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Full Time Downstream Process Development Scientist Jobs in California

Debut Biotech

Staff Process Engineer

San Diego, CA

This individual will serve as a subject matter expert in downstream processing, assisting a team of scientists and engineers through process development at bench, pilot, and manufacturing scale. The ...

Debut Biotech

Staff Process Engineer

San Diego, CA · On-site

This individual will serve as a subject matter expert in downstream processing, assisting a team of scientists and engineers through process development at bench, pilot, and manufacturing scale. The ...

Amgen

Process Development Senior Scientist

Thousand Oaks, CA

$96K - $131K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Process Development Senior Scientist What you will do Let's do this. Let's change the world. In ... downstream processing for oral solid dosage forms. * Experience supporting oral solid dosage form ...

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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 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.

What are some typical challenges faced by a full time 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 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.

How much does a full time downstream process development scientist make?

In California, a full-time downstream process development scientist typically earns between $80,000 and $130,000 annually, depending on experience, education, and the specific employer. Salaries may also include benefits such as health insurance and bonuses, with higher compensation often associated with advanced skills in bioprocessing and laboratory techniques.

What is a full time downstream process development scientist?

A full-time downstream process development scientist specializes in designing, optimizing, and scaling the purification processes used in biopharmaceutical manufacturing, such as chromatography and filtration. They work to improve product yield, purity, and efficiency, often using laboratory techniques and process modeling tools, typically within a regulated environment requiring compliance with industry standards.

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 are popular job titles related to Full Time Downstream Process Development Scientist jobs in California?

For Full Time Downstream Process Development Scientist jobs in California, the most frequently searched job titles are:

What job categories do people searching Full Time Downstream Process Development Scientist jobs in California look for?

The top searched job categories for Full Time Downstream Process Development Scientist jobs in California are:

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

Full Time Downstream Process Development Scientist jobs near you

Associate Director / Director, CMC Process Development

NGM Biopharmaceuticals

South San Francisco, CA • Hybrid

$180K - $220K/yr

Full-time

Re-posted 13 days ago

Job description

Associate Director / Director, CMC Process Development

Company Overview

NGM Biopharmaceuticals, Inc. is a privately held biotechnology company, focused on developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. NGM Bio's biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates, enable their rapid advancement into proof-of-concept studies and address high unmet patient need. Currently, NGM Bio is advancing NGM120, a GDF15/GFRAL antagonist antibody, to address two significant and distinct unmet needs, both of which are rooted in overactivation of the GDF15 pathway: hyperemesis gravidarum (HG) and cancer cachexia.

Position Summary

Join the CMC team at NGM Bio! Our team is responsible for late-stage development and cGMP manufacturing of monoclonal antibody therapeutics. In this role, you will work with the Head of CMC Development to create and execute late-stage development strategies while providing technical oversight of CDMOs for upstream/downstream process development and cGMP manufacturing.

  • Location: South San Francisco, CA
  • Work Mode: Hybrid (Minimum 2 days on-site per week)
  • Travel: 10-20% domestic and international travel

Responsibilities

  • Serve as the technical CMC lead for a late-stage monoclonal antibody (mAb) project.
  • Provide technical oversight of CDMOs for upstream/downstream process optimization, scale-up, cGMP Drug Substance manufacturing, process characterization, and process validation.
  • Partner closely with Regulatory, Quality, Clinical Development, Program Management, and CDMO partners to ensure timely execution of CMC development plans.
  • Proactively identify upstream/downstream technical and operational risks and implement mitigation strategies to support development timelines.
  • Author, review, and approve protocols, technical reports, batch records, SOPs, and relevant sections of regulatory submissions.
  • Ensure strict adherence to cGMP guidelines and, quality and regulatory compliance.
  • Serve as a subject matter expert, including Person-in-Plant, during cGMP manufacturing, audits and regulatory interactions.

Required Experience

  • MS or PhD in Biotechnology, Biochemistry, Chemical Engineering, Chemistry, or a related field.
  • 8+ years of experience in upstream and/or downstream process development for biologics, CMC operations, and CDMO management.
  • Hands-on experience troubleshooting and optimizing biologics DS manufacturing processes and scaling up to pilot and commercial scale.
  • Deep expertise in process characterization and process qualification for commercialization.
  • Broad experience/working knowledge of formulation dev, drug product manufacturing (Vials/PFS) and or analytical development would be a plus.
  • Strong scientific problem-solving and root-cause analysis skills.
  • Extensive knowledge of GMP regulations, and CMC-related global regulatory guidelines for biologics.
  • Strong analytical, data interpretation, communication, and regulatory documentation skills.
  • Ability to work independently and effectively in a dynamic, fast-paced, collaborative small biotech environment.

Salary Ranges

At the time of posting, the wage range for this role is $180,000 - $220,000 for Associate Director level and $220,000 - $250,000 for Director level candidates located in the Bay Area.

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