Position: Director Process Development and Manufacturing
Reports to: Executive Director/Head Process Development and Manufacturing
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 on developing treatments for bacteria designated by CDC and the WHO as urgent or serious threats of critical or high priority.
This is a key position within the process development and manufacturing and an excellent opportunity for career development in a fast-paced and highly collaborative environment in a company with pre-clinical, early and late-stage clinical programs. The individual will work closely with the manufacturing, analytical, quality assurance, clinical, regulatory and discovery teams through all stages of clinical development.
The successful candidate is expected to play an integral role in the development and manufacturing of therapeutic proteins and peptides using bacterial expression system and solid phase synthesis, respectively. Specifically, the successful candidate will drive innovation and development of the therapeutic candidate manufacturing process and ensure technology transfer to GMP facilities within a third-party Contract Manufacturing Organization (CMO). Candidate will serve as the key technical liaison of the manufacturing project with the CMO. The candidate is expected to manage development and cGMP process of bacterial fermentation and protein purification as well peptide manufacture by a CMO. Ability to prepare and review scientific and manufacturing reports, critical review of batch records from CMO and technical review of executed GMP batch records for completeness. The candidate will draft/review CMC sections in the IND/BLA. The following additional experience are plus: process validation, drug product manufacture, and analytical development.
- Ph.D.(+10 years) or (MSc/BSc +15 years) in Biochemistry, Biotechnology or Chemical Engineering required.
- A minimum of 10 years (or 15 years with MSc/BSc) direct experience developing protein and peptide therapeutics in industry with IND/BLA setting.
- Demonstrated skills in working with teams and executing projects in a cost effective and timely manner under GMP and Regulatory environment.
- Proven track record in leading clinical stage programs and cross-functional interactions through to successful IND and BLA.
- Biotech experience with protein and peptide drug substance manufacturing
- Previous experience with development and manufacture using bacterial fermentation.
- Author/review/Approve technical reports, batch records, protocols and manage third party CMO activities
- Communicate and present data and issues to peers and functional management and get resolutions to execute projects in a timely manner
- Work with the team to identify and qualify third party vendors and manufacturers intended for development work, process scale-up and CTM manufacturing,
- Ability to adapt and thrive in a dynamic fast paced, team oriented, clinical-stage environment.
- A scientifically motivated self-starter, capable of independently conceiving, conducting, and critically analyzing his/her own work with minimal supervision.
- Ability to vision and plan manufacturing projects from pre-development through IND and BLA
- A strong presenter and communicator, well versed with MS Word, Excel, MS project and Pdf edits with track changes preserving original contents.
- Effectively communicate with analytical, Quality Assurance, Pre-clinical, clinical and regulatory departments.
- Superior personnel management and organizational skills.
- Ability to quickly adapt to changes and develop appropriate plans for managing risks.
- Ability to influence, negotiate and successfully communicate with both internal and external stakeholders
- Strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
- Experience with development and manufacture peptides derived by solid phase synthesis.
- Experience with Drug Product manufacture.
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.
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