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QUALITY CONTROL 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 position location will begin at the American Red Cross facility in Philadelphia PA to support the routine manufacturing for Phase 3, which will then be transferred to the official Erytech site in Princeton NJ.

The QC manager is responsible for performing analytical test methods on in-process intermediates and varying stages of drug products, under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination by UV Absorbance, Enzyme activity, Endotoxin detection, Osmotic fragility, Microbiology control, challenge studies, aseptic techniques, and method validation.

Responsibilities:

  1. Timely facilitation of incoming sample receipt and accessioning flow, understand batch assignments across all assay types in accordance with agreed upon best practices.
  2. Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers
  3. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.
  4. Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
  5. Assist with monitoring and the control of laboratory supply and critical reagent inventories.
  6. Qualify as trainer for specified methods, provide training to less experienced staff. 
  7. Provide on call coverage to support oversight of QC laboratory equipment functionality.
  8. Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
  9. Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.

Qualifications

  1. Master of Science degree. 
  2. 3 years of relevant laboratory experience; QC specific experience is preferred.
  3. Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
  4. Demonstrated working knowledge with respect to certified QC methods.
  5. Good documentation, written and verbal communication skills are essential.
  6. Must possess the ability to perform most tasks with minimal supervision.
  7. Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
  8. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

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


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


HR 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.

Responsibilities:

  1. Recruitment and Selection (R&S)
    • Provide recruitment support to all US vacancies: source candidates, pre-screen, interviews, perform background and reference checks, prepare offer letters, ensure and optimize the onboarding process.
    • Ensure all recruitment activities align with company policy and guideline.
    • Search and build up partnership with suitable recruitment service providers.
    • Develop our Employer brand within
  2. Compensation and Benefit (C&B)
    • Drive local support and knowledge for incident/problem management for local healthcare topics based on local US regulations and company policy. Provide info to the employees in partnership with the broker.
    • Ensure all C&B programs are in compliance with the local government regulations, whilst keeping in line with the relevant company policy and competitive.
    • Administer and manage compensation and performance review, and provide professional input from the HR perspective.
  3. Training and Development (T&D)
    • Identify suitable training providers regarding to the demands of company training needs.
    • Identify and arrange training needs for employment development.
    • Follow up the action plan(s) on performance reviews.
    • Provide administrative support to local training programs.
  4. Employee Relations (E.R.)
    • Provide advice on various legal issues and interpret company HR policy and procedures.
    • Give professional support to local managers for employee relationship issue.
    • Ensure employee check-in and exit processes implementation smoothly, conduct exit interview for resigned employee
    • Initiate to build / strengthen company culture and employee engagement according to the Corporate values.
  5. HR administration & Management
    • Ensure all local HR documents and practices are in compliance with the local US regulations, whilst keeping in line with the relevant company policy.
    • Maintain accurate job descriptions and provide support to local managers to create and complete job description when needed.
    • Research effectiveness of HR programs and propose improvements to policies, programs, and procedures to improve HR effectiveness.

Qualifications

  • Bachelor’s degree in related field with a minimum 2 years related experience in a small-mid-size pharmaceutical/biotech environment or equivalent
  • 10 years of experience in human resources generalist functions
  • A strong interest in building up teams in a fast-growing environment
  • Strong interpersonal and communication skills are required
  • Ability to be self-directed and motivated
  • A keen interest in continuous improvement approaches and working in a multicultural environment.

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


PROCUREMENT LEAD

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Location:
Boston , MA

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.

The successful procurement candidate will manage and implement critical supply chain activities by establishing requirements with existing and prospective vendors. Manage the negotiations, purchase requisitions and receipt to support GMP manufacturing in the U.S. Develop and support master service agreements to achieve cross functional process that ensure compliance with company’s quality standards. The focus of this position will be to oversee the raw material program and be the liaison between Finance, Legal, Quality, and Production to develop and execute material agreements. Position involves sourcing materials and ensuring the timely acquisition of these materials from suppliers. Responsible for timely and accurate deliveries of raw materials and the proactive management of costs and metrics to ensure effective supply chain management.

