 |
MSAT Engineer, III - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/07/2025
Engineer III, Manufacturing, Sciences, and Technology (MS&T)Catalent Pharma Solutions is looking to hire an Engineer III, Manufacturing, Sciences, and Technology (MS&T) to support our GMP Manufacturing Team in Harmans, MDCatalent, 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--. 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.The Manufacturing Sciences & Technology (MS&T) Engineer III will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at Catalent Gene Therapy.-- The MS&T Engineer III is actively engaged in the technical transfer of client and Catalent Process Development information for implementation of cGMP processes. The individual will serve as a subject matter expert (SME) for biologic Upstream Processes and/or Downstream Processes.-- Success in this position requires the ability to work hands on in a cleanroom, and the ability to collaborate in a cross-functional, fast paced environment.The MS&T Engineer III role is critical to our patients.-- The Engineer III in MS&T is responsible for accurately transferring the process from the client and process development to manufacturing with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!--This is a full-time onsite position working Days; Monday - Friday, 8am-5pm and the position will provide support for both the BWI sites and BioPark.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 - Work with GMP manufacturing and Process Development in one or more of the following areas: cell culture, purification and/or fill & finish
- Support client projects as the MS&T Lead for tech transfer of projects from Catalent Process Development and external clients into GMP manufacturing.
- Author tech transfer documents, including detailed process descriptions and scale-up documents
- Author Master Production Records and SOPs to support GMP manufacturing projects
- Working with GMP Manufacturing as an on-the-floor Subject Matter Expert (SME)
- Working closely with project management to ensure MS&T project milestones are achieved; Assist with training GMP Manufacturing staff on Client processes
- Collect and trend process data for external (client) and internal review, and for support of client needs.
- With minimal guidance, draft and/or author technical reports, process tech transfer summary reports, and protocols in support of Tech Transfer and cGMP activities
- Serve as team leader for process and product investigations and author investigation reports
- Assist Clients in regulatory filing support as a process SME
- Evaluate and recommend equipment for client projects
- Other duties as assignedThe Candidate
- B.S. in Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 4-8 years of experience in the pharmaceutical or biotechnology industry -OR-
- M.S. in Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 2+ years of experience
- Knowledge/expertise relevant to protein and virus manufacturing in a cGMP environment is required.
- Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification and fill/finish required, experience is two or more preferred. --
- Experience with process modeling software such as SuperPro, JMP, MatLab, Aspen a plus.
- Experience in a CMO environment or in a similar client-customer-based work environment a plus.
- On-site presence, as the role requires time on the manufacturing floor and cross-functional collaborationThe anticipated salary range for this position in Maryland is $118,720 to $163,240 plus an 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