Urgent Requirement
Organization: Marksans Pharma Ltd
Location : Navi Mumbai
Department :Research & Development
Required : Manager – R & D
Experience :10-15 years
Interested Candidate can send their resume on audrey.fernandes@marksanspharma.com
Responsibilities:
Responsible for preparation and review of SOPs, protocols, reports, policies etc of Formulation Development (FD) dept.
Planning, execution and monitoring of projects of formulation activity from project feasibility stage to commercial.
Demonstrates understanding of machine principles & process related to equipment and processes across scales to transfer processes/ products
Planning, monitoring and execution of formulation development activity from project feasibility stage to commercial.
Mentoring scientists for QbD based formulation development of various generic dosage form
Coordination with analytical department for various analytical activities.
Coordination with external department team as per project requirement for all required project activities.
Design the scheme of experiments. Interpret the results from various analytical instruments like HPLC, UV, GC, IR, etc.
Visualize the developmental needs of the product.
Submit samples for conducting pilot and pivotal Bio studies of pilot and Exhibit batches respectively in consultation with team.
Understand the safety and environmental aspect.
Solve the problems and queries related to the development of the formulation and discuss them with the Tech Lead.
Understand/familiarize with the problems faced during Scale-up.
Interaction with inter department for regulatory filing documentation requirements.
Understanding regulatory queries, providing scientific justifications and responding to regulatory queries as and when required on time for respective products.
Desired Candidate :
Having leadership experience of handling a group of scientists.
Candidate must have experience for formulation equipment / instruments installation, operation & performance qualification.
Having experience of mentoring and handling of FD team members and good inter-departmental communications are required.
Having good experience in Reverse Engineering of Innovator’s product.
Having experience of successful technology transfer from R&D to Plant scale.
Regards,
Audrey Fernandes
Asst.Manager-HR
9152988980
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