Quality Control Analytical Chemist

MEDTERIALS INC; San Carlos (CA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Health insurance

Vision insurance

Job summary

Medterials, a small specialty pharmaceutical manufacturing and development company in San Carlos, is seeking a QC Analytical Chemist. You will perform analytical testing of GMP drug intermediates in the QC department, develop and validate analytical methods, and help maintain lab equipment and SOP compliance.

The role emphasizes problem solving, data integrity, ALCOA adherence, and collaboration with R&D. Expect hands-on work with HPLC, LCMS, Karl Fischer, DSC, UV-Vis, and routine method

Qualifications

• Bachelor’s degree in Chemistry with 4+ years GMP pharma experience, or MS with 2+ years.
• PhD in Analytical/Physical/Organic/Medicinal Chemistry considered.
• HPLC experience required; LCMS experience a plus.

Responsibilities

• Independently perform HPLC and LCMS assays following GMP regulations.
• Develop and validate new analytical methods.
• Support QC and R&D with analytical development and DOE.
• Maintain data integrity per ALCOA and complete GMP documentation.
• Operate equipment including pH meters, densitometer, and spectrophotometers.
• Provide equipment maintenance and help manage lab inventory.

Skills

Analytical testing

GMP compliance

ALCOA data integrity

Method development

Troubleshooting

Education

Bachelor's degree in Chemistry

Master's degree in Analytical Chemistry

PhD in Analytical/Chemistry

Tools

HPLC software

LC-MS software

Microsoft Excel

Statistical software

Job description

Benefits

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

Job Title

QC Analytical Chemist

Reports to

Chief Scientific Officer

Location

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

Position

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

Summary

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.

Duties and Responsibilities

• 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.

Qualifications

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.

Education/Experience

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.

General Skills

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.

Language Ability

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.

Software Skills

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 plus.

Equipment

• HPLC
• LC-MS
• Karl Fischer Titrator
• UV-Vis/Fluorescence Spectroscopy
• Bright Field/Dark Field Microscopy
• Densitometer
• Differential Scanning Calorimetry
• Osmometer
• pH Meter
• Rheometer

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may occasionally be exposed to fumes or airborne particles and regularly potentially exposed to toxic or caustic chemicals. The work environment and procedures are set up to minimize chemical exposure to all workers.

The noise level in the work environment is usually moderate.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands, talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand, walk, reach with hands and arms. The employee must occasionally lift and/or move up to 30 pounds.

Equal Opportunity Employer

Medterials is an equal opportunity employer. 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.

Contact

Medterials, Inc.
981 Industrial Rd. Ste. G
San Carlos, CA 94070 USA
650-394-8613
[e-mail]