Employment Opportunities

XGen Pharmaceuticals DJB, Inc. continues to experience steady growth and this results in rewarding employment opportunities for candidates with the right skills.    XGen Pharmaceuticals DJB, Inc. Offers Pay and Benefits that Include: Vacation, Simple IRA, Professional Growth, Advancement and Health Insurance.

Equal Employment Opportunity Policy Statement

Equal Employment Accomodation Notice

Equal Employment Pay Transparency

Equal Opportunity Employment is THE LAW

 

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OPPORTUNITIES: (4)

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Applicant Policy

There are many administrative and contractual responsibilities placed on XGen Pharmaceuticals DJB, Inc. as a government contractor. To remain in compliance with our Affirmative Action Plan, every resume and application received at XGen Pharmaceuticals DJB, Inc. must be documented, and all applicants are offered an opportunity to identify their race, sex, veteran status and disability.

For these reasons, XGen Pharmaceuticals DJB, Inc. has adopted the following Applicant Policy, effective August 1, 2020.

 

  • Resumes and interest applications are only accepted when there is a vacancy and/or listed  position. Please do not re submit a resume for a position previously applied for within the last 6  months as the previous resume submitted is still under consideration.
  • Resumes that do not meet the minimum qualifications for the position(s) indicated will not be  considered. No notification on the status will be given.
  • All interest applications and resumes must indicate the specific job(s) for which they are  applying to be accepted and reviewed.
  • All resumes and applications that do not specify a position, indicate “any position”, or are  submitted for a closed position, will be considered unsolicited. Unsolicited resumes will not be considered.
  • Resumes for an open and/or listed position will be accepted until the position is filled or until a sufficient number of qualified applications have been received. All resumes received after  that will not be considered but will be retained. No notification on the status of an application or resume will be given.
  • Applicants interested in applying for subsequent positions must submit another resume or  application for that specific position.
  • All open positions are listed with the local State Workforce Development Service and on our  company website at http://xgenpharmadjb.com/
  • Applicants must submit resumes electronically via the Employment section on the website  (careers@xgenpharmadjb.com).
  • Applications will not be mailed to applicants.
  • XGen Pharmaceuticals DJB Inc. is committed to providing reasonable accommodation to  applicants with disabilities on a case by case basis. If you need a reasonable accommodation for  any part of the employment process, please contact the Human Resource Department with your contact  information and the type of accommodation you need. To quickly respond to your request, please select “Application Accommodation Request” as the topic of your message.

Title: Supplier Quality Specialist

Reports to: Manager of Supplier Quality

 

Position Summary:

This position is responsible for providing daily oversight and support activities for supplier quality systems, working with the Manager of QA Supplier Quality and external domestic and international Suppliers and/or CMO’s, to provide sustaining quality and compliance support related to current XGen commercialized products and development projects.

Essential Duties:

  • Supports XGen DJB’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
  • Supports Manager of QA Supplier Quality in setting and implementing internal/external quality requirements to ensure XGen DJB’s products and/or services from external domestic and international Suppliers and/or CMO’s meet cGMPs and XGen DJB’s and customer expectations by:
    • Identifying and implementing effective quality control systems at the supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
    • Ensuring suppliers are compliant to all regulatory and XGen DJB requirements.
    • Supporting supplier management team in identifying opportunities for improvements.
    • Proactively investigating, identifying, and implementing best-in-class supplier quality practices.
    • Providing technical mentorship and resolve quality supply chain issues with suppliers.
    • Providing Quality support and technical expertise to cross-functional groups and personnel on projects, as appropriate.
    • Reviewing documents including standard operating procedures (SOPs), protocols, deviations, CAPAs, reports, and other GMP documents as required.
    • Filing and maintaining controlled documents.
  • Conducts external cGMP or for cause audits of third parties and/or partners to ensure supplier quality-related activities relative to contracted labs, manufacturers, and distribution warehouses performance meets quality system requirements, and that those requirements are effectively established and maintained in accordance with cGMP, other worldwide regulations, as applicable, and XGen DJB’s Quality Management System by:
    • Performing site inspections to drive improvement in supplier performance
    • Auditing, evaluating and qualifying new suppliers in accordance with audit plans developed by/with the Manager of QA Supplier Quality.
    • Reviewing and evaluating supplier’s audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet specifications and quality requirements
    • Following up on prior audit recommendations to ensure implementation and compliance
    • Creating, revising and maintaining supplier quality standard operating procedures
  • Maintains supplier quality agreements and schedules
  • Maintains the approved supplier list, supplier scorecard, and supplier audit schedule
  • Supports Manager of QA Supplier Quality in ensuring compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
  • Actively monitors supplier quality metrics
  • Actively participates in supplier quality related communication and feedback
  • Supports site regulatory inspections; interface with Regulatory Agencies during inspections.
  • Monitors, elevates, and reports metrics on cGMP systems by:
    • Performing/documenting customer complaint investigations, as needed
    • Preparing trend reports related to XGen DJB’s supplier quality systems.
    • Managing audit CAPAs to ensure that corrective and preventive actions are completed on time.
    • Assisting with investigations and resolving compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
  • Performs other related duties as assigned or directed.

