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24 days old

Sr. MSAT Manager

Kelly Services
Arcadia, CA 91007
For over 25 years Kelly Science & Clinical has been connecting scientific professionals with industry leading employers. Today we are excited to be hiring a **_Senior MSAT Manager_** for a cell and gene therapy company in Covina, CA. The **_Sr. MSAT Manager_** will 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 clients cell therapy products, including production support and technology transfer. We are looking for a Sr. MSAT Manager who 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.


**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 SOPs 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 adaptations

+ Works 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 others

+ Prepare and present to leadership and external clients and stakeholders on process execution, latest data and conclusions, plans and roadmap to meet client manufacturing goals

+ Executes on IND development timelines against operational plan

+ Builds a strong scientific and technical team, provides necessary training and ongoing coaching, discipline, and recognition of direct staff, including performing annual performance reviews

+ Supports 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 vendors

+ Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management

+ Interacts with outside vendors and senior management

+ Participates in multi-functional project teams, as necessary

+ Takes corrective action to bring about required changes using change control procedures


**Requirements:**


+ Ph.D. in a scientific or bioengineering discipline and 6-8 years of experience or M.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 team

+ Minimum 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 required

+ Fully competent and experienced working with cGMP Quality systems and demonstrated capabilities of conducting manufacturing deviation investigations, determining root cause using RCA tools and techniques

+ Demonstrated 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 failures

+ Knowledgeable of cGMP processes and technology transfer


**_Apply today to start a conversation on Whats Next for your Career!_**


+ Please feel free to schedule an interview directly with Athena to learn more: https://calendly.com/athp320/interview

+ Additional questions may also be e-mailed to athena.parker@kellyscientific.com.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-12 Expires: 2022-10-13

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Sr. MSAT Manager

Kelly Services
Arcadia, CA 91007

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