BioSpace
Associate Director - Engineering API External Manufacturing Peptides & Large Mol
BioSpace, Indianapolis, Indiana, us, 46262
Associate Director - Engineering API External Manufacturing Peptides & Large Molecules
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Associate Director - Engineering API External Manufacturing Peptides & Large Molecules
role at
BioSpace .
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, dedicated to discovering, developing, and delivering medicines that help people live longer, healthier, and more active lives. Our employees worldwide work to bring life‑changing medicines to those who need them and give back to communities through philanthropy and volunteerism.
Organization Overview We serve an extraordinary purpose by discovering, developing, and delivering medicines that improve the lives of people worldwide. Beyond breakthrough medications, we support communities through philanthropy and volunteerism.
Responsibilities The Associate Director - API EM Engineering Leader for Peptides and Large Molecule is a member of the API EM Plant Lead Teams, providing leadership and expertise to reliably supply and commercialize externally manufactured APIs, intermediates, and starting materials with safety first and quality always. The role reflects increasing technical complexity and commercialization activity associated with API EM operations as the pipeline portfolio progresses.
Engineering/HSE
Provide API EM organizational Engineering leadership for Peptides and Large Molecule as a member of the API EM Plant Lead Team, HSE Lead Team, Science Lead Team, and co‑lead the Engineering Lead Team.
Coach and mentor engineering associates in fundamental engineering support, including process knowledge, problem solving, and engineering design.
Provide administrative oversight and support to a team of process engineers across multiple geographies.
Develop and provide ongoing leadership for a PSM program within API EM to improve PSM capabilities and performance at CMs.
Ensure assessments of the HSE and PSM capabilities of each CM impacting Lilly products are completed during the sourcing process and maintained during the product lifecycle at a CM.
Ensure FUME assessments of CMs to understand risks presented to Lilly products' control strategy are completed and maintained.
Lead Lilly internal resources (API EM, ETC, and others as required) and partner with CM resources in executing HSE, PSM, and FUME capability assessments of CMs.
Lead internal resources and partner with CMs through specification, procurement, and IQ/OQ/PQ of equipment to ensure capital projects at CMs are delivered on time, within budget, and meeting technical expectations.
Adhere to the expectations of the Lilly Red Book when interacting with API EM’s CMs.
Basic Requirements
Bachelor of Science degree in Chemical Engineering or another engineering discipline with extensive pharmaceutical manufacturing experience.
7+ years of work experience in manufacturing operations and process engineering related roles.
Additional Preferences
Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
Experience managing capital delivery projects or commercialization/technical agenda projects.
Deep technical knowledge of bulk API manufacturing equipment and unit operations.
Ability to understand and influence integration points with other business areas, processes, and functions.
Direct or indirect experience with commercialization (Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE).
Ability to function in a team environment as a leader and as a member of teams.
Ability to manage and prioritize competing priorities and to communicate verbally and in writing to various audiences.
Experience in typical unit operations for large molecule expression and purification and small molecule manufacture.
Process Hazard Analysis experience.
Project management qualifications or demonstrated ability to develop detailed project plans including critical path and risk register analysis.
Location This role is located in Indianapolis, IN and is not approved for remote work.
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 resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. 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.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is \$118,500 - \$173,800. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program, including medical, dental, vision, prescription drug, retirement plans, flexible benefits, life insurance, and well‑being benefits.
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Associate Director - Engineering API External Manufacturing Peptides & Large Molecules
role at
BioSpace .
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, dedicated to discovering, developing, and delivering medicines that help people live longer, healthier, and more active lives. Our employees worldwide work to bring life‑changing medicines to those who need them and give back to communities through philanthropy and volunteerism.
Organization Overview We serve an extraordinary purpose by discovering, developing, and delivering medicines that improve the lives of people worldwide. Beyond breakthrough medications, we support communities through philanthropy and volunteerism.
Responsibilities The Associate Director - API EM Engineering Leader for Peptides and Large Molecule is a member of the API EM Plant Lead Teams, providing leadership and expertise to reliably supply and commercialize externally manufactured APIs, intermediates, and starting materials with safety first and quality always. The role reflects increasing technical complexity and commercialization activity associated with API EM operations as the pipeline portfolio progresses.
Engineering/HSE
Provide API EM organizational Engineering leadership for Peptides and Large Molecule as a member of the API EM Plant Lead Team, HSE Lead Team, Science Lead Team, and co‑lead the Engineering Lead Team.
Coach and mentor engineering associates in fundamental engineering support, including process knowledge, problem solving, and engineering design.
Provide administrative oversight and support to a team of process engineers across multiple geographies.
Develop and provide ongoing leadership for a PSM program within API EM to improve PSM capabilities and performance at CMs.
Ensure assessments of the HSE and PSM capabilities of each CM impacting Lilly products are completed during the sourcing process and maintained during the product lifecycle at a CM.
Ensure FUME assessments of CMs to understand risks presented to Lilly products' control strategy are completed and maintained.
Lead Lilly internal resources (API EM, ETC, and others as required) and partner with CM resources in executing HSE, PSM, and FUME capability assessments of CMs.
Lead internal resources and partner with CMs through specification, procurement, and IQ/OQ/PQ of equipment to ensure capital projects at CMs are delivered on time, within budget, and meeting technical expectations.
Adhere to the expectations of the Lilly Red Book when interacting with API EM’s CMs.
Basic Requirements
Bachelor of Science degree in Chemical Engineering or another engineering discipline with extensive pharmaceutical manufacturing experience.
7+ years of work experience in manufacturing operations and process engineering related roles.
Additional Preferences
Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
Experience managing capital delivery projects or commercialization/technical agenda projects.
Deep technical knowledge of bulk API manufacturing equipment and unit operations.
Ability to understand and influence integration points with other business areas, processes, and functions.
Direct or indirect experience with commercialization (Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE).
Ability to function in a team environment as a leader and as a member of teams.
Ability to manage and prioritize competing priorities and to communicate verbally and in writing to various audiences.
Experience in typical unit operations for large molecule expression and purification and small molecule manufacture.
Process Hazard Analysis experience.
Project management qualifications or demonstrated ability to develop detailed project plans including critical path and risk register analysis.
Location This role is located in Indianapolis, IN and is not approved for remote work.
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 resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. 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.
Compensation and Benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is \$118,500 - \$173,800. Full‑time employees are also eligible for a company bonus and a comprehensive benefits program, including medical, dental, vision, prescription drug, retirement plans, flexible benefits, life insurance, and well‑being benefits.
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