Verified Job
Lab Technician / Pharmacist
Senior R&D Scientist
Lab Technician / Pharmacist
#717763
Remote / WFH
CED Analytical Laboratory Inc.
Job Description
A Medisca Partner, CED Analytical Labs is an analytics testing laboratory that delivers customized solutions with an unwavering commitment to quality and innovation that their customers can always count on. Offering worry-free and agile testing services at the highest standards of quality, CED Analytics supports partners in the pharmaceutical compounding, life-science, and healthcare industries. Committed to Partners in Wellness, CED Analytics offers an unfailing devotion to improving lives across a multitude of needs and multitude of people.
The Senior R&D Scientist serves as an active member of the pharmaceutical laboratory and provides scientific support to ongoing method/assay development and validation. This includes generation of pre-protocol documentation (development/validation plans), conducting experiments, reviewing results, and providing reports on results and conclusions. As a senior member of the R&D team, you lead by example and provide support and guidance to other members of the team.
Responsibilities & Duties:
Applies the principles, theories, and techniques of Good Laboratory Practices (GLP) to produce and report appropriate pharmaceutical laboratory results
Monitors test methods and analyses to ensure that acceptable levels of analytical performance are maintained
Provides subject matter expertise to the laboratory, using a systematic approach to problem-solving
Develops new tests/assays and/or improvements to existing tests, as required by the business.
Writes formal validation plans, timelines, and reports and provides oversight into the creation and execution of validation plans and reports of all R&D projects
Participates in the training of R&D staff in principles of methods and applications within the services according to CED Analytical Laboratory quality system procedures
Assists in the investigation, installation, evaluation, and purchase of laboratory equipment instrumentation, computer software/hardware, and other specialty items
Participates in and records quality investigations and corrective actions, where appropriate
Reviews literature and competitive information for R&D planning and analysis of results
Collaborates with various groups for study level publication planning including manuscript writing and submissions
Collaborates to achieve publications for pharmaceutical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
Generates documents to support regulatory submissions and/or responds to questions from regulatory authorities about existing submissions
Method Validation
Maintain an optimized schedule of method development activities
Perform method/sample validation including:
Method development
Generating protocol specified data
Analysis of data according to validation parameters
Statistical analysis of data; stability study trending
Validation report writing
Sample Testing
Run lab experiments and record data in laboratory notebooks with accuracy and completeness
Calculate results as required in compendial methods and procedures.
Inventory Login & Upkeep
Maintain laboratory inventory of chemicals and supplies
Check stock levels and order commonly used chemicals as needed
Remove and update inventory for expired chemicals
Periodic inventory of chemicals and supplies on hand
Keeps and maintains work area clean, neat and organized during and after processing time
Ensure all instruments used are well maintained and the workspace is kept neat.
Compliance to FDA regulations and CED SOPs
Perform other duties as assigned.
Qualifications:
MS in chemistry or a science related field, or equivalent years of method validation and development experience
Eight (8) years of laboratory experience performing analytical testing
UPLC/HPLC/GC expertise, method development and/or method validation experience required
Working knowledge of cGMP/GLP, ICH, USP/NF, FDA regulations
Knowledge of Microsoft Office suite (Word, Outlook, Teams and Excel) required
Excellent communication skills; English (oral & written) required
Strong work ethic and reliable
Excellent time management and organizational skills
Able to work under pressure and successfully function in a fast-paced environment
What’s in it for you …
We invest time and resources into making sure Medisca is as good as the people we hire.
Balance Your Life – PTO, vacation policy and paid statutory holidays
Invest in your health – Group Benefit plan and health savings account
Your Future is Bright – Opportunities to learn and grow within CED
Save for your Future – 401k plan retirement
Help us grow – Employee Referral Program
We like to have fun – company events throughout the year
We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.
#LI-Onsite
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Report job
The Senior R&D Scientist serves as an active member of the pharmaceutical laboratory and provides scientific support to ongoing method/assay development and validation. This includes generation of pre-protocol documentation (development/validation plans), conducting experiments, reviewing results, and providing reports on results and conclusions. As a senior member of the R&D team, you lead by example and provide support and guidance to other members of the team.
Responsibilities & Duties:
Applies the principles, theories, and techniques of Good Laboratory Practices (GLP) to produce and report appropriate pharmaceutical laboratory results
Monitors test methods and analyses to ensure that acceptable levels of analytical performance are maintained
Provides subject matter expertise to the laboratory, using a systematic approach to problem-solving
Develops new tests/assays and/or improvements to existing tests, as required by the business.
Writes formal validation plans, timelines, and reports and provides oversight into the creation and execution of validation plans and reports of all R&D projects
Participates in the training of R&D staff in principles of methods and applications within the services according to CED Analytical Laboratory quality system procedures
Assists in the investigation, installation, evaluation, and purchase of laboratory equipment instrumentation, computer software/hardware, and other specialty items
Participates in and records quality investigations and corrective actions, where appropriate
Reviews literature and competitive information for R&D planning and analysis of results
Collaborates with various groups for study level publication planning including manuscript writing and submissions
Collaborates to achieve publications for pharmaceutical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts
Generates documents to support regulatory submissions and/or responds to questions from regulatory authorities about existing submissions
Method Validation
Maintain an optimized schedule of method development activities
Perform method/sample validation including:
Method development
Generating protocol specified data
Analysis of data according to validation parameters
Statistical analysis of data; stability study trending
Validation report writing
Sample Testing
Run lab experiments and record data in laboratory notebooks with accuracy and completeness
Calculate results as required in compendial methods and procedures.
Inventory Login & Upkeep
Maintain laboratory inventory of chemicals and supplies
Check stock levels and order commonly used chemicals as needed
Remove and update inventory for expired chemicals
Periodic inventory of chemicals and supplies on hand
Keeps and maintains work area clean, neat and organized during and after processing time
Ensure all instruments used are well maintained and the workspace is kept neat.
Compliance to FDA regulations and CED SOPs
Perform other duties as assigned.
Qualifications:
MS in chemistry or a science related field, or equivalent years of method validation and development experience
Eight (8) years of laboratory experience performing analytical testing
UPLC/HPLC/GC expertise, method development and/or method validation experience required
Working knowledge of cGMP/GLP, ICH, USP/NF, FDA regulations
Knowledge of Microsoft Office suite (Word, Outlook, Teams and Excel) required
Excellent communication skills; English (oral & written) required
Strong work ethic and reliable
Excellent time management and organizational skills
Able to work under pressure and successfully function in a fast-paced environment
What’s in it for you …
We invest time and resources into making sure Medisca is as good as the people we hire.
Balance Your Life – PTO, vacation policy and paid statutory holidays
Invest in your health – Group Benefit plan and health savings account
Your Future is Bright – Opportunities to learn and grow within CED
Save for your Future – 401k plan retirement
Help us grow – Employee Referral Program
We like to have fun – company events throughout the year
We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.
#LI-Onsite
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Report job
