Applying for: Director Of Manufacturing Operations

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Current Vacancies

Director Of Manufacturing Operations

Director Of Manufacturing Operations

 

Job Title: Director of Manufacturing Operations

Reports to: CEO

Thomas Francis is currently working with a privately-held biopharmaceutical company with locations in the US and Europe. The company develops and commercializes innovative cost-effective therapies for the delivery of pharmaceutical products.

The company is actively recruiting for a Director of Manufacturing Operations. This position will be based in either Germany or Switzerland. The Director of Manufacturing Operations will oversee medical device production being undertaken by Contract Manufacturers on behalf of the company. The role is an independent contributor initially but may be asked to build out a team as the company grows.

 

The ideal candidate would have familiarity with sterile disposable manufacturing, injection molding, machining, and electromechanical assembly (including embedded software). He/She should be familiar with FDA and Notified Body (MDD and MDR) expectations for medical device manufacturing process validation/qualification including the ability to review and audit device/lot history records for lot release decisions and serve as the company’s representative on Material Review Boards as well as oversee CAPAs issued against CMs (i.e. SCARs).

Job Requirements & Qualifications:

Reporting to the CEO, the ideal candidate would:

  • Be fluent in both German and English (written and spoken);
  • Have a minimum of 10 years of manufacturing operations experience within the medical device industry;
  • Have experience with 21CFR Part 820 (inclusive of the FDA’s 2011 Process Validation Guidance), 21 CFR Part 4, ISO 13485: 2016, MDD, MDR, and MDSAP;
  • Ideally, have experience with drug delivery systems and DFMA activities;
  • Ideally, be familiar with 6 sigma and statistical process control; and
  • Be able to travel internationally as needed.

Job Reference:

Life Sciences & Medical

Germany