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.
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