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Position Title: Scientist - Process Development, Downstream

M-F 1st shift

Summary:

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

The Scientist - Process Development, Downstream will perform a variety of laboratory procedures in Downstream Process Development. The Scientist - Process Development, Downstream is expected to have advanced knowledge of principles, theories, and concepts applicable to wide range of work in a downstream discipline and broad knowledge of principles and concepts applicable to protein purification. This position is expected to apply technical and functional knowledge to assist in experiment/project design that will enable the downstream process development team to meet goals.

The Role:

• Execute laboratory work plan (including data entry).

• Schedule development plans with input from supervisor or senior team member.

• Author 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.

• Participate in client meetings offering technical support and leading the project.

• Manage client projects.

• Act as the technical lead for client development projects, communicate project status internally and externally, and effectively provide technical explanation/rationalization.

• Critically analyze complex data, interpret and integrate experimental results with project objectives.

• Write procedural SOPs, batch production records, and reports.

• Accurately review batch records and other data, ensuring consistency.

• Execute purification experiments including automated chromatography (AKTA platform), filtration, clarification, column packing, and tangential flow filtration independently.

• Knowledge of protein purification and analysis with an in depth understanding of all modes of chromatography.

• Knowledge of scale up principles with respect to purification and filtration.

• Update group members on background and status of client projects by giving oral updates or internal presentations.

• Troubleshoot and problem solve in order to initiate and execute/monitor corrective actions.

The Candidate

• Bachelor's degree in a STEM discipline and 6-9 years related experience, OR

• Master's degree in a STEM discipline and 3-5 years related experience, OR

• Doctorate Degree in a STEM discipline and 0–2 years related experience.

• Process scale chromatography and filtration (viral, chromatography, tangential flow, normal flow) experience

• Operating, maintaining, and troubleshooting chromatography workstations and process skids, preferably in an industrial setting

• Viral clearance validation, process scale up, and technology transfer

• Knowledge and experience working in a cGMP environment

• Good documentation practices (GDP)

• Aseptic technique experience

• Experience writing standard operating procedures, batch records, and reports

• Experience mentoring junior staff regarding laboratory procedures and scientific projects

P osition Benefits:

• 152 hours PTO & 8 Holidays

• Medical, Dental & Vision Benefits and 401k

• 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 Catalent Careers (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .