Position: CMC Project Lead
Reports to: Vice President of CMC
ContraFect Corporation is a clinical-stage biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases. We are committed to innovative drug development and are 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. CF-301, our lead compound, is the first and only bacteriophage-derived lysin to enter clinical trials in the US. This biologic targets Staphylococcus aureus, including MRSA, and is the first of a new class of protein-based therapeutics for the treatment of serious bacterial infections. The company has recently reported positive Topline Results from a Phase 2 clinical study using CF-301 that demonstrated improved clinical outcomes for patients with staphylococcus aureus bacteremia. ContraFect is advancing this therapy toward a pivotal Phase 3 clinical trial.
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.
The CMC Project Lead is a Director level position that will play a critical role within a dynamic and growing CMC team to ensure that appropriate scientific, regulatory, and quality standards are followed across multiple programs. He/she will provide technical input and timeline oversight to our external protein production and purification CMOs to ensure a reliable supply of drug substance and drug product for clinical stage programs. This individual will execute strategies through the use of CMOs, CROs and CMDOs. The successful candidate will also provide project management support to ensure timely execution of CMC activities.
- Manage technical and timeline requirements with our CMO, CDMO vendors for protein manufacturing activities that will include process development, technology transfer, and GMP protein production
- Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required
- Review Technical/Quality agreements to ensure that outsourced activities are conducted in agreement with program goals
- Key contributor to CMO, CDMO selection for clinical protein supply based on project needs and capabilities through RFP procedures and site evaluations
- Provide CMC project management support and work closely with CMC partners including research and development, process development, drug substance manufacturing, clinical and quality functions
- Maintains knowledge of current best practices of drug delivery, and identifies emerging trends and technologies and lead implementation/feasibility assessment, as appropriate
- Actively participate in preparation of domestic and international regulatory filings in collaboration with Regulatory and Quality
- Willingness to travel domestically and internationally as needed
- An advanced degree (MS or PhD) in, Protein Biochemistry, Engineering or other related field with 10+ years of relevant experience in biologics drug development (pharmaceutical company, biotechnology company or CMO) in the areas of process development, manufacturing and fill/finish
- Proven track record of leading manufacturing projects to successful completion
- Extensive experience with the development, optimization and scale-up of manufacturing processes for biologic therapeutics, with prior experience at clinical and commercial stages in managing multiple functions such as upstream/downstream process development, analytical & formulation development is highly desirable
- Experience in oversight of technical transfer and implementation of CMC activities at CMOs and partner facilities is required
- Ability to support supply chain strategy while being technically competent to collaborate internally and with outside vendors on multiple process development issues
- Experience in working within a GMP manufacturing environment with keen familiarity of regulatory compliance requirements
- Experience with content development for regulatory submissions (e.g. IND, IND amendments, BLA submission) strongly preferred
- Ability to successfully work with a collaborative, fast‐paced project team in an entrepreneurial work environment
- Ability to influence, negotiate and successfully communicate with both internal and external stakeholders
- Excellent organizational, planning, and project management skills
- Strong communication (oral and written) and interpersonal skills and able to provide technical updates and program status to a broad range of technical and non-technical audiences
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.
ContraFect Corporation is an equal opportunity employer. We recognize the power and importance of a diverse employee population and welcome applicants with various experiences and backgrounds.
Please fill out the form below to submit your resume