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Staff & Academic Opportunities

Associate Director, GMP (Good Manufacturing Practice)

Position Summary

Oversees the operation of the Good Manufacturing Practice (GMP) facility, directs and leads the manufacturing staff, and ensures adequate application of the current GMPs required by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the institutional safety requirements to develop and manufacture investigational new drugs (INDs).

Job Responsibilities

  • Oversees the operation of the Good Manufacturing Practice (GMP) facility in compliance with GMP guidelines and internal procedures and policies. Identifying critical path issues and manages events that may affect timeline milestones.
  • Develops strategy for regulatory activities related to the Chemistry Manufacturing Control (CMC). Drafts and reviews regulatory filings associated with manufacturing.
  • Develops and monitors compliance with all office procedures; assist and reviews quality of work; conducts performance appraisals; mediates and resolved employee problems/issues.
  • Oversees conformances, change controls and CARA system handling.
  • Establishes and maintains the GMP quality system to develop and authorize key GMP production documents, batch records, validation protocols and reports. Develops and reviews the Quality Plan, Standard Operating Procedures and quality control documents. Supervises and evaluates GMP production personnel to ensure they are adequately trained and qualified to execute their functions
  • Complete team deliverables related to design, configuration, test, and implementation. Develops and maintains the production timelines by ensuring adequate resources.
  • Communicates timeline to the internal and external clients.
  • Supervises senior staff that manage production timelines to meet the needs for Cornell investigators and contractual obligations of outside clients.
  • Drafts and reviews regulatory to the FDA and European agencies for submissions associated with manufacturing.
  • Supervises process development activities to enable clinical drug production.
  • Initiates confidentiality and material control agreements with clients.
  • Provides oversight for GMP activities to develop and implement continuous improvements and best practice.
  • Attends scientific meetings of peers, FDA and professional societies; presents at weekly lab meetings; keeps abreast of scientific literature and new developments in the field.

Education

  • PhD

Experience

  • Approximately 8-10 years of related experience

Knowlwdge, Skills andAbilities

  • Must have good verbal, written, presentation communication skills, management and interpersonal skills, as well as good computational and database skills

Licenses and Certifications

N/A

Working Conditions/Physical Demands

Standard office work
Competencies
  • Appreciates and understands the connection between individual goals, departmental goals and the organizational mission.
  • Approaches our job knowing that there are internal and external customers whose expectations we strive to exceed.
  • Demonstrates integrity and ethics at all times.
  • Maintains a flexible and forward-thinking approach to the way work is done.
  • Maintains a team-oriented approach, and possesses the ability to cultivate positive and collegial workplace relationships.
  • Possesses excellent work-related skills and the ability to apply them, while continually seeking ways to improve.
  • Possesses the ability to facilitate the flow of information through effective written and oral communication.
  • Understands the need to be responsible for our own outcomes, and takes pride indelivering the best possible work product

To apply: email your cover letter and your CV to: geneticmedicine@med.cornell.edu; include “Associate Director, GMP” in the subject line.

Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

Senior Clinical Research Physician

Position Summary

Responsible for leading and driving all aspects of Clinical Research development, infrastructure administration and strategic planning and systems implementation for Department of Genetic Medicine (DGM) clinical operations, regulatory affairs, data/safety management and monitoring components of clinical research. This includes the assessment of clinical subjects to ensure they meet study criteria and perform all ongoing follow up. Will assist in the creation and delivery of operational and technical clinical research infrastructure initiatives and plans and establishment of clinical research and development milestones for DGM.


