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Full Time Downstream Process Development Scientist Jobs

The successful candidate will drive scientific excellence in downstream processing (DSP)-including ... These benefits are offered exclusively to permanent full-time employees. Contractors are not ...

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Full Time Downstream Process Development Scientist information

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How much do full time downstream process development scientist jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for full time downstream process development scientist in the United States is $38.66, according to ZipRecruiter salary data. Most workers in this role earn between $28.37 and $46.15 per hour, depending on experience, location, and employer.

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.
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Infographic showing various Full Time Downstream Process Development Scientist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $80,420 per year, or $38.7 per hour.

Associate Director/Director, Formulation & Downstream Process Development

Pivotal Life Sciences

San Diego, CA โ€ข On-site

Full-time

Re-posted 13 days ago


Job description

Job Title: Associate Director/Director, Formulation & Downstream Process Development

Location:San Diego

Job Type:Full-Time

About Us:A new stealth-mode biotech focused on in vivo gene editing.

Job Summary:We are seeking an Associate Director/Director to lead downstream process development for our targeted lipid nanoparticle (tLNP) platform. This is a hands-on, lab-based role focused on the purification, concentration, and buffer exchange of tLNP drug product using size exclusion chromatography (SEC), tangential flow filtration (TFF), and complementary downstream unit operations. The successful candidate will be a technical expert in nanoparticle purification, responsible for developing robust, scalable downstream processes that deliver high-purity tLNP product while preserving particle integrity, targeting functionality, and cargo activity. This individual will also contribute to formulation development, stability assessment, and technology transfer to CDMOs. Title and salary commensurate with experience.

The Director will provide scientific and technical leadership for downstream process development activities, partnering cross-functionally to establish strategy, and support advancement of the company's tLNP platform while remaining an active technical contributor.

Key Responsibilities:

  • Design, optimize, and execute downstream purification processes for targeted LNPs, with emphasis on SEC (gravity flow and column chromatography, including CIMmultus monolithic columns) and TFF (hollow fiber and flat sheet cassettes) at research and pilot scale.
  • Develop and optimize TFF operating parameters including transmembrane pressure, cross-flow rate, membrane molecular weight cutoff selection, diafiltration volumes, and flux decay management to maximize product recovery and minimize particle stress.
  • Establish SEC-based purification methods to separate assembled tLNP product from free protein, unincorporated lipid components, and process-related impurities; optimize resin selection, column loading, and elution conditions.
  • Characterize downstream process intermediates and final drug product using DLS, zeta potential, nanoparticle tracking analysis (NTA), cryo-TEM, encapsulation efficiency assays, and protein/lipid quantitation methods.
  • Evaluate and benchmark alternative and emerging purification modalities (e.g., bind-elute chromatography, membrane chromatography, depth filtration) for tLNP applications.
  • Develop and optimize final formulation and buffer exchange conditions to ensure tLNP stability, including excipient screening, cryoprotectant selection, and lyophilization feasibility assessment.
  • Lead process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs) for downstream unit operations.
  • Support technology transfer of downstream processes to CDMOs, including process documentation (batch records, SOPs, technical reports), on-site support, and process troubleshooting.
  • Collaborate with formulation scientists, analytical scientists, and biology teams to ensure downstream processes preserve LNP integrity, targeting ligand functionality, and cargo bioactivity.
  • Design and execute process development studies using DOE approaches to systematically optimize purification and formulation parameters.
  • Maintain detailed electronic laboratory notebooks and contribute to regulatory filings (IND/CTA) for downstream process and drug product CMC sections.
  • Stay current with advances in nanoparticle purification, LNP downstream processing, and scalable manufacturing technologies.
  • Provide scientific leadership for downstream process development strategy.
  • Establish technical priorities across multiple programs.
  • Partner cross-functionally with Formulation, Biology, Analytical, CMC, Manufacturing, and Regulatory.
  • Represent downstream process development in technical and strategic discussions.

Qualifications:

  • PhD. in Chemical Engineering, Biomedical Engineering, Pharmaceutics, Chemistry, Biochemistry, or a related field with 5+ years of industry experience; or M.S. with 8+ years of relevant industry experience, or B.S. with 10+ years of relevant experience.
  • Demonstrated hands-on expertise in TFF process development for nanoparticle or biopharmaceutical applications, including membrane selection, process optimization, and scale-up.
  • Direct experience with SEC or chromatographic purification of lipid nanoparticles, liposomes, or related colloidal drug delivery systems.
  • Strong understanding of LNP formulation and characterization, including DLS, zeta potential, cryo-TEM, encapsulation efficiency, and particle stability assessment.
  • Experience defining CPPs and CQAs for downstream processes and contributing to process characterization and validation.
  • Proficiency with DOE-based experimental design and statistical analysis of process development data.
  • Excellent scientific communication skills, including technical report writing, SOPs, and presentation of data to cross-functional teams.
  • Ability to work independently in the lab, manage multiple projects, and mentor junior scientists.
  • Demonstrated experience leading scientific programs and influencing cross-functional teams.
  • Experience mentoring and developing scientists.
  • Ability to establish technical strategy while remaining an active scientific contributor.

Preferred Qualifications:

  • Direct experience with targeted or functionalized nanoparticle purification, including separation of decorated particles from free targeting ligands (e.g., antibodies, peptides, aptamers).
  • Experience with monolithic column chromatography (e.g., CIMmultus) or membrane chromatography for nanoparticle purification.
  • GMP manufacturing experience for LNP or liposomal drug products, including process validation, batch record authoring, and deviation investigation.
  • Experience with AAV or viral particle purification and characterization.
  • Experience with lyophilization process development for nanoparticle formulations.
  • Familiarity with regulatory requirements for CMC sections of gene therapy INDs (ICH Q8-Q12) and experience supporting technology transfer to CDMOs.
  • Track record of scientific publications and/or patents in LNP purification, downstream processing, or nanoparticle formulation.

Benefits:

  • Competitive salary, equity, and benefits package. Salary Range $120,000 - $220,000 per year
  • Opportunities for professional growth and development.
  • Fast-paced collaborative and innovative work environment.

How to Apply:Interested candidates should submit their resume and a cover letter detailing their relevant experience. To be considered for the role, applicants must be:

  1. Eligible to work in the United States for any employer without sponsorship.
  2. Able to work onsite in the lab located in San Diego.
  3. A direct candidate and not from a third party, i.e. staffing agency.