job summary: Join this fast-paced and rapidly growing biotech start up! Here, you will contribute your talents in a purposeful way that impacts the lives of patients around the world. You will be supporting the development and manufacturing of cell and gene immunotherapies for the treatment of cancer and rare diseases, in a state of the art facility. Position Summary: Seeking a Senior Manager of Manufacturing Sciences and Technology, reporting directly to the Associate Director of Process Sciences, to lead a multi-functional team supporting the innovative cell/gene modified autologous and allogeneic cell therapy manufacturing processes. This role will be responsible for preclinical and clinical manufacturing support, leading a team focused on effective delivery of MSAT operationally focused services for cGMP manufacture of client's cell therapy products, including production support and technology transfer. The successful candidate will have extensive experience with cell/gene therapy processes and procedures, deep expertise on the underlying science and technology, detailed understanding of CMC requirement for IND/NDA filings, materials selection, equipment and process validation, and product testing. This position represents a seasoned people leadership skillset, and the energy and boldness to grow an innovative organization. Successful candidate has demonstrated experience in authoring CMC sections of IND and NDA applications to USFDA/EU/MMA submissions. Hours: 8:30- 5:00 location: Arcadia, California job type: Permanent salary: $140,000 - 160,000 per year work hours: 9 to 5 education: Masters responsibilities: Developing a strong and deep bench of technical process experts of cGMP cell/gene manufacturing.Responsible for successful transfer of processes (for allogeneic/autologous cell therapies, viral vectors) into production. As such, you are in direct contact with our clients, Process Sciences and Manufacturing teams.Supports the various manufacturing platforms to enable current and new product formats, increased product control, lower cost, and lower operational complexity.Ensure process manufacturability and responsible for continuous improvement of the manufacturing processes.Lead tech transfer activities from Process Development/Sciences to cGMP manufacturing, including the following aspects: Equipment, Materials, Process, Documents, Training, Tech Transfer Protocol and Report, Gap assessment and Risk assessment etc.Author and review of tech transfer documents, batch records, and SOP's to support tech transfer and cGMP manufacturing projects.Collect and trend process data, and present for review.Coordinate all process relevant major deviations and process adaptationsWorks strategically to accelerate the implementation of novel technologies for integration into new and existing drug product platform processes.Oversees the execution of process validation by ensuring adequate validation master plans and personnel to deliver on-time execution of validation studies.Play a key role in project team meetings and decisions working closely with other functions such as Research, (Process Sciences), Regulatory Affairs, Manufacturing, Quality, Clinical, Finance, Program Management, Business Development, and othersPrepare and present to leadership and external clients and stakeholders on process execution, latest data and conclusions, plans and roadmap to meet client and manufacturing goalsExecutes on IND development timelines against operational planBuilds a strong scientific and technical team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviewsSupports technology transfer of products and processes into the cGMP facility, and serves as a key SME with external manufacturing organizations and key clients as well as material/component and equipment vendorsInvestigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior managementInteracts with outside vendors and senior managementParticipates in multi-functional project teams, as necessaryTakes corrective action to bring about required changes using change control procedures qualifications: Ph.D. in a scientific or bioengineering discipline and 6-8 years of experience, ORM.S. and 8-10 years experience in MSAT or manufacturing of cell and gene therapies (preferred), vaccines or biologics.At least 5 years experience of managing a technically sound, scientific multi-functional teamMinimum of 5 years experience in FDA-regulated industry with experience in evaluating process materials and components in the cell therapy biotechnology industry.Direct experience with cell and gene therapy process execution, IND filing, and supporting clinical products is requiredFully competent and experienced working with cGMP Quality systems and demonstrated capabilities of conducting manufacturing deviation investigations, determining root cause using RCA tools and techniques Knowledge, Skills & Abilities: Demonstrated ability to design laboratory experiments and evaluate data to provide scientific guidance on process optimizationDemonstrated ability to technically trouble shoot and resolve manufacturing challenges to successfully produce cell therapy products at a high-performance rate.Demonstrated ability to lead investigations, risk assessments, tech transfer, process monitoring, and routine clinical support; experience with process characterization, PPQ and PV is highly desirable.Capable of suggesting effective CAPA for manufacturing process failuresDeep knowledge of FDA regulatory requirements for drug products and IND filingKnowledgeable of cGMP processes and technology transferKnowledge of cGMP in the pharmaceutical industry. Application to cell/gene therapy a plus.Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required skills: Cell Biology, IND, FDA, CAPA, GMP (Good Manufacturing Practice), Manufacturing Operations, Process Engineering Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.