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R&D Director, Biologics
- An U.S pharmaceutical company
- R&D Director, Biologic
Our client is an international pharmaceutical company and provides laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Our client is a quality driven, responsive partner with strong global and deep scientific and medical expertise.
Review and report surgical pathology and cytology samples including routine H&E staining, Immuno-histochemistry and FISH assays on a daily basis.
* Ensure reporting is completed within the TAT required for the assay/ study.
* Comply with the international standards for scoring of the assays and participate in peer review programs, CAP proficiency surveys on a regular basis.
* Participate in the development and validation of new assays in the AP lab with review and interpretation of results for new assays on a regular basis. Involved in trouble shooting and resolution of technical issues related to assay protocol.
* Participate in the training sessions with pharma and other diagnostic partners for scoring of new assays leading to certification and subsequent analysis of patient samples.
* Participate in sponsor discussions for new study requests and / or new assay development as and when required.
* Participate in scientific review for new study requests, provide pathologist expertise and input for the study requirements as and when required.
* Ensure that the highest standards of quality and customer service are maintained. Collaborate with Quality Assurance staff on development and implementation of effective programs. Monitor outside proficiency testing program as required; take corrective action promptly when results are unsatisfactory.
* Establish effective staff selection and training program to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures.
* Keep abreast of new technical developments. Implement new tests, equipment, programs and/or procedures in the department as needed. Lead continuous improvement initiatives to increase quality of services and operational efficiency.
* In depth knowledge of clinical testing procedures and applicable laboratory testing regulations within biological industry
* Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements
* Knowledge of occupational safety and health rules and regulations
* Excellent written and oral communication skills
* Molecular Pathology is an advantage.
* an Anatomic Pathologist in either hospital or pharmaceutical industry is an advantage.
* Phd degree is a must
Excellent salary, benefits and long term career opportunity.
People oriented culture.