Senior Analytical Tech Transfer Scientist

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

Job summary

A leading pharmaceutical company seeks an Analytical Chemist to oversee method validation, perform testing, and maintain compliance with regulations. Ideal candidates will have a Bachelor's degree in chemistry and at least 5 years of relevant lab experience. Responsibilities also include detailed documentation, operation of analytical instruments, and collaboration in product development projects. Join a dynamic team dedicated to quality and innovation.

Qualifications

• Minimum of five years of related laboratory experience.
• Proficient in analytical method verification/validation.
• Knowledgeable in USP, ICH, cGMP, and cGLP requirements.

Responsibilities

• Perform analytical method technology transfer and analytical testing.
• Maintain detailed records using LIMS and laboratory software.
• Participate in inter-departmental teams for new product introduction.

Skills

Analytical method development

Analytical chemistry

Technical writing

Problem solving

Communication skills

Education

Bachelor’s degree in chemistry or related science

Tools

UPLC

HPLC

GC

XRD

ICP-MS

FTIR

TOC

Malvern 3000 Mastersizer

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