Senior Scientist I, QC - Method Validation
Company: Disability Solutions
Location: Madison
Posted on: May 8, 2024
Job Description:
Senior Scientist I - Quality Control, Method
Validation.SummaryCatalent 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.Working for Catalent Biologics is an
opportunity to join an entrepreneurial team.-- Catalent Biologics
is making significant investments in people and capabilities.--
This is a unique opening to join a small, fast growing business,
backed by a global public company.-- People joining our team will
have the opportunity for career development as our business
continues to grow and expand.-- Catalent-Madison employees are
helping to improve future patient outcomes by working on products
that are designed to treat cancer, various autoimmune, fibrotic and
blood disorders, HIV, diabetes, heart and lung diseases as well as
Alzheimer's.----The Quality Control (QC) team is responsible for
testing products, raw materials and the manufacturing environment
to ensure the Safety, Quality, Identity, Purity and Potency
produced by the Catalent Madison Biologics facility.The Method
Validation team is responsible for analytical testing, data
analysis, document writing, and data reporting to support
phase-appropriate method validation of analytical methods. These
methods directly support the Stability and Release and In-Process
testing teams.This is a full-time on-site position, Monday - Friday
8am-4:30pm.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
- Independently executes and properly documents cGMP Quality
Control Methods and testing.
- Authors technical documents such as SOPs and reports.
- Interacts as an SME for internal and external customers.
- Supports training of specific analytical techniques.
- Enters data into Laboratory Information Management System
(LIMS) or laboratory reports.
- Performs general lab housekeeping in adherence to 5S
standards.
- Initiates and leads investigations or deviations in
Trackwise.
- Performs self-review of analytical data and technical review of
peers' analytical data for accuracy and consistency with
SOP's.
- Actively participates in team meetings and/or training
sessions.
- Other duties as assigned.The Candidate
- PhD 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
- Experience writing technical documents.
- Familiarity with clean room procedure, aseptic technique, and
general lab equipment experience.
- cGMP, Good Documentation Practices (GDP) or Good Laboratory
Practices (GLP) knowledge experience.
- HPLC, CE experience required, (icIEF) strongly preferred.
- Strong understanding of analytical chemistry and simple,
moderately complex, and complex lab equipment.Physical Requirements
- Frequent sitting, standing, walking, reading of written
documents and use of computer monitor screen, reaching with hands
and arms, talking, writing, listening.
- Occasional stooping, kneeling, crouching, bending, carrying,
grasping.
- Frequent lifting and/or moving up to 10 pounds and occasional
lifting and/or moving up to 50 pounds.
- Must comply with EHS responsibilities for the position.
- Working in a lab environment will require working with skin
irritants, lung irritants, electrical equipment, sharp instruments,
toxic materials, and hazardous waste. Safety procedures must be
followed to minimize exposure, including proper use of PPE
(personal protective equipment) and clean room gowning.
- Working conditions will be Heating Ventilation and Air
Conditioned controlled.Why 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, Madison , Senior Scientist I, QC - Method Validation, Other , Madison, Wisconsin
Didn't find what you're looking for? Search again!
Loading more jobs...