And facilities at both the Durham and RTP sites, which transfers, develops, and qualifies analytical assays involving live cell cultures for GMP manufacturing Maintain broad knowledge of state of the art principles and theory Provides technical leadership in the group, serves ,…
Full Description :
This role serves as the head of the Cell-Based Assay (CBA) group that resides within the Analytical Development department. This role is responsible for managing the CBA staff and facilities at both the Durham and RTP sites, which transfers, develops, and qualifies analytical assays involving live cell cultures for GMP manufacturing. Additionally, this position plays a key role in maintaining and expanding service offerings in the CBA space, and keeping the group state-of-the-art with respect to assessing the biological potency of the biopharmaceuticals in support of both development and GMP manufacturing aims. Job Description:
Responsible for management and assignment of CBA tasks in support of ongoing development and GMP manufacturing programs, including stand-alone projects. These program activities include the transfer, development, qualification, and validation of cell-based analytical methods. Additionally, this position is responsible for overseeing the use of CBAs for any release or stability testing needed (non-GMP as well as GMP testing).
Responsible for producing high quality documentation, client reports, etc. suitable for publication and regulatory requirements.
Responsible for the management and professional development of lower level scientists and associates; orient new employees as to the organization and department policies, and what results are expected of them. Review their position responsibilities with them. Communicate and administer procedures for the area in accordance with approved policies. Periodically analyze the workload and the staffing needs of the department; recommend increases or decrease to staff; prepare position documentation for new and/or modified positions; identify and define qualifications required for new and modified positions; interview candidates for opening and make hiring recommendations.
Responsible for overseeing the upkeep and maintenance of CBA laboratories, facilities, and instrumentation at both Durham and RTP sites. Will serve as owner for those instruments and equipment that are dedicated to the CBA function (biosafety cabinets, incubators, refrigeration units, etc.).
Maintain broad knowledge of state of the art principles and theory; provides technical leadership in the group, serves as in-house advisor on key scientific discipline areas.
Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
Able to react to change productively and handle other essential tasks as assigned.
PhD and 5+ years directly related experience or B.S. and a minimum of 12 years of related experience or MS and 10 years of related experience.
Good oral presentation and technical writing skills are required.
Extensive cell-based assay experience is highly recommended.
Prior experience managing a laboratory and staff is preferred.
, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.