Director of Quality Control

Employer
Bachem
Location
Vista, CA
Posted
Jul 09, 2018
Required Education
Bachelors Degree
Position Type
Full time

Bachem. Pioneering Partner for Peptides

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 and the US, 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.

Job Summary:

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.

Essential Functions and Responsibilities:

  • 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

Minimum Qualifications:

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

What We Offer

An exciting opportunity to dive in and begin your career with a company that offers a competitive total rewards package that includes:

  • Full range of health benefits including medical, dental, vision and long-term disability
  • 401(K) Safe Harbor Plan (3% company contribution, 100% vested)
  • iPay Incentive Plan
  • 11 Paid Company Holidays, Personal Time, Sick Leave and Vacation Time
  • Travel to Switzerland for certain key positions
  • Company sponsored events! (Summer BBQ and Holiday Party)
  • Generous product discounts

Our Values

Bachem recognizes that highly motivated and well-qualified employees are its most important asset. The competence, motivation and performance of individuals and the team are key to the development and long-term success of our business. We therefore strive to attract, retain and develop talented and committed people to all of our Group Companies. Bachem ensures equal opportunities for its employees and will not tolerate any discrimination.

Physical Requirements:

This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment.  The ability to lift up to 25 lbs. is required. 

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Environmental Conditions:

Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.