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Associate Downstream Process Development Scientist Jobs in California

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Downstream Process Development Scientist / Tech Transfer Consultant * Employment Type: Contract ... Associate Director * Industry: Biotechnology / Biopharmaceutical Manufacturing Viltis is seeking an ...

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Associate Downstream Process Development Scientist information

What is an associate downstream process development scientist?

An Associate Downstream Process Development Scientist is a professional who works in the biotechnology or pharmaceutical industry, focusing on developing and optimizing processes that purify biological products, such as proteins or antibodies, after they have been produced by cells. Their work is crucial for ensuring the final product meets quality and safety standards before it is used in research or clinical applications. They typically perform laboratory experiments, analyze data, and collaborate with other scientists and engineers to improve yield and efficiency. This role is often entry-level or early-career, providing hands-on experience in process development and technical troubleshooting.

What are the key skills and qualifications needed to thrive as an associate downstream process development scientist, and why are they important?

To excel as an Associate Downstream Process Development Scientist, you need a solid understanding of biochemistry, chemical engineering, and downstream purification techniques, often supported by a bachelor's or master's degree in a life science or engineering discipline. Familiarity with chromatographic systems (such as AKTA), filtration equipment, and analytical tools, as well as knowledge of GMP/GLP regulations, is typically required. Strong problem-solving, attention to detail, and effective teamwork and communication skills help you navigate complex experiments and collaborate with cross-functional teams. These skills ensure efficient process optimization, compliance with regulatory standards, and successful development of biopharmaceutical products.

What is the difference between Associate Downstream Process Development Scientist vs Associate Upstream Process Development Scientist?

AspectAssociate Downstream Process Development ScientistAssociate Upstream Process Development Scientist
Primary FocusPurification and recovery of bioproductsCell culture and fermentation processes
Required SkillsProtein purification, chromatography, filtrationCell culture, bioreactor operation, media preparation
Work EnvironmentLaboratories, manufacturing facilitiesLaboratories, bioreactor labs
Common CertificationsBiotech or bioprocessing certificationsBiotech or bioprocessing certifications

Both roles are essential in biopharmaceutical development, focusing on different stages of the production process. The Associate Downstream Process Development Scientist specializes in purification techniques, while the Associate Upstream Process Development Scientist concentrates on cell growth and fermentation. Understanding these distinctions helps candidates target their skills and career paths effectively.

What are some typical challenges faced by an associate downstream process development scientist, and how can they be addressed?

Associate Downstream Process Development Scientists often encounter challenges such as optimizing purification processes, troubleshooting equipment performance, and ensuring batch-to-batch consistency. These challenges can be addressed by maintaining meticulous documentation, collaborating closely with upstream and analytical teams, and staying current with best practices in chromatography and filtration. Proactively seeking feedback from experienced colleagues and participating in cross-functional meetings can also help in identifying solutions and improving process efficiency.

What are the most commonly searched types of Downstream Process Development Scientist jobs in California?

The most popular types of Downstream Process Development Scientist jobs in California are:

What cities in California are hiring for Associate Downstream Process Development Scientist jobs?

Cities in California with the most Associate Downstream Process Development Scientist job openings:

Downstream Process Development Scientist - Tech Transfer Consultant

Viltis

San Carlos, CA • On-site

$75 - $90/hr

Contractor

Retirement

Posted 21 hours ago

Posted today

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Job description

Downstream Process Development Scientist / Tech Transfer Consultant 

  • Employment Type: Contract
  • Compensation: $75–$90/hour, depending on experience and technical background.
  • Function: Process Development / Manufacturing Sciences / Technology Transfer
  • Reporting To: Associate Director
  • Industry: Biotechnology / Biopharmaceutical Manufacturing

Viltis is seeking an experienced Downstream Process Development / Tech Transfer Consultant to support a biotechnology client with downstream process development, pilot plant execution, scale-up, and technology transfer activities.

This contract position will work as part of an established process development team and report to an Associate Director. The consultant will take ownership of key downstream technical workstreams while partnering closely with internal cross-functional teams and external CMO/CDMO manufacturing partners.


Key Responsibilities

  • Support downstream process development, optimization, scale-up, and technology transfer activities.
  • Lead significant portions of downstream technical execution with external CMO/CDMO partners.
  • Support pilot plant and on-site scale-up activities, including execution, troubleshooting, and process evaluation.
  • Provide technical leadership for downstream unit operations, including membrane filtration and tangential flow filtration (TFF).
  • Develop, review, and support technical documentation associated with process development and technology transfer.
  • Evaluate process performance, identify technical risks, and recommend appropriate solutions during scale-up and manufacturing transfer.
  • Partner with Process Development, Manufacturing, Quality, Regulatory, and other cross-functional groups to ensure successful execution of program objectives.
  • Support activities associated with Process Performance Qualification (PPQ) campaigns.
  • Contribute to commercial manufacturing readiness and product launch activities.
  • Participate in technical discussions, investigations, troubleshooting, and decision-making with internal teams and external manufacturing partners.
  • Ensure downstream processes are appropriately transferred, understood, and executable at the receiving manufacturing site.
  • Operate effectively within a broader technical team while independently owning assigned downstream workstreams.

Required Qualifications

  • 10+ years of experience in biopharmaceutical process development, with substantial experience focused on downstream processing.
  • Strong technical expertise in downstream process development and scale-up.
  • Demonstrated experience with technology transfer to manufacturing facilities and/or CMO/CDMO partners.
  • Hands-on experience with membrane filtration and tangential flow filtration (TFF).
  • Experience supporting pilot-scale or manufacturing-scale downstream operations.
  • Strong understanding of downstream process parameters, process characterization, troubleshooting, and scale-up considerations.
  • Ability to independently lead technical workstreams while collaborating effectively within a multidisciplinary team.
  • Strong technical communication, documentation, problem-solving, and stakeholder-management skills.


Preferred Qualifications

  • Experience supporting PPQ campaigns.
  • Experience supporting commercial product launches or commercial manufacturing readiness.
  • Previous experience working directly with CMOs/CDMOs on process transfer and manufacturing execution.
  • Experience supporting biologics manufacturing in a regulated GMP environment.
  • Experience transitioning processes from development through clinical and commercial manufacturing.


About Viltis

Viltis provides specialized consulting and workforce solutions to organizations across the biotechnology, pharmaceutical, medical device, and life sciences industries. We connect experienced technical professionals with projects where their expertise can make an immediate impact.