Senior Scientist I - Quality Control - Data Review
Company: Disability Solutions
Location: Madison
Posted on: April 24, 2024
Job Description:
Senior Scientist I - Quality Control - Data ReviewCatalent 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.This position requires a variety of skills
necessary for biotech company operations. Perform technical quality
data review of stability, release, and in-process manufacturing
samples for a large variety of testings, including but not limited
to, Appearance, pH, Osmo, SEC, IEX, CE, cIEF, ELISA,--and SDS-PAGE,
while adhering to SOPs and working in a cGMP compliant environment.
This position will be required to understand the intricacies of
testing types to provide a high quality of technical review. Other
duties may include database entry/review of data and data packets
and contributions to process improvement initiatives.This is a
full-time on-site 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:
- Independently performs quality data review of cGMP
records.
- Authors technical documents such as SOPs and reports.
- Coordinates with Supervisor to prioritize and schedule
activities to meet deadlines.
- Supports continuous process improvement initiatives.
- Interacts as an SME for internal and external customers.
- Supports training of specific analytical techniques.
- Actively participates in team meetings and/or training
sessions.
- All other duties as assignedThe Candidate:
- Requires Ph.D. Degree in Biology, Biotechnology, Chemistry or
related life sciences field OR
- Master's Degree in Biology, Biotechnology, Chemistry or related
life sciences field with a minimum of 4 years of industry
experience OR
- Bachelor's Degree in Biology, Biotechnology, Chemistry or
related life sciences field with a minimum of 6 years of industry
experience OR
- Associate Degree in Biology, Biotechnology, Chemistry or
related life sciences field with a minimum of 10 years of industry
experience OR
- High School Diploma or equivalent with a minimum of 11 years of
industry experience
- Intermediate to advanced proficiency in MS Office
preferred
- Familiarity with EMPOWER software preferredWhy 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.--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, Dubuque , Senior Scientist I - Quality Control - Data Review, Other , Madison, Iowa
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