Associate Scientist, Biologics

SGS•Lincolnshire, IL

About The Position

The Associate Scientist position is responsible for method development, validation and transfer, verification of methods used pharmaceutical products or raw materials. Responsible for the development and validation of analytical procedures used to analyse drug substances and drug products as well as the transfer of these procedures to the various sites. Responsible for re-evaluating, optimising and troubleshooting methods as required by clients. Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines. Perform the development and validation of analytical testing procedures for drug substances and drug products. Write protocols, drafts methods and technical reports for the Research and Development department and clients. Keep all records and lab notebooks in good order. Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in timely manner. Write and review technical data, documents, SOPs and proposals as required. Assist in the failure investigations within other SGS groups and design investigation protocols and suggest corrective actions. In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate. Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the document reviewer.

Requirements

BSc or MSc/PhD
3 - 5 years with demonstrated ability to complete more complex role/duties
Experience in Mass Spectrometry and HPLC
Able to read, understand and follow work instructions in a safe, accurate and timely manner.
Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
Demonstrates excellent verbal and written communication skills.
Ability to work well with others & independently.
Proven time management skills and a strong attention to detail.
Works well under pressure

Responsibilities

Method development, validation and transfer, verification of methods used pharmaceutical products or raw materials.
Development and validation of analytical procedures used to analyse drug substances and drug products as well as the transfer of these procedures to the various sites.
Re-evaluating, optimising and troubleshooting methods as required by clients.
Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
Perform the development and validation of analytical testing procedures for drug substances and drug products.
Write protocols, drafts methods and technical reports for the Research and Development department and clients.
Keep all records and lab notebooks in good order.
Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in timely manner.
Write and review technical data, documents, SOPs and proposals as required.
Assist in the failure investigations within other SGS groups and design investigation protocols and suggest corrective actions.
In case of a testing failure, immediately report to the Department Head or the designee before proceeding further with the test, lead/assist failure investigations to identify the cause of failure and prepare a deviation report and/or Corrective Preventative Actions (CAPA) if it is appropriate.
Ensure that work order documentation is complete in every respect and all results are entered into the Electronic Laboratory Information System or client’s Certificate of Analysis before submission to the document reviewer.

Benefits

Medical, dental and vision insurance
life insurance
employee wellness programs
Competitive pay
401(k) with company match (immediate vesting upon enrollment)
employee referral program
annual bonus target
Online training courses
virtual and classroom development experiences
tuition reimbursement program
Paid-time off (vacation, sick, company holidays, floating holidays, volunteer time)