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

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Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.

The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role 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, Container Closure 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 RTP 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 RTP.

• 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 RTP.

• 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

• Minimum 10 years' experience in the biopharmaceutical industry

Additional Preferences:

• Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred

• 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.)

• 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

• Knowledge of microbiology and sterility assurance

Other Information:

• 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 RTP site with ability to travel to Indianapolis and other global Lilly sites as required

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