Director, Drug Product Development
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.
The Director of the Drug Product Development function is a virtual role reporting to the Executive Director, Process Development and Manufacturing, responsible for managing experimental studies in preformulation, formulation and manufacture of recombinant therapeutic proteins and synthetic peptides. The primary responsibility will be for a late-stage product development and BLA preparation. All activities are performed using third party Contract (CMO) facilities. The responsibilities include process development and optimization of the technical operations associated with liquid and lyophilized drug product, compatibility studies for drug administration, process characterization, GMP manufacturing and process validation.
- Develop and optimize formulations for biologic therapeutics, including evaluation of physical characteristics of development API (stability, solubility, particle size, etc.), execution and analysis of stability studies, of lab scale/pilot scale and cGMP batches and adjustment of processes and methods, as needed,
- Design and execute various studies to support formulation selection and manufacturing unit operations including stability and excipient selection, freeze/thaw, mixing, sterile filtration, vial filling and lyophilization,
- Lead/manage DOE and risk assessments to finalize the DP formulation and manufacturing processes,
- Design Process Validation protocols and to support both liquid and lyophilized drug products,
- Design of compatibility studies to support administration of biologic therapeutics,
- Author technical reports and present data to peers and functional management,
- Work with the team to identify and qualify third party vendors and manufacturers intended for development work, process scale-up and CTM manufacturing,
- Key technical representative to third parties manufacturing non-GMP and GMP drug product batches, including batches to support clinical trials,
- Oversee the labeling and distribution of clinical trial materials,
- Preparation of CMC documents related to clinical trial applications and provide technical support for IND and BLA filings,
- Collaboration with internal Quality and Compliance department to assure that CROs are performing according to cGMPs,
- Interaction with analytical and drug substance CMC team members to build the CMC development plan and ensure execution thereof,
- Represent the CMC team in the cross-functional development team(s),
- Follow general laboratory safety procedures, as related to biologically derived material.
- BS/MS with at least fifteen (15) years of experience or a Ph.D. with at least ten (10) years of experience in a bio-pharmaceutical area with appropriate therapeutic product development experience.
- Demonstrated skills in working with teams and executing projects in a cost effective and timely manner.
- Demonstrated experience managing and directing CMO/CDMOs.
- Proven track record in planning and executing preclinical/early clinical and late-stage programs and cross-functional interactions through to successful INDs and BLAs.
- Ability to adapt and thrive in a dynamic fast paced, team oriented, clinical-stage environment.
- A scientifically motivated self-starter with accountability for 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.
- Superior personnel management and organizational skills.
- Ability to speak up and raise issues and work collaboratively to help drive to resolution in a fast-paced project team in an entrepreneurial work environment.
- Experience at the product development/manufacturing interface.
- In depth knowledge of GMP requirements, SOPs and policies relevant to product development.
- Thorough knowledge of regulatory requirements and drug development process for therapeutics.
- 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.
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.