms)

Sterility Assurance Steward– Technical Services / Manufacturing Science (TS/MS)

Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a Fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated professionals who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide. We are dedicated to producing medicine with an unwavering commitment to safety and a relentless focus on quality.

The Sterility Assurance Steward– Technical Services / Manufacturing Science (TS/MS) is a role that encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle.

A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the Alzey site.

Key Objectives / Deliverables:

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
• Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
• Lead and / or participate in complex projects associated with sterility assurance programs.
• Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)
• Lead major deviations for root cause analysis related to sterility assurance programs.
• Remain abreast of external regulatory requirements associated with sterility assurance programs.
• Influence revision to corporate guidance associated with sterility assurance programs.
• Identify and implement continuous improvement for sterility assurance programs.
• Provide design input related to new processes (e.g., facilities, equipment, etc.) for Alzey.
• Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections.
• Assists with writing of regulatory submissions for sterility assurance programs.
• Create, review, approve and provide sterility assurance training for new hires and personnel from other sites.
• Provide technical mentorship to a less senior scientists within the TS/MS organization.
• Provide technical mentorship to a less senior cross-functional personnel within Alzey.
• Provide technical consultation across the Parenteral Network.

Minimum Requirements:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline
• In depth knowledge and understanding of GMPs and internal standards
• In depth knowledge of parenteral processing
• In depth knowledge of microbiology and sterility assurance
• In depth knowledge of risk management and the understanding / ability to use risk assessment tools
• Ability to analyze complex data and solve problems
• Strong technical writing and presentation skills
• Teamwork / interpersonal skills ability to effectively influence

Additional Preferences:

• Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
• Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.)

Education Requirements:

• Minimum 7 years' experience in the biopharmaceutical industry
• Advanced Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred
• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

Other Information:

• Please apply with Resumé in English
• Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
• Position will be based out of Alzey site with ability to travel to Indianapolis and other global Lilly sites as required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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