112102 - Manufacturing Manager
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#112102 Manufacturing ManagerExtended Deadline: Thu 12/9/2021
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
UCSD Layoff from Career Appointment: Apply by 10/04/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/14/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This posting will remain open until filled.
The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.
The Advanced Cell Therapy Laboratory (ACTL) is a state of the art current Good Manufacturing Practice (cGMP) manufacturing facility whose highly skilled team will support UC and local investigators transition novel therapies through the Investigational New Drug (IND) and Phase I/II clinical trials.
The Manufacturing Manager for the UC San Diego Advanced Cell Therapy Laboratory (ACTL) oversees the manufacture, testing, and storing of cGMP cell therapy products and ensures compliance with related policies, procedures, and regulatory guidelines. They anticipate risk and build contingencies to help mitigate impact. They lead the manufacturing team readiness efforts to meet clinical supply needs and provide review and approval of manufacturing batch records and other associated documentation. They also steer quality investigations and develop and implement agreed upon corrective and preventive actions.
Working collaboratively with the drug product sponsor, the Manufacturing Manager leads technology transfer for product manufacture and characterization and as such directs the Process Development group to onboard and implement new processes. They must assess and prioritize projects to align with the broader departmental and organizational strategy and ensure the necessary resources are in place and optimally allocated to achieve results.
The Manufacturing Manager builds and develops a diverse and robust team in an environment that fosters accountability, innovation, continuous improvement, learning and knowledge-sharing.
This position also acts as a resource to clinical staff and investigators as needed and may perform other related functions as required.
Provides supervision and guidance to research staff. Oversees program administration, program development, and research activities. Receives assignments in the form of objectives with goals and the process by which to meet goals. Exercises judgment within defined procedures and policies to determine appropriate action. Recommends changes to department policies and practices. Identifies risks and responds accordingly. Providespriority setting and work flow analysis.
Ten (10) years of related experience, education/training, OR a Bachelor’s degree in related area plus six (6) years of related experience/training.
Academic background and experience in relevant area of research and product manufacturing. Six (6) years of related cellular therapy or equivalent laboratory experience in a Good Manufacturing Practices (GMP) facility. Strong theoretical knowledge of a biological science to include cell therapy.
Experience supervising staff or students in an academic or research setting. Strong supervisory skills. Provides consistent, effective technical supervision/leadership to the ACTL. Strong ability to train and educate ACTL staff and others as required to learn cell therapy processes.
Strong leadership skills including effective communication, negotiation, coaching, and conflict resolution. Ability to exercise good judgment, tact, diplomacy, and discretion in handling a variety of complex and highly confidential matters.
Proven familiarity with cGCP, cGMP and cGLP guidelines and conditions.
Demonstrated knowledge of a wide variety of cellular therapy laboratory techniques, including cell culture, flow cytometry, etc.
Strong skills in analyzing, researching and synthesizing large amounts of data for preparing sound and relevant proposals/analyses. Experience and ability to compile and analyze complex information, policies, procedures and to formulate logical objective conclusions and recommendations and to develop and implement effective solutions.
Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders.
Demonstrated knowledge of program development as well as grant proposal development and administration.
Knowledge of human resources management practices and policies.
Knowledge of financial principles and budget practices.
Knowledge university, state, and federal policies that influence higher education. Strong understanding of cGMP and cGLP guidelines as well as demonstrated strong knowledge of The United States Food and Drug Administration (FDA) guidelines and regulations.
- Knowledge of or ability to learn and keep updated on UCSD policies and procedures.
- Employment is subject to a criminal background check.
- Must be able to maintain confidentiality.
- Must have the ability to travel to offsite collaborator and vendor locations.
- Must be able to work various hours and locations based on business needs.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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