Associate Director, Technical Operations 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

• Provides technical and administrative management oversight for the Biologics division within Tech Ops for US based staff and operations. Participates in the preparation and management of the annual ESI controlled budget plan for the Tech Ops unit. Works to establish and implement appropriate business plans with the Tech Ops Director, Unit Sr. Director and/or Unit Head.

• Proactively promotes and coordinates “window” communication between MDC/PST and EDCS teams related to technology improvements and technology transfers. Influences, promotes, and coordinates communication within and between Tech Ops and other EDCS units regarding biologics when appropriate.

• Personally responsible and accountable for one or more significant technical programs assigned to the Tech Ops unit in support of one or more ESI managed products. Works in close collaboration with the Raleigh based Quality and SCM Units to assure timely completion of defined project technical requirements. Actively participate in project team meetings, IPT/CMC meetings, supplier review meetings and interaction with business development partners (where applicable).

• Works to identify appropriate KPIs for the US Biologics team and monitor the performance against the KPIs to ensure staff is fully informed of the operational objectives, goals, and achievements.

• Works to assist in establishing and implementing talent development within Tech Ops Biologics to foster global talent development. Participates in and promotes hhc and compliance activities.

• Lead process performance monitoring, operational excellence activities, and process improvement strategies.

• Works with the Biologics US staff to provide recommendations of potential technology based strategic initiatives that could lead to technology improvements that would maximize patient benefit, improve product quality and/or reduce costs.

Requirements

• Advanced degree in (Bio)Chemical Engineering or Engineering or Biological Sciences or equivalent job experience/degree required.

• Experience:

  • 10+ years with an undergraduate degree (BS), or comparable experience with Master’s or (PhD) practical scientific experience in a multi-discipline cGMP environment.

  • Knowledgeable in Biologics manufacturing

    • Upstream: mammalian cell culture, equipment operations, and CIP/SIP operations

    • Downstream: purification, formulation, downstream equipment operation, and CIP operations

    • Drug Product Manufacturing: Sterile fill/finish operations

• Knowledgeable in technology transfer, equipment validation, utilities, and facility.

• Ability to identify, investigate, and solve process and equipment problems.

• Strong working knowledge of cGMP, EMEA, and JP regulations and ICH guidelines with the ability to interpret and translate into effective and compliant procedures.

• Excellent written and communication skills.

• Excellent project planning and management skills with the ability to manage multiple assignments simultaneously.

• Excellent interpersonal skills with the ability to adjust according to the needs of the intended audience.

• Travel (global and domestic) 20% or more may be required.

• Ability to mentor and train staff in scientific/engineering principles, and to support staff management, performance and professional development.

• Ability to identify and establish strategically important working relationships within and outside of the ESI organization (e.g. CMOs/Partners, MDC/PST, ECL, EML)

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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 prohib