1-866-390-4411 info@x-gen.us

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

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Available Positions (3)

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Title: Manager of Accounting
Reports to: Vice President, Enterprise Operations and Governance

FLSA: Exempt

Position Summary:
This position is responsible for the accounting operations of the company in accordance with generally accepted accounting principles. Responsibilities include supervising the accounting department staff and overseeing accounts payable, accounts receivable, and general ledger administration.

Essential Duties & Responsibilities:

  • Supervise, direct and manage the work of the accounting staff, including but not limited to accounts receivable transactions, collection, accounts payable transactions, returns, inventory reporting, sales analysis, royalty payments, chargebacks and routine general ledger reconciliations.
  • Manage the performance of the accounting staff in accordance with the company’s performance management program.
  • Manage customer accounts including new account setup, monitoring and auditing
  • Responsible for all month and fiscal year end closings and associated reconciliations.
  • Manage a documented system of accounting policies, processes and procedures; including routine internal auditing of policies, processes and procedures designed to identify potential improvements to the company’s financial performance.
  • Engage in ongoing cost reduction analyses in all areas of the company.

Qualifications / Requirements:

  • Must be proficient in MS Word and Outlook
  • Advanced MS Excel skills preferred
  • Detail oriented with strong analytical skills and experience
  • Experience in financial report writing and financial audits
  • ERP proficiency, ERP implementation or testing experience
  • Team player, big picture, collaborative, skilled at gaining alignment
  • Financial analysis experience preferred

Education/Experience:

  • S. degree in Accounting, or equivalent, with 5 years related and relevant experience
  • 5 years management experience; CMA certification a plus

 

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Title: Regulatory Affairs Specialist I
Reports to: Regulatory Affairs Manager

FLSA: Exempt

Position Summary:
This position will perform the actions necessary for full regulatory compliance for all drug products, from initial FDA regulatory submittal through the end stages of the product life cycle. Daily Regulatory Affairs responsibilities include drug product labeling, annual product reports, post-approval requirements, ANDA filings and post approval submissions.

Essential Duties & Responsibilities:

  • 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 Manufacturers (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.
  • Travels to training and may accompany other Quality or Regulatory personnel to CMs or agency sponsored meetings.
  • Monitor and investigate 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.

Qualifications / Requirements:

  • Moderate knowledge of word processing, spreadsheet, database, internet, electronic document management systems and be familiar with electronic submissions software.
  • Strong computer skills including Adobe Acrobat Professional, Excel, MS Word, Powerpoint.
  • Must be highly organized and possess strong communications and facilitation skills.
  • Regulatory Affairs and Regulatory Operations experience desirable.
  • Must have the ability to work with minimal supervision.
  • Traveling required as necessary to support your job functions

Education/Experience:

  • Bachelor’s degree, or Two Year Associate degree in Chemistry, Biochemistry, Biology, or combination of the above.
  • 0-2 years of Direct Regulatory Affairs Experience desired

 

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Title: Senior Shipper/Receiver
Reports to: Warehouse Supervisor

FLSA: Non-Exempt

Position Summary:
This position is responsible assisting the warehouse supervisor in running the day to day operations of the warehouse.

Essential Duties & Responsibilities:

  • Coordinate daily Shipper/Receiver staff activities as directed by the Warehouse Supervisor
  • Procure all warehouse supplies and maintain adequate inventories.
  • Ensure warehouse organization, safety and cleanliness.
  • Accurate and efficient pick, pack and process of sales orders
  • Trace and monitor status of shipments in transit
  • Receive and store incoming material in compliance with corporate SOP ‘s 155-000, 155-010 and 155-020
  • Perform daily inventory counts and stock rotation of drug products
  • Help train and develop shipping department staff.
  • Supervise all warehouse operations, including scheduling shipping department activities to meet daily workload demands, in absence of Warehouse Supervisor

Qualifications / Requirements:

  • Ability to develop and organize a shipping schedule
  • Computer and spreadsheet skill
  • Strong interpersonal skills, ability to manage others’ daily work activities

Education/Experience:

  • Requires High School diploma.
  • Minimum 5 years warehouse/inventory experience

 

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