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Senior Scientist Downstream Process Development Jobs

Kelly Services

Senior Scientist

Lincoln, NE · On-site

$79K - $123K/yr

Senior Scientist, Research & Development Location: Lincoln, Nebraska (Onsite) Schedule: Monday ... from R&D into manufacturing environments. * Develop scalable upstream and downstream processes ...

Amgen, Inc.

Process Development Sr Scientist

Thousand Oaks, CA · On-site

$96K - $131K/yr

Process Development Sr Scientist What you will do Let's do this. Let's change the world. In this vital role you will join Amgen's Attribute Sciences (AS) department within the Process Development (PD ...

Amgen

Process Development Sr Scientist

Thousand Oaks, CA

$96K - $131K/yr

Process Development Sr Scientist What you will do Let's do this. Let's change the world. In this vital role you will join Amgen's Attribute Sciences (AS) department within the Process Development (PD ...

Lundbeck

Downstream Development Associate II

Bothell, WA · On-site

$38 - $45/hr

... Process Science & Validation Team. The Lu-SBP team leads and supports the development of new ... Summary: Performs downstream process development experiments and supporting activities, which ...

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How much do senior scientist downstream process development jobs pay per year?

As of Jul 11, 2026, the average yearly pay for senior scientist downstream process development in the United States is $110,545.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,500.00 and $125,000.00 per year, depending on experience, location, and employer.

What does a Senior Scientist in Downstream Process Development do?

A Senior Scientist in Downstream Process Development focuses on developing, optimizing, and scaling up processes to purify biological products such as proteins or antibodies after cell culture (the 'downstream' part of biomanufacturing). They design experiments, analyze data, and work with cross-functional teams to ensure product quality and regulatory compliance. Their role is critical in moving biopharmaceutical products from research to commercial production by ensuring efficient and robust purification processes.

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

To thrive as a Senior Scientist in Downstream Process Development, you need advanced knowledge in bioprocess engineering, protein purification, and process scale-up, typically supported by a Ph.D. or Master’s degree in a relevant field. Expertise with chromatography systems (such as AKTA), analytical instrumentation, and familiarity with regulatory requirements like GMP are essential. Strong problem-solving abilities, leadership, and effective communication skills distinguish top performers in this role. These competencies are crucial for developing robust, scalable processes that meet quality standards and drive successful product development.

What are some common challenges faced by Senior Scientists in Downstream Process Development, and how can they be addressed?

Senior Scientists in Downstream Process Development often encounter challenges such as optimizing purification processes for novel biologics, scaling up from lab to production scale, and ensuring product consistency and regulatory compliance. Addressing these challenges typically involves close collaboration with cross-functional teams, continuous process optimization, and staying current with industry advancements in chromatography and filtration technologies. Proactive problem-solving, effective communication, and leveraging data analytics are also key strategies for overcoming obstacles in this role.
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Senior Scientist Downstream Process Development jobs near you
Infographic showing various Senior Scientist Downstream Process Development job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $110,545 per year, or $53.1 per hour.
Associate Director, Downstream Process Development

Associate Director, Downstream Process Development

Allakos

Redwood City, CA • On-site

Full-time

Re-posted 12 days ago

Job description

Associate Director, Downstream Process Development
Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases.
Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:
As a member of the Allakos team you will have the opportunity to be a key member of the Biologics DS development and Tech Transfer team and responsible for activities related to Downstream Process Development of our late-stage clinical biologic (Mab) molecule AK002 and other early-stage programs. This position will be responsible for the Process Development, Tech Transfer, and oversite of Engineering/Clinical batches at contract manufacturing site/s. Additionally, there will be a strong focus on BLA-enabling activities including process characterization, PPQ Batches and BLA authoring and review.
Your Role:
  • Provide technical leadership to the Downstream Process Development group and technology transfer of AK002 process to CMO sites.
  • Accountable for activities pertaining to the downstream process development lab. Supervise planning and execution of experiments. Analyze results and communicate them effectively to management.
  • Coordinate with Upstream Development, Analytical, and Facilities departments to successfully complete the DSP activities.
  • Provide input for the strategy and experimental plan for downstream process characterization studies. Generate protocols, supervise execution, use statistical tools to analyze results, and review reports for studies.
  • Assist in the planning of downstream process development experiments for new molecules and supervise execution of the same.
  • Supervise the Engineering and Clinical batches at CMOs, review and approve Deviations and CAPA documents for these batches.
  • Plan and supervise PPQ batches at CMOs. Review and approve protocols and reports for PPQ batches.
  • Author BLA submission documents.
  • Travel domestically and internationally up to 10% of the time.
What We Value:
  • At least 12 years of relevant experience (10+ with M.S., 8+ for Ph.D.) successfully working in the biopharmaceutical industry with proven track record of leadership and success.
  • At least 5 years managing cross functional projects and leading teams.
  • Extensive experience in Downstream Process Development and process characterization of biologics, such as Mabs and fusion proteins.
  • Strong background in statistical design of experiments (DoE) and associated analysis
  • Experience in technology transfer and facility fit assessments.
  • Should have worked with late and commercial stage biologics, with experience in process development, process characterization, PPQ batches, and other BLA enabling studies and CPV programs.
  • Experience working with Contract Manufacturers is preferred.
  • Experienced in BLA submission write ups.
  • Experienced in people and stakeholder management, conflict resolution, and building consensus.
  • Good understanding of cGMP-regulations including relevant US/EU regulatory and quality requirements, practices, and standards.
  • Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams.
  • Ability to travel at least 10% of the time.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership.
Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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About Allakos

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

51 - 200 Employees

Headquarters location

Redwood City, CA, US

Year founded

2012

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