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QA MANAGER

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Location:
Princeton NJ

Employment Type:
Full Time

Description:
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases.

Placing the patient at the heart of our priorities, demonstrating ethics and respect towards each person, Erytech is focused on becoming a global leader in rare cancer and orphan diseases space.

Since our inception, our mission has been to make a sustained investment in R&D in order to meet the challenges of public health and to offer innovative therapies to target markets with high unmet medical needs, particularly in the field of cancer.

Our company has been classified as a Pharmaceutical Facility and develops its activities in close collaboration with health professionals, particularly physicians and pharmacists.

Scope:
Manage QA Team at a Sterile Drug Product Manufacturing site. Manage implementation and ensure application of required quality activities in compliance with cGMPs and applicable Regulatory Files. Lead Inspection Readiness Program to ensure successful Inspections out-come and act as site QA contact during FDA Inspections. Contribute to Erytech continuous quality improvement efforts.

Responsibilities:

  • Release Drug Products for clinical trials and/or commercial use and manage all related QA activities in compliance with cGMPs, such as, but not limited to investigations, Change Controls and Annual Product Reviews.
  • Lead implementation of QMS at the site in collaboration with Corporate Quality.
  • Manage site cGMP training program and provide training as needed.
  • Identify, create and implement quality system and process improvements
  • Provide quality support and guidance to other departments.
  • Manage site QA team
  • Propose and implement meaningful quality performance indicators
  • Contribute to supplier qualification program
  • Contribute to Corporate QA efforts as required.
  • Other duties as required.

Qualifications

  • Bachelor’s or Master’s degree and with a minimum 8 years’ experience in a pharmaceutical/biotech environment of which minimum 5 years in QA.
  • Experience with FDA Inspections
  • Experience in management
  • Experience in supplier audits is an asset
  • Strong interpersonal and communication skills are required
  • Willingness to travel up to 10% of the time

To apply this offer, please send your application (resume and cover letter in Word of PDF format) with the reference ERY-US-QA to: career@erytech.com



FACILITIES MANAGER

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Location:
Princeton , NJ

Employment Type:
Full Time

Description:
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases.

Placing the patient at the heart of our priorities, demonstrating ethics and respect towards each person, Erytech is focused on becoming a global leader in rare cancer and orphan diseases space.

Since our inception, our mission has been to make a sustained investment in R&D in order to meet the challenges of public health and to offer innovative therapies to target markets with high unmet medical needs, particularly in the field of cancer.

Our company has been classified as a Pharmaceutical Facility and develops its activities in close collaboration with health professionals, particularly physicians and pharmacists.

Duties:
The facilities Manager will establish engineering and facilities systems to support cGMP operations. This position will play a major role in supporting the construction of a cGMP manufacturing facility for clinical and commercial biologic products. Person will be responsible for management of preventive maintenance, calibrations and repairs to instrument and control systems for production equipment, QC laboratory equipment, and data management systems in collaboration with other departments.

This hands-on person will possess a strong work ethic, the desire to work in a collaborative team along with a passion for creative thinking and problem solving. Individual will monitor the progress of commissioning and maintenance activities between project teams, consultants, and contractors during site start-up and during on-going production. This position will coordinate and maintain all stages of equipment and systems throughout its lifecycle including modifications, upgrades and maintenance. Incumbent will ensure compliance with all local and state safety requirements and create a zero-injury mindset at every level of the organization.

  • Create and execute comprehensive Facilities/Engineering technical documents including SOPs, along with risk and life cycle management documents for site, manufacturing and QC equipment as necessary.
  • Work with other Departments and Corporate-based Erytech systems to establish and adapt protocols, procedures and documentation as necessary.
  • Manage and support in-house engineering for production and QC equipment additions/upgrades. Act as a liaison between internal departments and external consultants to insure all project objectives are successfully met.
  • Develop and manage 24/7 critical operations team to ensure all critical facility, process and analytical lab equipment are in an operational state of readiness.
  • Support Manufacturing and Supply Chain efforts as necessary for cGMP operation.
  • Work with Quality to support PAI readiness plan for QC, Production and Facilities to ensure equipment and systems life cycle documents are maintained to organizational standards.
  • Recommend and implement enhancements to facility systems that result in improved quality performance, increased customer satisfaction, and/or simplification of processes to reduce costs.
  • Work with department heads to reduce service contracts by training technicians and end users by writing service procedures.
  • In conjunction with QC and Manufacturing, develop work flow analysis for sample flows to increase efficiency by minimizing movements between individuals and equipment.
  • Work with Quality and IT to develop life cycle plans for GMP equipment that ensures data integrity and equipment reliability.
  • Coordinate the scheduling of calibrations and maintenance activities with area management to minimize disruption to manufacturing or laboratory operations.
  • Manage departmental performance against established KPI’s and metrics and take necessary actions to correct deficiencies.

Qualifications:

  • Minimum 10 years related experience with working knowledge of mechanical, electrical, instrumentation and control systems in a pharmaceutical/biotech environment
  • B.S. Engineering or similar discipline
  • Strong understanding of cGMPs is a must, applicable best practices, and regulatory guidances
  • Strong, constructive communication skills, highly motivated with strong work ethic
  • Proven track record of driving continuous quality and operational improvements in a facilities/24-7 operations environment
  • Able to effectively manage multiple competing priorities to delivery results in a timely manner
  • Proven track record managing mechanical, electrical, building/equipment automation, and life safety systems
  • Experience with PAIs and regulatory authority audits for QC, manufacturing, and Facilities equipment and systems is a plus
  • Flexibility on work schedules and duties!

To apply this offer, please send your application (resume and cover letter in Word of PDF format) to: career@erytech.com


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