Associate Vice President - Drug Product Development
Eli Lilly and Company
3 months ago
Remote friendly (Indianapolis, IN)
United States
$237,000 - $347,600 USD yearly
Operations
Position Summary
- The AVP provides technical leadership to multidisciplinary teams, scientists, and engineers involved in the development and commercialization of biopharmaceutical processes and products. Provides technical oversight/leads initiatives, evaluates and implements new capabilities/technologies, and delivers strategic technical direction internally and externally.
Responsibilities
- Provide technical leadership for development projects, collaborations, and component initiatives.
- Maintain deep knowledge of scientific/operational issues to support pipeline progression and resolve cross-functional problems.
- Guide platform development for clinical development and commercialization of bioproduct molecules for new products.
- Own the strategic technical agenda; set strategic direction across science/technology/business and ensure implementation to meet pipeline and organizational objectives.
- Serve as scientific advisor; monitor progress, ensure scientific rigor, and act as a technical resource when issues arise.
- Collaborate with technical leaders across divisions to align scientific expectations, objectives, and work processes.
- Communicate technical successes/failures to promote continuous learning and improvement.
- Advocate and help create strategic partnerships; serve on steering teams and provide oversight for partnerships/alliances.
- Represent CM&C in due diligence for in-licensing/out-licensing opportunities.
- Write and/or review technical documents (internal reports, external disclosures, regulatory documents).
- Foster compliance with quality, safety, confidentiality, and corporate integrity standards/policies.
- Provide technical consultations to Discovery, Regulatory, Quality, Medical, PK/PD, Toxicology, ADME, Clinical Pharmacology, and Manufacturing.
- Provide career development coaching, feedback, and assessment to scientists in BR&D and other organizations.
- Stay aware of regulatory requirements and ensure development strategies meet them.
- Engage with the external scientific community and stay current with relevant literature.
- Hold roles on external scientific advisory boards/expert committees/panels.
- Share and apply learning across the organization and external scientific community.
Basic Qualifications
- Ph.D. in chemistry, chemical engineering, analytical, biochemistry, biology, or pharmaceutical sciences, plus 10+ years of parenteral process and drug product development experience (or equivalent: Ph.D. plus 15–20 years in related parenteral biotech/biopharmaceutical experience).
- Experience with both early- and late-phase clinical programs.
- Experience preparing control strategies and regulatory submissions supporting clinical development.
Additional Preferences
- Knowledge of traditional and new modalities of parenteral drug product development; parenteral manufacturing/aseptic technologies; and drug product process development.
- Experience with technical development of oligos, protein, peptide, and gene therapies.
- Technical leadership in formulation and drug delivery.
- Experience collaborating with partner functions (including discovery) and drug product delivery/device to develop integrated, patient-focused solutions.
- Strong communication, interpersonal, and leadership skills; thorough understanding of development, manufacturing needs, and regulatory requirements to support project progression to registration and launch.
Benefits (explicitly stated)
- Company bonus (for eligible full-time equivalent employees; depends on company and individual performance).
- Comprehensive benefits: company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave benefits; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- The AVP provides technical leadership to multidisciplinary teams, scientists, and engineers involved in the development and commercialization of biopharmaceutical processes and products. Provides technical oversight/leads initiatives, evaluates and implements new capabilities/technologies, and delivers strategic technical direction internally and externally.
Responsibilities
- Provide technical leadership for development projects, collaborations, and component initiatives.
- Maintain deep knowledge of scientific/operational issues to support pipeline progression and resolve cross-functional problems.
- Guide platform development for clinical development and commercialization of bioproduct molecules for new products.
- Own the strategic technical agenda; set strategic direction across science/technology/business and ensure implementation to meet pipeline and organizational objectives.
- Serve as scientific advisor; monitor progress, ensure scientific rigor, and act as a technical resource when issues arise.
- Collaborate with technical leaders across divisions to align scientific expectations, objectives, and work processes.
- Communicate technical successes/failures to promote continuous learning and improvement.
- Advocate and help create strategic partnerships; serve on steering teams and provide oversight for partnerships/alliances.
- Represent CM&C in due diligence for in-licensing/out-licensing opportunities.
- Write and/or review technical documents (internal reports, external disclosures, regulatory documents).
- Foster compliance with quality, safety, confidentiality, and corporate integrity standards/policies.
- Provide technical consultations to Discovery, Regulatory, Quality, Medical, PK/PD, Toxicology, ADME, Clinical Pharmacology, and Manufacturing.
- Provide career development coaching, feedback, and assessment to scientists in BR&D and other organizations.
- Stay aware of regulatory requirements and ensure development strategies meet them.
- Engage with the external scientific community and stay current with relevant literature.
- Hold roles on external scientific advisory boards/expert committees/panels.
- Share and apply learning across the organization and external scientific community.
Basic Qualifications
- Ph.D. in chemistry, chemical engineering, analytical, biochemistry, biology, or pharmaceutical sciences, plus 10+ years of parenteral process and drug product development experience (or equivalent: Ph.D. plus 15–20 years in related parenteral biotech/biopharmaceutical experience).
- Experience with both early- and late-phase clinical programs.
- Experience preparing control strategies and regulatory submissions supporting clinical development.
Additional Preferences
- Knowledge of traditional and new modalities of parenteral drug product development; parenteral manufacturing/aseptic technologies; and drug product process development.
- Experience with technical development of oligos, protein, peptide, and gene therapies.
- Technical leadership in formulation and drug delivery.
- Experience collaborating with partner functions (including discovery) and drug product delivery/device to develop integrated, patient-focused solutions.
- Strong communication, interpersonal, and leadership skills; thorough understanding of development, manufacturing needs, and regulatory requirements to support project progression to registration and launch.
Benefits (explicitly stated)
- Company bonus (for eligible full-time equivalent employees; depends on company and individual performance).
- Comprehensive benefits: company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance/death benefits; time off/leave benefits; well-being benefits (EAP, fitness benefits, employee clubs/activities).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.