What are the responsibilities and job description for the Analytical Tech Transfer Scientist position at Piramal Pharma Solutions?
Business: Piramal Pharma Solutions
Department: QC Operations
Location: Sellersville
Job Overview
- 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.
Experience
- 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.
Required:
- Bachelor’s degree in chemistry or related science
- Minimum of five years of related laboratory experience
