Manufacturing Associate II

Company: Disability Solutions
Location: Princeton
Posted on: October 25, 2024

Job Description:

Position Summary: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 Pharma Solutions in Princeton, NJ is hiring a Manufacturing Associate II is responsible for supporting the overall GMP manufacturing process while adhering to Standard Operating Procedures in a controlled Clean Room environment and following cGMP guidelines and FDA standards and safety regulations.This is a full-time position. The core hours are Monday - Friday 7:00AM - 4:00PM --Catalent 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

• Perform and support all manufacturing for both clinical and commercial activities that meet the site's strategic objectives and is compliant with cGMP's, safety regulations, and FDA standards;
• Executes and completes Batch Production Records under cGMP, and documents in detail using SOPs and BPRs for the processes and manufacturing steps;
• Execute production activities that include cell culturing, aseptic processing, cell counts, expansion, separation and cryopreservation using appropriate techniques and equipment;
• Collaborate with the Process Development and Manufacturing Sciences and Technology (MSAT) group to transfer new projects into GMP;
• Identify, communicate, and implement process improvements;
• Generate and revise internal and external documents (SOPs, Batch Records);
• Collaborates with the manufacturing leadership and MS&T to assist closing deviations as well as CAPAs in a timely manner;
• Work closely with Supervisors and MA III's for current and new manufacturing projects. Assist with processes/techniques to meet contract objectives in a timely manner;
• Perform cleaning/disinfection of the manufacturing classified areas as needed per area procedure;
• Ensure Batch Production Record (BPR) review is performed in a timely manner;
• All other duties as assignedThe Candidate
  • High School Diploma with 2+ years of GMP Manufacturing experience required; OR Associate degree in a scientific, engineering or biotechnology discipline with 2+ years related experience; coursework with biotechnology focus highly desirable; --OR Bachelor's Degree with an emphasis in a---scientific or engineering discipline---with a minimum of 6 months+ of relevant work experience;
  • Experience in biologics manufacturing, sterile manufacturing, quality assurance or engineering areas is preferred;
  • Experience in Cell Culture, Cell counts, Cell expansion (incubators), Cell Washing, Cell Separation, Cryopreservation, and aseptic manipulations in a Biosafety Cabinet (BSC) is highly preferred.
  • Experience working under pressure meeting timelines;
  • Flexibility with work schedule - accommodate changes in the schedule including working on other shifts as per operational needs (1st, 2nd or 3rd shift, holidays and weekends) as required;
  • Excellent oral and written communication skills required. Strong technical writing ability preferred;
  • 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--
    • 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--
    • 152 Hours + 8 paid holidays
    • Several Employee Resource Groups focusing on D&I
    • Dynamic, fast-paced work environment
    • Community engagement and green initiatives--
    • Generous 401K match--
    • Company match on donations to organizations
    • Medical, dental and vision benefits effective day one of employment--
    • Tuition Reimbursement--- Let us help you finish your degree or start a new degree!
    • 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.--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, Hoboken , Manufacturing Associate II, Other , Princeton, New Jersey