Sr. QC Compliance Specialist, Biologics (HYBRID)

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.

Job Summary

The Senior QC Compliance Specialist, Biologics plays a critical role as the technical quality lead for routine release and stability testing of commercial biologics executed by contract laboratories.

The position requires familiarity with techniques including, but not limited to, compendial, HPLC, ELISA, CE, LC-MS, real time PCR, spectrophotometry, SDS-PAGE, Viral and Cell-based assays, and other technologies suited for the assessment of recombinant protein-based biopharmaceuticals. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success

Essential Functions

Technical oversight of routine testing executed by contract laboratories for commercial Biologics including:

• Monitoring release and stability testing to ensure data integrity, regulatory compliance, product quality, and on-time completion.

• Acting as the technical reviewer of data sets, quality records and lab investigations generated by contract test labs.

• Authoring CoAs, technical reports, internal quality records in accordance with regulatory requirements.

• Supporting data trending, interpretation and statistical analysis of commercial release and stability studies.

• Serving as the SME for product specific test methods for internal and external quality control.

• Collaborating frequently with internal and external cross-functional groups to provide status updates, workflows, and timelines for routine testing activities. These groups include CMOs/contract test labs, manufacturing operations, quality, regulatory and program management.

• Monitoring product specific reference standard programs in collaboration with the network Analytical/Quality experts to sustain routine testing activities. This includes driving efforts for reference standard qualification, annual re-qualification, and distribution to contract test labs.

• Supporting analytical method validation and method transfer activities.

Requirements

Education:

• BS/BA (required) in pertinent life sciences or closely related field; advanced degree desirable.

Technical:

• 5+ years of pharmaceutical/biotech working experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department in an FDA-regulated industry.

• Hands-on experience within a bioanalytical lab. Familiarity with equipment and test methods which may include HPLC, CE, PCR, ELISA, gel-based assays and other compendial assays used to test biopharmaceuticals.

• 1+ years of Method Validation, Analytical Transfers, or laboratory investigation experience preferred.

• Thorough understanding of principles, practices, and standards for biopharmaceutical testing.

• Well versed in ICH and regulatory requirements for quality as it relates to QC operations, Laboratory compliance, data integrity, and quality events.

• Experience performing statistical analysis of data sets using software such as JMP or Minitab is a plus.

• Proficient in Microsoft Office tools.

Must Possess:

• Strong communication skills and technical writing skills.

• Must be self-directed, goal-oriented, and quality conscious.

• High attention to detail with the ability to rapidly see the big picture and assess the impact of data and/or decisions.

• Values consistent with Eisai Values (Integrity, Respect, Professionalism, Quality and Teamwork); together with an intrinsic understanding of Eisai's hhc Mission and the need to always think first of the Patient.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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