In Vivo Research Associate II/Study Director
Apply NowCompany: Pacific BioLabs
Location: Hercules, CA 94547
Description:
Job Type
Full-time
Description
JOB DUTIES:
Perform Test Sample/Article administration via various routes including intraperitoneal (IP), subcutaneous (SQ), intravenous (IV), intramuscular (IM), inhalation, oral gavage, ophthalmic, and dermal dosing. Participate in a range of in vivo tests such as Toxin Potency Testing, Toxin Safety Testing, Sensitization Testing, Irritation Testing, Systemic Testing, and Implantation Testing. Engage in intra-departmental testing such as In Vitro Cell-Based Potency Assay. Perform or assist in surgical procedures involving anesthesia administration, monitoring of animals, subcutaneous/intramuscular implantation of Sponsor-provided Test Article/medical devices, and observation of clinical signs. Provide veterinary aid to laboratory animals under the guidance of attending veterinarians. Perform or assist in necropsy and specimen collection, including organ tissues, blood (whole blood, plasma, serum), fecal, and urine samples. Carry out tissue fixation for immunohistochemistry, H&E staining, or clinical chemistry. Prepare buffer/diluent for Test Sample/Article and conduct sterility testing to ensure the absence of microbial contamination. Prepare Test Sample/Article through dilution/extraction processes for toxin and non-toxin testing. Assume the role of Study Director (GLP) or Lead Analyst (GMP) for specific in vivo studies (as directed by In vivo Department management). Duties may include ACUP (Animal Care and Use Protocol), SOPs (Standard Operation Procedures) and Study Protocol review, and Study conduct (scheduling, securing test material and animal preparation, dose administration and clinical observation, data collection and review, and report of analysis, etc.). As Study Director (GLP) or Lead Analyst (GMP), ensure that all reasonable requests from In Vivo Department management pertaining to the conduct of a given test or group of tests are met in a timely and effective manner. Provide appropriate staff with notification of any special requests regarding log-in, reporting, and billing activities. Ensure that all reasonable client requests pertaining to the conduct of a given test are met in a timely and ultimately effective manner. Ensure that testing submitted by clients is completed within established parameters governing turnaround time, quality specifications, etc. Ensure that all animals housed at the facility are consistently treated in a humane manner as specified in current USDNNIH regulations. Ensure that other Study Directors (GLP) and Lead Analysts (GMP) working in the In vivo Services Department receive the help and cooperation they need to successfully complete their studies. Participate in review and approval of appropriate department ACUPs, SOPs and Protocols. Assist in training new employees on basic and advanced procedures. Maintain thorough knowledge and understanding of all general SOPs pertaining to the in vivo laboratory and the conduct of in vivo studies. Consistently operate in compliance with GMP/GLP regulations as these pertain to work performed in the in vivo laboratory. Develop an understanding of the experimental, scientific, and regulatory basis for conduct of specific studies conducted in the In vivo Services Department. Develop and implement new techniques and procedures within the In vivo Department for support of testing. Adhere to PBL personnel policies as specified in the Employee Handbook and to relevant PBL SOPs governing documentation and reporting. Comply with PBL SOPs pertaining to the handling of client complaints. Participate in general staff training sessions as these are scheduled and in company-wide projects (e.g., the Strategic Planning effort) designed to improve the overall effectiveness of PBL. Participate in the design and execution of laboratory testing in accordance with Standard Operating Procedures and/or client-protocols.
Requirements
MINIMUM REQUIREMENTS:
Bachelor's degree in Animal Science, or closely related field. 2 years of work experience in the offered position, as Research Associate, or in a closely related position.
This notice of job vacancy is being provided as a result of the filing of an application for permanent alien labor certification for an In Vivo Research Associate II/Study Director. Any person may provide documentary evidence bearing on the application to:
United States Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210
Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors.
Salary Description
91,000
Full-time
Description
JOB DUTIES:
Perform Test Sample/Article administration via various routes including intraperitoneal (IP), subcutaneous (SQ), intravenous (IV), intramuscular (IM), inhalation, oral gavage, ophthalmic, and dermal dosing. Participate in a range of in vivo tests such as Toxin Potency Testing, Toxin Safety Testing, Sensitization Testing, Irritation Testing, Systemic Testing, and Implantation Testing. Engage in intra-departmental testing such as In Vitro Cell-Based Potency Assay. Perform or assist in surgical procedures involving anesthesia administration, monitoring of animals, subcutaneous/intramuscular implantation of Sponsor-provided Test Article/medical devices, and observation of clinical signs. Provide veterinary aid to laboratory animals under the guidance of attending veterinarians. Perform or assist in necropsy and specimen collection, including organ tissues, blood (whole blood, plasma, serum), fecal, and urine samples. Carry out tissue fixation for immunohistochemistry, H&E staining, or clinical chemistry. Prepare buffer/diluent for Test Sample/Article and conduct sterility testing to ensure the absence of microbial contamination. Prepare Test Sample/Article through dilution/extraction processes for toxin and non-toxin testing. Assume the role of Study Director (GLP) or Lead Analyst (GMP) for specific in vivo studies (as directed by In vivo Department management). Duties may include ACUP (Animal Care and Use Protocol), SOPs (Standard Operation Procedures) and Study Protocol review, and Study conduct (scheduling, securing test material and animal preparation, dose administration and clinical observation, data collection and review, and report of analysis, etc.). As Study Director (GLP) or Lead Analyst (GMP), ensure that all reasonable requests from In Vivo Department management pertaining to the conduct of a given test or group of tests are met in a timely and effective manner. Provide appropriate staff with notification of any special requests regarding log-in, reporting, and billing activities. Ensure that all reasonable client requests pertaining to the conduct of a given test are met in a timely and ultimately effective manner. Ensure that testing submitted by clients is completed within established parameters governing turnaround time, quality specifications, etc. Ensure that all animals housed at the facility are consistently treated in a humane manner as specified in current USDNNIH regulations. Ensure that other Study Directors (GLP) and Lead Analysts (GMP) working in the In vivo Services Department receive the help and cooperation they need to successfully complete their studies. Participate in review and approval of appropriate department ACUPs, SOPs and Protocols. Assist in training new employees on basic and advanced procedures. Maintain thorough knowledge and understanding of all general SOPs pertaining to the in vivo laboratory and the conduct of in vivo studies. Consistently operate in compliance with GMP/GLP regulations as these pertain to work performed in the in vivo laboratory. Develop an understanding of the experimental, scientific, and regulatory basis for conduct of specific studies conducted in the In vivo Services Department. Develop and implement new techniques and procedures within the In vivo Department for support of testing. Adhere to PBL personnel policies as specified in the Employee Handbook and to relevant PBL SOPs governing documentation and reporting. Comply with PBL SOPs pertaining to the handling of client complaints. Participate in general staff training sessions as these are scheduled and in company-wide projects (e.g., the Strategic Planning effort) designed to improve the overall effectiveness of PBL. Participate in the design and execution of laboratory testing in accordance with Standard Operating Procedures and/or client-protocols.
Requirements
MINIMUM REQUIREMENTS:
Bachelor's degree in Animal Science, or closely related field. 2 years of work experience in the offered position, as Research Associate, or in a closely related position.
This notice of job vacancy is being provided as a result of the filing of an application for permanent alien labor certification for an In Vivo Research Associate II/Study Director. Any person may provide documentary evidence bearing on the application to:
United States Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210
Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors.
Salary Description
91,000