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Manager, Validation QC

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

The Manager, Validation is to manage the validation and development stage analytical testing within

the QC department to ensure that all department activities in compliance with current GMP rules and

regulations.

 

Your Tasks

Maintain and coordinate the operation of the validation/method development department in coordination with client/company/regulatory goals.  This includes prioritizing work for development/validation with the validation personnel on a regular basis

Review laboratory notebooks, raw data, development/summary reports, protocols and operational SOPs as necessary

Maintain and coordinate the operation of the stability department in coordination with client/company/regulatory goals.  This includes prioritizing work for stability testing with the stability personnel on a regular basis

Oversee the execution of validation and stability protocols activities and ensure adherence to GMPs and any other regulatory guidelines

Work with clients via teleconferences/meetings to ensure their goals are met and the methods and data are delivered to them. Ensure information is suitable for their intended use and received in a timely fashion.  Keep open channels of communication with the customer and provide status updates as necessary

Author and/or review validation & stability protocols, validation & stability reports and method development reports, as necessary.  Write standard operating procedures, standard test procedures and other related GMP documentation.  Review data for completeness and accuracy

Maintain up-to-date scientific knowledge pertaining to the field of analytical chemistry (e.g. theories, practices, equipment and technology), stability programs (e.g. practices, software and technology) as well as validation and stability regulatory requirements

Work with QA, QC and MFG to help maintain validation and GMP compliance

Schedule use of equipment and coordination of instruments with QC
 

Your Profile

PhD in Chemistry or Biochemistry with a minimum of 5 years’ experience in peptide analytical chemistry or

Master’s Degree in Chemistry or Biochemistry with a minimum of 7 years’ experience in peptide analytical chemistry or

Bachelor’s Degree in Chemistry or Biochemistry with a minimum of 9 years’ experience in peptide analytical chemistry

Broad  knowledge of modern analytical chemistry

Extensive experience in GMP laboratory testing

Hands-on  experience with HPLC, GC, MS, LC-MS

Methods development experience

Experience writing standard operating procedures (SOPs) and technical reports

Prior supervisory and project management experience

Thorough understanding of peptides and their chemistry

Ability to drive projects to success under pressure

Creativity  to solve technical  and  compliance problems

Excellent written and oral communication skills

Basic computer knowledge, including Microsoft Word, Excel and PowerPoint

Ability to effectively organize, prioritize, and work in a fast-paced, deadline driven work environment

Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues

Detail oriented with the ability to troubleshoot and resolve problems

Ability to work independently and manage one’s time

Communicate effectively and ability to function well in a team environment

 

 

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.


Nearest Major Market: Los Angeles