Senior Analytical Tech Transfer Scientist

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company seeks an analytical chemist responsible for method development, validation, and testing of pharmaceutical products. The role involves operating various analytical instruments, troubleshooting as needed, and ensuring compliance with regulatory standards. Ideal candidates will possess strong analytical skills and detailed knowledge of methodologies in a regulated laboratory environment.

Qualifications

• Experience in a regulated pharmaceutical analytical laboratory.
• Proficient in MS Office and laboratory software.
• Knowledgeable in cGMP and cGLP requirements.

Responsibilities

• Perform analytical testing of pharmaceutical products and maintain detailed records.
• Write laboratory documentation and execute technology transfer protocols.
• Assist in developing laboratory expertise in analytical technologies.

Skills

Analytical method development

Method validation

Troubleshooting

Interpersonal communication

Organizational skills

Analytical technical writing

Tools

UPLC

HPLC

GC

USP

Job description

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