CMC Compliance Manager

Employer
Bachem
Location
Torrance, CA
Posted
Jun 05, 2021
Ref
672782301
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

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

The CMC Compliance Manager fulfills a critical role in the development of new NCEs and Generics as well as in the life cycle management of Bachem’s product portfolio. This individual provides guidance to internal and external stakeholders and ensures compliance of NCEs and Generics with all the laws, regulations, and guidance applicable to pharmaceutical drug development and manufacturing.

Your Tasks:

  • Provide guidance to internal and external stakeholders (e.g. Manufacturing, QC, RA, customers) to ensure compliance of NCEs and Generics with all the laws, regulations, and guidance applicable to pharmaceutical drug development and manufacturing.
  • Represent Quality unit in NCE and Generics project teams. Responsible for identifying project risks regarding regulatory filing strategy and initiation of measures to reduce them.
  • Generate, review and approve product specifications and product specific statements/memos.
  • Review and approve product related technical documents e.g. validation protocols and reports.
  • Represent Bachem during customer visits and audits.
  • Stay abreast of CMC development requirements and ensure implementation throughout the organization.
  • Ensure compliance and continuous improvement of Bachem America’s CMC development concept.
  • Support responses to customers RFP’s and contribute to the preparation of quotations for projects and services.
  • Support the annual product portfolio review.

Required:

  • Master’s or Bachelor’s Degree in Organic Chemistry or related field
  • Minimum of 5 years’ experience in pharmaceutical or device industry
  • Excellent written and oral communication skills
  • Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
  • Ability to effectively organize, multitask, 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

Preferred:

  • Experience in Peptide and/or Oligonucleotide development and manufacturing
  • Experience in analytical methods validation and process validation