Skills: 

  • GMP Compliance
  • Auditing
  • FDA and other regulatory agency requirements including, but not limited to change controls, PV, CAPA, deviations, etc.
  • Internal/External Audits

Travel:   25% Domestic and International travel required  

Education/Experience:

  • Bachelor’s degree in Science or Regulatory Discipline. 3 to 5 years of work experience in Quality Assurance within the pharmaceutical industry and/or 2 to 3 years of experience working with Quality Systems.

Physical Requirements:

  • Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear. The employee must regularly lift and/or move up to 10 pounds.

EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet

Title: EPMO Project Manager

Reports to: Director of EPMO

 

Position Summary:

Manage non-product related, enterprise-wide business projects, including assisting in prioritization of projects, development of business cases, management of project budgets, development and management of project plans, and assignment of, indirect supervision of and prioritization of internal and external project teams consisting of as many as 25 people.

Essential Duties:

  • Support XGen DJB’s Mission, Vision and Values statement by adhering to the Code of Ethics and Professional Conduct and conforming to established performance expectations.
  • Manage the business project pipeline and assignment and prioritization of resources
  • Collaborate with all departments to coordinate assignment and completion of project tasks
  • Assign resources to projects and project objectives and monitor progress
  • Indirectly supervise internal and external project teams consisting of as many as 25 people, ensuring they have what they need to complete assigned tasks in the required timeframe Develop project plans and facilitate resolution of issues to reach project goals
  • Assist in creation of project budget and manage expenses appropriately
  • Manage and communicate ongoing changes in risks, tasks, goals, or performance
  • Lead project meetings with business partners and colleagues
  • Participate in contract reviews

Performs other related duties as assigned or directed

Skills: 

  • Project Management, Supplier Management, Budget Management, GMP Compliance, Data Analysis

Education/Experience:

  • Bachelor’s degree preferred

Experience:

  • Minimum: 5 years
    Proficient: 10 years

Travel: Up to 5%

Physical Requirements:

  • Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear. The employee must regularly lift and/or move up to 10 pounds

EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet

Title: Executive Assistant

Reports to: Senior Human Resource Manager

 

Position Summary:

This position provides a wide range of skilled, efficient, and confidential administrative support services for executive staff members. The responsibilities of this role extend beyond that of an executive assistant or secretary and include leadership, organizational and administrative functions.

Essential Duties:

  • Supports XGen DJB’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
  • Demonstrates confidentiality in execution of all responsibilities
  • Manages the day-to-day operations of the Executive area
  • Organizes and maintains files and physical and electronic records
  • Plans and schedules meetings and appointments
  • Manages the corporate calendars
  • Supports Executive staff members by establishing project schedules, managing projects, and conducting research as requested
  • Prepares and edits routine and advanced correspondence including letters, memos, presentations, and reports to all levels of management; Responsible for confidential and time-sensitive material
  • Makes meeting, travel, and guest arrangements
  • Advises employees of policy, procedures & practices
  • Screens and routes phone calls, emails, mail, and visitors
  • Routes and resolves information requests
  • Ordering of office supplies
  • Coordinates space and office organization, and special projects
  • Demonstrates and promotes a professional working environment
  • Complete projects, special assignments, other tasks, and duties as required and assigned

Performs other related duties as assigned or directed

Skills: 

  • Executive Support, Organizational Development, Project Management, Scheduling, Travel Planning, Travel Administration, Administration

Education/Experience:

  • Bachelor’s degree

Experience:

  • Minimum: 5 years
    Proficient: 8 years

Travel: Up to 5%

Physical Requirements:

  • Possess sufficient manual dexterity to be able to bend, sit, stand and reach with hands and arms; Visual and auditory skills required, including close vision, peripheral vision, depth perception and ability to adjust focus and ability to speak and hear. The employee must regularly lift and/or move up to 10 pounds

EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet

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Application Procedure Candidates:

For consideration, please submit an electronic cover letter and resume, along with salary requirement, on our website. (careers@xgenpharmadjb.com)  Resumes and cover letters will be accepted until the position is filled.

Thank you for your interest in XGen Pharmaceuticals DJB, Inc.

XGen Pharmaceuticals DJB is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people.  EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet


MEDIA INQUIRIES:

300 Daniel Zenker Dr
Horseheads, NY 14845

+1 (866) 390-4411
info@xgenpharmadjb.com