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Responsibilities

DPEM TS/MS Sterility Assurance/Micro Secondary Loop Subject Matter Expert provides oversight, assistance, and guidance to CMs and other DPEM members for parenteral quality assurance activities. Secondary loop is responsible for improving technical capabilities, supporting operational control strategy, resolution of the most critical/complex deviations and leading complex projects.

This role provides guidance to primary loop with respect to daily Contract Manufacturer (CM) micro and sterility assurance activities and provides oversight of these activities in collaboration with the QA Sterility Assurance SME, to ensure they are executed in accordance with company quality policies and procedures and comply with current Good Manufacturing Practice (cGMP) guidelines and regulations. This role is responsible for providing technical oversight and formal mentoring to primary loop TS/MS representatives.

Key Objectives/Deliverables:

Oversight of Parenteral Quality Management System and Operations:

• Subject Matter Expert and Technical Mentor for Production and Sterility Assurance quality system elements. Provide feedback, coaching, mentoring to the personnel on the interpretation of corporate and regulatory GMP requirements (GQS) related to sterility assurance and micro topics.

• Through liaison with DPEM Flow Team and TS/MS and Quality Joint Process Team (JPT) members, monitors the performance at contract manufacturers and identify concerns as relevant. Escalate concerns in a timely manner with recommendations.

• 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 proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.

• Provide technical guidance to the Process Team for sterility assurance programs and for root cause investigations related to sterility assurance programs.

• Responsible for Sterility Assurance review at CM in collaboration with the QA Sterility Assurance SME.

• Ensure continuous regulatory and technology oversight.

• Assess capabilities of existing CMs to produce additional products, particularly about Sterility Assurance.

• Lead or support risk assessments related to sterility assurance programs.

• Create, execute, review, and/or approve technical documents related to sterility assurance programs.

• Create, execute, and/or evaluate change controls related to sterility assurance programs.

• Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends.

• Develop internal network contacts (TS/MS and QA) for supporting investigations, keeping aware of emerging topics in Lilly and understanding the impact on Contract Manufacturing oversight.

• Develop strategies for ensuring that Contract Manufacturers are aware of emerging industry trends and influencing their plans for meeting the standards.

• Improve DPEM technical capabilities by providing guidance to primary loop representatives.

• Define the appropriate technical standards for CMs, especially relating to sterility assurance aspects and cooperate when appropriate with internal experts in the preparation of Lilly standards.

• Review new and revised standards (Global Quality Standards and Common Quality Practices) related to GQS400. Complete related assessments and determine impact on DPEM processes and procedures. Work with DPEM management and Quality Systems owners to develop and create appropriate action plan to ensure alignment with required standards.

• Participate in the creation and review of local procedures related to sterility assurance activities.

• Determine training needs for DPEM team members as appropriate.

• In collaboration with QA Sterility Assurance SME, prepare and present GQS400 review at Site Quality Lead Team at least once a year in accordance with GQS 101 including global standards changes and assessment.

• Track and monitor sterility assurance/micro metrics looking for potential trends across different CMs manufacturing the same product or using same technologies.

Contract Manufacturing support (as required):

• Provide support to primary loop for deviations, change controls, adverse microbiological data trends, CAPA identification, validation and qualification dossiers, technical report writing, as needed.

• Help and give the CM guidance on resolution of technical /quality issues, in conjunction with “Technical Services / Manufacturing Science” (TSMS).

• Review/approve major deviations and change controls, technical reports, and any other technical document, as needed.

• Lead critical/complex deviations (as required).

• Keep DPEM management informed of issues/ progress, including internal notification to management of quality issues, when required.

• Provide input to monthly reports to senior management.

• As required, participate in performance reviews i.e. dashboard, annual product review (APR), PQE, OPV, profile and portfolio review.

• Provide sterility assurance support for new products / new implementation of new CMs.

• Participate in due diligence assessments of prospective new external partners, as required. Assess new CMs, particularly with regard to their level of implementation of Lilly standards and recommend their suitability as a future partner.

• Define, in conjunction with product TSMS, the qualification protocols prior to the start of manufacturing operations.

• Define, in conjunction with product TSMS, the validation protocols, and approve them prior to the start of manufacturing operations.

Continuous Improvement:

• Provide technical leadership and project management oversight to drive improvement to DPEM and CM Sterility Assurance Quality system.

• Support CMs efforts to maintain and improve their quality systems.

• Participate on Lean initiatives to help improve productivity.

Relationships:

• All functions at the contract manufacturers from senior management to shop floor personnel.

• Lilly TSMS, QA, US and European Parenteral manufacturing sites

• Internal and External parenteral networks, including the Sterility Assurance HUB.

• Global Quality Auditing and Compliance group.

Basic Qualifications

• Bachelor’s degree in Microbiology, Pharmacy, or Chemistry with at least 8 years of experience in technical and quality functions within a parenteral manufacturing plant, ideally both in parenteral products and dry products.

• Willingness to travel

OR

• PhD in Microbiology with at least 2 years of experience in technical and quality functions within a parenteral manufacturing plant, ideally both in parenteral products and dry products.

• Willingness to travel

Additional Skills/ Preferences

• Established technical, quality, and internal/external networks.

• Experience with Lilly systems (Trackwise, QDocs…etc.).

• Understanding of micro/sterility testing.

• Strong Coaching/Mentoring skills.

• Appreciation for cultural diversity.

• Strong written and communication skills, especially attention to detail.

• Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.

• Ability to organize, prioritize, multi-task and influence others.

• Strong decision making and problem-solving skills.

• Willingness to learn new technologies.

• Capability to work in a virtual and complex environment.

• Technical understanding of GMPs and the Global Quality Standards.

Additional Information

• Shift is days, but off hours may be necessary to support operations.

• Travel is possible, up to 30 %.

• Business title may vary depending leveling.

• This is an onsite position that requires onsite presence the majority of the time (not remote).

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