Associate Director - Drug Product External Manufacturing - Technical Services

Role Summary

Associate Director - Drug Product External Manufacturing - Technical Services

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.

Responsibilities

• Lead the technical service primary loop team responsible to provide technical oversight of the technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards.
• Accountable for technical excellence and compliance while meeting deliverables for day to day operation on making and supply medicines and new product commercialization.
• Ensure all products are manufactured according to a validated process, following the approved control strategy and maintaining in a validated state during the product cycle.

Make & Supply Medicine

• Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing process.
• Ensure capable and in control processes at contract manufacturers; establish and maintain robust control strategy for manufacturing/packaging/distribution operations that meet Lilly standards.
• Define processes and critical parameters in alignment with regulatory submission.
• Ensure compliance with cGMPs, regulatory commitments and Lilly Functional Standards; maintain inspection readiness.
• Ensure quality of externally manufactured products through oversight, CAPAs, metrics and monitoring systems.
• Build relationships with contract manufacturers to align intents and objectives.
• Validation: define strategies, revisions, protocol approvals, validation plans, final reports and master plan; approve strategy documents and protocols.
• Change Control: evaluate impacts of proposed changes to validated processes and regulatory commitments.
• Deviations: evaluate impact on product and process; identify root causes and implement corrective actions to prevent recurrence.
• Ensure investigations are completed timely and appropriately.
• APR, ARs and OPVs: ensure process reviews and changes are completed timely and in compliance.
• Ensure External Manufacturing documentation (Quality Agreements, Manufacturing Requirements Document, validation documents) in place and compliant.
• Build external relationships to create benchmark opportunities and identify best practices.
• Oversee execution of the technical agenda with external partners in line with BP, cGMPs and internal standards.
• Escalate risks to Sr. Management in a timely fashion (supply, manufacturing issues, major deviations, safety, cybersecurity).
• Lead implementation of activities aligned with process improvement, control strategy or new regulation; incorporate needs into the CMs technical agenda.

New CMs

• Contribute to CM selection by assessing capabilities of external companies and providing functional recommendations to sourcing options.

Governance

• Be a member of the Flow Team and Science Lead Team, Site Quality LT.
• Support the functional Business plan and participate in the DPEM BP consolidation; ensure BP implementation within targets.
• Establish networking with internal stakeholders and align with central TS/MS and development.
• Partner with JPT Leader, Quality Managers and Secondary Loop to ensure TS/MS actions/objectives are completed.

People

• Provide staffing to meet technical and functional agendas.
• Lead the performance management process; oversee development of PM plans and conduct reviews.
• Coach and develop team members; provide feedback.
• Support diversity in recruiting and development; lead recognition, merit pay, and promotion decisions.
• Support technical talent assessment and succession planning; recruit and onboard new resources.
• Encourage knowledge sharing within team and with internal and external partners.
• Develop and grow technical ability to align with DPEM business needs for the supported Platform.

Relationships

• Contract manufacturers‚Äô personnel at all levels; Lilly Affiliate personnel and senior management; TS/MS, QA, Auditing groups; laboratories at Lilly sites; US and European manufacturing sites; product and technical leaders and development scientists.

Qualifications

• Required: Bachelor's Degree in Pharmacy, Chemistry, Engineering, or related fields.
• Required: 5+ years‚Äô experience in pharmaceutical manufacturing in technical services and/or quality.
• Required: Previous leadership experience.

Skills

• Knowledge of cGMPs and drug product manufacturing.
• Strong communication, attention to detail in procedures and protocol development.
• Technical curiosity, critical thinking, learning agility.
• Leadership, interpersonal and teamwork skills; ability to work in a team environment.
• Data-driven decision making; ability to work with external partnerships.
• Willingness to learn new technologies; ability to work in virtual/complex environments.
• Willingness to travel.

Education

• Bachelors Degree in Pharmacy, Chemistry, Engineering, or similarly related fields.