z. (Archive) Employment

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.

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Equal Employment Pay Transparency

Equal Opportunity Employment is THE LAW

 

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(OPPORTUNITIES: (6)

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Title: Regulatory Affairs Labeling Specialist

Reports to: Director of Regulatory Affairs

 

Position Summary:

The Regulatory Affairs Labeling Specialist is responsible for assuring compliance of federally-regulated product label information, for overseeing labeling changes for lifecycle products, assisting in the development of labeling content for new products, and reviewing applicable regulatory documentation and artwork. This position will also support implementation of approved labels which may include document control, QC/proofread, and tracking project milestones and status.

Essential Duties & Responsibilities:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
  • Ensures company compliance with all regulations and laws pertaining to company business.
  • Collaborates with internal teams and external parties to create labeling for Pharmaceutical Generic products.
  • Ensures that labeling, art, and proofs meet all medical, legal and regulatory requirements as per U.S FDA and CFR 21 labeling guidelines.
  • Monitors, evaluates and recommends improvements to labeling process, quality systems, tools and/or policies.
  • Under general supervision, participates in global labeling projects to completion, working closely with other personnel to ensure accuracy of all labeling as well as timeliness of projects so that all commitments and deadlines are met.
  • Facilitates the review and approval processes for all artwork and labeling from development through final proofs.
  • Evaluates content of labeling changes and determine appropriate reviewers, disposition of stock and implementation strategies.
  • Reviews artwork ensuring that all components meet the appropriate labeling requirements and guidelines.
  • Gathers and evaluates all relevant information to support labeling changes for each project and maintain detailed audit trail.
  • Under general supervision, negotiates and collaborates with Regulatory Affairs, QA and other team members to obtain approval and facilitate implementation of labeling in an accurate and timely manner.
  • Helps develop printed product labeling, coordinates labeling changes and manages communication with CM and labeling artwork supplier.
  • Assists in the preparation of new and revised SPLs for ANDAs throughout product life cycle.
  • Responsible for drug listing of original or revised SPLs, as appropriate, to support U.S. commercial launch and post-marketing activities.
  • Responsible for the maintenance of SPL software database to track the history and version control of each SPL.
  • Ensures appropriate tracking of labeling projects via defined procedures and optimal use of systems. Champions and/or participates in continuous improvement efforts related to business practices and tools utilized within role.
  • Ensures consistency of labeling across product lines and compliance with Client policies and procedures.
  • Stays current with labeling guidelines and regulations by FDA.
  • Performs other related duties as assigned or directed

Qualifications/Requirements:

Education/Experience:

  • Bachelor’s degree in Science Field, such as Chemistry, Biology, Pharmacy, or equivalent

Skills: 

  • Solid working knowledge of FDA drug labeling
  • Advanced knowledge of Adobe Illustrator and/or Adobe Acrobat and other related graphic design software
  • Regulatory Compliance
  • Document Preparation
  • Writing Procedures and Documentation
  • Project Management
  • Must be organized and possess communications and facilitation skills
  • Must have the ability to work with minimal supervision

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: Senior Business Development Manager

Reports to: Vice President of Business Development

 

Position Summary:

The Senior Business Development Manager is responsible for identifying prospective new products and new business through strategic alliances, ANDA submissions, new product acquisitions, licenses and/or joint ventures. This position identifies, researches, evaluates and recommends new business opportunities for corporate consideration.

Essential Duties & Responsibilities:

  • Supports X-GEN’s Mission and Vision statement by adhering to the Code of Corporate Values and conforming to established performance expectations.
  • Examines potential business deals and evaluates market strategies, deal requirements and deal financials in accordance with corporate strategy
  • Evaluates and recommends negotiating strategies and positions by studying integration of new venture with company strategies and operation; examining risks and benefit
  • Constructs and Manages new business deals by establishing requirements; developing and drafting contracts; integrating contract requirements with business operations
  • Demonstrates meaningful contribution to financial success of company through measurable achievements and timely outcomes
  • Performs other related duties as assigned or directed

Qualifications/Requirements:

Education/Experience:

  • Bachelor’s degree in a life science or a pharmaceutical degree, plus minimum three years of pharmaceutical development and industry experience.

Skills: 

  • Product Development
  • Business Analysis
  • Business Strategy
  • Strategic Partners
  • Negotiation
  • Product Management

Travel: 

  • 40% or more

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 QA Compliance

Reports to: Director of Quality

 

Position Summary:

This position is responsible for the development, establishment, execution, ownership, and compliance of GMP/GDP Quality Systems (including, but not limited to change control, investigations, pharmacovigilance, product complaints, deviations, and CAPA) to ensure GMP compliance throughout the organization. Provides guidance to other departments regarding compliance to XGen DJB’s Quality as well as Regulatory Agency procedures, policies and regulations

Essential Duties & Responsibilities:

  • Supports XGen DBJ’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;
    • Explains variances, exceptions and other impacts that occur between budget and actual expenses;
    •  Administers personnel policies and procedures as established by company
  • Responsible for the oversight and management of all Quality/GMP/GDP compliance systems
    • Provides guidance and actively participates in client audits & in FDA inspections
    • Responsible to provide regulatory guidance and assistance to support regulatory submissions
    • Provides guidance and direction to the QA Compliance Specialist
    • Manages all internal and external customer queries with respect to quality matters.
    • Establishes and performs quality training programs for all employees.
    • Supports the design, implementation and maintenance of the quality systems, procedures, and policies to ensure compliance with the current regulations and all applicable regulatory requirements.
    • Evaluates and interprets US and Global regulations, guidance’s, standards to ensure that the site and
      product complies with all applicable regulations and submissions.
    • Participates in the creation, review, approval and lifecycle management of controlled quality
      documents (e.g. SOPs) and supporting documents within the Quality department.
    • Ensures internal review of QMS documents from other functional areas
    • Analyzes compliance metrics, and identifies potential improvement activities.
    • Communicates issues/trends to Quality Director.
    • Ensures all deviations, investigations, customer complaints, adverse events, etc. are properly
      investigated and provide final approval for investigation.
    • Ensures a robust deviation management system is executed to ensure effective root cause and
      corrective and preventive action is defined
    • Performs other related duties as assigned or directed.

Qualifications/Requirements:

Education/Experience:

  • Bachelor’s degree in Science Field, such as Chemistry, Biology, Pharmacy, or equivalent

Skills: 

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

Education/Experience:

  • Bachelor’s degree in Science or Regulatory Discipline. 10 years of work experience in Quality Assurance
    within the pharmaceutical industry and 2-4 years’ experience working with quality systems.Travel:
  • Bachelor’s degree in Science or Regulatory Discipline. 10 years of work experience in Quality Assurance

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 XGen’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

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: 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 XGen’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

    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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    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.

      Education:

      • Bachelor’s degree in Biochemistry or Science related area

      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 internal 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

       

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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.

      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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      MEDIA INQUIRIES:

      300 Daniel Zenker Dr
      Horseheads, NY 14845

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