Duties:

  • Coordinate selection and monitor vendors/suppliers to ensure materials received meet established requirements in a compliant and cost-effective manner.
  • Develop and maintain industry best-practices, negotiate rates and agreements, and aggressively work directly with vendors, carriers, and brokers to ensure efficient deliverables.
  • Assess and forecast market conditions, and availability of raw materials. Obtain and clarify technical issues relating to raw materials.
  • Establish and review systems and procedures to ensure and enhance overall performance.
  • Facilitate development of team/partner relationships with vendors/suppliers and maintain relationships for long-term contracts for consistent delivery of quality materials.
  • Work with other manufacturing operations groups to develop material schedules and coordinate movement of materials between departments to support raw material plan and production schedule.
  • Monitor the cost, schedule, and performance aspects of agreements/contracts.
  • May analyze and prepare materials requirement plans for inventory management computer systems, ensuring that computer applications used to support regulated work are in compliance with FDA 21 CFR Part 11 and EU GMPs
  • Participate in project and task force meetings and provide assistance in the selection of materials and software to help improve work practices and GMP compliance.
  • Network with key contacts in Finance, Legal, Quality, and Materials Management to obtain, review, award and maintain material agreements.
  • Seek continuous improvement of the overall efficiency of the supply chain process and obtain market information.
  • Other duties as required

Qualifications:

  • Bachelor’s degree in related field with a minimum 4 years related experience in a pharmaceutical/biotech environment or equivalent (Business, Supply Chain & Logistics or Materials degree preferred)
  • Experience procuring materials in a Commercial Manufacturing operation is required
  • Materials management experience including negotiating vendor/supplier agreements
  • Flexibility on work schedules and duties
  • Knowledge of cGMPs, applicable standard practices and regulatory guidances
  • Strong interpersonal and communication skills are required
  • Ability and willingness to be regularly, predictably and reliably at work
  • Willingness to travel up to 20% of the time

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


SR. PROJECT MANAGER

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Location:
Cambridge, MA or 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 successful candidate will manage the planning, development and execution of projects to support clinical to commercial cGMP manufacturing of biologic therapeutics. Coordinate facility build activities and with other project streams that support initial tech transfer and production. Support Supply Chain and Quality infrastructure activities related to site initiation and production start-up. Organize multi-functional activities to ensure completion of project(s) while adhering to schedule requirements.

  • Responsible to build schedules to support projects for Facilities, Quality and Production.
  • Support the creation and integration of road maps for significant cross-functional efforts.
  • Contribute to the development and improvement of project tools to monitor and track the overall projects and programs that are critical to business and strategic objectives.
  • Facilitate communication regarding critical issues and business impacts.
  • Receive and transmit information requiring accurate explanation and interpretation to technical and non-technical audiences.

Qualifications:

  • Requires a B.S. degree in a life sciences or pharmaceutical sciences discipline with 10+ years of experience in managing technical projects or programs in biotech, biologics or pharmaceutical industry
    Or a M.S. degree in a life sciences or pharmaceutical discipline with 7+ years of experience in managing technical projects or programs in biotech, biologics or pharmaceutical industry.
  • Project Management Professional (PMP) or other relevant certification strongly desired.
  • French speaking is a plus.
  • Excellent interpersonal and communication skills are required.
  • Strong leadership and motivational skills developed through leading successful multi-functional matrix teams. Global experience preferred.
  • Must have knowledge of cGMP processing, experience with Regulatory Agency requirements is a plus.
  • Strong knowledge of Microsoft Office programs (Word, Excel, PowerPoint, Project)
  • Comfortable working in fast-paced environment with competing priorities and ambiguity.
  • Ability to anticipate and solve problems.
  • Ability and willingness to be regularly, predictably and reliably at work!

To apply this offer, please send your application (resume and cover letter in Word of PDF format) 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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