BioSpace
Associate Director - Drug Product External Manufacturing - Technical Services
BioSpace, Indianapolis, Indiana, us, 46262
Associate Director - Drug Product External Manufacturing - Technical Services
The Associate Director will lead the technical service primary loop team responsible for providing technical oversight and ensuring compliance across external manufacturing operations, aligning with Lilly's Global Contract Manufacturing Standards.
Responsibilities Make & Supply Medicine
Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing processes.
Ensure capable and in control processes at contract manufacturers (CMs). Establish and maintain a robust control strategy for all manufacturing/packaging/distribution operations that meet Lilly standards.
Align critical parameter definitions with regulatory submission requirements.
Ensure each department and external partner operates in compliance with cGMPs and Lilly Functional Standards, and maintain inspection readiness.
Ensure quality of externally manufactured products through oversight, CAPAs, metrics, and monitoring systems.
Build relationships with CMs to align intents and objectives.
Validate process strategies, revisions, protocol approvals, validation plans, final reports, and master plans. Approve strategy documents and applicable protocols.
Implement change control, evaluating impacts on validated processes and compliance.
Evaluate deviations, root causes, corrective action plans to prevent recurrence.
Ensure timely completion of investigations.
Conduct process reviews (APR, ARs, OPVs) and verify timely completion of identified changes.
Maintain documentation such as Quality Agreements, Manufacturing Requirements Documents, and validation documents.
Build external relationships to benchmark best practices.
Oversee execution of the technical agenda with external partners in line with business plans, cGMPs, and internal standards.
Escalate risks to senior management in a timely manner.
Lead implementation and execution of activities aligned with emerging needs related to process improvement, control strategy, or new regulation.
New CMs
Contribute to the CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options.
Governance
Serve as a member of the Flow Team, Science Lead Team (LT), and Site Quality LT.
Support the functional Business Plan and participate in DPEM BP consolidation.
Establish effective networking with internal stakeholders and ensure alignment with central TS/MS and development.
Partner with the Joint Process Team (JPT) Leader, Quality Managers, and Secondary Loop to ensure TS/MS members complete actions/objectives.
People
Provide adequate staffing to meet the technical and functional agenda.
Lead performance management by overseeing development of employee PM plans and conducting interim/final reviews.
Coach, develop, and provide feedback to team members.
Support diversity in recruitment and development.
Lead recognition, merit pay, and promotion decisions.
Support technical talent assessment and succession planning.
Recruit and onboard new resources.
Encourage knowledge sharing and education within the team, with key internal partners, and external partners.
Develop and grow technical capabilities consistent with DPEM business needs.
Relationships
Engage all levels of personnel at contract manufacturers.
Collaborate with Lilly Affiliate personnel and senior Country and Area management.
Work with Lilly TS/MS, QA, Auditing groups, Laboratories at Lilly sites, as well as U.S. and European manufacturing sites.
Coordinate with Senior TS/MS management, product and technical leaders, development scientists, CMC PMs, and molecule stewards.
Basic Requirements
Bachelors Degree in Pharmacy, Chemistry, Engineering, or a similarly related field.
5+ years of experience in pharmaceutical manufacturing in technical services and/or quality.
Previous leadership experience.
Additional Preferences
Knowledge and ability to apply basic statistical tools.
Regulatory related experience.
Established technical, quality, and internal networks.
Prior experience supporting drug product parenteral manufacturing.
Thorough understanding of cGMPs and drug product manufacturing.
Strong communication skills, especially attention to detail in written procedures and protocol development.
High degree of technical curiosity and critical thinking.
High learning agility.
Strong leadership, interpersonal, and teamwork skills.
Use of data and science to support decisions.
Willingness to learn new technologies.
Capability to work in a virtual and complex environment.
Willingness to travel.
Appreciation for cultural diversity.
Other Information
Shift is days, but off hours may be necessary to support operations.
Travel up to 30%.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. Anticipated wage for this position is $123,000 - $180,400.
Benefits Lilly offers a comprehensive benefit program to eligible employees, including 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, leave of absence, and well-being benefits.
