Associate II, Manufacturing
Company: Disability Solutions
Location: Severn
Posted on: February 3, 2025
Job Description:
We're hiring a night shift Associate II, Manufacturing role to
support cGMP downstream and 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 downstream and 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 7:00PM - 7:00AM 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 using SOPs and BPRs, for the processes and manufacturing
steps.
- Generate 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.
- Support initiation and closure of deviations; may serve as the
lead in the departmental investigation and be responsible for
closing out deviations and CAPAs.
- Work closely with production management for current and new
manufacturing projects and help develop processes/techniques to
meet contract objectives and avoid operational delays.
- Interact with clients during initial and subsequent
manufacturing campaigns; may be responsible for overseeing and
escorting the person-in-plant (PIP) during manufacturing
campaigns.
- Other duties, as assigned.The Candidate
- Bachelor's degree in a Scientific, Engineering or Biotech field
with a minimum of 1 year experience in 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 in upstream
(fermentation/bioreactor) or downstream (column chromatography,
buffer/media skid) biologic production processes under GMP
compliance.
- High School Diploma or General Education Diploma (GED) with a
minimum of 4 years' experience in upstream
(fermentation/bioreactor) or downstream (column chromatography,
buffer/media skid) biologic production processes under GMP
compliance.
- Prior experience in cGMP downstream biopharmaceutical
manufacturing, highly preferred.
- An 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
- 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, Severn , Associate II, Manufacturing, Other , Severn, Maryland
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