Engineer III, MS&T
Company: Disability Solutions
Location: Severn
Posted on: October 16, 2024
Job Description:
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.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. 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 Paragon 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.
- Serve as team leader for process and product investigations and
author investigation reports
- Assist Clients in regulatory filing support as a process SMEThe
candidate:
- B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or
related field with 4 - 8 years of experience in the pharmaceutical
or biotechnology industry -OR-
- M.S. 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.
- Experience in one or more of the following manufacturing areas:
cell and/or microbial culture, protein purification and
fill/finish
- Experience in a CMO environment or in a similar client-customer
based work environment a plusThe anticipated salary range for this
position in Maryland is $118,720 - $163,240--plus an annual bonus.
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:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement ProcessesCatalent
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, Aspen Hill , Engineer III, MS&T, Engineering , Severn, Maryland
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