Lead Associate - Biomanufacturing, Downstream
Company: Disability Solutions
Location: Madison
Posted on: May 4, 2024
Job Description:
Lead Associate - Biomanufacturing, DownstreamCatalent 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 Lead Associate position is a
senior-level position in the Manufacturing team and is responsible
for providing process and technical leadership during the
manufacture of biopharmaceutical products within a clean room
environment. The position is expected to follow detailed
instructions and established procedures.--This is a full-time
salaried position, Monday - Friday, 8:00am to 5:00pmCatalent 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 Downstream purification and mRNA production
activities, such as in-vitro transcription (IVT) reactions,
chromatography, tangential flow filtration (TFF), viral filtration,
bulk drug substance filling, and column packing/qualification
- Performs advanced troubleshooting during chromatography, TFF,
viral filtration, IVT reactions, bulk drug substance filling, and
column packing/qualification--
- 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
- Leads "Just Do It" (JDI) Continuous Improvement activities and
longer-term CI projects
- Acts as a formal "mentor" for more junior team members and
coaches junior team members on complex production activities--
- Coordinates implementation of SOP and batch record updates,
ensuring operator awareness and planning training where
required
- Completes all training activities required to maintain quality
compliance within expected milestones
- Other duties as assignedThe Candidate: --
- Requires Masters Degree in a scientific, engineering or
biomanufacturing discipline with a minimum of 3 years of relevant
experience OR--
- Bachelors or Associates Degree in a scientific, engineering or
biomanufacturing discipline with a minimum of 5 years of relevant
experience OR--
- High School Diploma with a minimum of 9 years of relevant
experience
- Ability to operate within a clean room environment as
needed
- Frequent lifting and/or moving up to 10 pounds and occasional
lifting and/or moving up to 50 poundsWhy 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 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.--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 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, Madison , Lead Associate - Biomanufacturing, Downstream, Other , Madison, Wisconsin
Didn't find what you're looking for? Search again!
Loading more jobs...