Senior Analytical Scientist – Small Molecule Development
Pay Rate: $65–$85/hour, depending on experience
Employment Type: 6-Month Contract (potential for extension or permanent conversion)
Schedule: Monday–Friday, 9:00 AM–5:00 PM
Start Date: ASAP/2 weeks of offer
Position Overview
We are seeking an experienced Senior Analytical Scientist to join the Pharmaceutical Sciences group within the CMC Development & Manufacturing department of a clinical-stage biopharmaceutical company focused on oncology drug development.
This is a highly hands‑on laboratory position supporting small molecule pharmaceutical development, with an emphasis on analytical method development, product characterization, instrumentation, and troubleshooting.
The selected candidate will collaborate closely with Process Chemistry (Drug Substance), Formulation (Drug Product), and Analytical Sciences teams to support analytical activities across multiple development programs.
The ideal candidate will have a strong background in small molecule pharmaceutical R&D, extensive analytical instrumentation experience, and the ability to independently conduct experiments, interpret data, troubleshoot complex analytical challenges, and present scientific findings.
Key Responsibilities
- Independently lead analytical development and product characterization activities supporting small molecule drug candidates.
- Develop, optimize, and troubleshoot analytical methods to support early- and late-stage pharmaceutical development.
- Perform hands‑on analytical testing and characterization using instrumentation such as HPLC/UPLC, GC, LC‑MS, UV‑Vis, FTIR, Karl Fischer, DSC, TGA, and XRPD.
- Operate, troubleshoot, maintain, and support the qualification or validation of analytical laboratory instruments.
- Design and execute experiments, analyze samples, interpret results, and recommend solutions to analytical challenges.
- Support analytical testing and characterization of both drug substances (APIs) and formulated drug products.
- Collaborate with Process Chemistry, Formulation Development, and other CMC functions to support development activities.
- Assist with troubleshooting analytical challenges associated with external contract development and manufacturing organizations (CDMOs).
- Utilize laboratory software such as Agilent OpenLab CDS, ChemStation, and Waters Empower for instrument control, data acquisition, processing, and reporting.
- Maintain accurate, detailed, and timely experimental documentation using electronic laboratory notebooks (ELNs).
- Analyze experimental data, identify trends, and prepare technical reports summarizing findings and recommendations.
- Develop scientific presentations and communicate analytical results through internal meetings, technical discussions, and seminars.
- Author or review technical documentation, analytical reports, and relevant sections of regulatory submissions.
- Follow established laboratory procedures, safety standards, and applicable GLP/cGMP requirements.
- Work independently with minimal supervision while collaborating effectively with multidisciplinary scientific teams.
Required Qualifications
- Strong hands‑on experience in small molecule pharmaceutical or biotechnology development is required.
- Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline with 8+ years of relevant research experience, OR
- Ph.D. in a related scientific discipline with 3+ years of hands‑on pharmaceutical or biotechnology industry experience, OR
- Bachelor's degree in a relevant scientific discipline with 10+ years of extensive industry experience, including demonstrated ability to independently conduct research, analyze results, and present scientific findings.
- Strong background in pharmaceutical R&D, analytical development, CMC, or small molecule characterization.
- Extensive hands‑on experience with analytical instrumentation, including chromatography and other characterization techniques such as HPLC, GC, LC‑MS, UV‑Vis, FTIR, Karl Fischer, DSC, TGA, and XRPD.
- Demonstrated experience independently developing, optimizing, and troubleshooting analytical methods.
- Familiarity with Agilent OpenLab CDS and ChemStation or comparable chromatography data systems.
- Experience maintaining laboratory documentation using an electronic laboratory notebook (ELN).
- Strong scientific problem‑solving skills and the ability to independently investigate and resolve analytical challenges.
- Experience interpreting complex analytical data and preparing detailed scientific reports.
- Strong technical communication skills, including the ability to present experimental findings and recommendations to scientific teams.
- Ability to work independently in a fast‑paced, hands‑on laboratory environment with limited supervision.
- Excellent organizational skills, attention to detail, and ability to manage multiple scientific priorities.
Preferred Qualifications
- Experience supporting drug product development, formulation, or analytical characterization of finished pharmaceutical products.
- Experience working in late‑stage pharmaceutical development, particularly Phase III clinical programs.
- Previous experience collaborating with CDMOs or contract research organizations (CROs).
- Experience supporting both drug substance and drug product analytical activities.
- Experience with analytical method transfer, regulatory filings, or commercialization activities.
- Hands‑on experience in a pharmaceutical manufacturing or production environment.
- Experience delivering technical seminars, scientific presentations, or communicating complex analytical findings to cross‑functional teams.
- Familiarity with Waters Empower and additional chromatography data systems.
Additional Information
This opportunity offers the chance to contribute to late-stage oncology drug development within a collaborative pharmaceutical R&D environment.
The position is highly laboratory-focused and offers exposure to multiple areas of CMC development, including analytical sciences, process chemistry, and formulation development.
The initial contract is expected to last approximately six months, with potential for permanent employment based on business needs and performance; conversion is not guaranteed.
Compensation: $65–$85/hour, depending on qualifications and experience.