Senior Scientist, Analytical Development

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Job description

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Sr. Scientist, Analytical Development

The Analytical Development team is responsible for developing analytical methods to support cell line, upstream, and downstream development, and performing robustness assessments of the methods prior to transferring them to the QC department. The team is also responsible for characterizing primary and high order structures of manufactured protein biopharmaceutical products.

This is a permanent, full time position. It is a salaried role. The shift is Monday-Friday 8a-5p.

Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers' growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

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:

• Develop and execute laboratory work plans/schedules independently, using customer milestones/and Division/site performance standards and metrics
• Develops and reviews statement of work and ensures project stays within scope
• Authors and may approve technical documents, such as protocols, test methods, test reports, certificates of analysis, and operating procedures
• Review technical documents for accuracy, thoroughness and regulatory compliance
• Trains others on procedures and laboratory techniques. Trains, coaches or mentors others on technical, personal development or business issues
• Participates in internal and client meetings, offering technical support and leading the project

The Candidate:

Education or Equivalent:

• Ph.D. in Biotechnology, or related field with at least 2 - 4 years of laboratory experience, preferably in an industrial setting.
• MS in Biotechnology or related field with at least 5 - 10 years of industry laboratory experience.
• B.S/B.A. in Biotechnology, or related field with at least 8 - 15 years of industry laboratory experience.

Experience:

• Hands-on expertise in developing/optimization/troubleshooting/execution of methods for two or more of the following: HPLC/UPLC (including but not limited to RP-HPLC, SEC and IEX), CE and iCE (cIEF) SDS-PAGE, Western, and ELISA and other general biochemical analyses/methods for protein/mAb analysis
• Expertise with biophysical methods for protein/mAb characterization, such as MS, CD, DSC, MFI, and light scattering, is a plus
• Experience writing standard operating procedures and development reports
• Strong understanding of GMP documentation and guidelines
• Experience with assessment of method robustness (assay performance characterization) required to support phase appropriate method qualification
• Familiarity with requirements for phase appropriate method validation and testing

Catalent Benefits:

• 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
• 19 days 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
• On-site fitness center and wellness programs

Catalent's standard leadership competencies that are used to interview and for Performance & Development:

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

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.
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Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.