EEO Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a résumé for a position at Lilly, please complete the accommodation request form. Lilly is proud to be an EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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Responsibilities Make & Supply Medicine
Provide oversight to ensure reliable supply of medicines through effective and efficient manufacturing processes.
Ensure capable and in control processes at contract manufacturers (CMs). Establish and maintain a robust control strategy for all manufacturing/packaging/distribution operations that meet Lilly standards.
Align critical parameter definitions with regulatory submission requirements.
Ensure each department and external partner operates in compliance with cGMPs and Lilly Functional Standards, and maintain inspection readiness.
Ensure quality of externally manufactured products through oversight, CAPAs, metrics, and monitoring systems.
Build relationships with CMs to align intents and objectives.
Validate process strategies, revisions, protocol approvals, validation plans, final reports, and master plans. Approve strategy documents and applicable protocols.
Implement change control, evaluating impacts on validated processes and compliance.
Evaluate deviations, root causes, corrective action plans to prevent recurrence.
Ensure timely completion of investigations.
Conduct process reviews (APR, ARs, OPVs) and verify timely completion of identified changes.
Maintain documentation such as Quality Agreements, Manufacturing Requirements Documents, and validation documents.
Build external relationships to benchmark best practices.
Oversee execution of the technical agenda with external partners in line with business plans, cGMPs, and internal standards.
Escalate risks to senior management in a timely manner.
Lead implementation and execution of activities aligned with emerging needs related to process improvement, control strategy, or new regulation.
New CMs
Contribute to the CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options.
Governance
Serve as a member of the Flow Team, Science Lead Team (LT), and Site Quality LT.
Support the functional Business Plan and participate in DPEM BP consolidation.
Establish effective networking with internal stakeholders and ensure alignment with central TS/MS and development.
Partner with the Joint Process Team (JPT) Leader, Quality Managers, and Secondary Loop to ensure TS/MS members complete actions/objectives.
People
Provide adequate staffing to meet the technical and functional agenda.
Lead performance management by overseeing development of employee PM plans and conducting interim/final reviews.
Coach, develop, and provide feedback to team members.
Support diversity in recruitment and development.
Lead recognition, merit pay, and promotion decisions.
Support technical talent assessment and succession planning.
Recruit and onboard new resources.
Encourage knowledge sharing and education within the team, with key internal partners, and external partners.
Develop and grow technical capabilities consistent with DPEM business needs.
Relationships
Engage all levels of personnel at contract manufacturers.
Collaborate with Lilly Affiliate personnel and senior Country and Area management.
Work with Lilly TS/MS, QA, Auditing groups, Laboratories at Lilly sites, as well as U.S. and European manufacturing sites.
Coordinate with Senior TS/MS management, product and technical leaders, development scientists, CMC PMs, and molecule stewards.
Basic Requirements
Bachelors Degree in Pharmacy, Chemistry, Engineering, or a similarly related field.
5+ years of experience in pharmaceutical manufacturing in technical services and/or quality.
Previous leadership experience.
Additional Preferences
Knowledge and ability to apply basic statistical tools.
Regulatory related experience.
Established technical, quality, and internal networks.
Prior experience supporting drug product parenteral manufacturing.
Thorough understanding of cGMPs and drug product manufacturing.
Strong communication skills, especially attention to detail in written procedures and protocol development.
High degree of technical curiosity and critical thinking.
High learning agility.
Strong leadership, interpersonal, and teamwork skills.
Use of data and science to support decisions.
Willingness to learn new technologies.
Capability to work in a virtual and complex environment.
Willingness to travel.
Appreciation for cultural diversity.
Other Information
Shift is days, but off hours may be necessary to support operations.
Travel up to 30%.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. Anticipated wage for this position is $123,000 - $180,400.
Benefits Lilly offers a comprehensive benefit program to eligible employees, including 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible benefits, life insurance, leave of absence, and well-being benefits.
EEO Statement Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a résumé for a position at Lilly, please complete the accommodation request form. Lilly is proud to be an EEO employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
#J-18808-Ljbffr