Senior Scientist, Cell Therapy Process Development

Company: Disability Solutions
Location: Princeton
Posted on: September 2, 2024

Job Description:

Senior Scientist, Cell Therapy Process Development Position Summary:Catalent Pharma Solutions in Princeton, NJ is hiring a Senior Scientist, Cell Therapy Process Development who is responsible in contributing to the development of early and late stage clinical cell therapy manufacturing processes. This position is responsible for development and technology transfer of internal and client related projects. The successful candidate will contribute to the design, execution, and analysis of development studies in the lab employing modern bioprocess methodologies such as Design of Experiment and Quality by Design. This position will actively interact with internal MFG/AD/QC/QA team and external client SMEs to develop and drive the strategy to support the successful delivery of client projects. The ideal candidate for this position should have work experience in cell therapy process development, manufacturing science, analytical development, and familiarity with GMP/FDA/ICH.This is a full-time role position: Monday - Friday, days.Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Our U.S. commercial cell therapy manufacturing facility is located in Princeton, NJ, and is part of Catalent's cell therapy network including our European Center of Excellence for cell therapy in Gosselies, Belgium. The CGMP manufacturing facility is equipped with 16 flexible clean rooms, QC labs, and warehouse space to support late-stage and commercial-scale autologous and allogeneic cell therapy productionCatalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role

• Develop and optimize cell therapy manufacturing processes from scratch or using existing processes;
• Apply Quality by Design (QbD) methodology and Design of Experiments (DoE) approach in development to maximize capacity and reduce cost of goods. Assist in defining Target Product Profile (TPP), identifying Critical Process Parameters (CPP) and Critical Quality Attributes (CQA);
• Lead and assist in technology transfer, GAP analysis, process industrialization of client projects; --
• Identify, assess, and implement new technologies to improve product quality, success rate, reproducibility and/or reduce cost and time of manufacturing processes;
• Act as the accountable point of contact from the process development for product/process support for technology transfers and ongoing cGMP drug product manufacturing;
• Responsible for trouble shooting, deviation investigation and product impact assessment for projects employing developed technology/processes'
• Coordinate with AD/QC team in analytical method development and characterization of products that are currently in development;
• Organize and prioritize work to meet timelines and ability to execute on multiple projects. Support client facing activities for the cell therapy process development team;
• Support Business and Project Management team for technical discussion with prospects/clients;
• Provide appropriate documentation and support clients in authoring CMC sections'
• Demonstrate strong oral and written communication skills. Author protocols, reports, risk assessments, SOPs, and batch records'
• Supervise, train and mentor junior staff to create a high performing team;
• All other duties as assigned;The Candidate
  • Bachelors with 8+ years' experience; OR MS with 6+ years' experience; OR Ph.D. and 4+ years of experience in a biotechnology, cell therapy industry required;
  • Deep understanding and experience of cell therapy process development is required;
  • Expertise in bioprocess development, QbD and DoE methodology;
  • Knowledge in various cell therapy/culture technologies; --
  • Experience with common equipment used in cell therapy manufacturing such as Sepax, Lovo, G-Rex, Xuri Bioreactors, CliniMACs Plus, CliniMACS Prodigy, MaxCyte GT;
  • Experience with nucleic acid/viral vector transduction/transfection is preferred; Hands-on experience with flow, PCR and cell-based assays is a plus;
  • Experience in GMP and Aseptic processing is preferred;
  • Communicates clearly and concisely with diverse audiences, in both oral and written contexts, and is comfortable giving and receiving feedback;
  • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
    • Defined career path and annual performance review and feedback process--
    • Diverse, inclusive culture--
    • 152 Hours PTO + 8 paid holidays
    • Several Employee Resource Groups focusing on D&I
    • Dynamic, fast-paced work environment
    • Positive working environment focusing on continually improving processes to remain innovative
    • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--
    • Competitive salary with bonus potential--
    • Community engagement and green initiatives--
    • Generous 401K match--and Paid Time Off accrual--
    • Medical, dental and vision benefits effective day one of employment--
    • Tuition Reimbursement--- Let us help you finish your degree or earn a new one!
    • WellHub program to promote overall physical wellness--
    • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent offers rewarding opportunities to further your career!-- Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.--Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.------personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.--------Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Trenton , Senior Scientist, Cell Therapy Process Development, Healthcare , Princeton, New Jersey