Position: Director of GMP Quality
REPORTING TO: VP Regulatory Affairs and Quality Systems
ContraFect Corporation, a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics for life-threatening, drug-resistant infectious diseases. We are committed to innovative drug development, leading the way with novel technologies to create new therapies that address the high unmet medical needs of patients suffering from serious infections for which there are limited available treatment options. The company is located in Westchester County, near New York City.
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. We are looking for positive individuals who will add 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. Exebacase, our lead compound, is the first and only bacteriophage-derived lysin (cell wall hydrolase) to enter clinical trials in the US. Exebacase, which targets Staphylococcus aureus, including MRSA, is the first of a new class of protein-based therapeutics for the treatment of serious bacterial infections. Exebacase has recently been granted Breakthrough Therapy designation by the FDA and is currently being studied in a Phase 3 clinical trial for the treatment of S. aureus bacteremia including endocarditis. In addition to exebacase, we have an exciting pre-clinical and discovery pipeline of lysins and amurin peptides targeting antibiotic resistant Gram-positive and Gram-negative bacteria. Our primary focus is developing potential treatments for bacteria designated by CDC and the WHO as urgent or serious threats of critical or high priority.
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 leadership with the CMC group to provide oversight of external vendor qualification and quality programs to ensure compliance with and adherence to GMP quality standards. This includes but is not limited to hosting Regulatory Inspections as well as third party audits including CAPA completion on time and in full. Define and execute continuous improvements to the GMP Quality Management System with cross functional team members to ensure regulatory compliance.
- Serve as GMP Quality team member on the CMC Team – prepare updates on quality issues; provide input to discussions which may involve GMP quality issues by communicating proactively and effectively
- Collaborate with CMC team functions to confirm adherence to GMP compliance throughout all stages of development including, but not limited to, documents, CMO oversight, issue escalation, internal/external audit support.
- Manage QA reviews of manufacturing documentation (i.e. Quality Agreements, Batch Records, COAs and release documents, protocols, deviation investigations, change controls, CAPAs, reports, etc.) for compliance with regulations.
- Develop, implement, and maintain standards, policies, and procedures for GMP regulatory compliance
- Manage/oversee GMP SOP training of CMC staff
- Manage/oversee PAI preparedness at CMOs in preparation of Pre-approval inspections by Regulatory Authorities and be on site for PAI Inspection to support BLA approval.
- Plan and ensure conduct of Quality audits (qualification, requalification, and for cause) for all vendors supporting development programs through commercialization to ensure complicance with GMPs.
- Review relevant vendor quality management plans
- Participate in the evaluation and selection of CMOs and other manufacturing vendors
- Investigate potential/suspected GMP quality issues, escalate to Head of Quality and/or Quality committee as appropriate
- Lead/participate in quality and compliance improvement initiatives within and outside of the CMC department.
- Maintains a focus of performance with view of continuous improvement.
- Ability to manage multiple priorities and aggressive timelines
- Expected to operate independently and highly autonomously; accountable to proactively fulfill tasks and achieve results within assigned timelines.
- Bachelor of Science degree or equivalent combination of education and work experience.
- Minimum of 15 years industry experience with at least 8 years with a proven track record of having managed GMP Quality functions supporting clinical development through to commercialization.
- Demonstrated leadership regarding the preparedness and participation in audits by external Regulatory Agencies to support NDA/BLA/MAA approvals.
- Experience in developing and implementing Inspection Readiness and PAI Plans.
- Strong working knowledge of cGMPs with knowledge of GLPs a plus.
- Detail oriented with strong analytical and organization skills.
- The successful candidate for the position of Director of GMP Quality must have a demonstrated record of accomplishments in the life sciences industry expanding a QMS from a clinical stage company to commercialization.
- Candidates must bring a strong entrepreneurial orientation along with teamwork skills and an absolute commitment to competing with the highest level of integrity in a remote working environment.
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.
Please fill out the form below to submit your resume.