Senior Analytical Tech Transfer Scientist

Piramal Pharma Limited; Pennsylvania; On-site; USD 69,000 - 101,000; Full time

Job summary

A pharmaceutical company in Pennsylvania is seeking a Senior Analytical Tech Transfer Scientist to perform analytical method transfer and validation. The role involves operating advanced analytical instruments, ensuring compliance with regulatory standards, and participating in product development initiatives. Candidates must hold a relevant degree and possess significant laboratory experience in a pharmaceutical setting.

Qualifications

• Minimum five years of related laboratory experience required.
• Experience in analytical method development and validation is essential.
• Knowledge of USP, ICH, cGMP, and cGLP is preferred.

Responsibilities

• Perform analytical method technology transfer including method verification and validation.
• Maintain accurate records using laboratory software.
• Lead inter-departmental teams for new product introduction.

Skills

Analytical method development

Analytical validation

Troubleshooting analytical instrumentation

Attention to detail

Interpersonal communication

Education

Bachelor’s degree in chemistry or related science

Tools

UPLC

HPLC

GC

LIMS

MS Office

Job description

Senior Analytical Tech Transfer Scientist

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Senior Analytical Tech Transfer Scientist

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• 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.
  
  

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
  
  

Qualifications

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Pharmaceutical Manufacturing

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