Associate II, Manufacturing

Company: Disability Solutions
Location: Severn
Posted on: February 2, 2025

Job Description:

We're hiring an Associate II, Manufacturing role to support cGMP upstream manufacturing process for our pharmaceutical manufacturing facility in Baltimore, Maryland.Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.The Associate II, Manufacturing is responsible for supporting the overall cGMP upstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.This is a full-time, salaried position and is 100% on-site. The schedule is a rotating 7:00AM - 7:00PM schedule (2 days on, 2 days off, 3 days on rotation.)Catalent's FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus in Baltimore, Maryland. The campus, featuring two manufacturing facilities, supports Phase 3 through commercial manufacturing of advanced therapeutic products, including Adeno-associated Virus (AAV), and other viral vector-based therapies and vaccines.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

• Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps.
• Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports.
• May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP.--
• Generate and revise internal and external documents (SOPs, BRs.)
• Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
• Troubleshoot process and equipment problems.
• Work with Facilities and Validation to maintain manufacturing equipment.--
• Other duties, as assigned.The Candidate
  • Bachelor's degree in a Scientific, Engineering or Biotech field with a minimum of 1 year experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance.
  • Associate's degree in a Scientific, Engineering or Biotech field with a minimum of 2 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance.
  • High School Diploma or GED with a minimum of 4 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance.
  • Prior experience in cGMP upstream biopharmaceutical manufacturing, highly preferred.
  • Prior experience with TFF (tangential flow filtration) and biomanufacturing harvest clarification, highly preferred.
  • Experience working in an aseptic environment, highly preferred.
  • Proficient in MS Office and related PC skills.The anticipated salary range for this position in Maryland is $58,240 to $80,080 plus shift differential and annual bonus, when eligible.-- The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent
    • Medical, dental, vision, and wellness benefits are effective on the first day of employment.
    • Potential for career growth on an expanding team and organization.
    • 152 hours of paid time off annually plus 8 paid holidays.
    • Community engagement and green initiatives.
    • Engaging D&I Employee Resource Groups.
    • Tuition reimbursement program.
    • Generous 401K match.Catalent 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, Annandale , Associate II, Manufacturing, Other , Severn, Virginia