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Manufacturing Science Materials Management Associate

Branchburg Township, New Jersey

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Req ID R-550 Title Manufacturing Science Materials Management Associate City Branchburg State / Province New Jersey Country United States

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 39,000 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.

This position is responsible for providing technical oversight of raw materials and consumables utilized during the manufacture of monoclonal antibodies and fusion proteins to ensure the reliable supply of material with safety first and quality always.  Scope of work includes qualification, implementation, continuous improvement, investigation support and technology transfer.   This position will interact with Engineering, Manufacturing, Validation, Quality Assurance, Quality Control, Procurement, Regulatory departments, other Lilly sites and external suppliers.  Knowledge of cell culture, purification and the support systems used in the manufacture of biotech products is required.

Responsible for supporting manufacturing operations through the performance of the following duties:

  • Provide technical support and expertise for the qualification and implementation of new raw materials and consumables
  • Work effectively and efficiently in a cross-functional team with Quality Control, Quality Assurance, Operations Planning, and Procurement to ensure reliable supply of raw materials and consumables
  • Lead technical evaluations of second sources of key raw materials and consumables to firm up supply chain
  • Provide technical support during the evaluation of supplier change notifications (SCN)
  • Own extractable and leachables risk assessments as needed to support commercial manufacturing
  • Provide technical support and ownership for the qualification and monitoring of working cell banks
  • Anticipate and resolve complex problems.  Drive solutions that impact the site
  • Lead medium to large -scale projects or programs with moderate risks  Requires comprehensive business and technical knowledge to improve products or processes
  • Build relationships with internal and external partners
  • Provide technical review and input for protocols and reports, both within and external to Technical Services/Manufacturing Science (TS/MS)
  • Author Standard Operating Procedures SOPs as they relate to the activities of TS/MS
  • Understand and perform all job responsibilities in compliance with safety and regulatory expectations, as well as, cGMP

Basic Qualifications :

  • BS degree in Biochemistry, Chemistry, Bio/chemical engineering or related science
  • Minimum of 5 years experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment

Additional Skills/Preferences:

  • Lesser years of experience will be considered under extraordinary circumstances or where consistent high-level performance measures have been sustained
  • Experience in cell culture and/or protein purification development and commercialization
  • Process and equipment knowledge of cell culture and purification functions
  • Ability to independently master assigned processes and to coordinate activities with internal and external partners
  • Excellent communication skills, both oral and written
  • Have prior understanding of cGMP and regulatory requirements

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-550.

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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