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Employment

X-GEN Pharmaceuticals, Inc. continues to experience steady growth and this results in rewarding employment opportunities for candidates with the right skills. X-GEN 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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Title: Manager of Regulatory Affairs
Reports to: Director of Regulatory Affairs


FLSA:  Exempt

General Responsibilities:

Works directly with department and project personnel to ensure compliance and inform of updates to regulations.  Ensures that projects and proposals meet all relevant guidelines, standards, and regulatory rules, conducting research where needed.  Oversees preparation of all Regulatory submissions to FDA, including the review of data, testing procedures, and compliance aspects of proposals and reports.  Investigates and reports adverse events, compliance violations and similar problems.  Ensures company compliance with all regulations and laws pertaining to company business.

Essential Duties:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code Of Corporate Values and conforming to established performance expectations.
  • Manages overall activity of the department and directly supervises assigned personnel as follows:
    • Assists in the selection of new personnel as appropriate;
    • Makes provisions for the proper orientation and training of new personnel;
    • Reviews employee performance on a regularly scheduled basis;
    • Develops recommendations for employee career planning and development and oversees process for individual skills assessment and continuing education plans;
    • Coaches and directs personnel to ensure compliance with departmental goals, objectives and budgets;
    • Conducts regular meetings and provides guidance and direction to personnel;
    • Reviews employee’s time records, makes any necessary corrections, obtains appropriate signatures and submits for payroll processing;
    • Organizes, schedules, prioritizes and distributes workload among assigned personnel;
    • Keeps personnel informed of pertinent policies and procedures affecting the department and/or their jobs; Creates an atmosphere in which upward communication from employees is encouraged;
    • Administers personnel policies and procedures as established by company policy;
  • Manages cost center expenses as follows:
    • Constructs budget within prescribed guidelines;
    • Manages expenses to stay within budget; requests and approves payments depending on level of authority;
    • Reviews expenses on a regular basis to ensure proper recording of account expenses;
  • Oversees preparation, data, testing procedures and compliance aspects of proposals and reports.
  • Investigates and reports adverse events, compliance situations and similar problems.
  • Works directly with departments and project personnel to ensure compliance and inform of updates to regulations.
  • Ensures projects and proposals meet all relevant guidelines, standards, and regulatory rules, conducting research where needed.
  • In conjunction with the Director of Operations and the Director of Quality Assurance develops, implements, manages and evaluates regulatory strategy and tactics for all FDA regulatory submittal through the end stages of the product life cycle
  • Authors and critically reviews SOPs, protocols, technical documents, labeling, data and reports to ensure suitability for regulatory filing
  • Reviews product advertising and promotional material and analyze for compliance with current regulations
  • Monitors and investigates change in the regulatory environment through direct interaction with regulatory agencies, attendance at trade seminars, routine review of the federal register, FDA Internet updates and other trade publications to assess the impact on internal operations
  • Provides leadership to RA staff and continually reviews processes to streamline and improve company processes including performance issues and staff training needs
  • Performs other related duties as assigned or directed

Basic Qualifications:

Education:

Bachelor’s Degree in Chemistry or related science

Training (licenses, programs, or certificates):  

  • Regulatory Affairs Certification (RAPS-RAC) preferred but not required

Skills: 

  • People Management
  • Project Management
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • Documentation
  • Technical Analysis
  • Auditing

Proficient reading, writing, grammar, and mathematics skills
Proficient 
interpersonal relations and communication skills, including use of English language
Proficient computer skills including Microsoft Office, Go To Meeting, eCTD software, SPL Portal, DocuProof, Artwork Management software, Adobe Acrobat Professional

Travel:   30% domestic travel required  

Manager Qualifications:
Number Supervised: 5 people

Experience:
Minimum: 5 Years experience in Pharmaceutical Regulatory Affairs
Proficient: 10 Years experience in Pharmaceutical Regulatory Affairs

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.

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Title: Forecast Planner
Reports to: Senior Director of Commercial Operations

General Responsibilities:

Monitors and adjusts master manufacturing schedule based on production and sales performance. Analyzes market forecasts, and trend analysis to determine inventory needs. Creates and implements inventory master schedules, in conjunction with Product Management and the appropriate Contract Manufacturing Organizations.

Essential Duties:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
  • Develops, maintains, utilizes, and validates predictive models to forecast demand.
  • Manages inventory tools and analyzes data about surplus and discards.
  • Communicates and explains statistical models and recommendations to diverse audiences.
  • Monitors demand forecasts and ensures accurate reporting and analysis of data.
  • Monitors production process and implements process improvements.
  • Efficiently assigns production to minimize company costs and meet delivery deadlines
  • Manages and maintains current inventory in conjunction with Product Management.
  • Tracks shipments to ensure they are complete, correct, and on time.
  • Predicts future inventory needs, producing plans for buying based on forecasts and sales data in conjunction with Product Management
  • Performs other related duties as assigned or directed

Basic Qualifications:

Education:

  • Bachelor’s degree or 3 years of relevant experience.

    Skills: 

    • Scheduling, Forecasting, Production Management, Purchasing, Supplier Management

    Education/Experience:

    • Bachelor’s degree or 3 years of relevant experience.

    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

     

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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@x-gen.us)  Resumes and cover letters will be accepted until the position is filled.

    Thank you for your interest in X-Gen Pharmaceuticals.

    X-GEN Pharmaceuticals 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

    If you would like to submit a resume for future consideration, please use the form below.

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