Associate - Biomanufacturing, Upstream
Company: Disability Solutions
Location: Madison
Posted on: October 18, 2024
Job Description:
Associate - Biomanufacturing, UpstreamCatalent 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 Biologics is a fast-growing business within
Catalent Pharma Solutions focused on providing innovative
technologies and solutions to help more and better biologic
treatments get to patients.--The business includes our proprietary
GPEx cell line engineering platform, our new state-of-the-art
biomanufacturing facility in Madison, WI, and our market leading
biologics analytical services as well as SMARTag Antibody Drug
Conjugate technology in Emeryville, CA.-- Leveraging our growing
differentiated technology portfolio, world class manufacturing
capability, and other integrated services across the Catalent
network, Catalent Biologics is positioned to drive significant
growth for Catalent.The Manufacturing department is responsible for
the execution of clinical and commercial manufacturing in
accordance with regulatory, site, and client requirements.
Manufacturing cGMP production activities include solution
preparation, master/working cell bank production, upstream cell
culture, downstream protein purification, mRNA and molecular
therapeutics production, and small-scale fill/finish. Further,
manufacturing operations is tasked to utilize continuous
improvement methodologies to realize process optimization,
efficiency gains, and waste reduction to maximize capacity
outputs.--The Biomanufacturing Associate position is an
intermediate-level position in the Manufacturing team and is
responsible for the manufacture of biopharmaceutical products
within a clean room environment. The position is expected to follow
detailed instructions and established procedures under
supervision.This is a full-time on-site hourly position, Wednesday
- Saturday 6:00am to 4:00pmCatalent 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 basic Upstream cell culture activities, such as
aseptic manipulation of cell culture within a Grade A environment,
large-scale cell culture within single-use bioreactors (SUBs),
clarification of bulk harvest product, and cell bank vialing.
- Performs basic troubleshooting aseptic processing, large-scale
cell culture activities, and clarification of bulk harvest
product.
- Accurately follows manufacturing Batch Production Records
(BPRs) and Standard Operating Procedures (SOPs) in accordance with
current Good Manufacturing Practices (cGMPs) and with a focus on
"right-first-time" execution. Documents all activities in
accordance with Good Documentation Practices (GDPs) in BPRs, Forms,
and other quality documentation
- Recognizes deviations from the intended procedure and raises
awareness through the Rapid Response process.
- Assesses procedures for opportunities to improve the format,
delivery, clarity, and process flow.
- Proactively identifies safety, quality, and efficiency
improvements; Actively participates in the Catalent Way (Continuous
Improvement Culture)
- Performs general cleanroom housekeeping, including room and
equipment cleaning, disposal of waste, and maintenance of 5S
standards.
- All other duties as assignedThe Candidate: --
- Must have Masters Degree in a scientific, engineering or
biomanufacturing discipline with no experience required OR
- Bachelors or Associates Degree in a scientific, engineering or
biomanufacturing discipline with a minimum of 1 year of relevant
experience OR
- High School Diploma with a minimum of 4 years of relevant
experience
- Ability to use Excel, Word, and other office systems.
- GMP experience preferred
- Frequent lifting and/or moving up to 10 pounds and occasional
lifting and/or moving up to 50 pounds requiredWhy you should join
Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 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 Reimbursement--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, Dubuque , Associate - Biomanufacturing, Upstream, Other , Madison, Iowa
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