Research Scientist

Responsibilities Method Development, Validation & Transfer : Develop, optimize, and validate HPLC, UHPLC, and GC methods for the identification and quantification of active pharmaceutical ingredients (APIs), vitamins (fat- and water-soluble), excipients, and related impurities in pharmaceutical and nutraceutical formulations. Method Development, Validation & Transfer : Serve as technical lead for method validation and verification activities of limited scope, exercising initiative and judgment to deliver to program timelines. Method Development, Validation & Transfer : Transfer validated methods to QC laboratories and contract testing partners; lead method troubleshooting and forensic investigations of unexpected analytical results. Method Development, Validation & Transfer : 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. Laboratory Operations & Testing : Perform stability testing and physical testing methods (e.g., dissolution, rheology, particle size, content uniformity) for prototype and commercial products. Laboratory Operations & Testing : 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. Documentation & Compliance : Author and review analytical method procedures, validation protocols, and validation reports, applying sound technical judgment. Documentation & Compliance : Lead or support investigations of laboratory deviations and out-of-specification (OOS) or out-of-trend (OOT) data. Documentation & Compliance : 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. Technical Leadership & Collaboration : 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. Technical Leadership & Collaboration : Partner with Formulation Development, Quality Control, Regulatory Affairs, Manufacturing, contract manufacturers, and CROs to support project deliverables; provide guidance to junior scientists and technicians. Technical Leadership & Collaboration : 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. 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. For U.S. locations that require disclosure of compensation, the starting pay for this role is between $70,000 and $95,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. #J-18808-Ljbffr