Job Description : Purpose :
Adhere with the cGMP principles and maintain them in an effective manner. Ensuring hundred percent in compliance with all applicable regulations, work performed in area of responsibility is conducted in right manner.
Performs all functions associated with managing a team in the MS&T department
Lead and Responsible for smooth Technology Transfer (TT) to and from Julphar site & successful commercialization of the product to Plants
Formulation development of Generic Drug Formulations, trouble shooting of Existing Formulations for quality improvement and technology transfer of products & processes.
Transfer developed processes to the Manufacturing Team. Write and revise process document reports and transfer protocols.
Maintaining awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with teams.
Key responsibilities & Accountability :
Managing and schedule multiple projects, set objectives and prioritize activities to meet the milestones in a fast pace environment.
He / She will work closely with R&D, Business Development, Operations and Quality to identify appropriate technology partners and assessing manufacturing capabilities and giving feedback to the teams and to the sites
Responsible for evaluation of technology dossiers, feasibility analysis, gap assessments.
To build and maintain communication channels and processes and maintain effective dialogue with Technology Partner and internal stakeholders to ensure smooth & successful execution of TT projects.
To ensure strict adherence to approved project budget, milestone & timelines
To ensure receipt of Technology Transfer documents from Tech Partner, distribution to stakeholder, creation of evaluation reports and plant documents.
Working knowledge of QbD driven formulation development, patent search and preparation of Prototype Formulation Report of assigned projects.
Supporting manufacturing of pilot / scale-up batches with necessary documentation and technology transfer of products and processes to production.
Qualifications : - Education
Master’s Degree either in Pharmacy, Chemistry, Chemical Physics, or any related medical field is an advantage. - Experience :
At least 10-12 years’ experience in the Technology Tranfer / Product Development / Research and Development from a Pharmaceutical field.
Training : Key Competencies :
Strong demonstration of Accountability and Ownership, must take initiatives without been asked for
Fluent in oral and written English communication and inter personal skills.
Can work independently with less supervision
High on collaboration and interpersonal skill Technical Competencies :
Knowledge of Chemical Processes, principles of unit operations of pharmaceuticals equipment and relevant production techniques of different dosage forms.
High on Business Acumen and overall understanding of the big picture for his function and the department