Senior Analytical Chemist (Quality Control)
Essential Requirements: Undergraduate and graduate degrees in chemistry, chemical engineering, physics, or material sciences. Experience in analytical, formulation, and synthetic chemistry. Experience in a GMP (or similarly regulated) laboratory. Pharmaceutical and/or biotechnology industry experience required.
Responsibilities:
- Sampling and testing of raw materials, intermediates, and finished products using current pharmacopoeias, any associated ‘wet’ chemistry, and instrumental techniques (HPLC, UHPLC, IR, UV, CAD), as appropriate.
- Method development for material characterization (peptide, small molecule, and nanoparticle).
- Analyze results of experimental studies and write reports for both corporate records and regulatory bodies.
- Providing reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA), process development reports, method development reports, and stability reports.
- Knowledge of common formulation techniques and methodologies.
- Knowledge of common HPLC softwares (Workstation, Chromeleon, ChemLab).
- Method Development and Tech Transfer.
- Developing and/or performing all formulation requirements on new formulas; includes creation of theoretical formulation, bench mix development, product description/formulation sheet, lab tests, stability testing/monitoring, color verification, etc.
- Prepare and execute analytical method validation protocols and studies.
- Prepare and execute stability studies on various materials.
- Writing of briefs and reports summarizing data and conclusions.
- Stability testing of products for new formulations and ongoing stability trials, using physical (pH, viscosity) and instrumental (HPLC, UV) techniques as appropriate.
- Writing analytical specifications using current pharmacopoeias and ICH guidelines and reviewing existing analytical specifications.
- Assist in verification studies as required.
- Inventory monitoring.
- Calibrating analytical equipment as required, working with vendors to maintain service contracts for equipment.
- Ensuring procedures are carried out carefully and accurately to eliminate errors.
- Ensuring good relations and communication within the team.
- Ability to explain analytical work and progress to other personnel or trainees.
- Observing and complying with GMP, Health and Safety Policies, and SOPs.
- Undertaking any other duties within the department or other departments as requested by the manager, with proper training and understanding.
Person Profile:
- Highly proficient in the use of key analytical equipment (HPLC, UHPLC, IR, UV) and testing of finished products.
- Demonstrable track record and skills/experience in a similar position at a similar level.
- Experience working in a GMP environment.
- Good IT skills, e.g., Microsoft Office.
- Credible and confident communicator (written and verbal) at all levels.
- Meticulous attention to detail and high standards.
- Excellent planning, organizational, and time management skills.
- Ability to work accurately under pressure, adhering to deadlines.
- Strong analytical and problem-solving skills, with good math skills.
- Self-motivated, proactive, and committed to learning and development.
Location: Boston Metropolitan Area
Salary and Benefits: Commensurate with experience. Competitive salary and benefits, with potential stock options.
Additional Information
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Research, Analyst, and Information Technology
- Industries: Biotechnology