Director Of Clinical Microbiology

Contrafect Corporation Yonkers , NY 10701

Posted 3 weeks ago

Job Application

Position: Director of Clinical Microbiology

Reports to - Vice President of Research

Background:

ContraFect Corporation, 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, 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. CF-301, our lead compound, is the first and only bacteriophage-derived lysin (cell wall hydrolase) to enter clinical trials in the US. CF-301, which targets Staphylococcus aureus, including MRSA, is the first of a new class of protein-based therapeutics for the treatment of serious bacterial infections. CF-301 is currently being studied in a multinational, multicenter Phase 2 clinical trial for the treatment of S. aureus bacteremia including endocarditis. In addition to CF-301, we have an exciting pre-clinical and discovery pipeline of lysins targeting anti-biotic resistant gram positive and gram negative bacteria. Our primary focus in on developing treatments for bacteria designated by CDC and the WHO as urgent or serious threats of critical or high priority.

In addition, we are developing a triple antibody therapy for the potential treatment for serious influenza infections. We are using ContraFect's technical expertise to develop biotherapeutic products for infectious diseases that have high unmet medical needs, particularly products used in hospital-based markets.

Position Summary:

The Director will provide an important leadership role in Microbiology by overseeing the day to day operation of the ContraFect Microbiology Laboratory and the performance of clinical microbiology development studies in the field of protein-based therapeutics to treat serious bacterial infections. The laboratory is a major site for the conduct of clinical microbiologic testing of our lead compound, CF-301, in support of marketing authorization applications (NDA/BLA, MAA), approval and eventual clinical use if approved. Together with the VP of Research, the Director of Clinical Microbiology will institute quality metrics, work flows, cycle times and actively strive to increase the efficiency of the lab and the timeliness and quality of reports delivered by the research scientists. The laboratory conducts a wide range of Research activities including lysin identification and characterization, antimicrobial susceptibility testing, time kill assays, synergy studies, molecular cloning, protein engineering and optimization, research scale protein production and purification, in vitro microbiologic profiling, as well as bioassays to support preclinical studies (e.g. ELISAs, etc.).

The Director will have a key role in working directly with the VP of Research in the planning and implementing of all laboratory processes and procedures in addition to the forecasting of resource and equipment needs and the reporting of results from in vitro microbiology studies. The Director will also have the opportunity to conduct hands on research in support of ContraFect's Research efforts under the direction of the VP of Research, and is expected to publish and present at scientific meetings. The incumbent will be a key partner to the VP of Research and will work to continuously improve the technical performance of the lab across all domains, including the design, conduct and reporting of work conducted in the lab.

Importantly, the ContraFect Laboratory may also perform cell-based bioassays (e.g.lytic assay) as part of GMP drug substance and drug product release testing and stability protocols. The successful candidate will be responsible for ensuring quality and compliance in the conduct of the cell-based bioassay in accordance with the principles of GLP, in partnership with the Associate Director of Bioanalytics and Laboratory Operations, the VP of Research and the Quality team at ContraFect.

Responsibilities

  • Organize and run a diverse microbiology laboratory with a wide research base, which includes handling, maintenance and study of pathogenic microorganisms, antimicrobial susceptibility testing (MIC, MBEC, checkerboard, time-kill, lytic assays, synergy studies, resistance determinations, etc.), mutagenesis and genetic screens, mechanism of action studies, identification and development of novel antimicrobial agents, as well as planning, scheduling and oversight of experiments

  • At the Direction of the VP of Research, support the operational activities associated with molecular cloning and plasmid production in coli, creative protein design and optimization, recombinant protein expression, purification, and characterization, DNA library preparation and screening, and cell-based activity assays

  • Design, validate, conduct and manage critical microbiologic experiments as directed by the VP of Research to advance ContraFect's discovery and development programs and to support discovery, preclinical and clinical stage compounds

  • Interact closely with the VP of Research and others to oversee planning, conduct and reporting of experiments performed in the lab

  • Serve as Study Director for advanced or specialized microbiology studies at the direction of the VP of Research. Duties here include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis

  • Provide technical and scientific guidance to scientists working in the lab and the laboratory manager

  • Lead the development, implementation, and maintenance of systems, processes, and plans to ensure that results of experiments are delivered in a compliant manner, and within quality, cost and timeline parameters as agreed with the VP of Research

  • Develop long term strategic plan so that the lab functions at the highest level of quality, including the forecasting of resource, reagent, equipment and staffing needs to maintain the highest standards of scientific and technical excellence and efficiency in the laboratory

  • Ensure compliance with ContraFect laboratory SOPs, including those GMP SOPs, relevant to the conduct of laboratory work (e.g. the lytic assay) intended to support drug substance and drug product release and stability protocols for use in clinical and non-clinical trials.

  • Play a lead role in the development, review and approval of Laboratory SOP's, protocols, and reports

  • Maintain thorough knowledge and understanding of GLP and familiarity with GMP as relevant to work performed in lab on CF-301 drug substance and drug product release and stability protocols for use in clinical and non-clinical trials

  • Maintain working knowledge of current industry standards and practices pertaining to clinical microbiology), molecular biology, was well as protein biochemistry and protein engineering

  • Represent ContraFect externally to scientific experts, regulators, development partners and funding agencies as directed by the VP of Research

  • Contribute to the authorship of regulatory submissions (INDs, NDAs/BLAs, MAAs, etc.), as well as other documents such as Investigator Brochures, Microbiology manuals for clinical studies, IMPDs, and similar documents

  • Author scientific abstracts, manuscripts and reports. Present data at scientific meetings, and grant review meetings

  • Supervise, motivate, review, and develop direct reports through mentorship, training and identification of other learning opportunities

Education, Experience, Skills

  • A Ph.D. in microbiology, or a related field is required, with at least 5 years of post-graduate clinical microbiology experience in pharmaceutical or biotechnology setting or at a CRO

  • Extensive 'hands on' experience and knowledge in areas of microbiology (including the safe handling of bacterial pathogens)

  • Experience in successful management of a microbiology laboratory in an academic, industry or biotechnology setting or experience managing a CRO laboratory in relevant discipline (e.g. microbiology) required

  • Direct people management experience is preferred

  • Knowledge/experience in molecular biology and protein biochemistry, particularly designing, expressing and purifying recombinant proteins is a plus

Requirements

  • Demonstrated the ability to carry out independent microbiology research through the design, conduct, and reporting of studies and a proven track record of publications and scientific presentations

  • A working knowledge of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) is required

  • Solid leadership skills required. Must be able to give directions clearly. Must be able to lead both by example and through direct instruction. Must be able to build consensus among a group of individuals. Good listening skills required. Must be able to actively elicit feedback from staff.

  • Excellent written and oral communication skills, including strong formal presentation and analytical skills

  • Ability to present complex microbologic data to a wide range of audiences including: internal project teams, academic experts/leaders in the field, grant reviewers, and development partners

  • Excellent people and project management skills

  • Ability and desire to successfully work with a collaborative, fastpaced 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

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.


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Director Of Clinical Microbiology

Contrafect Corporation