Job Description

Summary of Responsibilities:

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These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties.

Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from client sites. Responsible to be an interface with contract laboratories, suppliers, customers and peers to define and improve project performance and expectations. Responsible to coordinate with CRO and ensure that project is completed with in timeline. Designs scientific experiments. Actively and personally monitor lab work. Recommends expansion or curtailment of investigations on the basis of experimental results or scientific information. Responsible for the preparation of test methods, technical documents, protocols and reports whenever required Is responsible for the proper recording of information. Ensures that records and raw data are properly retained. Summarizes, interprets, reviews data and draws conclusions. Analyzing and drawing interpretation out of the dissolution data sets. Trouble shooting the problems associated with instruments or methods. Performing activities following the GMP/ safety requirements related to the assigned activity. Key interactions areas: Drug Product development, Reg. CMC/LOC, Spec management Must have knowledge of invitro dissolution testing, experienced in comparative dissolution testing including Multimedia Dissolution testing and dissolution investigations Knowledge of statistical evaluation and DoE is preferred. Knowledge of Regulatory Guidelines on dissolution studies e.g. FDA-SUPAC and ICH for validations and other emerging market like China, Latin America

Qualifications (Minimum Required):

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Master's in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD ) as applicable. Fortrea may consider relevant and equivalent experience in lieu of educational requirements." Speaking-English and/or other languages as applicable

Experience (Minimum Required):

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At least 10-12 year experience in analytical field is desirable 7-9 years of relevant industrial experience in Analytical science /Formulation science / material management and overall drug development and manufacturing process Good verbal, written and presentation skills Solid leadership capabilities including attention to detail and multi-tasking skills Ability to interact and influence with line and middle management, global counterparts, and external contacts on a functional and tactical level Experience in coaching project team members to strengthen their abilities and skill sets Strong attention to deadlines and budgetary guidelines Be able to anticipate/identify problems and takes appropriate action to correct. Capabilities to face internal and external Audit situation. Knowledge of medical and drug terminologies, Medical device reporting, GxPs and worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products desirable Knowledge of ICH guidelines

Preferred Qualifications Include:

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Masters in Pharmacy or related science degree (or equivalent) preferred with more than 7-9 years of experience in formulation or Analytical development, dissolution development experience preferred . "Fortrea may consider relevant and equivalent experience in lieu of educational requirements."

OR

Knowledge of data management system, pharmaceutical product life cycle and Management Information System (MIS) will be preferred Experience in DoE, Statistical expertise is preferred Diploma or certification in Regulatory Affairs will be preferred

Work Environment:

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Work environment: Office based
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