Eli Lilly and Company
Pharmaceutical
AssociateDirectorTechnicalServices/ManufacturingScience(TSMS)APIExternalManufacturing(Peptides)
“Associate Director - Technical Services/Manufacturing Science (TSMS) - API External Manufacturing (Peptides) at Eli Lilly and Company. Skills: Technical leadership in peptide manufacturing, Process development and optimization, Scale-up and technology transfer, cGMP compliance, Team management. 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 cycl”
What You'll Achieve.
Ensure the robust and compliant manufacturing of peptide drug substances; Achieve departmental goals; Successful scale-up, validation, and regulatory compliance; Enhance yield, reduce cost, and improve product quality; Seamless process execution and product delivery
Industry & Context.
Resolving complex technical challenges; Troubleshoot complex manufacturing issues; Analytical and problem-solving skills; Data-driven approach to decision-making
What They're Looking For.
Must Have
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.
Nice to Have
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., 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/NDALA) is highly preferred.
What You'll Do.
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.
Lead and manage a team of scientists
providing technical guidance
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
and regulatory compliance.
and interpret experiments to optimize existing peptide manufacturing processes
and improve product quality.
Author and review technical reports
and regulatory submissions related to peptide manufacturing processes and product quality.
Lead investigations into manufacturing deviations
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.
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure seamless process execution and product delivery.; Present technical findings and recommendations to senior leadership and external stakeholders.
Communication Scope
Excellent written and verbal communication skills; Ability to articulate complex technical concepts clearly and concisely to diverse audiences
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