Research Scientist

Responsibilities

• Method Development, Validation & Transfer
• Develop, optimize, and validate HPLC, UHPLC, and GC methods for the identification and quantification of APIs, vitamins, excipients, and related impurities.
• Serve as technical lead for method validation and verification activities of limited scope, exercising initiative and judgment to deliver to program timelines.
• Transfer validated methods to QC laboratories and contract testing partners; lead method troubleshooting and forensic investigations of unexpected analytical results.
• Generate and interpret data to support specification setting for new and existing products.
• Laboratory Operations & Testing
• Operate and maintain analytical instrumentation including HPLC, UHPLC, GC, UV-Vis spectrophotometers, dissolution apparatus, and Karl Fischer titrators.
• Perform stability testing and physical testing methods (e.g., dissolution, rheology, particle size, content uniformity) for prototype and commercial products.
• Prepare reagents, mobile phases, standards, and sample solutions; support laboratory safety, housekeeping, inventory, and periodic compliance audits.
• Documentation & Compliance
• Maintain accurate, contemporaneous records in laboratory or electronic laboratory notebook (ELN) systems, consistent with ALCOA+ data integrity principles.
• Author and review analytical method procedures, validation protocols, and validation reports, applying sound technical judgment.
• Lead or support investigations of laboratory deviations and out-of-specification (OOS) or out-of-trend (OOT) data.
• Adhere to cGMP, GLP, USP/NF, EP, ICH, and applicable FDA requirements (21 CFR Parts 111, 210, 211).
• Technical Leadership & Collaboration
• Function in a semi-independent role as a consistent contributor and technical driver across all assigned projects, taking responsibility for technical projects of limited scope or defined parts of larger, more complex efforts.
• Deliver at least one essential, measurable contribution per the manager’s expectations—e.g., innovative methods, technique/process improvements, resolution of a significant technical issue, technical reports, or peer-reviewed lectures or presentations.
• Partner with Formulation Development, Quality Control, Regulatory Affairs, Manufacturing, contract manufacturers, and CROs to support project deliverables; provide guidance to junior scientists and technicians.
• Manage personal resources and laboratory time across concurrent projects, and present technical findings in team meetings and project updates.

Requirements

• Minimum Education: B.S. in Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related physical or biological science from an accredited institution.
• Preferred: M.S. or Ph.D. in Analytical Chemistry, Chemistry, or Pharmaceutical Sciences, with coursework in instrumental analysis, separation science, and pharmaceutical analysis.
• Minimum Experience: B.S. with a minimum of 3 years, M.S. with a minimum of 2 years, or Ph.D with 0–2 years of relevant analytical or pharmaceutical laboratory experience (assessed on a case-by-case basis), including hands-on HPLC analytical method development for cGMP use and a demonstrated record of semi-independent contribution.
• Preferred: Method development experience with vitamins, dietary supplements, or oral solid dosage forms; familiarity with USP monograph and compendial testing; and exposure to manufacturing processes and forensic investigation approaches.

Required Skills

• Analytical techniques: reversed-phase HPLC and UHPLC (isocratic and gradient); detection by UV/PDA, RI, fluorescence, and ELSD (LC-MS a plus); GC/GC-MS principles; sample preparation (extraction, dilution, filtration, SPE); dissolution, rheology, and particle size testing.
• Scientific knowledge: strong foundation in analytical chemistry and separation science; experimental design and basic statistical evaluation; pharmaceutical dosage forms and excipients; vitamin chemistry; ICH guidelines (Q1A, Q2, Q3) and USP General Chapters (e.g., , , ).
• Software & data systems: chromatography data systems (Empower, OpenLab, or Chromeleon); Microsoft Office, including Excel for statistical calculations; ELN and LIMS familiarity preferred.
• Attention to detail and commitment to data accuracy and integrity, with a problem-solving and analytical troubleshooting mindset.
• Strong written and verbal communication for technical reporting and cross-functional collaboration, including with external partners.
• Effective time management across concurrent projects and a collaborative, continuous-learning orientation within a multidisciplinary R&D environment.

Physical & Work Environment Requirements

• Laboratory environment with exposure to chemicals, solvents, and equipment; required use of PPE (lab coat, safety glasses, gloves).
• Ability to stand for extended periods, lift up to 25 lbs, and perform repetitive motions associated with sample preparation.
• Standard business hours, with occasional flexibility to support project timelines or stability pulls.

Benefits

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review