Director of ContraFect Microbiology Laboratory

Employer
ContraFect
Location
Yonkers, NY, United States
Posted
May 01, 2021
Ref
1383
Hotbed
Pharm Country
Required Education
Bachelors Degree
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 developing potential treatments for bacteria designated by CDC and the WHO as urgent or serious threats of critical or high priority.

Position Summary:

The Director will provide an important leadership role in ContraFect's Microbiology Laboratory by overseeing the day-to-day operations and discovery and development studies in the field of protein-based therapeutics to treat serious bacterial infections. The laboratory conducts a wide range of Research activities including lysin and amurin peptide identification and characterization, mechanism of action studies, antimicrobial susceptibility testing (MIC, MBC, MIC/MBC ratio) and QC studies, in vitro microbiologic profiling studies (development of resistance studies, time-kill assays, checkerboard assays to investigate synergy and antagonism, activity against biofilms, post-antibiotic effect)-, as well as molecular cloning, protein engineering and optimization, research scale protein production and purification, bioassays to support preclinical studies (e.g. ELISAs, etc.) and as part of GMP drug substance and drug product release testing and stability protocols.

The Director will have a key role in working directly with the VP of Clinical Microbiology in the planning and implementing of all laboratory processes and procedures, including workflows and standard operating procedures to ensure the accuracy, reproducibility and quality of data generated by the laboratory in support of the nonclinical and clinical development of ContraFect's direct lytic agents (DLAs). Importantly, the Director will also oversee workflows to ensure procedures are in place for accurate record keeping, including content, dating and sign-off of laboratory notebooks, and timely preparation of final reports. The Director will work closely with the VP of Clinical Microbiology to perform quality checks, in-depth data reviews of all reports intended for regulatory submission to assess "regulatory readiness" and inclusion of all necessary data. In addition, the Director will have oversight of laboratory processes and procedures related to management and handling of reagents, isolates, and other critical materials in accordance with ContraFect's Laboratory SOPs. The ContraFect Research Laboratory Manager will have dotted line reporting responsibilities to this Director, with regard to the forecasting of resource and equipment needs and the reporting of results from laboratory testing. The Director will partner closely with the VP of Clinical Microbiology and the Head of Regulatory and Quality to ensure Laboratory preparedness for potential onsite regulatory inspections and will serve as the primary point of contact in the event of an onsite regulatory inspection (e.g. FDA) together with the Head of Quality or designee. The Director of the Microbiology Laboratory will also have the opportunity to provide input into the design and conduct of in vitro and in vivo studies and interpretation of data generated thereof. The incumbent will be a key partner with and report to the VP of Clinical Microbiology and will work to continuously improve the technical performance of the laboratory across all domains, including the design and conduct of experiments and the accuracy, quality and timely reporting of work conducted in the laboratory in compliance industry norms and regulatory requirements.

The laboratory performs microbiological characterization studies to profile our lead compound, exebacase, in support of the eventual submission of marketing authorization applications (NDA/BLA, MAA), approval and eventual clinical use if approved. Together with the VP of Research, and VP of Clinical Microbiology, the Director will to the institute quality metrics, work flows, cycle times and actively strive to increase the efficiency of the laboratory and the timeliness and quality of reports delivered by the research scientists.

Responsibilities
  • Organize and run a diverse microbiology laboratory with a wide research base. Activities will include the oversight of the appropriate handling, maintenance and study of pathogenic microorganisms, mechanism of action studies, antimicrobial susceptibility testing (using standardized and modified methods and QC testing), molecular characterization studies, resistance development studies, time-kill studies, biofilm assays, checkerboard assays, assessment of post-antibiotic effects etc.
  • Oversee key experiments conducted as directed by the VP of Research to advance ContraFect's discovery and development programs and to support investigational compounds entering clinical trials.
  • Provide guidance/expertise to the design and conduct of nonclinical studies as required.
  • Responsibilities include: oversight of test scheduling, application of test method(s) and controls, data collection, review, analyses and presentation for preparation of final reports in a timely manner. Oversee the review and approval of all final reports generated by the ContraFect Microbiology laboratory and contract research laboratories.
  • Serve as subject matter expert with regard to laboratory standards (CLSI and EUCAST) and provide technical and scientific guidance to scientists working in the microbiology laboratory.
  • Responsible for the transfer of microbiological methods unique to the DLAs to GXP contract research organizations/laboratories.
  • 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 time as agreed with the VP of Research and VP of Clinical Microbiology.
  • Develop long term strategic plans together with VP of Research and Laboratory Manager so that the laboratory 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 GXP 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 and or other experiments in support of clinical studies and or regulatory approvals.
  • Play a lead role in the development, review and approval of ContraFect Research SOPs, protocols, and final reports.
  • Work closely with VP of Clinical Microbiology to review ‘legacy' reports to ensure they meet regulatory standards and requirements, and as required prepare necessary amendments. Institute workflows and rules to ensure that newly authored reports meet requirements and that supportive source documentation is fully reviewed, approved and available, in the event of regulatory (or other) inspection.
  • Oversee and direct technical transfer of methods and materials to external GxP laboratories, as required, to support the assay/method development, and the conduct of confirmatory in vitro microbiologic profiling of ContraFect's proprietary compounds in a GxP environment in support of regulatory filings/BLA.
  • Maintain thorough knowledge and understanding of GxP requirements and other relevant guidance as these pertain to laboratory work performed on ContraFect's assets under IND or those nominated as IND candidates.
  • Maintain working knowledge of current industry standards and practices pertaining to microbiology (CLSI and EUCAST), and molecular biology.
  • Contribute to the authorship of regulatory submissions (INDs, NDAs/BLAs, MAAs, etc.), as well as other documents such as Investigator Brochures, Central Laboratory Microbiology Procedures for clinical studies, IMPDs, and similar documents.
  • Potential opportunity to 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
  • In the absence of the department VP of Research, assume responsibility for managing the department at the direction of the Head of R & D and VP of Clinical Microbiology

Education, Experience, Skills
  • A Ph.D. in microbiology, or a related field is required, with at least 5 years of post-graduate work in an academic, pharmaceutical, biotechnology or CRO setting
  • Extensive ‘hands on' experience and knowledge in areas of microbiology (including the safe handling of bacterial pathogens), clinical microbiology standards, molecular biology and protein biochemistry, particularly designing, expressing and purifying recombinant proteins. Experience in successful management of a research laboratory in an academic, pharmaceutical industry or biotechnology setting or experience managing a CRO laboratory in relevant discipline (e.g. microbiology)
  • Direct people management experience strongly preferred.

Requirements
  • Demonstrated the ability to carry out independent research through the design, conduct, and reporting of research studies and a proven track record of publications and presentations.
  • A working knowledge of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) is desirable.
  • 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 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, fast-paced project team in an entrepreneurial work environment.
  • Ability to influence, negotiate and communicate with internal and external stakeholders
  • Excellent organizational and planning 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.