Quality Control Analytical Chemist

Benefits

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

QC Analytical Chemist

Chief Scientific Officer

981-G Industrial Rd. San Carlos, CA 94070 USA

Full Time, Monday-Friday. Overtime and weekend work may be required to meet project and production timelines.

Medterials is seeking a QC Analytical Chemist with chemistry education and experience to work in a small, specialty pharmaceutical manufacturing and development company. This person’s primary responsibility is to work within the QC department to perform analytical testing of GMP drug intermediates. The person will also work in development of new analytical methods, refinement of existing analytical methods and perform method validations.

The person will also participate in equipment and laboratory maintenance for the analytical department. We are looking for a committed, detail-oriented individual who can carry out routine analytical tests compliant to GMP/GLP practices primarily using HPLC’s, but can also contribute to assay development and problem solving to support both QC and R&D efforts. The position is full time and on site at Medterials in San Carlos, CA.

• Analytical Tasks:
  • Independently perform HPLC and LCMS assays following GMP regulations.
  • Independently perform other analytical assays including Particle Size Analysis, Karl Fischer titration, Differential Scanning Calorimetry, Fluorescence Spectroscopy, following the company’s Test Methods and GMP regulations.
  • Perform new method development, design and execute validation of the new test methods.
  • Provide R&D support with analytical development, design of experiments, investigations, and testing.
  • Analyze analytical results including basic statistical metrics such as means and standard deviations, confidence intervals, correlation analysis.
  • Operate common lab equipment, such as analytical scale, pH meter, densitometer, spectrophotometer etc.
  • Maintain data integrity and ensure compliance with company SOP’s and Work Instructions.
  • Accurately fill out GMP forms, logbooks, record experimental details electronically and in an assigned lab notebook following ALCOA guidelines.
  • Assist in writing test methods for lab instruments, work instructions, investigations and testing reports.
• Maintenance Tasks:
  • Must be able to maintain and troubleshoot equipment used in assays.
  • Maintain analytical equipment and keep a clean environment for the lab.
  • Clean glassware and tools for assays and general chemical lab usage.
  • Manage hazardous waste and satellite collection points.
  • Maintain analytical supplies and materials inventory.

To perform this job successfully, an individual must be able to perform each essential duty independently and satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Chemistry degree is required. Minimum requirements are a Bachelor’s degree (BS) in Chemistry with at least four years GMP pharmaceutical industry experience or a Master’s degree (MS) in Analytical Chemistry or other Chemistry field with at least two years GMP pharmaceutical industry experience. Entry level with no experience will be considered for candidates with a Doctor of Philosophy (PhD) in Analytical Chemistry, Physical Chemistry, Organic Chemistry, or Medicinal Chemistry.

HPLC experience is required; LCMS experience is a plus.

Must be organized and detail oriented. Must be able to manage time efficiently. Must be able to work effectively with staff members of different backgrounds. Able to troubleshoot problems associated with assays and equipment that are being used.

Must be able to follow verbal instructions and written protocols. Must be able to communicate any issue or problem with Supervisor and laboratory staff in a timely manner. Most be able to assimilate data and produce comprehensive technical reports.

To perform this job successfully, candidates must have a working knowledge of Microsoft Office Suite (Word and Excel), HPLC Analysis Software, and basic internet tools. Statistical analysis software experience is a…