Senior Associate Scientist – Analytical Development Catalent Pharma Solutions

Ourlivesmadison; Madison (WI); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

PTO and holidays

Benefits day one

401K match

Tuition reimbursement

Job summary

Catalent Madison seeks a Senior Associate Scientist in Analytical Development to evaluate client analytical methods and develop robust assays using AQbD and DoE. This role covers protein and macromolecule analysis (SDS-PAGE, ELISA, LCMS) and supports method transfer to QC within GMP frameworks.

The successful candidate will record data, manage timelines, mentor colleagues, and participate in quality systems; weekend work may be required; on-site work schedule is M-F 8am-5pm.

Qualifications

• High School Diploma/GED with 10+ years of experience.
• Associate’s degree in STEM with 6-9 years of laboratory experience.
• B.S./B.A. in STEM with 3-6 years in a laboratory environment.
• MS in STEM with 0-3 years of industry laboratory experience.

Responsibilities

• Analyze proteins and biomolecules using SDS-PAGE, ELISA, Western Blot, HPLC, CE, cIEF, LCMS.
• Develop robust assays using DoE and AQbD.
• Record and review experimental data with GMP documentation.
• Support shipments to clients with proper paperwork and timelines.
• Mentor or train others and participate in team meetings.

Skills

DoE experimental design

AQbD

GMP knowledge

Data recording

Mentoring

Education

High School Diploma/GED

Associate’s degree in STEM

B.S./B.A. in STEM

MS in STEM

Tools

SDS-PAGE

Agarose Gel

ELISA

Western Blot

HPLC

CE

cIEF

LCMS

qPCR

Sanger Sequencing

Job description

Senior Associate Scientist – Analytical Development

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

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 COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

Catalent Pharma Solutions in Madison, WI is hiring a Senior Associate Scientist – Analytical Development.The Analytical Development team is responsible for evaluating client analytical methods and/or optimizing/developing methods required to support cell line, upstream, and downstream development, and transferring them to the QC department for phase appropriate validation. The team is also responsible for characterizing primary and high order structures; confirming product comparability across scale and establishing product degradant profiles and specifications for reference standards of mRNA proteins/mAbs generated at Catalent's, Madison site. The team executes on this by applying the concepts of analytical quality by design (AQbD) in compliance with FDA and other regulatory agency requirements and in conformance with the sites GMP quality systems. The team's role is therefore central to the success of projects that enter cell line and process development and technology transfer workstreams and also ensures that analytical methods can be applied in establishing product critical quality attributes (CQA) and supporting IND-enabling studies and applications that are essential in providing high quality drug products for our clients and their patients.

The Role:

• Understand and apply biochemical/biophysical and immunological concepts associated with macromolecules including proteins, nucleic acids, and lipids and the methods for analysis
• Execute all activities related to the analysis of proteins and other biological macromolecules from mammalian cell culture and process development ranging from SDS-PAGE/Agarose Gel analysis, ELISA and Western Blot analysis, various HPLC based methods, CE, cIEF, product binding/activity assays, qPCR, and Sanger Sequencing with a preferred focus on LCMS peptide mapping, intact mass analysis, and released N-glycan
• Independently support developing robust assays, including use of experimental design (DoE) and applying the principles of AQbD
• Accurately record experimental data/observations in data sheets or lab notebooks
• Review and verify analytical data and reports ensuring accuracy and consistency
• Accurately support shipments of samples to clients with appropriate information/paperwork
• Maintain project timelines
• Perform general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering and stocking supplies, etc.
• Actively participate in team meetings
• Become fully trained on departmental SOPs, write procedural SOPs as necessary
• Strong understanding of GMP documentation and guidelines
• Follow Good Documentation Practices (GDP)
• Mentor or train others, as assigned
• Some weekend work required
• Seek out guidance as necessary
• Other duties as assigned

The Candidate:

• High School Diploma/GED with 10+ years of experience
• Associate’s degree in STEM discipline with 6-9 years of experience
• B.S/B.A. in any STEM discipline with at least 3-6 years’ experience in a laboratory environment
• MS in STEM discipline with 0-3 years of industry laboratory experience

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement– Let us help you finish your degree or start a new degree!

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.

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 [e-mail]. 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.