Fera Pharmaceuticals is a new breed of specialty pharmaceutical company.  It's been built from the ground up with the vitality and vision to expand quality treatment options--and improve lives.


 

Director, Manufacturing and Quality Assurance 


Responsibilities


GMP:

  • Manage development and commercial projects with contract manufacturers (CMOs) to completion
  • Oversee process optimization, scale-up and registration batch manufacture for new products
  • Review and approve all documentation including master batch records, specifications, analytical results, validation protocols and reports
  • Work with internal colleagues to support project plans and evaluation of potential vendors / suppliers
  • Maintain quality compliance program for the manufacture of Fera products
  • Maintain a quality compliance program for all vendors including an effective change management system
  • Coordinate the completion of required documentation for instituting process changes at all manufacturing/packaging/analytical sites
  • Participate in vendor audits
  • Coordinate with Regulatory and CMOs to facilitate the assembly and submission of NDAs, ANDAs and Supplements
  • In conjunction with Regulatory Affairs and CMOs, manage and coordinate all product complaints and investigations according to current FDA regulations
  • In conjunction with Regulatory Affairs and CMOs, manage and coordinate product recalls
  • Develop internal SOPs as necessary
  • Ensure that Fera and its contract manufacturers comply with all corporate and regulatory cGMP guidelines and SOPs
  • Approve product for market release


GCP Responsibilities:

  • Assist in the review and development of SOPs and procedures to support clinical operations
  • Provide support for clinical study operations including review and approval of documents, vendor selection and audit reports
  • Provide assistance for external audit preparation and conduct as required
  • Support organization regarding study drug development, labeling, distribution, return and destruction


GPvP Responsibilities:

  • Ensure proper SOPs are in place to comply with US and foreign Regulatory requirements for safety reporting
  • Ensure compliance with SOPs and regulations through the development of pharmacovigilance compliance program and auditing of internal safety reporting procedures as appropriate to Regulatory agencies
  • Ensure that SOPs and procedures are in place to identify and report potential safety trends and signals
  • Work closely with Regulatory Affairs to ensure proper and timely reporting of safety reports


Business Development Responsibilities:

  • Provide scientific feedback on products being considered for development or purchase
  • Participate in ongoing research projects
  • Proactively look for business opportunities and facilities


Education and Experience Requirements:  Bachelor’s degree or foreign equivalent in Chemistry / Pharmacy or related and 5 years relevant work experience


Location:  Fera Pharmaceuticals is located in Nassau County, Long Island, NY


Send resume to:  contact@ferapharma.com