Senior Associate 1, cGMP Biomanufacturing-Downstream (Sun-Wed, 2pm-12am) - SIGN ON BONUS OFFERED
Company: Catalent
Location: Madison
Posted on: June 25, 2022
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Job Description:
Senior Associate 1, Biomanufacturing - Downstream (Wed-Sat
6am-4pm)Position Summary:The Manufacturing department is
responsible for the execution of clinical and commercial
manufacturing in accordance with regulatory, site, and client
requirements. Manufacturing 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. The
Manufacturing team executes batch production records and SOPs in a
cGMP environment, focusing on 'right first time' and on-time
delivery.The Senior Associate 1 on the Downstream Manufacturing
team is responsible for leading the manufacturing of
biopharmaceutical products through the use of general analytical
and liquid handling equipment. This role is also responsible for
the use and maintenance of single and non single-use chromatography
and filtration skids, as well as large scale chromatography column
packing and qualification. The Senior Associate 1 serves as a
project lead to ensure daily production activities are planned for
and executed as required, communicating with other resource groups
as required.This is a full-time, hourly position. Wednesday -
Saturday 6:00am - 4:00pm.Our new, state of the art Madison, WI
facility, with expanded mammalian cell line engineering and
biomanufacturing capabilities utilizing single-use systems, offers
increased flexibility and manufacturing scale to support our
customers' growth. We offer a broad range of integrated formulation
and analytical services to solve your most difficult development
challenges in Biologics.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 in Kansas City, MO and
Research Triangle Park, NC, 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.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:Operates single-use biomanufacturing processing skids,
including but not limited to, chromatography (single-use and non
single-use), tangential flow filtration, and normal flow
filtration.Performs packing, unpacking, and qualification of
large-scale chromatography columns.Performs filling activities of
final product within a Grade A (ISO5) environment.Serves as Room
Lead for normal flow filtration, tangential flow filtration, and
chromatography (single-use and non single-use)
processes.Orchestrates execution of daily processing activities for
the assigned roomPerforms verification of other team members'
work.Communicates with floor support groups as required.Serves as
Lot Lead and drives tactical preparations and batch closure
tasksPerforms all pre-execution scheduling and planning for
assigned production lot.Responsible for tactical execution of
assigned production lot.Identifies and raises opportunities for
procedural improvements. Drafts new SOPs and reviews/revises
existing ones.Participates in and drives continuous improvement
initiatives.Supports deviation investigations and change
control/protocol execution in a time-sensitive fashion.Executes
other duties as assigned.The Candidate:Bachelors or Associates
Degree in a scientific, engineering or biomanufacturing discipline
with a minimum of 2 year of relevant experience, ORHigh School
Diploma with a minimum of 5 years of relevant experienceClean room,
aseptic technique, and/or general lab equipment experience.GMP
experience preferred.Catalent Benefits:Defined career path and
annual performance review and feedback processDiverse, inclusive
culturePotential for career growth on an expanding team within an
organization dedicated topreserving and bettering lives152 hours of
paid time off annually + 8 paid holidaysCompetitive salary with
yearly bonus potentialCommunity engagement and green
initiativesGenerous 401K match and Paid Time Off accrualMedical,
dental and vision benefits effective day one of employmentTuition
reimbursementOn-site fitness center and wellness programsCatalent
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.Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each stage.personal
initiative. dynamic pace. meaningful work.Visit Catalent Careers 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
DisabilityAccommodations@catalent.com. 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.
Keywords: Catalent, Madison , Senior Associate 1, cGMP Biomanufacturing-Downstream (Sun-Wed, 2pm-12am) - SIGN ON BONUS OFFERED, Other , Madison, Wisconsin
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