Job type full-time
Full job description
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) missionWe’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and developmentOur history includes the development of many innovative medicines, notably the discovery of the world`s most widely-used treatment for alzheimer’s diseaseAs we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a differenceIf this is your profile, we want to hear from you.
Director of biologics operations support services will be responsible for leading and building a scientific team focused on validation, support operations, and warehouse managementThe director will oversee all new equipment qualification projects and ensure the current validated state of a biopharmaceutical manufacturing plantManage, review, and enhance validation practices, processes and procedures to fully comply with current regulatory, industry and corporate standards with an eye to current fda, emea and japanese regulatory standardsThrough effective interaction with eisai exton personnel, consultants and equipment suppliers, the director is responsible for the development, execution, direction and maintenance of validation programs for the facility itself as well as all of the instruments, equipment, computer systems, supporting processes, and other utilities and processes contained withinResponsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated for intended use.
The director will ensure the management of day-to-day operation of support operations functions (medium/feed/buffer preparation, weigh/dispense, washer/autoclave, facility cleaning/cleaning validation program) and warehousing providing diverse services for production of clinical trial and commercial materials including scheduling of staff, preparation and close-out of documentation, preparation of assemblies and solutions, suite change-over, and warehouse management including receipt and movement of materials ensuring compliance to relevant regulationsThis position supports the quality and operational processes for work performed by eisai exton, and by external contractorsOther projects and responsibilities may be added at the company`s discretion.
Maintain an equipment, system, and cleaning validation plan for a pilot plantCreate validation requirements, plans, protocols, reports, and test documentation for the facility as well as all of the equipment in the facility15% develop and implement solutions to equipment validation or system testing/engineering issues and recommend quality improvement strategies10% work with, and manage, designated eisai exton personnel, external contractors, and suppliers to identify equipment, instrument, computer system, and other validation needsReview and approve validation documentation created by internal staff and external contractors and suppliers15% oversee the warehouse material management including receipt and movement of materials, cycle counting, and ensuring compliance to relevant regulations oversee material staging, preparation of bill of materials, batch records, sops, and close-out reports for each campaign10% lead and assist in troubleshooting product and equipment issues and deviationsProvide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective and preventive actionsReview, approve and implement change control projects with focus on assessing and controlling impact to the validated state10% ensure adherence of operations to cgmp, ich, emea and jp guidelines as well as industry best practices, safety standards and osha guidelines10% interact cross-functionally with upstream and downstream operations, facilities, r&d, quality assurance, quality control, validation, and other internal and external functions to support successful product development10% recruit, train, and develop staff supporting supply chain, validation, support operations and warehouse managementEnsure staff are trained in process specific knowledge, equipment operation, and relevant regulations10%
Bs, ms, or phd in biological sciences or engineering or equivalent
12+ yrs of practical scientific/technical experience in facility/equipment/system validation, materials management, and batch production operations, as well as comprehensive equipment and systems expertise in a regulated biotech, or pharmaceutical industry
Minimum of 5-7 years of experience managing validation/operations/logistics projects required; expertise in quality systems management environments highly preferred.
Hands on experience with commissioning & validation of utilities, analytical instruments, pas/bas, bioprocessing systems, and other types of equipment, supporting processes and computer software programs.
Knowledgeable in washer/autoclave/buffer/media equipment/process scale-up and warehouse management.
Knowledgeable in disposable bioprocess technologies, systems, and practices.
Ability to identify, investigate, and solve process and equipment problems using both good engineering practices and current biopharmaceutical industry standards.
Strong working knowledge of current global good manufacturing practices (cgmps), eu & fda regulations (21 cfr parts 210, 211), good automated manufacturing processes (gamp) and 21 cfr part 11 electronic recordkeeping/electronic signatures.
Excellent written and communication skills, including gdps.
Excellent interpersonal and presentation skills.
Ability to manage multiple key projects and functions in a lean environment
Team player who can excel in a “hands-on” entrepreneurial environment.
Ability to supervise, mentor, train, and develop staff.
Eisai requires all new hires to be fully vaccinated against covid-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable lawThis requirement is a condition of employment at eisai, and it applies regardless of whether the position is located at an eisai site, field based or is fully remoteIf you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
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 statusSimilarly, considering the need for reasonable accommodations, eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai incParticipates in e-verifyE-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.