Executive Director, Analytical Development

Employer
ContraFect
Location
Yonkers, NY, United States
Posted
Apr 02, 2021
Ref
1370
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Position Summary:

This is a key position within the ContraFect CMC function 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 process development, manufacturing, 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. Specifically, the successful candidate will bring a depth of analytical experience to build the Analytical Development organization and drive innovation and development of the therapeutic candidate analytical characterization and control process and ensure efficient technology transfer to GMP facilities within a third-party Contract Manufacturing Organization (CMO). The incumbent will manage the technical interaction between the Analytical Development team and the project CMO/CRO. The Executive Director is expected to generate product characterization strategies, prepare and review scientific reports generated internally or with third parties and perform critical review of validation documents from CMO/CRO. The candidate will author/review CMC sections for IND/BLA submissions. Knowledge of the following areas are a plus: process validation, biosynthetic drug substance and drug product manufacture.

Key Responsibilities:
  • Build analytical chemistry group and provide leadership, technical guidance, management, and strategic direction in all aspects of analysis for a diverse portfolio of peptide and protein therapeutic products,
  • Develop resource, budget and operational plans for the Analytical Development team,
  • Act as the primary Analytical Development project contact for one or more projects post candidate selection,
  • Interact closely the external sites (CMOs) in our Manufacturing network in identifying, implementing, and troubleshooting laboratory test methods and workflows to ensure compliant, robust, and responsive supply,
  • Represent Analytical Development at cross functional matrix team meetings and engagements with Senior Leadership,
  • Develop detailed product characterization strategies to support ongoing product development within the Process Development organization,
  • Develop and validate robust analytical methods for drug substance and drug product,
  • Review and interpret data to support the release and stability testing of drug substance and drug product,
  • Review experiments, stability protocols, and other key documents,
  • Author and approve sections of regulatory documents,
  • Represent the department in regulatory interactions (questions and filings) and at high level relevant regulatory meetings (eg FDA, EMA).
  • Oversee development and support of flexible cross-modality analytical capability to ensure analytical support of peptide and protein API and drug products,
  • Coordinate external collaborations and evaluate potential innovative research areas,
  • Oversee Quality Control activities, including analytical testing performed by third parties to support release or rejection of intermediate, bulk and finished products by Quality Assurance,
  • Develop and propose specifications, sampling instructions, test methods and other Quality Control procedures,
  • Monitor contract analytical testing,
  • Propose and approve validation protocols for analytical methods,
  • Approve stability programs, specifications, sampling instructions, test methods and other Quality Control procedures.

Qualifications

Required:
  • BS/MS with at least fifteen (20) years of experience or a Ph.D. with at least ten (15) years of experience in a pharmaceutical-related area with appropriate product development experience
  • Proven leader of technical teams and subordinates
  • Experience in development of analytical methods, characterization strategies and control of biopharmaceutical parenteral products
  • Thorough understanding of the pharmaceutical product development process, from pre-formulation through technology transfer to manufacturing and product registration
  • Experience at the product development/manufacturing interface
  • Demonstrated capability in science and technology-driven pharmaceutical product development
  • Experience in the design and implementation of product development plans.
  • Experience in the development of regulatory documentation.
  • Extensive experience working in GMP environment
  • Successful track record drafting and defending CMC sections of IND, BLA/NDA submissions

Preferred:
  • 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.
  • In depth knowledge of GMP requirements, SOPs and policies relevant to product development.
  • Thorough knowledge of regulatory requirements and drug development process.
  • Experience and knowledge to represent the department in regulatory interactions (questions, and filings) and at high level relevant regulatory meetings (eg FDA, EMA, MHRA).
  • Ability to provide a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence

Our Values:

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.