Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing

BioSpace; Indianapolis (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k)

Pension

Medical, dental, vision

Well-being benefits

Employee clubs

Job summary

Lilly seeks an experienced Associate Director for the TS/MS team focused on peptides in Indianapolis. You will provide technical leadership from process development through commercialization, ensuring robust, compliant manufacturing of peptide drug substances.

Responsibilities include leading a team of scientists, optimizing manufacturing, and guiding CAPAs, with collaboration across R&D, Quality, Regulatory Affairs, and Supply Chain.

Qualifications

• B.S. in Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline.
• 8+ years of relevant experience in manufacturing within the pharmaceutical/biotechnology industry.
• Proven leadership experience supervising scientific and technical staff.

Responsibilities

• Lead and manage a team of scientists, providing technical guidance and performance management.
• Serve as the primary technical leader for peptide manufacturing processes including synthesis and purification.
• Oversee transfer of new peptide processes from development to manufacturing with scale-up and validation.
• Design, execute, and interpret experiments to optimize peptide manufacturing and product quality.
• Author/review technical reports, protocols, and regulatory submissions related to peptide manufacturing.

Skills

Leadership

Communication skills

Analytical skills

Problem solving

Education

B.S. in Chemistry/Biochemistry/Chemical Engineering

Job description

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. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Eli Lilly and Company is seeking an experienced and highly motivated Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, specializing in Peptides. In this role, you will provide critical technical leadership and scientific expertise to ensure the robust and compliant manufacturing of peptide drug substances, from process development through commercialization and life cycle management.

Job Responsibilities

• Lead and manage a team of scientists, providing technical guidance, mentorship, and performance management to achieve departmental goals.
• Serve as the primary technical leader for peptide manufacturing processes, including synthesis and purification, resolving complex technical challenges and driving continuous improvement initiatives.
• Oversee the transfer of new peptide processes from development to manufacturing, ensuring successful scale-up, validation, and regulatory compliance.
• Design, execute, and interpret experiments to optimize existing peptide manufacturing processes, enhance yield, reduce cost, and improve product quality.
• Author and review technical reports, protocols, and regulatory submissions related to peptide manufacturing processes and product quality.
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure seamless process execution and product delivery.
• Lead investigations into manufacturing deviations, non-conformances, and out-of-specification results, implementing effective corrective and preventive actions (CAPAs).
• Stay abreast of industry best practices, emerging technologies, and regulatory requirements related to peptide manufacturing and analytical methods.
• Present technical findings and recommendations to senior leadership and external stakeholders.

Basic Qualifications

• B.S. in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline
• 8+ years of relevant experience in manufacturing within the pharmaceutical or biotechnology industry
• Proven leadership experience, including direct supervision and mentorship of scientific and technical staff.

Additional Preferences

• Strong understanding of cGMP regulations, ICH guidelines, and regulatory expectations for pharmaceutical manufacturing.
• Demonstrated ability to troubleshoot complex manufacturing issues and implement robust solutions.
• Excellent written and verbal communication skills, with the ability to articulate complex technical concepts clearly and concisely to diverse audiences.
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
• Ability to work effectively in a fast-paced, dynamic, and highly collaborative environment.
• Experience with process validation, technology transfer, and regulatory filings (IND/NDA/BLA) is highly preferred.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $180,400

In addition, Lilly offers a comprehensive benefit program to eligible employees.

• including eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

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