Boston, MA 02108
The Chemist/Senior Chemist is responsible for the technology transfer of analytical methods to the QC Lab (i.e., Qualification or Validation)
Senior Chemists will train and qualify junior chemists on these procedures.
- Prepares protocols and reports for the technology transfer of analytical methods to the QC Lab.
- Train and qualify QC Lab Analysts and Technicians on analytical methods used in the QC Lab.
- Performs OOS investigations as required.
- Independently prepares scientific reports and documents and presents findings. Independently collect, analyze and interpret data, recognize aberrant results.
- Understands the chemical and mathematical rationale behind test methods and their calculations.
- Perform trouble shooting of equipment and test methods.
- Review and approve analytical data as needed.
- Attends project meetings and prepares project updates .
- Maintain a safe, clean, well-organized, and efficient laboratory work environment.
- Perform other testing or projects as required by the QC Lab Director.
- Represent the QC Lab Director in her absence.
- Minimum BSc. in Science, Chemistry or Analytical Chemistry
- Knowledge of CGMP, ICH and FDA guidelines.
- Knowledge of manufacturing environments and laboratory techniques and procedures in the execution of projects on target with quantity, quality, timeline, and safety expectations.
- Understand procedures and policies, Good Documentation Practices, and Good Analytical Laboratory Practices.
- Excellent written and verbal communication skills with high attention to detail.
- Sound knowledge of Instrumental analysis and wet chemistry as well as operation of HPLC, GC, FTIR, UV-Vis spectrophotometer, KF, polarimeter, viscosity meter and standard QC instrument. Agilent and Open Lab knowledge desired.
- Minimum 5-7 years related experience in a CGMP QC lab of pharmaceutical industry for Senior position
- Excellent understanding of mathematical related calculations.
- Demonstrates ability to exercise good judgment and make decisions quickly