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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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(OPPORTUNITIES: 4)

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Title: Quality Manager, External Manufacturing


Reports to: Director of Quality

FLSA:  Exempt

 

 

General Responsibilities:

This position is responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of generic pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements and X-GEN’s Quality Management System. The Manager, External Manufacturing, Quality Assurance, will act as the lead quality point of contact for assigned Projects.

Essential Duties:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
  • Independently manage and provide quality oversite as well as lead daily quality related interaction and commercial production execution and/or product transfers with third parties and cross functional teams to assure:
      • Quality and compliance related matters meet appropriate GMP and regulatory requirements
      • Product is safe, pure and effective for distribution by direct review and inspection of the finished goods and documentation.
      • All documentation for release is present, accurate and within established ranges and specifications
      • Approval or rejection of product based on conformance to specifications, current Good Manufacturing Practices (cGMP’s) requirements and /or contractual agreements.
      • Representation of the department and X-Gen on cross-functional project teams and external business partner meetings
      • Compliance with cGMP’s, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external partners
      • High performance of third party contract manufacturers by implementation of quality metrics and scorecard
  • Assures timely launch of new products by:
      • Serving as the Quality lead for technical transfer activities at external manufacturing partners
      • Reviewing ANDA filings for identification of deficiencies and compliance to the requirements
      • Supporting manufacturing activities related to regulatory filings (i.e. on-site presence for engineering, validation, registration batch manufacturing, timely review and approval of documents, etc.)
      • Participation in and advisement of responses related to filing deficiencies.
  • Supports X-GEN’s Operations related to commercial product distribution by:
      • Approving and releasing commercial product
      • Leading investigations associated with product non-conformances and deficiencies identified during inspections, manufacturing, and product complaints
      • Certifying that all incidents, complaints, and investigations are properly documented
      • Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action
      • Investigating and determining the need for field alerts or recalls of company products manufactured by third party contract manufacturers
      • Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation
      • Perform on-site visits during manufacturing/packaging of X-GEN products and attend quality business reviews at external manufacturing partners to assess compliance with cGMPs and X-GEN’s requirements
      • Participating in Agency and X-GEN inspections of external manufacturing partners to ensure successful inspection outcomes and maintain a constant state of inspection readiness at these sites
      • Performing quality risk assessments and driving risk reduction improvement plans and remediation where necessary
      • Driving quality compliance and performance metrics with external manufacturing partners and reporting metrics on a routine basis
      • Compliance with cGMP’s, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external
  • Performs other related duties as assigned or directed.

Qualifications/Requirements:

Education/Experience:

  • Bachelor’s Degree in Science (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or related area)
  • 5-8 years of work experience in Quality Assurance within the pharmaceutical industry or 3-5 years of experience working with pharmaceutical Contract Manufacturing Organizations (CMOs) and business

Skills: 

  • Contractor Management
  • Relationship Management
  • Understanding of FDA trends, regulations, and guidelines
  • Writing Procedures and Documentation
  • Must be organized and possess communications and facilitation skills
  • Traveling required as necessary to support job function

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: 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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Title: Regulatory Affairs Specialist II


Reports to: Director of Regulatory Affairs

 

Position Summary:

Conduct research to support regulatory submissions. Prepare and submit documentation to regulatory agencies. Ensure company compliance with all regulations and laws pertaining to company business. Compile and maintain appropriate technical document for regulatory submissions.

Essential Duties:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
  • Conduct research to support regulatory submissions.
  • Prepare and submit documentation to regulatory agencies.
  • Ensure company compliance with all regulations and laws pertaining to company business
  • Compile and maintain appropriate technical documents for regulatory submissions
  • Use pre-established guidelines with assistance creates regulatory submissions related to the maintenance of ANDAs such as quarterly and annual reports, while learning to meet submission commitments and deadlines
  • Participates in the development, monitor and implement technical applications required to most efficiently transmit regulatory submissions
  • Collaborate with Contract Manufactures (CMs) to obtain technical information/documentation and implement changes for compliance with current regulations
  • Collaborate with other departments within the company to obtain technical information/documentation and implement changes to comply with current regulations
  • With assistance reviews SOPs, protocols, technical documents, labeling, data and reports to ensure suitability for regulatory filing
  • With assistance develops printed product labeling and coordinate labeling changes and manage communication with CM and labeling artwork supplier. Coordinate the filing of all labeling changes
  • Relies on limited experience and judgment to provide knowledge based input to support formulation of regulatory strategy and tactics for all regulatory submissions
  • Create, monitor and track regulatory submissions (ANDAs) and related maintenance documentation (amendments, supplements, annual reports, etc) to meet submission commitments and deadlines
  • Communicates directly with FDA reviewers concerning requirements, input and timelines for filed applications and amendments
  • Author and critically review SOPs, protocols, technical documents, labeling, data and reports to ensure suitability for regulatory filing
  • Develop printed product labeling and coordinate labeling changes and manage communication with CM and labeling artwork supplier
  • Coordinate the filing of all labeling changes
  • Performs other related duties as assigned or directed

Education:

  • Bachelor’s degree in Biochemistry or Science related area

Skills: 

  • Regulatory Compliance
  • Document Preparation
  • Data Analysis
  • Writing Procedures and Documentation
  • Project Management
  • Contractor Management
  • Must be organized and possess communications and facilitation skills
  • Must have the ability to work with minimal supervision
  • Traveling required as necessary to support job function

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

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+1 (866) 390-4411
info@x-gen.us