Job Responsibilities

  • Leads the creation of all aspects of WCMC DGM Clinical Research strategic infrastructure, development and administration. Recruits, develops, and motivates high quality resources to assure timely achievement of function objectives and goals.
  • Assess study subjects for general health and parameters relating to inclusion criteria of clinical research protocols.
  • Perform subject clinical assessments and follow-up visits.
  • Responsible for establishing, developing and directing the delivery of the strategic operational and technical Clinical Development Plans and programs based on innovative research methodologies, combine drug development/pharmaceutical industry knowledge.
  • Assists in the development of the clinical section of Investigational New Drug Applications (IND).
  • Provides effective support to research staff and operational support to hospitals/departments/divisions that participate in DGM clinical trials.
  • Prepare complex written research reports and verbally present results to key stakeholders on an independent basis. Writes clinical part of DGM grants. Reviews and edits what other researchers write for the clinical portion of their grants.
  • Reads clinical database for ongoing and timely visibility of measured parameters.
  • Directs and supports regulatory affairs efforts in the development of required submissions.
  • Assists and supports Clinical Investigators in the development of presentations and publications of the clinical study results resolution.
  • Leads the DGM effort in recruitment of subjects under approved protocols.

Education

  • Medical Degree (MD) or MD/PhD


Knowledge, Skills and Abilities

  • Basic understanding of research and development process for biologic/pharmaceutical products.
  • Strong organizational and self-management skills.


Optional - Competencies

  • Appreciates and understands the connection between individual goals, departmental goals and the organizational mission.
  • Maintains a team-oriented approach and possesses the ability to cultivate positive and collegial workplace relationships.
  • Maintains a flexible and forward-thinking approach to the way work is done.
  • Approaches the position knowing that there are internal and external customers whose expectations we strive to exceed.
  • Possesses the ability to facilitate the flow of information through effective written and oral communication. Demonstrates integrity and ethics at all times.
  • Possesses excellent work-related skills and the ability to apply them, while continually seeking ways to improve. Understands the need to be responsible for our own outcomes and takes pride in delivering the best possible work product.

To apply: email your cover letter and your CV to: geneticmedicine@med.cornell.edu; include “Senior Clinical Research Physician” in the subject line.

Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

Postdoctoral Associate in Gene Therapy

Position Summary

The Laboratory of Ronald G. Crystal, MD, at Weill Cornell Medicine in New York City (https://geneticmedicine.weill.cornell.edu/ ) is recruiting postdoctoral associates for projects related to gene therapy. The Department conducts a broad range of gene therapy projects from the laboratory bench to clinical trials. Projects include proof-of-concept models for development of new therapeutic strategies, pre-clinical data generation for regulatory filings, and clinical trial data acquisition and analysis. We are looking for postdoctoral associates with energy and new ideas who can take advantage of our extensive infrastructure to advance the field of gene therapy. Current pre-clinical and clinical targets include:

  • AAV-mediated gene transfer to the CNS for the treatment of Alzheimer’s Disease, lysosomal storage diseases (e.g., Batten disease), and chronic traumatic encephalopathy
  • systemic AAV-mediated gene therapy for alpha-1 antitrypsin deficiency, Friedreich’s ataxia, chronic eosinophilia, eosinophilic esophagitis, aldehyde dehydrogenase 2 deficiency, and oxidative stress diseases
  • adenovirus-based vaccines to treat addiction

In addition, we are actively developing next-generation gene therapy tools and methods of analysis including:

  • improved gene expression cassettes
  • gene expression control systems
  • genome-wide analysis to characterize vector efficacy
  • positron-emission tomography to track the fate of gene therapy vectors after delivery
  • improved GMP vector production

Requirements:

Candidates must hold a doctoral degree (PhD, MD, or MD/PhD). Successful applicants will be able to carry out independent research with guidance of faculty members, have excellent written and verbal communication skills, demonstrate patience, organizational skills, and collegiality in the laboratory, and practice responsible conduct of research. Candidates are not required to have experience in gene therapy, but should demonstrate productivity through high quality, first author publications in a related field.

To apply: email your cover letter, names and contact information for three references familiar with your research skills and accomplishments, and your CV to geneticmedicine@med.cornell.edu; include “Gene Therapy Postdoc” in the subject line. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

There are currently no staff opportunities open at this time. Please check back later.
(646) 962 2672

Contact Information

Genetic Medicine 1305 York Ave., 13th Floor New York, NY 10065 Phone: (646) 962-2672 Fax: (646) 962-0380