The Chemist performs sample preparation, analytical testing, analysis and reporting in support of Accredited Laboratories' testing services. Working under the guidance of the Laboratory Director and senior analysts, this role ensures samples are received, prepared, tested, and documented accurately and in compliance with ISO/IEC 17025, cGLP, and FDA requirements. The Chemist plays a hands-on role in delivering timely, reliable results that clients and regulators depend on.
KEY RESPONSIBILITIES & DUTIES
Method Development & Validation
· Develop, optimize, and validate analytical methods for peptide identification, assay, purity, and related substances.
· Design and execute validation protocols in accordance with ICH, FDA, USP, and ISO 17025 requirements.
· Establish system suitability criteria, calibration procedures, and quality controls.
· Generate validation reports and maintain complete technical documentation.
· Support transfer of validated methods into routine laboratory operations.
Analytical Testing
Perform peptide analysis using: HPLC, UPLC, LCMS, UV/Vis
- Conduct routine sample preparation, analysis, data review, and result reporting.
- Perform peptide potency, identity, purity, degradation, and stability studies.
- Investigate analytical anomalies, OOS (Out-of-Specification) results, and system suitability failures.
- Record raw data accurately and completely, following good documentation practices and data integrity (ALCOA+) principles.
Instrument Operation & Maintenance
- Maintain and troubleshoot analytical instrumentation.
- Execute routine maintenance, performance verification, and calibration activities.
- Coordinate vendor service when required.
- Ensure instruments remain compliant and audit-ready.
Quality & Compliance
- Follow approved SOPs and test methods precisely; flag any deviations or out-of-specification results to a supervisor immediately.
- Support instrument calibration, qualification, and preventive maintenance activities.
- Maintain compliance with laboratory safety, chemical hygiene, and waste-handling procedures (OSHA).
- Assist with maintaining reference standards, reagents, and consumables inventory.
- Operate in compliance with ISO 17025 quality requirements and laboratory SOPs.
- Prepare and revise SOPs, test methods, worksheets, and technical documents.
- Participate in internal audits, proficiency testing, method reviews, and accreditation activities.
- Maintain accurate laboratory notebooks, electronic records, and analytical data packages.
Documentation & Data Integrity
- Complete laboratory records, worksheets, and LIMS entries accurately and in real time.
- Support internal reviews, audits, and proficiency testing (PT) sample analysis as assigned.
- Maintain training records and complete required competency assessments.
Scientific Support
- Interpret chromatographic and mass spectrometric data.
- Provide technical expertise on peptide chemistry and analytical methodologies.
- Support customer inquiries regarding peptide testing services.
- Assist business development and laboratory leadership in expanding peptide testing capabilities.
Cross-Functional Collaboration
- Communicate testing status, delays, or issues clearly to the Laboratory Director and relevant stakeholders.
- Support client and regulatory audits by providing requested records and demonstrating good laboratory practices.
- Collaborate with fellow analysts to balance workload and meet turnaround-time goals.
WHAT SUCCESS LOOKS LIKE
Accuracy & Compliance
- Testing is performed accurately and in accordance with approved methods and SOPs.
- Data is complete, legible, and audit-ready, with no findings related to documentation practices.
Timeliness
- Samples are processed and tested within target turnaround times.
- Instrument and equipment issues are reported and addressed promptly to avoid testing delays.
Team & Safety
- Laboratory safety and chemical hygiene practices are followed consistently.
- The Chemist is viewed as a reliable, detail-oriented contributor to the lab team.
QUALIFICATIONS & SKILLS
EDUCATION & EXPERIENCE
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related Scientific Discipline.
- 3-5 years of laboratory experience
- At least 2 years of direct peptide analysis experience
- Demonstrated experience with HPLC, UPLC, LCMS
- Experience developing and validating analytical methods
- Experience working in a regulated laboratory environment
- Strong understanding of:
· Peptide structure and chemistry
· Reverse-phase chromatography
· Gradient optimization
· Mass spectrometry interpretation
· Method validation principles
· Data integrity and laboratory documentation
SKILLS (REQUIRED)
- Strong understanding of laboratory practices, GLP, and data integrity principles.
- Comfortable using laboratory equipment and willing to learn analytical instrumentation
- Strong attention to detail and ability to follow written procedures precisely.
- Moderate computer skills, including data entry into LIMS or spreadsheets.
- Strong written and verbal communication skills.
- Excellent analytical and problem-solving skills.
- Effective written and verbal communication.
- Commitment to quality, accuracy, and customer service.
- Ability to work efficiently both independently and as part of a team.
PREFERRED EXPERIENCE (NOT REQUIRED)
- Experience in an ISO/IEC 17025-accredited or contract testing laboratory.
- Experience with dietary supplement, nutraceutical, food, or pharmaceutical testing.
- Familiarity with compendial methods (USP, AOAC, FCC).
WORK ENVIRONMENT & PHYSICAL REQUIREMENTS
- Laboratory environment with regular exposure to chemicals, reagents, and laboratory hazards; personal protective equipment (PPE) required.
- May require standing for extended periods and handling samples and equipment.
- Computer work and frequent communication via phone, email, and in-person discussions.
BENEFITS
- Competitive hourly rate commensurate with experience.
- Group healthcare, vision, and dental benefits.
- Paid vacation, sick leave, and holidays.
- [Retirement / 401(k), professional development, and additional benefits as applicable.]
Pay: From $80,000.00 per year
Application Question(s):
- What are your pay expectations for this position?
Work Location: In person
