Summary of Responsibilities:

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):

• 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):

• 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:

• 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:

• Work environment: Office based

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