Your Role: Associate-Manufacturing

The Technical Services & Manufacturing Services (TSMS) Associate is responsible supporting in-transfer, troubleshooting, optimization, and execution of analytical methods in support of product development activities at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to analytical methods to analyze samples produced during mAb production and for final product testing. The subject matter expert acts as critical link between TSMS, QC and R& D.

Your Responsibilities:

• Support in-transfer and optimization of new analytical methods for new product development, process improvement, and lifecycle management projects. Perform technical support and testing as required to support development / technical studies, method validations, and / or commercial product release.
• Author and provide critical review of technical documents including but not limited to; development / technical study plans, SOPs, risk assessments, investigations, change controls, method validations, and stability protocols and reports. Define and coordinate sampling strategies, sample collection, handling, and testing requirements.
• Collect and analyze method data, preparing and delivering presentation of results in technical forums & evaluate and implement new technologies (equipment, reagents, methods, etc) where appropriate to improve business outcomes.
• Lead and participate in method-related investigations and root-cause analyses of OOS/OOE events. Ensure issues are identified and captured in the relevant quality management system and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.
• Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures. Exemplify “Safety First and Quality Always” mind-set.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s degree in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or a related discipline.

• Experience: 5+ years’ experience working in a laboratory / quality control setting.

• Detailed understanding of analytical characterization methods for biological products, working knowledge of cGMP standards and experience working in a regulated environment, and demonstrated success operating in cross-functional teams.
• Proven analytical thinking and problem-solving skills, strong verbal, written, and interpersonal communication skills, and strong organizational and computer skills.

What will give you a competitive edge (preferred qualifications):

• MSc or PhD in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or a related discipline.
• Experience in tech transfer, optimization, and validation of analytical methods for characterization of biological products (eg. mAbs, recombinant proteins, vaccines).
• Demonstrated success leading cross-functional teams / projects.
• Experience with SAP, JMP, Veeva Vault.
• Excellent technical writing skills.
• Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.

Additional Information:

• Travel: Minimal travel requirements < 5%.

• Location: Elwood, Kansas

• Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.

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