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Full Time Downstream Process Development Scientist Jobs in Wisconsin

Oterra

Product Development Scientist

Sturtevant, WI

... scientific and engineering principles in the research, development and production of color ... Learns and uses processing equipment in lab and pilot plant with minimal supervision including ...

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Full Time Downstream Process Development Scientist information

What does a Full Time Downstream Process Development Scientist do?

A Full Time Downstream Process Development Scientist is responsible for designing, optimizing, and scaling up processes that purify biological products such as proteins, antibodies, or vaccines after they are produced in cells or microbes. This role involves developing and improving techniques like filtration, chromatography, and centrifugation to ensure high purity and yield of the final product. The scientist also conducts experiments, analyzes data, and collaborates with cross-functional teams to transfer processes from the lab to manufacturing. Their work is critical for producing safe and effective biopharmaceuticals on a large scale.

What is the difference between Full Time Downstream Process Development Scientist vs Downstream Process Engineer?

AspectFull Time Downstream Process Development Scientist
Primary FocusDesigning, optimizing, and developing downstream purification processes for biopharmaceuticals
Required CredentialsBachelor's or Master's in Biotechnology, Biochemistry, or related field; experience in process development
Work EnvironmentLaboratories, R&D settings, collaborative teams in biotech or pharma companies
Typical ResponsibilitiesProcess scale-up, method validation, troubleshooting, documentation

While both roles involve downstream bioprocessing, the Full Time Downstream Process Development Scientist focuses on process development and optimization, whereas the Downstream Process Engineer typically handles process implementation and manufacturing support. The scientist role emphasizes research and development, while the engineer role is more operational. Candidates often hold similar degrees and certifications, but their daily tasks and focus areas differ.

What are some typical challenges faced by a Downstream Process Development Scientist, and how can they be addressed?

Downstream Process Development Scientists often encounter challenges such as optimizing protein purification processes to achieve high yield and purity, troubleshooting unexpected impurities, and scaling up processes from laboratory to manufacturing scale. These tasks require strong problem-solving skills, meticulous attention to detail, and effective collaboration with upstream teams, analytical scientists, and manufacturing staff. Addressing these challenges involves staying current with new purification technologies, maintaining robust documentation, and participating in cross-functional meetings to ensure seamless process integration and regulatory compliance.

What are the key skills and qualifications needed to thrive as a Full Time Downstream Process Development Scientist, and why are they important?

To thrive as a Full Time Downstream Process Development Scientist, you need a strong background in biochemical engineering, protein purification, and analytical techniques, typically supported by a degree in biochemistry, biotechnology, or a related field. Proficiency with chromatography systems (e.g., HPLC, FPLC), filtration technologies, and knowledge of regulatory and quality systems like GMP is essential. Strong problem-solving abilities, teamwork, and effective communication skills help you collaborate with cross-functional teams and troubleshoot process challenges. These skills are crucial for developing robust purification processes that ensure product quality, regulatory compliance, and efficient production in biopharmaceutical environments.
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Full Time Downstream Process Development Scientist jobs near you
Senior Scientist - Downstream Process Development, mRNA

Senior Scientist - Downstream Process Development, mRNA

Catalent Pharma Solutions

Madison, WI • On-site

$92K - $126K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 3 days ago

Catalent rating

7.6

Company rating: 7.6 out of 10

Based on 54 frontline employees who took The Breakroom Quiz

50th of 74 rated pharmaceutical

Job description

Senior Scientist - Downstream Process Development, mRNA

Position Summary:

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

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. 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.

Catalent Pharma Solutions in Madison, WI is hiring a Senior Scientist - Downstream Process Development, mRNA. The Process Development Senior Scientist, mRNA will lead and support the development, optimization, and process characterization of manufacturing processes for mRNA-based therapeutics and vaccines, spanning early-phase clinical through commercial programs. This role requires hands-on expertise in mRNA process development, including in vitro transcription (IVT), purification, and analytical characterization. The scientist will bring deep mRNA technical expertise and demonstrate continuous learning and adaptability, recognizing that supporting multiple modalities, including protein biologics, may be required to meet evolving client and business needs.

The Role:

  • Design andoptimizeIVT reactions, enzymatic processing, andpurificationworkflows

  • Develop scale-down models and execute DOE studies for process characterization andprocess development
  • Author process development reports, validation protocols, and risk assessments (FMEA, CPP identification)
  • Definea control strategy for mRNA DS (CPPs, CQAs, IPCs, acceptance criteria, sampling plans) and defending it through late phase / commercial readiness
  • Apply Quality by Design (QbD) principles and statistical tools for process characterization and PPQ readiness
  • Ensure compliance with FDA, EMA, and ICH guidelines for process validation and lifecycle management
  • Establish andmaintainSOPs for mRNA synthesisandpurification to ensure reproducibility and compliance
  • Collaborate with analytical teams for method development and validation of mRNA drugsubstance.Experience authoring or reviewing method validation/qualification strategy and understanding suitability for intended use (development vs GMP release)preferred
  • Ability to support downstream process development for monoclonal antibodies and other protein modalitiespreferred.
  • Participate in tech transfer activities to GMP manufacturing sites for both mRNA and protein programs.
  • Process scale chromatography and filtration (chromatography, tangential flow, normal flow) experience
  • Operating,maintaining, and troubleshooting chromatographyworkstationsand process skids preferably in an industrial setting
  • 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 staffregardinglaboratory procedures and scientific projects
  • Other duties as assigned.

The Candidate:

  • Bachelor's degree in a STEM discipline and 8-15 years related experience, OR
  • Master's degree in a STEM discipline and 5-10 years related experience, OR
  • Doctorate Degree in a STEM discipline and 2-4 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 project

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.

Visit Catalent Careers 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.

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About Catalent

Sourced by ZipRecruiter

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.

Industry

Pharmaceutical product wholesalers

Company size

10,000+ Employees

Headquarters location

Somerset, NJ, US

Year founded

2007

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