Analytical R&D Scientist
Job Title:
Analytical Research & Development Scientist (Injectables, Analytical Method Development)
đź“Ť Location: 12393 Belcher Rd S, Ste 450 | Largo, FL 33773 | USA
🏢 Company: BPI Labs LLC
đź•“ Job Type: Full-Time
🎓 Target Applicants: Master’s and PhD candidates in Pharmaceutical Sciences, Analytical Chemistry, or related fields
About Us
BPI Labs LLC is a rapidly growing pharmaceutical company specializing in the research, development, and manufacturing of complex injectable drug products. Our mission is to advance innovation in sterile formulations through scientific excellence, robust analytical capabilities, and unwavering quality standards. We are expanding our Analytical Research & Development (AR&D) team to support the characterization and method development of drug substances and finished injectable products that meet global regulatory expectations.
Job Overview
We are seeking a highly motivated Analytical Research & Development Scientist with a strong background in analytical method development and pharmaceutical analysis. This role involves developing, validating, and transferring analytical methods for both drug substance (API) and drug product (injectables). The successful candidate will play a key role in supporting formulation development, stability programs, and regulatory submissions.
Key Responsibilities
Analytical Method Development & Validation
Design, develop, and validate analytical test methods for drug substances (APIs) and finished injectable products, ensuring accuracy, specificity, precision, and robustness.
Develop impurity profiling, stability-indicating methods, and dissolution or release methods where applicable.
Support analytical method transfer to Quality Control or contract testing laboratories.
Characterization & Testing
Characterize physical and chemical properties of drug substances and formulations using advanced analytical techniques (e.g., UPLC, GC, GC-MS, LC-MS, SEC-MALLS, Zetasizer, Ion Chromatography).
Conduct compatibility, extractables/leachables, and degradation studies.
Execute stability studies in compliance with ICH guidelines, interpret data trends, and support specification setting.
Instrumentation & Troubleshooting
Operate and maintain analytical instruments such as UPLC, HPLC, GC, GC-MS, SEC-MALLS, UV-Vis, FTIR, Zetasizer, and other relevant technologies.
Troubleshoot analytical issues and optimize existing methods for better performance and reproducibility.
Collaboration & Documentation
Work closely with Formulation Development, Quality Assurance, and Manufacturing teams to support all stages of product development.
Prepare and review analytical method validation protocols, reports, stability summaries, and regulatory documentation per USFDA and ICH standards.
Ensure accurate and compliant documentation in laboratory notebooks and electronic systems.
Continuous Improvement
Stay current with emerging analytical technologies, regulatory trends, and scientific literature.
Recommend and implement analytical improvements to enhance laboratory efficiency and data quality.
Qualifications
Master’s or PhD in Pharmaceutical Sciences, Analytical Chemistry, or related field.
1–5 years of experience in pharmaceutical analytical method development (preferred, but recent graduates with strong research experience are encouraged to apply).
Hands-on experience with UPLC/HPLC, GC, GC-MS, SEC-MALLS, Ion Chromatography, and particle size analysis (Zetasizer).
Strong understanding of analytical validation per ICH Q2(R2) and USFDA requirements.
Knowledge of stability studies, impurity profiling, and regulatory documentation practices.
Excellent communication, problem-solving, and organizational skills.
Ability to work collaboratively in a dynamic, cross-functional environment.
What We Offer
Hands-on training in state-of-the-art analytical technologies.
Opportunities to work on novel injectable product development projects from concept to regulatory submission.
A collaborative and innovative workplace culture with mentorship from experienced scientists.
Competitive compensation and growth opportunities within a fast-expanding organization.
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BPI Labs LLC
Position Title: Analytical Research & Development Scientist (Injectables, Analytical Method Development)
Location: 12393 Belcher Rd S, Suite 450, Largo, FL 33773, USA
Job Type: Full-Time
About BPI Labs LLC
BPI Labs LLC is a rapidly growing pharmaceutical company based in Largo, Florida, specializing in the research, development, and manufacturing of complex injectable drug products. We are committed to scientific innovation, operational excellence, and compliance with the highest standards of quality. Our mission is to develop safe, effective, and high-quality pharmaceutical products that meet global regulatory standards and improve patient outcomes.
As part of our continued expansion, we are strengthening our Analytical Research & Development (AR&D) capabilities to support the development of advanced injectable formulations and ensure robust analytical support throughout the product life cycle.
Position Summary
BPI Labs LLC is seeking a highly motivated and detail-oriented Analytical Research & Development Scientist to join our AR&D team. The ideal candidate will possess strong scientific and technical expertise in analytical method development, validation, and characterization for both drug substances (APIs) and drug products (injectables). This position offers the opportunity to work on a variety of challenging and innovative projects in a fast-paced, collaborative environment.
Key Responsibilities
Analytical Method Development and Validation
Develop, optimize, and validate analytical test methods for drug substances (APIs) and finished injectable products in accordance with ICH and USFDA guidelines.
Establish stability-indicating, impurity profiling, dissolution/release, and characterization methods for new drug formulations.
Support method transfer and verification activities with Quality Control and external contract testing laboratories.
Testing and Characterization
Conduct analytical testing and characterization of raw materials, intermediates, APIs, and finished products using advanced analytical instruments such as UPLC, HPLC, GC, GC-MS, LC-MS, SEC-MALLS, Zetasizer, Ion Chromatography, UV-Vis, and FTIR.
Perform stability studies, degradation profiling, compatibility assessments, and extractable/leachable studies.
Evaluate analytical data for product specifications, trending, and regulatory submission.
Laboratory Operations and Troubleshooting
Operate, calibrate, and maintain laboratory instruments to ensure data reliability and instrument performance.
Troubleshoot method or equipment issues, propose corrective actions, and document results.
Maintain a safe and compliant laboratory environment following cGMP, GLP, and safety standards.
Collaboration and Documentation
Work closely with Formulation Development, Quality Assurance, Manufacturing, and Regulatory Affairs teams to support development and commercialization activities.
Prepare technical reports, analytical method validation protocols, method transfer documents, and stability summaries in alignment with regulatory expectations.
Ensure complete, accurate, and timely documentation in laboratory notebooks and electronic systems.
Continuous Learning and Innovation
Stay current with emerging analytical technologies, ICH/FDA regulatory updates, and industry trends.
Recommend and implement new techniques to enhance analytical capability and laboratory efficiency.
Qualifications and Experience
Master’s or PhD in Pharmaceutical Sciences, Analytical Chemistry, or a related discipline.
Hands-on experience in analytical method development and validation for pharmaceutical injectables (preferred).
Working knowledge of UPLC/HPLC, GC, GC-MS, SEC-MALLS, Zetasizer, Ion Chromatography, and related analytical tools.
Understanding of ICH Q2(R2), cGMP, and USFDA analytical method validation guidelines.
Strong analytical thinking, problem-solving ability, and technical writing skills.
Excellent teamwork and communication skills with a commitment to quality and scientific integrity.
What We Offer
Exposure to cutting-edge analytical technologies and advanced method development platforms.
Opportunities for career growth within a dynamic and expanding organization.
A collaborative, innovation-driven environment where scientific excellence is recognized and rewarded.
Comprehensive training, mentorship, and performance-based professional development.