Supervisor - Biomanufacturing, Downstream/mRNA
Company: Disability Solutions
Location: Madison
Posted on: October 18, 2024
Job Description:
Supervisor - Biomanufacturing, Downstream/mRNACatalent 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 Supervisor will oversee a team/shift
responsible for Downstream manufacturing of biologics drug
substance and mRNA & Molecular Therapeutics, supporting direct
execution and providing leadership oversight.--The Downstream/mRNA
Biomanufacturing Supervisor will be responsible for his/her team's
execution of production activities including column chromatography,
normal flow filtration / tangential flow filtration (TFF), viral
reduction / filtration, in-vitro transcription (IVT), and bulk drug
substance filling in a clinical and commercial cGMP
environment.--S/he will be present on the floor to support
execution in compliance with SOPs and GMP guidelines, provide
coaching and development to employees, and drive a 'right first
time' culture.--S/he will ensure batch manufacturing readiness,
meet production schedule deliverables, drive a continuous
improvement culture, support Person In Plant (PIP), and continually
optimize staff and operating model in support of client program
requirements and site financial objectives.--The Supervisor will
coordinate activities and drive standard work with Supervisors of
other shifts.--This position generally supervises 5-15 direct
reports.--The Supervisor spends the majority of time assigning,
reviewing, checking work, assisting in the manufacturing suites and
eliminating ordinary difficulties. This person also recommends
candidates for hiring, termination, prepares and conducts
performance reviews and salary reviews, and applies company
policies.This is a full-time on-site salaried position, Wednesday -
Saturday, 10:00pm to 8:00am CSTCatalent 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: --
- Authors and revises Standard Operating Procedures (SOP), Batch
Production Records (BPR) and Job Aids (JA)
- Performs daily review and final sign-off of executed cGMP
documentation (BPRs, forms)
- Supervises general cleanroom housekeeping, including room and
equipment cleaning(s), disposal of trash and recyclables, and
adherence to 5S standards
- Trains, monitors, and mentors direct reports on
biomanufacturing activities; Mentors staff regarding regulatory
requirements and supports operators with deviation management
- Holds 1x1s with employees; Leads team meetings and/or training
sessions.-- Acts as Subject Matter Expert (SME) on biomanufacturing
activities
- Supervises completion of routine and preventive maintenance on
biomanufacturing equipment; Supervises/executes equipment
qualification/validation protocols, as required
- Supports deviation investigations and change control/protocol
execution in a time sensitive fashion
- Drives and supports continuous process improvement
initiatives.
- Other duties as assignedThe Candidate: --
- Must have Masters Degree in a scientific, engineering or
biomanufacturing discipline with a minimum of 2 year of relevant
experience OR
- Bachelors or Associates Degree in a scientific, engineering or
biomanufacturing discipline with a minimum of 4 years of relevant
experience OR
- High School Diploma with a minimum of 6 years of relevant
experience
- GMP experience required
- Demonstrable leadership experience at Catalent (including but
not limited to participation in Catalent-sponsored leadership
programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may
be considered in place of external experience
- Frequent lifting and/or moving up to 10 pounds and occasional
lifting and/or moving--up--to--50--pounds is 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 , Supervisor - Biomanufacturing, Downstream/mRNA, Other , Madison, Iowa
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