Director, Quality Control

Employer
Bachem
Location
Torrance, CA
Posted
May 04, 2022
Ref
781370801
Discipline
Quality, Quality Control
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.

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

  • 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
  • Experience with Master Control
  • Experience with SAP

Candidates for positions as US employees of Bachem Americas, Inc. (“Company”) must be in the process of or fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of employment, except for U.S. employees who request and qualify under applicable law for disability and religious accommodation from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S employee will be required to provide proof of vaccination status, or request and receive a disability or religious accommodation for which the applicant is entitled under applicable law, before their first day of employment or any later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regard to an individual’s disability, religion or on any other basis prohibited by law.