CMC Operations Manager
CMC Operations Manager🔍School of Medicine, Stanford, California, United States📁Administration📅Jan 05, 2021 Post Date📅88123 Requisition #The Center for CancerCell Therapy (CCT) is offering an exciting new professional opportunity: CMCOperations Manager (ASA2); a role specifically created to support operationallogistics of Process Development and GMP Manufacturing for CCT, to help developinnovative cell and gene-based therapies for the treatment of disease and thepromotion of health in pediatric and adult patients.
This position offers theopportunity to be involved in a team-based approach to providing CMCoperational support to the CCT process development and manufacturing team, todevelop and implement leading-edge cell and gene-based therapies for Phase Iand II clinical trials. This person will be directly involved in managingrelationships and will serve as the liaison between multiple groups, to ensureefficient communications and processes. TheCMC Operations Manager reports to the Associate Director of Process Development& Manufacturing, CCT and plays a critical role in developing the CMCOperations Infrastucture, and managing relationships with internal and externalCMOs. They may also contribute to New Drug (IND) submissions to the IND and increating policies and procedures to ensure compliance with US Food and DrugAdministration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFRParts 210, 211); Human Cells, Tissues, and Cellular and Tissue-based Products(21 CFR Part 1271); and Biologics (21 CFR 600) regulations. The Center for Cancer Cell Therapy is a part ofthe Stanford Cancer Institute (SCI), which is one of an elite number ofNational Cancer Institute-Designated Comprehensive Cancer Centers in thecountry, and is a prominent, dynamic, growing and complex Institute within theStanford University School of Medicine. The SCI actively works to buildsynergies and collaborations among faculty with cancer-relevant expertise from fourSchools and over 30 departments across Stanford University. Duties include: Manage the CMC operations for CCT GMP manufacturing with external and internal CMOs, including but not limited to: review of technical documents for accuracy, coordinate logistics for patient samples, inventory clinical materials, liaise with internal groups at Stanford, and author memos and CMC IND sections for our investigator initiated cell therapy trials. Provide support on collaboration with investigator project teams to manage and coordinate the authoring, review, and finalization of CMC and regulatory documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progressSupport preparation, assembly of clinical, pre-clinical, and CMC information for submissions of Investigational New Drugs (INDs) including amendments, supplements and annual reports for multiple simultaneous submissions for manufactured products across a broad spectrum of biological systems Includes project/submission maintenance; templates; word processing and formatting; proof-reading; bookmarks and hyperlink publishing; and archiving for R&D regulatory documents. This position also executes and maintains processes for managing regulatory submissions, correspondences, and commitments in accordance with Good Documentation Practices. Contribute to installation and maintenance of software for regulatory submissions and documentationLiaise with internal teams such as process development scientists, manufacturing scientists, quality control, quality assurance and clinical research staff and operations. Liaise with external teams such as CTF, Clinical Micro/Pathology, LCGM, and adult and pediatric clinical teams.Support future facility licensing and registration, GMP validation activities of cell processing facility and other cGMP/GLP activities (change controls, QSR implementation, SOP and RMS reviews) via direct interactions with QAInform training required for CMC Ops and Regulatory Affairs staff within CCT * Other duties mayalso be assignedDESIRED QUALIFICATIONS:
EDUCATION & EXPERIENCE(REQUIRED):Bachelor's degree and 5 years of relevant experience, or combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.Demonstrated ability to develop and meet budget goals.Demonstrated solid planning and organizational skills.Demonstrated experience working independently and as part of a team.Excellent interpersonal, written and oral communication skills.Strong relevant subject matter knowledge. PHYSICAL REQUIREMENTS*:Constantly perform desk-based computer tasks. Frequently stand/walk, sitting, grasp lightly/fine manipulation.Occasionally use a telephone. Rarely lift/carry/push/pull objects that weigh 11-20 pounds. * - Consistent withits obligations under the law, the University will provide reasonableaccommodation to any employee with a disability who requires accommodation toperform the essential functions of his or her job. WORK STANDARDS:Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
- Working knowledge of US CMCregulations as well as ICH and US guidance documents required.
- Bachelor's degree in Life Sciences,advanced degree preferred.
- Experience in CMC operations,regulatory affairs or other relevant experience in investigational stagebiologics. Cell Therapy/CAR T experience preferred.
- Ability to contribute tomultiple projects/submissions concurrently.
- Strong interpersonal skills andthe ability to work in a project team environment.
- Excellent written and oralcommunication skills in English.
- Strong technical writing andediting skills.
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