US ~ Boothwyn, PA
Analytical Scientist III
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
The position may reside in any one of the functional areas and carry out the responsibility under minimal supervision:
- Stability protocol development
- Stability program administration, including active stability program, pull stability sample, oversee stability testing progress, generate/review stability reports
- Formulation development work including Material characterization and physical testing
- Various in-process and finished product testing
Main tasks and responsibilities will include:
- Responsible for the implementation of LIMS at our Philadelphia Site
- Operate and troubleshoot the following instruments/equipment to test pharmaceutical samples:
- Dissolution apparatus
- Karl-Fisher water content titrator
- Other analytical instruments as directed
- Follow analytical test methods, compendial methods, experimental procedures and SOP’s
- Document test results in laboratory notebook, in real-time, and communicate status of test results to supervisor
- Peer review of laboratory notebooks for technical details
- Maintain control of all project related samples submitted to the laboratory
- Write and review methods, reports, etc.
- Perform housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Comply with all company and site policies and procedures
- Manage responsibilities and work in an efficient manner to assure accurate and timely data reports
- Consult and work closely with supervisor regarding any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy
- Train on all the SOPs and company procedures on regular basis and remain up to date with the training curriculum
Additional Position Requirements
- Remain current in profession and industry trends
- Make a positive contribution as demonstrated by making suggestions for improvement
- Learn new skills, procedures and processes including aspects of formulation development
- Is available for other duties as required
- Is available for overtime as needed
- Requires B.S. in Chemistry or equivalent with at least of 5 years or M.S. with at least 2 year related experience of related experience, or Ph.D. degree with 0-2 years of industrial pharmaceutical laboratory experience or a combination of equivalent training, experience and education.
- Knowledge of experiment documentation, operation and basic troubleshooting of analytical instrumentation and knowledge of GMP, GLP, and ICH guidelines.
- Experience in administration of stability required.
- LABWARE LIMS experience preferred.
- Language Skills
- Read and interpret documents such as safety rules, operating and maintenance instructions, manuals, and standard operating procedures.
- Mathematical Skills
- Work with mathematical concepts such as mean, standard deviation and relative standard deviation
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions
- Reasoning Ability
- Identify problems, collect data, and establish facts
Other Skills, Abilities, and Qualifications
- Knowledge of chemical concepts and theories
- Familiar with a variety of laboratory equipment and data acquisition
- Excellent written/oral communication skills,
- Computer knowledge (excel, word)
- GMP regulations
- Ability to work independently as well as with others in a team environment
- While performing the duties of this job, the employee will be exposed to a variety of laboratory chemicals and pharmaceuticals
- While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and see, talk or hear, or smell
- The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl
- The employee must occasionally lift and/or move heavy objects weighing up to 40 pounds
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.