Associate Director
4 days ago
We are seeking an experienced Associate Director to lead our Technical Services team in the development and implementation of technical strategies to ensure the reliable and compliant manufacturing of bulk drug substance.
Responsibilities:- Ensure that the team has a thorough understanding of protein chemistry, control strategy, and manufacturing platform related to the purification process of drug bulk substance.
- Prioritize and execute routine process monitoring, manufacturing support, and ensure that processes remain in control and capable in accordance with regulatory requirements and cGMPs.
- Develop technical capabilities within the technical staff and performance management.
- Provide technical leadership for the preparation, review, and approval of technical documents, including investigations, change controls, manufacturing tickets, periodic product reviews, process validation, and other technical documents.
- Act as the primary technical representative in a cross-functional setting on Flow Team Meeting, Deviation Board, etc.
- Lead the development and execution of process validation, process changes, and implementation of technical agenda projects with the collaboration of the secondary loop and other functions.
- Bachelor's Degree in scientific disciplines of Chemistry, Biochemistry, Microbiology, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, or Bio/Chemical Engineering.
- 5+ years of experience in any of the following disciplines: Technical Services, Pharmaceutical Manufacturing, Protein Manufacturing, Quality Control, Quality Assurance, product and/or process development, or Engineering.
- 1+ year of supervisory experience in a relevant industry.
- Technical writing and presentation skills.
- Excellent interpersonal skills that promote engagement and teamwork within a cross-functional environment.
- Knowledge of cGMP, applicable global regulatory manufacturing guidance, and process/cleaning validation in drug substance pharmaceutical manufacturing.
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 for further assistance.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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