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Senior Scientist Downstream Process Development Jobs in Frederick, MD

GAP SOLUTIONS INC

Biologist (50849)

Gaithersburg, MD

Develop downstream (purification) processes, under the supervision of a project lead scientist, for ... Coordinate with project management to ensure development milestones and study deliverables are met ...

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Senior Scientist Downstream Process Development information

See Frederick, MD salary details

$66.1K

$109.9K

$163.6K

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

As of Aug 24, 2026, the average yearly pay for senior scientist downstream process development in Frederick, MD is $109,911.00, according to ZipRecruiter salary data. Most workers in this role earn between $91,000.00 and $124,300.00 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?

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 Frederick, MD as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 19% Part Time, and 2% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution, with an average salary of $109,911 per year, or $52.8 per hour.

Senior Scientist I, Method Development (Immunoassay)

Pharmaron

Germantown, MD • On-site

$95K - $115K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 16 days ago

Job description

Senior Scientist I, Method Development (Immunoassay)
Salary: $95K-$115K
Location: Germantown, MD
About Pharmaron
Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.
We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit .
About the Role
We are seeking an independent, hands-on Senior Scientist I with strong large-molecule bioanalytical method development experience to join our Immunoassay team in Germantown, MD.
This role is ideal for a scientist who can own method development projects from experimental design through completion, work through technical challenges independently, and apply sound scientific judgment when assays do not perform as expected.
The successful candidate will bring experience working in a regulated CRO bioanalytical laboratory environment, with broad hands-on expertise across PK, ADA, and biomarker assays. This person should be comfortable working at the bench, troubleshooting complex assay issues, communicating directly with sponsors and internal stakeholders, and providing technical guidance to junior scientists.
This is a hands-on scientific role, not simply a project oversight position. We are looking for someone who can independently assess a problem, determine the appropriate experimental path forward, execute the work, interpret the data, and see the project through to a successful outcome.
What You'll Do
Own Method Development Projects
  • Independently lead day-to-day method development activities for assigned preclinical and clinical programs.
  • Design, execute, analyze, and document experiments in accordance with SOPs, regulatory expectations, and project requirements.
  • Take ownership of projects from initial method optimization through pre-validation and, when applicable, validation or qualification.
  • Aid in identifying technical issues in Method Qualification/Validation or Sample Analysis and determine appropriate troubleshooting strategies.
  • Work through unexpected experimental results and see technical challenges through resolution and project completion.
  • Ensure methods are scientifically sound, robust, reproducible, and fit for their intended purpose and stage of drug development.

Apply Broad Bioanalytical Expertise
  • Develop and optimize large-molecule ligand-binding assays (LBA) supporting:
    • Pharmacokinetics (PK)
    • Anti-drug antibodies (ADA)
    • Biomarkers/PD
  • Apply expertise across a range of large-molecule modalities, including monoclonal antibodies, bispecifics, ADCs, ASOs, fusion proteins and peptides.
  • Use sound scientific judgment to select and optimize assay formats, reagents, platforms, and experimental conditions.
  • Interpret assay performance and make data-driven decisions regarding method refinement.

Troubleshoot & Solve Problems
We are looking for a scientist who does more than execute established procedures.
You should be able to:
  • Recognize when an assay is not performing as expected.
  • Develop a logical troubleshooting strategy.
  • Design experiments to identify root causes.
  • Evaluate competing hypotheses and determine the most scientifically appropriate path forward.
  • Optimize assay conditions based on experimental data.
  • Make independent decisions while knowing when escalation or additional input is appropriate.
  • Drive problems through resolution rather than simply identifying them.

Work Directly with Sponsors & Internal Teams
  • Serve as a technical point of contact for assigned studies.
  • Participate in sponsor discussions and provide clear, scientifically sound study updates.
  • Present and explain experimental results, conclusions, challenges, and recommendations.
  • Collaborate with project teams, laboratory staff, leadership, and Business Development.
  • Support proposal development, study scoping, and technical discussions when needed.
  • Manage multiple priorities while maintaining quality and project timelines.

Mentor & Provide Scientific Leadership
  • Provide technical guidance and day-to-day scientific support to junior laboratory staff.
  • Review experimental approaches, data, and documentation.
  • Help establish strong scientific and laboratory practices across the team.
  • Contribute to scientific presentations, conferences, posters, and publications when appropriate.

What We're Looking For
Required Experience
  • PhD in a relevant scientific discipline with 5-6 years of experience in regulated large-molecule bioanalytical environments, including 3-4 years of independent method development leadership; or
  • Master's degree with 6-7 years of relevant experience, including 4-5 years of independent method development leadership; or
  • Bachelor's degree with 7-8 years of relevant experience, including at least 5-6 years in a regulated environment supporting large-molecule drug development.

Critical Qualifications/The strongest candidates will have:
  • Previous CRO or client-facing bioanalytical experience
  • Demonstrated ability to independently own method development projects from design through completion
  • Strong hands-on experience across PK, ADA, and biomarkers
  • Deep troubleshooting and assay optimization experience
  • Hands-on experience with multiple LBA platforms
  • Ability to communicate directly with sponsors and defend scientific decisions
  • Experience working through complex technical problems without requiring extensive direction

Bioanalytical Platforms
Extensive hands-on experience with multiple established LBA platforms is strongly preferred, including platforms such as:
  • MSD
  • Gyros
  • AlphaLISA / Alpha
  • ELISA Spectrophotometry
  • Similar established ligand-binding assay platforms

Experience with flow cytometry and/or PCR-based platforms is an added plus.
Experience with SoftMax and Watson LIMS is strongly preferred.
What Success Looks Like
Success in this role means you can take a method development problem and own it.
You will be expected to:
  • Develop methods on time and ensure they meet scientific and project requirements.
  • Responsible for monthly Method Development financial revenue targets.
  • Work independently while appropriately escalating critical issues.
  • Identify assay problems quickly and develop effective troubleshooting strategies.
  • Make scientifically defensible decisions based on data.
  • Drive experiments through optimization and resolution rather than stopping at problem identification.
  • Deliver complete, well-documented, high-quality work.
  • Clearly communicate results, challenges, and recommendations to sponsors and internal stakeholders.
  • Provide meaningful scientific guidance to junior staff.
  • Build strong client relationships through reliable execution and technical expertise.

Why Pharmaron?
Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.
Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
  • Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
  • 401(k) Retirement Plan with generous employer matching
  • Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
  • Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
  • 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
  • Employee Assistance Program (EAP), mental health resources, and wellness programs
  • Family-friendly benefits, including fertility support and maternity resources
  • Professional development and career growth opportunities within a leading global CRO/CDMO

How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
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