Manufacturing Manager - 118835
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#118835 Manufacturing ManagerFiling Deadline: Fri 9/30/2022
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UCSD Layoff from Career Appointment: Apply by 9/21/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 9/30/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Advanced Cell Therapy Laboratory (ACTL) offers expert assistance and hands-on services to investigators who require cGLP/cGMP systems and facilities. We aid in the transition from research and development to compliant and clinically-relevant manufacture of cell therapy products for IND-enabling studies or Phase I/II 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 whichto 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.
10 years of related experience, education/training, OR a Bachelor's degree in related area plus 6 years of related experience/training.
Academic background and experience in relevant area of research and product manufacturing. Six 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.
Demonstrated 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.
Demonstrated leadership skills including effective communication, negotiation, coaching, and conflict resolution. Strong ability to exercise good judgment, tact, diplomacy, and discretion in handling a variety of complex and highly confidential matters.
Ability to build relationships, collaborate and problem solve both internally and with external organizations.
Strong 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. Demonstrated 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. Strong organizational skills to coordinate large volumes of work, establish priorities, and meet deadlines.
Advanced oral and written communication skills with the ability to communicate effectively with diverse stakeholders.
Commitment to equity, diversity and inclusion.
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.
Demonstrated 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).
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
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