Senior Scientist - Analytical Development
Company: Disability Solutions
Location: Madison
Posted on: April 19, 2024
Job Description:
We're hiring for a Senior Scientist, Analytical Development to
support late-stage development programs in Madison,
Wisconsin!Catalent 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.--The Senior Scientist,
Analytical Development--is responsible for accelerating multiple
late-stage programs. The Analytical Development team is responsible
for developing analytical methods to support cell line, upstream,
and downstream development, and transferring them to the QC
department. This is a full-time, hourly position and is 100%
site-based. The schedule is Monday - Friday 1st shift. --Catalent's
Madison, Wisconsin site is a state-of-the-art biomanufacturing
facility specializing in integrated formulation and analytical
services. Our site features our proprietary Gene Expression
Technology (GPEx) cell line engineering platform, and
biomanufacturing capabilities utilizing single-use systems.-- Our
employees are helping to improve future patient outcomes by working
on products that are designed to treat COVID-19, cancer, various
autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and
lung diseases as well as Alzheimer's.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
- Develops/optimizes assays including but not limited to HPLC,
CE, and cIEF to analyze protein and mAb samples to support process
development at different stages.
- Understands and applies method qualification and validation
(Phase III) per the ICH guidelines.
- Reviews qualification and validation protocols and
reports.
- Writes procedural SOPs and reports.
- Experience with development and transfer of analytical methods
to support late phase and commercial processes.
- Troubleshoots and solves analytical instrument problems.
- Troubleshoots and problem solves for analytical methods to
initiate and execute/monitor corrective actions.
- Acts as the technical lead for Client development projects,
communicates project status and effectively provides technical
explanation/rationalization.
- Critically analyzes complex data, interprets, and integrates
experimental results with project objectives.
- Other duties as assigned.The CandidateEducational
qualifications:
- Ph.D. in Chemistry or Biochemistry with a minimum of 2 years of
experience in the biotechnology industry or post-doctoral training
in protein MS.
- Master's degree in chemistry or Biochemistry with a minimum of
5 years of experience in the biotechnology, or related,
industry.
- Bachelor's degree in chemistry or Biochemistry with 8+ years'
experience in the biotechnology, or related, industry.Highly
preferred qualifications:
- Hands-on experience in developing MS, LCMS, and HPLC/UPLC
methods for protein and/or mAb analysis, including but not limited
to: RP-HPLC-MS; SEC-HPLC-MS; IEX-HPLC-MS.
- Familiarity with biophysical methods for protein and mAb
characterization, such as Peptide Mapping, N-Glycan, CD, DSC, MFI,
and light scattering.
- Method development and method gap assessment experience for
Phase III and commercial products.
- Knowledge and experience working in a cGMP environment, while
using Good Documentation Practices (GDP).
- Experience mentoring junior staff regarding laboratory
procedures.Why you should join Catalent
- Defined career path and annual performance review and feedback
process.
- Medical, dental and vision benefits effective on first day of
employment.
- Potential for career growth on an expanding team and
organization.
- 152 hours of paid time off annually plus 8 paid holidays.
- Community engagement and green initiatives.
- Competitive salary with bonus potential.
- Tuition reimbursement program.
- Diverse, inclusive culture.
- Generous 401K match.---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, Madison , Senior Scientist - Analytical Development, Other , Madison, Wisconsin
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