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Senior Manager of MSAT

Company: Theragent Inc
Location: Arcadia
Posted on: November 20, 2022

Job Description:

Senior Manager of MSAT What We DoTheragent is a privately-owned Contract Development and Manufacturing Organization (CDMO) focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. We are a small, biotech startup headquartered in Arcadia, CA. Our state-of-the-art facility provide high-quality, reliable, and value-added solutions to our clientele for challenging pre-clinical and clinical trial projects. Our innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.
Why Theragent?Take the next step in your career and join Theragent today to change patient lives through the products we help develop and manufacture. Here, you will contribute your talents in a purposeful way that impact the lives of patients around the world. You will develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Innovation, Transparency, Accountability, Integrity, Diversity, Humility to name a few are embedded in everything we do. No matter your role may be, Theragent strives to ensure all our teammates are empowered and given the necessary tools to lead us in our relentless pursuit to extending patient lives.
Our Mission:To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.
Position Summary:Theragent is 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. Primary 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 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 and Theragent 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
    Reports to: Associate Director of Process Sciences
    FLSA Status: Exempt
    Location: Arcadia, CA
    Knowledge, Skills & Abilities:
    • Demonstrated ability to design laboratory experiments and evaluate data to provide scientific guidance on process optimization
    • 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
    • Deep knowledge of FDA regulatory requirements for drug products and IND filing
    • Knowledgeable of cGMP processes and technology transfer
    • Knowledge 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
    • Professional Knowledge
    • Problem Solving
    • Team Player / Building Relationships
    • Multi-tasking
    • Customer Focus
    • Action and detail oriented
    • Active Listening
    • Decisive Decision Making
      Education & Professional Experience: - 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
      Working Conditions:
      • Laboratory environment
      • Must wear PPE due to safety requirements in designated lab areas
      • May be required to work in controlled or clean room environments
        Travel: Occasional. Less than 10%
        Physical / Mental Demands:
        • Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 40lbs.
        • Ability to sit, stand, walk, and move within workspace for extended periods.
        • Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
          Environmental Conditions:
          • Primarily office environment but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes
          • Ability to work safely and effectively when working alone or working with others
            This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities, and activities may change at any time with or without notice.
            Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
            Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.

Keywords: Theragent Inc, Arcadia , Senior Manager of MSAT, Executive , Arcadia, California

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