Lab Technologist – In Vitro

Planet Pharma; Northwood (OH); On-site; USD 42,000 - 65,000; Full time

Job summary

Planet Pharma seeks an associate with laboratory experience to execute routine testing per SOPs and analyze data under GLP standards in our Ohio facility.

The role involves cell line maintenance, sample preparation, extraction per ISO/USP/JHMW regulations, and collaboration with Study Directors and QA. Training and some administrative duties may be provided.

Qualifications

• Basic mathematical knowledge is essential for calculations.
• One year relevant laboratory experience preferred.
• Bachelor’s degree in biology or related scientific field is required.

Responsibilities

• Executes routine lab testing per SOPs, with appropriate data analysis.
• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
• Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing.
• Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
• Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
• Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required.
• May assist Associates with performing routine test article/product preparation according to work instructions.
• May communicate test schedule updates to management as needed.
• Maintains ancillary records (logbooks, worksheets).
• May be required to perform personal gowning, environmental testing, and submitting organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing.
• Adheres to established company processes.
• May provide administrative support.
• May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
• Completes chain of custody documentation for test article tracking.
• Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• May assist in ordering and/or stocking supplies subject to approval
• May assist trainers or may become a certified trainer to provide Associates with on the job training for basic lab tasks, media preparation, or cell work.
• Other duties as assigned

Skills

Basic mathematical knowledge

Laboratory experience

Education

Bachelor's degree in Biology or related field

Job description

Job Description:

• Executes routine lab testing per SOPs, with appropriate data analysis
• Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits).
• Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing.
• Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays.
• Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits.
• Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized.
• Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory.
• Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required.
• May assist Associates with performing routine test article/product preparation according to work instructions.
• May communicate test schedule updates to management as needed.
• Maintains ancillary records (logbooks, worksheets).
• May be required to perform personal gowning, environmental testing, and submitting organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing.
• Adheres to established company processes.
• May provide administrative support.
• May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed.
• Completes chain of custody documentation for test article tracking.
• Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• May assist in ordering and/or stocking supplies subject to approval
• May assist trainers or may become a certified trainer to provide Associates with on the job training for basic lab tasks, media preparation, or cell work.
• Other duties as assigned

Qualifications & Technical Competencies:

• One year relevant laboratory experience preferred.
• Basic mathematical knowledge is essential for surface area/volume ratio calculations that are part of the sample preparation process.
• Bachelor’s degree in biology or related scientific field is required.Individuals with sufficient relevant work experience may be considered at the discretion of management.