BioSpace
Sr. Director – Technical Services & Manufacturing Sciences (TSMS) – Tech Transfe
BioSpace, Indianapolis, Indiana, us, 46262
Sr. Director – Technical Services & Manufacturing Sciences (TSMS) – Tech Transfer
Organization Overview We serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Position Summary The Senior Director of TSMS – Tech Transfer is a strategic leadership role within the central TSMS organization, responsible for leading global technical teams in the successful transfer of drug substance and dry oral products (including SDD) processes across internal and external manufacturing sites. Key Responsibilities: Lead organization of TSMS technical experts on global tech transfer teams supporting both the initial commercialization of pipeline products and node to node transfers of commercial products across the drug substance and dry products portfolio. Responsible for the development of standardized business processes and Playbooks to support global tech transfers across multiple platforms and multiple sites (including simultaneous transfers to dual sourcing sites). Ensure alignment of Playbooks with Single Process Map deliverables and ensure buy-in from BR&D/SMDD and Analytical (AQCL) on generation of standardized business processes. Ensure the team is appropriately structured to own and continuously improve Tech Transfer Playbooks and associated training programs. Ensure consistency in technical deliverables and documentation across transfers. Strategic & Portfolio Management Partner with CMC PMs and development teams to guide tech transfer execution using Lilly’s Single Process Map. Co-own commercialization playbooks with Commercialization and Molecule Stewards. Ensure adequate staffing and capability of tech transfer teams. Provide escalation and troubleshooting support for complex tech transfer challenges. Organizational Leadership Represent TSMS at governance bodies and technical network meetings. Build relationships and influence across manufacturing sites and central functions. Lead performance management, talent development, and succession planning. Mentor and coach project managers and technical leaders in commercialization and tech transfer. Qualifications: Minimum: B.S. in Chemistry, Pharmacy, Engineering, or related scientific discipline. Preferred: Master’s or Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or Microbiology. Experience 15+ years in pharmaceutical manufacturing or technical services within a cGMP environment. 5+ years of experience in drug substance or dry product tech transfer and commercialization. Proven leadership in cross-functional teams and successful molecule transfers. Deep technical knowledge of parenteral products and control strategies. Skills & Competencies Strong project management and strategic planning skills. Excellent communication and stakeholder engagement. Ability to influence across sites and central functions. Experience mentoring and developing technical talent. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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
Organization Overview We serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Position Summary The Senior Director of TSMS – Tech Transfer is a strategic leadership role within the central TSMS organization, responsible for leading global technical teams in the successful transfer of drug substance and dry oral products (including SDD) processes across internal and external manufacturing sites. Key Responsibilities: Lead organization of TSMS technical experts on global tech transfer teams supporting both the initial commercialization of pipeline products and node to node transfers of commercial products across the drug substance and dry products portfolio. Responsible for the development of standardized business processes and Playbooks to support global tech transfers across multiple platforms and multiple sites (including simultaneous transfers to dual sourcing sites). Ensure alignment of Playbooks with Single Process Map deliverables and ensure buy-in from BR&D/SMDD and Analytical (AQCL) on generation of standardized business processes. Ensure the team is appropriately structured to own and continuously improve Tech Transfer Playbooks and associated training programs. Ensure consistency in technical deliverables and documentation across transfers. Strategic & Portfolio Management Partner with CMC PMs and development teams to guide tech transfer execution using Lilly’s Single Process Map. Co-own commercialization playbooks with Commercialization and Molecule Stewards. Ensure adequate staffing and capability of tech transfer teams. Provide escalation and troubleshooting support for complex tech transfer challenges. Organizational Leadership Represent TSMS at governance bodies and technical network meetings. Build relationships and influence across manufacturing sites and central functions. Lead performance management, talent development, and succession planning. Mentor and coach project managers and technical leaders in commercialization and tech transfer. Qualifications: Minimum: B.S. in Chemistry, Pharmacy, Engineering, or related scientific discipline. Preferred: Master’s or Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or Microbiology. Experience 15+ years in pharmaceutical manufacturing or technical services within a cGMP environment. 5+ years of experience in drug substance or dry product tech transfer and commercialization. Proven leadership in cross-functional teams and successful molecule transfers. Deep technical knowledge of parenteral products and control strategies. Skills & Competencies Strong project management and strategic planning skills. Excellent communication and stakeholder engagement. Ability to influence across sites and central functions. Experience mentoring and developing technical talent. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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