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Research Associate

2 months ago

San Carlos, United States Medterials, Inc Full time

Job Description

Job Title: Research Associate / QC Chemist

Reports to: Director of Analytical Services

Location: San Carlos, CA 94070 USA


Position: Full Time, Monday-Friday. Weekend work may be required to meet project and production timelines.


Summary: Medterials is seeking a QC Chemist to work in a small, specialty pharmaceutical manufacturing and development company. This person’s primary responsibility is to perform analytical testing of GMP drug intermediates and maintenance of the analytical equipment. The person will also assist in development of new test methods and refinement of existing analytical methods.  We are looking for a committed, detail-oriented individual who can carry out routine tests compliant to GMP/GLP practices, and can contribute to assay development to support both QC and R&D efforts. 


Duties and Responsibilities 

1)    Analytical Tasks:

a)    Independently prepare solutions and samples for HPLC assays, operate HPLC and LCMS.

b)    Independently prepare solutions used in testing and sample preparations for other analytical assays.

c)    Analyze results including basic statistical metrics such as means and standard deviations.

d)    Operate common lab equipment, such as analytical scale, pH meter, densitometer, spectrophotometer etc.

e)    Perform analytical testing with DSC, Karl Fischer, rheometer, training to be provided if necessary.

f)     Maintain data integrity and ensure compliance with company SOP’s and Work Instructions.

g)    Accurately file out forms, logbooks, recording experimental details electronically and in an assigned lab notebook.

h)    Assist in analytical method development, optimization and validations.

i)     Assist in writing test methods for lab instruments, work instructions and reports.

2)    Maintenance Tasks:

a)    Must be able to maintain and troubleshoot HPLC assays.

b)    Able to perform maintenance and troubleshoot basic lab equipment.

c)    Maintain analytical equipment and keep a clean environment for the lab.

d)    Clean glassware for HPLC and general chemical lab usage.

e)    Manage hazardous waste and satellite collection points.

f)      Maintain analytical supplies and materials inventory.

3)    Assist others in Manufacturing activities including verifying tasks and countersigning GMP documents, and other activities as required.


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:

Minimum Bachelor's degree (BS/ BA) in Analytical Chemistry, Biochemistry or related field. A minimum of four to five years GMP industry experience required, preferably in the pharmaceutical industry.  HPLC experience is required, Waters systems and Empower software preferred. 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 in a timely manner.


Software Skills:

To perform this job successfully, candidate must have a working knowledge of using Microsoft Office Suite (Word and Excel), Waters Empower HPLC Software and basic internet tasks.


Equipment:

HPLC                                     pH Meter

LC-MS                                    Osmometer

Spectrophotometer                Karl Fischer

Difference Scanning Calorimeter

Densitometer

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 exposed to toxic or caustic chemicals. Work environment is 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. The employee is occasionally required to help others to lift or move heavy objects, such as equipment, containers, furniture, etc.


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. B

San Carlos, CA 94070 USA

info@medterials.com