Associate II, Manufacturing (Downstream)
Company: Disability Solutions
Location: Severn
Posted on: October 30, 2024
Job Description:
Manufacturing Associate IISummary: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.Both facilities
support Phase 3 through commercial manufacturing of advanced
therapeutic products including AAV and other viral vector-based
therapies and vaccines.The Manufacturing Associate II is
responsible for supporting the overall GMP upstream or 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 & commercial GMP
manufacturing. Lifting to 40 lbs., unassisted may be required at
times. Frequent standing and walking is required, as this role
requires presence on the manufacturing floor. Shift work and
weekend work is required.This is a full-time on-site
positionCatalent 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--
- Recommend equipment and other supply purchases within the
production areas
- 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
- Participate in facility expansion and equipment validation
activities
- Is fully trained on all cGMP manufacturing operations and
documentation and adhering to safety guidelines
- Other duties as assignedThe Candidate:
- HS or GED with 4-7 years' experience with upstream
(fermentation/bioreactor) or downstream (column chromatography,
buffer/media skid) biologic production processes under GMP
compliance OR
- Associate's degree in a Scientific, Engineering or Biotech
field with 2-4 years' experience with upstream
(fermentation/bioreactor) or downstream (column chromatography,
buffer/media skid) biologic production processes under GMP
compliance OR
- Bachelor's degree in a Scientific, Engineering or Biotech field
with 1-3 years' experience with upstream (fermentation/bioreactor)
or downstream (column chromatography, buffer/media skid) biologic
production processes under GMP compliance
- Outstanding knowledge, and ability to apply scientific
principles utilized to solve operational, as well as routine
production tasks
- Excellent documentation skills including comprehension, review
& establishing Batch Production Records, SOP's, deviation & summary
reports
- Thorough knowledge of current Good Manufacturing Practices
(cGMP's), and all relevant safety procedures within the company.
General understanding of most areas in Manufacturing and supporting
functional groups.
- Must be team-oriented (proactively builds healthy working
relationships between peers, their department and other
groups).
- Able to fluently communicate in English.-- Exhibits excellent
written and oral communication skills.
- Possesses a basic knowledge of non-manufacturing functions such
as QC, Regulatory, QA, and/or Materials ManagementThe 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.Position Benefits:
- Defined career path and annual performance review and feedback
process--
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives--
- 152 hours of paid time off annually +--8--paid holidays--
- Competitive salary with yearly bonus potential--
- Community engagement and green initiatives--
- Generous 401K match and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition ReimbursementCatalent 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, Chantilly , Associate II, Manufacturing (Downstream), Other , Severn, Virginia
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