Position: Quality Control Manager, Manufacturing
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.
Seeking an experienced Quality Control Manager, Manufacturing to oversee and manage quality control related activities at Contrafect for both early and later stage programs. Roles and responsibilities include:
- Ensure that appropriate cGMP quality compliances are met for both internal and external for Quality Control related activities for all ContraFect developmental programs at early and late stage
- Responsible for batch release and management of stability programs in conjunction with CMOs/CROs and internal project manager/QAs, these may include but not limited to: initiation of new stability studies, review and approve stability protocols, review the release and stability results in time for accuracy, OOS/OOT investigations, close of LIRs, trending stability data; setting batch retest/expiry date as needed, assisting with closure of temperature excursion investigations
- Working with CROs/CMOs to ensure that method qualification/validation are performed according to applicable ICH and other regulatory guidance in a timely manner. Review and approve method qualification and validation protocols as well as method qualification/validation reports
- Oversee the reference material and critical reagent management programs
- Remain current with USP, EP, and ICH requirements as applicable
- Provide assistance in regulatory documentation drafting (such as IND , BLA, etc) on relevant sections.
- Extensive experience with analytical method development, qualification and validation in a Quality Control setting
- Strong understanding of quality and compliance principles and regulations governing biological products (preferably for proteins and peptides)
- Expertise in analytical methodologies for biologic molecules, particularly for proteins
- Working knowledge and ability to apply cGMP in conformance to US, EU and ICH guidelines
- Ability to multi-task, prioritize complex daily workload and work in a virtual environment
- Excellent oral and written communication skills
- Prior experience working with CROs/CDMOs is preferred
- 5+ years of industry experience, preferably in biology, biochemistry, or other biologic-science related discipline, is required
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.
Salary: Commensurate with experience.
No phone calls, please.
Please fill out the form below to submit your resume.