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 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

• Oversees the Metrology department and is responsible for maintaining compliance of the Metrology program.
• Manages contract/consulting Metrology staff.
• Serves as SME and lead decision maker for the Metrology program, ensuring goals and tasks are met within. Interact with regulatory agencies as needed.
• Monitors and manages calibration program and technicians to ensure instruments and equipment are properly calibrated per the required schedule. Tracks progress and maintains appropriate metrics.
• Ensures departmental training is appropriate and up to date.
• Coordinates outside calibrations/schedule with vendors
• Serves as project manager for Metrology projects and improvements.
• Ensures that all applicable SOPs are in place and followed.
• Works closely with equipment owners to ensure that all documentation is complete and accurate (Integration forms, ECIs, etc.)
• Maintains Metrology databases.
• Generates and reviews documents and supports the Director, Gliadel Operations
• Other duties as assigned such as batch record review and validation support.
• Ensures CAPAs and other changes related to the Metrology program are meaningful and effective.
• Lead continued successful transition to new computerized system (Blue Mountain)
• Support PV and commercial production
• Identifies and pursue continuous improvement.
  
  

Requirements

• Bachelor’s degree or equivalent level of skill and experience in an applied science
• 7 years’ work experience in pharmaceutical manufacturing required.
• Experience leading contractors/direct reports.
• Previous GMP and GDP experience required.
• Working knowledge of Metrology and/or Facilities databases required
• Strong understanding of industrial/pharmaceutical instrumentation, equipment, and measurement principals, as well as process controls
• Ability to specify new or replacement instrumentation and standards to support new projects or existing.
• Strong troubleshooting and problem-solving skills; ability to analyze and diagnose instrument failures.
• Demonstrated ability to multi-task and successfully manage multiple priorities.
• Results oriented; high level of initiative and ability to work independently with limited instruction and oversight. May require occasional general instruction on non-routine tasks or projects.
• Works well with others and possesses the ability to build and maintain positive relationships.
• Demonstrated ability to work in a team environment and lead a team.
• Highly organized with focus on quality/attention to detail.
• Strong written and verbal communication skill required.
• Experience in writing deviations and/or strong technical writing experience required.
• Proficient in Microsoft Office.
• Ability to lift or relocate machinery as needed.
• Ability to walk throughout facility as needed.
  
  

- VF

- SC1

Eisai Salary Transparency Language:

The base salary range for the Sr Metrology Associate is from :82,300-108,000

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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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