Associate Scientist

Job Description

PRINCIPAL ACCOUNTABILITIES:

Microbiological Assays and Testing

Turbidimetric/Chromogenic/Gel Clot method for the detection of bacterial endotoxins

Microbial Limits Test/Bioburden determination, manipulation, and maintenance of ATCC microorganisms and microbial isolates

Sterility Test, Growth Promotion and Particulate Matter determination using instrumentation and/or microscopy

Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods

Perform sample shipments to contract testing laboratories

Validation Support

Ability to perform bioburden swab testing by current detection methods.

Ability to perform biological indicator testing by current methods.

Ability to perform endotoxin challenge vial testing.

GMP Documentation

Document test results and conclusions in a GMP manner

Ensure test forms are complete before submission for approval

Data entry for finished products and raw material in Laboratory Information Management System

Performs responsibilities in compliance with company quality systems and regulatory requirements

Adheres to all company safety, health and environmental policies, procedures, and directives

Conducts all laboratory activities in a safe manner by use of SDS and Safety Notifications to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel

Ensures all equipment is in a GMP/validated/calibrated state before use

Technical Writing

Develop and execute protocols and Standard Operating Procedures for the implementation of microbiology equipment, assays and test methods

Reviews data generated by laboratory personnel

Provides guidance and training to other laboratory personnel on operation of instruments and performing test methods

Ability to troubleshoot instruments in the event of any problems

Utilizes classical microbiological methods for the identification of microorganisms per current version of Bergey’s Manual of Systematic Bacteriology

Support of Environmental Monitoring Program

Utilities –Testing of clean steam, USP water, and Water for Injection for bioburden, total organic carbon (TOC), and presence of endotoxins; and nitrogen and process air for total microbial count and total particulates

Environmental Monitoring of facilities for non-viable particulates, viable air and surface by use of calibrated and validated monitoring equipment and procedures.

Other Responsibilities:

Performs responsibilities in compliance with company quality systems

Adheres to all company safety, health and environmental policies, procedures and directives

Conducts all laboratory activities in a safe manner by use of SDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel

Data analysis and entry into software systems such as Microbiology Information Management Systems

STRATEGIC FOCUS:

The focus desired and expected on the position over the next 1-3 years

Perform responsibilities in compliance with company quality systems and provide support to all manufacturing activities

Adhere to all company environmental, health and safety policies and procedures

Conduct all laboratory and cleanroom activities in a safe manner and according to appropriate written procedures.

Perform microbiological assays according to US, EU, ISO regulations and company procedures and test methods

Maintain the laboratory metrics program. Complete the qualification of sanitizers used in the manufacturing facilities.

EXPERIENCE:

One year professional experience (not including college labs)

Lab testing experience

Pharmaceutical experienceCompany Description

Dynamic Engineering firm with incredible team culture and long term growth opportunities!

Full-time