Associate I, Manufacturing
Company: Disability Solutions
Location: Severn
Posted on: October 23, 2024
Job Description:
Job DescriptionManufacturing Associate ISummary: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 I perform and documents cGMP activities to support
upstream or downstream production areas and operations. This
involves operation of process equipment, execution of validation
protocols, completion of cGMP documents, creating/ revising cGMP
documents and other assignments as directed.Shift work and/or
weekend work may be required at times.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:
- Performs Processing Steps and/or Manufacturing Support
activities, monitoring process against the batch record.
- Documents/Records cGMP data and information for processing
steps and/or equipment activities, following standard operating
procedures. Key documentation includes batch records and equipment
logbooks.
- Understands basic cGMP requirements and follows those
requirements, including requirements for good documentation
practices.
- Completes /reviews validation protocols, deviation reports,
change controls in accordance with cGMP's
- Performs the weighing, dispensing of raw materials for media
and buffers
- Performs the preparation of small and large volume media and
buffer solutions, filtration, and transfer of product.
- Operates bench top equipment including pH, conductivity, osmo
meters, pumps, tubing welders, filter integrity testers etc.
- Dispensing, labeling, transfer/staging of raw materials and
parts
- Assembly/disassembly, cleaning and sterilization of components,
parts, and equipment
- Maintaining equipment, area, and cleaning logbooks
- Cleaning sanitizing production rooms and equipment
- Stocking production and cleaning supplies
- May author/ review/improve SOP's, batch records, protocols, and
technical reports
- Actively participates in training activities, managing their
individual training plan
- Proficient and knowledgeable in the operation and basic
troubleshooting of at least one manufacturing area.
- Other duties as assignedThe Candidate:
- High School Diploma with a minimum of 2-4 years GMP
Manufacturing experience,
- ---OR
- Certificate and/or associate degree in a scientific,
engineering or biotechnology discipline with a minimum of 0-2 years
related experience; coursework with biotechnology focus highly
desirable ,
- OR
- Bachelor's Degree (BS/BA) from an accredited college or
university with an emphasis in a scientific or engineering
discipline and a minimum of 0-1 years relevant experience
- Basic knowledge of current Good Manufacturing Practices
(cGMP's). Working knowledge of all relevant safety procedures
within the company. General understanding of most areas in
Manufacturing and supporting functional groups.
- Familiar with or experience with cGMP Biotech or Pharmaceutical
operations:
- 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 Management.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.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, Olney , Associate I, Manufacturing, Other , Severn, Maryland
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