Senior Scientist I, Method Development (Immunoassay)
Germantown, MD - USA
Job Summary
Position: 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 25000 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.
Were proud of the impact we make and just last year we supported 887 discovery projects 1100 CMC programs and 1397 clinical trials across all phases. Our teams are involved in everything from small molecules ADCs biologics and gene therapies and we work with more than 3300 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 Youll 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 Were Looking For
Required Experience
- PhD in a relevant scientific discipline with 56 years of experience in regulated large-molecule bioanalytical environments including 34 years of independent method development leadership; or
- Masters degree with 67 years of relevant experience including 45 years of independent method development leadership; or
- Bachelors degree with 78 years of relevant experience including at least 56 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 25000 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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Required Experience:
Senior IC
About Company
Pharmaron provides comprehensive research, development, and manufacturing services across drug discovery, preclinical, clinical, and commercialization.