Director, Quality Control

Employer
Bachem
Location
Torrance, California
Posted
Feb 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

Director, Quality Control

Torrance, CA.

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 synthesis for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe and the U.S., 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.

                                                                     Bachem. Pioneering Partner for Peptides 

Your Responsibilities

The Director of Quality Control is the leader of Quality Control/ Stability laboratory and the Method Transfer/ Validation function.  They are the head of Quality Control for the testing of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial products.

Your Tasks 

  • Maintain the Quality Control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics 
  • Develop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validation
  • Ensure continuous improvement and effectiveness of the quality control labs
  • Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements
  • Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees
  • Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records
  • Investigate and document out-of-specification results and deviations during product testing
  • Assure and oversee testing and raw materials, ensure safe, secure, and documented storage of final products in GMP manufacturing   

Your Profile

Required:

·         Master’s Degree in Chemistry or Chemical Engineering with a minimum of 5 years’ work experience in GMP manufacturing or

·         Bachelor’s Degree in Chemistry or Chemical Engineering with a minimum of 8 years’ work experience in GMP manufacturing

·         At least 3 years management experience

·         Knowledge of cGMP and FDA regulations

·         Exhibit detail oriented documentation skills

·         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:

·         PhD in Chemistry

·         Experience with Peptides and Oligomer manufacturing processes

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.

Interested

Please submit your application with full supporting documents and apply at:

External: https://workforcenow.adp.com/jobs/apply/posting.html?client=bachem&jobId=192117&lang=en_US&source=CC3

Note* Please copy and paste URL to open and apply.

Bachem Group is an Equal Opportunity Employer.