 |
Associate I, Manufacturing - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/03/2025
Position Summary:Catalent Pharma Solutions in Harmans, MD is hiring an Manufacturing Associate I. The Manufacturing Associate I is responsible for supporting the overall GMP upstream and downstream 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, and commercial GMP manufacturing. This is a full-time on-site position, 7pm-7am on a 2-2-3 rotationCatalent, 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.Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including 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
- Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
- Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
- Work closely with various departments and aid other teams as necessary
- Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
- All other duties as assigned;The Candidate
- High School Diploma or GED is required, Associates or Bachelors preferred
- With a High School Diploma or GED, two or more years of experience with downstream biologic production process is required, including column chromatography, buffer, and media skid
- With an Associates or Bachelors degree no additional experience is required
- Outstanding knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks is required
- Thorough knowledge of current Good Manufacturing Practices (cGMP's), and safety procedures is required
- General understanding of most areas in Manufacturing and supporting functional groups is required
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;The anticipated salary range for this position in Maryland is $58,240 - $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:
|
 |
RSS Job Feeds