Job Application

Position: Executive Director Quality Systems

Location: Remote

REPORTING TO: VP Regulatory Affairs and Quality Systems

Background

ContraFect Corporation, a late-stage clinical biotechnology company focused on the discovery and development of biotherapeutics for life-threatening, drug-resistant infectious diseases is located in Westchester County, near New York City. We are dedicated to innovative drug development, leveraging novel technologies to create new therapies that address the high unmet medical needs of patients suffering from serious, antibiotic-resistant  infections for which there are limited available treatment options. We are using ContraFect’s technical expertise to develop biotherapeutics for serious bacterial infections, including those caused by MDR and XDR strains that have high unmet medical needs, particularly products used in hospital-based markets.

An opportunity is available to grow with us in an environment that is both challenging and energetic. ContraFect is seeking self-motivated and collaborative individuals to join our team and to contribute their talent and expertise to the team. We are looking for positive individuals who will add the strength of their personality to our committed and dedicated employee base and contribute to the development of novel therapeutic agents which have the potential to change the therapeutic landscape for treating serious infections.

It is an exciting time in our Company’s history as we advance our direct lytic agent (DLA) platform of lysins and amurin peptides into the clinic.  Exebacase (CF-301), our lead lysin, is the first and only direct lytic agent to report promising results in Phase 2 and to advance to Phase 3 of development. Earlier this year, the FDA granted Breakthrough Therapy designation to exebacase for development as a treatment for  MRSA bloodstream infections (bacteremia), including right-sided endocarditis, when used in addition to standard-of-care (SOC) anti-staphylococcal antibiotics.  The exebacase Phase 3 study, known as the DISRUPT Study (“ Direct Lysis of Staph aureus Resistant Pathogen Trial”)  ongoing in the United States and will serve as the single pivotal trial to support the BLA.  ContraFect also has an active discovery pipeline of DLAs discovered at ContraFect which are progressing towards the clinic with support from major funding agencies including the Department of Defense, CARB-X and the Cystic Fibrosis Foundation. Our lead IND candidate, CF-370, a lysin targets MDR Pseudomonas aeruginosa, a bacteria identified as a serious threat in the CDC’s Antibiotic Threats in the US, 2019 report.

ContraFect has been highly successful in raising significant capital to fund their continued commitment to innovative R&D.  This includes non-dilutive funding from the Cystic Fibrosis foundation, $18.9 million from CARB-X for antibacterial research, $7.2 million from USAMRMCto advance CF-296, and $6.94 million from CARB-X to support the development of amurin platform against all Gram-negative ESKAPE pathogens. Also, ContraFect has conducted numerous capital raises, including public and private offerings. The gross proceeds from the most recent public offering were approximately $52.5 million, and an additional $3 million from a concurrent private placement transaction with Pfizer, the pharmaceutical company’s second investment in ContraFect.

Position Summary:

The ideal candidate will have a proven track record of accomplishments in the life sciences/pharmaceutical/biotechnology industry. This role will work closely with other departments and requires a highly collaborative work ethic.  This position is responsible for the leadership of the Quality Systems department within a clinical stage biotechnology company with a lead candidate with Breakthrough Therapy designation in Phase 3 development and preparing for commercialization.  The candidate will be responsible for leading the assessment  and enhancement of ContraFect’s the quality systems to ensure inspection readiness, by  directing the day to day function of the quality group and collaborating with the functional areas to ensure GXP compliance.

Key Responsibilities:

  • Set strategic direction for the Quality Systems function to successfully lead a clinical development company to commercialization.
  • Establish and maintain Quality Systems to support GXP activities.
  • Enhance and maintain GXP Policies and Procedures to assure regulatory compliance and product quality.
  • Partner with functional area leads to assess GXP compliance risks and develop and implement risk mitigation measures.
  • Provide hands on quality leadership to support GCP compliance and BIMO inspection readiness for a Phase 3 pivotal study.
  • Ensure compliant documentation, training, and quality management system processes.
  • Provide leadership in preparation for successful regulatory agency inspections.
  • Provide long range planning of Quality System related activities.
  • Lead Quality initiatives and drive continuous improvement efforts.
  • Partner with functional areas to assess GXP compliance risks and develop and implement risk mitigation measures.
  • Ensure compliant documentation, training, and quality management system processes.
  • Implement Quality Management Review process, providing KPIs and Quality metrics.
  • Evaluate quality and compliance issues and determine corrective actions and need for escalation.
  • Provide leadership and subject matter expertise during regulatory inspections of Quality Systems.
  • Mentor staff and develop the team.

Education/Experience/Skills:

  • BS/BA degree in Scientific Discipline (Masters or higher preferred) with at least 15 years in the pharmaceutical industry, including at least 10 years in Biotech or Pharma.
  • Demonstrated record of accomplishments in the life sciences industry expanding from a clinical stage companies through to commercialization.
  • Thorough working knowledge of Quality Systems to support GXP operations and ensure compliance with GXP regulations.
  • Extensive history and successful track record of implementing GCP quality systems and procedures, and providing guidance to the clinical team to ensure GCP compliance for a Phase 3 program leading to product approval.
  • Demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance.
  • Procedural document authoring
  • Development and implementation of processes for CAPA, Non-Conformances, Risk Management, Management Review
  • Highly proficient in quality management platforms and tools
  • Outstanding communication skills (interpersonal, verbal and written).
  • Proven track record of industry successes including experience leading and supporting regulatory inspections (Sponsor, BIMO, and PAI)
  • Exceptional leadership skills working with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
  • Candidates must have strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity in a remote/virtual working environment.

Our Values:

            Respect.  People matter.
            Patient- Focus.  Act with urgency and passion to save lives.
            Leadership.  Set high standards, and empower others to do the same.
            Innovation.  Challenge the status quo to deliver solutions.
            Collaboration.  Work together to achieve our vision.
            Quality.  Strive for excellence in all that we do.
            Integrity.  Courage to be honest, ethical, and transparent.

ContraFect does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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