Associate Director, QC 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.

Essential Functions

Overall leadership of the Product Quality QC Biologics team. US staff are both remote and based out of the Raleigh office.

Responsible for overall leadership to direct and manage QC team in providing QC / QA oversight of services performed at contracted laboratories;

manage QC projects to improve method performance robustness and overall analytical control strategies; guide staff to ensure creation and maintenance of reference standards to support product portfolio.

Responsible for developing and maintaining strategic relationships with other Eisai units, technical leaders in QC, QA, R&D, and with key internal and external partners.

Provide technical and managerial expertise to work closely with the development team to select / qualify external laboratory partners and coordinate outsourced QC activities.

Provides technical expertise and business acumen to :

Direct / manage assessments and resolution of technical issues.

Draft, review and approve relevant technical documents, such as change controls, regulatory submissions, deviations, validations, method transfers, APRs, etc. as applicable.

Conduct and facilitate thorough investigations into lab related deviations, discrepancies, and ensure appropriate CAPA is assigned to remediate recurrence.

Responsible for talent development within the QC team. Accountable to develop, motivate and retain key personnel to support the product release and stability testing at US / international sites.

Guide QC teams through goal setting, performance assessment, professional development, and engagement. Participate in and promote the importance of hhc and compliance activities to the QC staff and assures active participation by the US staff in hhc socialization activities with patients.

Participates in the preparation and management of the annual budget plan for the QC unit and monitors progress of the budget implementation.

Assist in development of resources, operational plans, and organizational objective setting.

Provides technical leadership to prioritize, schedule and monitor multiple multifaced analytical projects. Maintain a technical understanding of the regulations applicable to laboratory testing in a cGMP environment.

Requirements

Graduate level degree in biological sciences or related subject required. Ph.D. highly preferred with equivalent expertise required.

Significant relevant, analytical experience with biologics, several of which must be in a people management position.

Prior contract manufacturing project management experience is highly preferred. Prior experience with manufacturing from pre-IND through phase 3 or commercial production is highly desired.

Significant knowledge of biologics manufacturing and analytical methodology as well as ICH, cGMP, EMEA and JP guidelines as they pertain to the manufacturing of monoclonal antibody-based therapies required.

Demonstrated technical knowledge in laboratory analytical techniques, including, but not limited to, biological assays, electrophoresis, chromatographic, spectroscopic, and / or microbiological assays.

Thorough technical understanding of analytical laboratory compliance requirements and regulatory expectations.

Demonstrated understanding of statistical tools and analysis.

Strong communication (verbal and written) skills.

Well-developed interpersonal interaction skills, with a proven ability to influence diverse groups and manage relationships.

Sound leadership skills (decision making, prioritization, mentoring, conflict resolution) demonstrating a hands-on, proactive stance with willingness and ability to assist all team members to achieve corporate goals.

Strong attention to detail, analytical problem solving, the ability to set priorities and achieve goals, strategic thinking, energy, enthusiasm and an entrepreneurial mindset.

Ability to work independently; clear self-motivation.

Ability to participate in hybrid schedule (2 days onsite at Eisai Raleigh / 3 days work from home).

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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.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.

Please click on the following link for more information :

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