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Employment

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 (2)

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Title: Director of Quality and Regulatory Affairs
Reports to: Vice President, Enterprise Operations and Governance

Position Summary:
This position establishes strategy, oversees and coordinates the quality assurance and regulatory affairs functions. Ensures the quality of all products. Responsible for continuously reviewing the quality practices and procedures to ensure the highest standards. Participates in the submission of new drug applications to ensure rapid and timely approval on new drug products.

Essential Duties & Responsibilities:

  • Supervises quality and regulatory department employees; coaches, trains and promotes a good working environment. Conducts performance reviews and actively communicates with department employees.
  • Responsible for the activities of testing and evaluating proprietary pharmaceuticals.
  • Ensures compliance with federal and state regulations and interpretations, specifically the FDA and NY State Board of Pharmacy.
  • Responsible for development, implementation, management and ongoing evaluation of regulatory strategy and activities to ensure full regulatory compliance for all drug products from FDA regulatory submittal through the end stages of the product life cycle.
  • Interacts with regulatory personnel in order to expedite approval of pending applications.
  • Assists the review of all product changes for possible submission filing.
  • Oversees the stability testing program for re-pack powders and contract manufactured products where we hold the ANDA.
  • Oversees the assurance of the company’s compliance with all Standard Operating Procedures (SOPs) in conjunction with the Manager of Quality Assurance.
  • Reviews all FDA submissions (ANDAs, CBE-30, CBE, Annual Report, Drug Listing, Promotional) for accuracy and content from a Quality Management perspective.
  • Responsible for the oversight of documenting and reporting adverse reactions, drug product complaints and inquiries.
  • Ensures all cGMP training is completed.
  • Performs and oversees audits of Contract Manufacturers and Contract Laboratories.
  • Directs and documents all FDA inspections and authors inspection responses.

Qualifications / Requirements:

  • Knowledge of SOPs, cGMP, Government Regulations and Guidance

Education/Experience:

  • Bachelor’s degree in Chemistry, plus a minimum of ten years of applicable experience.

 

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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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