Executive Director
Company: ContraFect Corporation
Location: New York
Posted on: January 15, 2021
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Job Description:
Position: Executive Director, Analytical Development Reports to:
VP of Manufacturing Background: 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:
Keywords: ContraFect Corporation, New York , Executive Director, Executive , New York, New York
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