Senior Scientist I, Method Development (Immunoassay)

Pharmaron • Germantown, MD

2d • Onsite

About The Position

Pharmaron is 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.

Requirements

• 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.
• 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
• 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 SoftMax and Watson LIMS is strongly preferred.

Nice To Haves

• Experience with flow cytometry and/or PCR-based platforms is an added plus.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree