Senior Analytical Tech Transfer Scientist

ESSENTIAL JOB RESPONSIBILITIES

• Perform analytical method technology transfer including method verification and method validation.
• Read and interpret analytical methodology and USP monographs.
• Perform analytical testing of pharmaceutical drug products and/or raw materials following analytical methodology while adhering to internal and external customer requirements and schedules.
• Maintain accurate, detailed records of work performed using LIMS and other laboratory software.
• Operate UPLC/HPLC/GC as well as other analytical instruments and perform troubleshooting and calibration as needed.
• Review laboratory data and laboratory records for accuracy and compliance to procedures.
• Write laboratory related documents including protocols, reports, and/or methods.
• Participate as a lab lead on inter-departmental teams for new product introduction/improvement activities. Execute technology transfer and/or validation protocols to support these teams.
• Assist in the development of laboratory expertise in analytical technologies to increase the capability to support internal and external customers for future requirements.
• Potential for up to 5% domestic travel.

EXPERIENCE

Required

• Experience in analytical method development and validation.
• Perform routine analytical chemistry drug product, drug substance, and excipient testing according to approved methodology in a regulated pharmaceutical analytical laboratory.
• Experience in UPLC/HPLC/GC and other spectroscopic instruments.
• Proficient in analytical method verification/validation and technology transfer activities including technical writing and cleaning validation.
• Ability to perform calibrations and troubleshoot analytical instrumentation as needed.
• Knowledgeable in USP, ICH, cGMP, and cGLP requirements.
• Organized and detail oriented, self-driven, and capable independently solving problems.
• Capable of handling multiple projects at one time, and changing priorities based on business needs.
• Excellent interpersonal, oral, and written communication skills.
• Proficient in MS Office applications and other laboratory software applications.
• Able to work effectively independently and as part of a team.
• Able to work overtime, including weekends, when required

Preferred

• Experience in XRD, ICP-MS, FTIR, TOC, and/or Malvern 3000 Mastersizer instrumentation.
• Experience in analytical method development and validation.
• Proficient in analytical technical writing related to protocols, reports, and methodology

Education

• Bachelor's degree in chemistry or related science
• Minimum of five years of related laboratory experience

Physical Requirements

• Lift up to 40 lbs.
• Able to work safely with heavy equipment.
• Regularly stand, walk, sit, use hands to finger, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
• Ability to climb ladders, bend, stoop, and kneel.
• Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
• Not allergic to chemicals or bio-substances found in laboratory or production facilities.
• This is a Safety Sensitive position