Chemist - Method Development

Pace Analytical Services, LLC Located in: Minneapolis,  Minnesota
(Private and Secure - Guaranteed!)

Pace Analytical Services, LLC Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Overview

The successful candidate will independently perform analytical testing, method development and method validation to support the clinical trial process of a drug delivery device. Analytical lab experience working with HPLC and/or UPLC is critical.

 

Responsibilities

  • Independently develop, optimize, tweak and validate analytical methods using the HPLC, UPLC and/or LC-MS
  • Complete associated technical documentation – protocols, development and validation reports, specifications, etc.
  • Carry out complex experiments involving a variety of lab skills to achieve project goals
  • Conduct stability testing using in-process or developed methods
  • Comply with FDA guidelines and SOPs in a cGMP environment
  • Performs dissolutions, extractions and other preparatory techniques on samples
  • Gathers and records data according to SOP and protocol guidelines, and performs technical evaluation of data to analyze, interpret and report on results
  • Communicates with staff and clients as needed throughout the analytical process to ensure compliance with protocols and SOPs
  • Maintains and troubleshoots analytical equipment as required

CRITICAL REQUIREMENTS

    • Bachelor's degree in chemistry or a related scientific field
    • Experience independently developing and validating methods for the HPLC, UPLC and/or LC-MS
    • Working knowledge of GMP and applicable ISO standards is preferred
    • Ability to independently troubleshoot instrumentation
    • Ability to work in a fast-paced environment
    • Ability to meet deadlines and multitask
    • Flexibility with changing priorities
    • Excellent computer skills
    • Experience with Empower 3 software a plus
    • Experience with ELN software a plus

COMPANY INFORMATION

Pace Analytical Services, LLC is a privately held, industry-leading sampling and analytical testing firm. Pace provides analytical lab solutions for testing, staffing and equipment, with a wide scope of services. Environmental: analytical testing and sampling Life sciences GMP laboratory: testing for pharmaceutical, medical and drug-devices Laboratory operations: staffing and instrumentation services With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace has the capacity to support a diverse client base—from local, state and national government programs to industry, engineering/consulting, mining, energy and R&D. Our 39 years of experience give us the expertise and vision to partner with these clients, providing analytical testing and services to support both short-term needs and long-term development—even in today’s challenging economic environment. Pace continually invests in highly trained scientific staff, leading instrumentation and new methodologies to ensure high accuracy and efficiency. Our advanced training program includes an online learning management program, and robust quality assurance and control programs mitigate risk throughout all Pace laboratories. Plus, PacePort provides easy, up-to-date data access and management for clients—available online, anytime. Most Pace labs are NELAP accredited excluding Columbus and Raleigh. Both Pace Analytical Life Sciences operations are FDA registered, DEA registered (Class II - V) and GMP compliant. Pace Analytical Life Sciences (Oakdale site) and the Metrology Operations of the LabOps Division are ISO 17025 accredited. The LabOps Division is ISO 9001/2008 certified.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Validation,  Laboratory,  Analysis
Preferred Industry Background:
  Pharmaceuticals,  Biotechnology,  Laboratory / Diagnostic Services
Managing a team of:
N/A
Required Travel:
Not at all

Base Salary:
Confidential
Bonus:
Benefits:
Medical, dental, vision, 401k with company match, sick pay, holiday pay, vacation pay, wellness prog
Other Compensation:
Education Required:
Any