Hiring Asst. Manager / Deputy Manager– Formulation Development

Job Description

We are looking for the following role
Job Role: R&D Formulation Development
Job Title: Asst. Manager / Deputy Manager– Formulation Development
Department: Formulation Development – R&D
Desired Qualification: M. Pharm (Pharmaceutics) from recognized University
Experience: 8 – 15 years in Pharmaceutical Formulations R&D in regulated market
Reporting: Head– Formulation Development

Job Description:

1.    The candidate must be experience in regulated market like EU, USA, BR, JP etc
2.    Responsible for leading and directing the formulation development function as well as strategies and activities critical to our product development programs
3.    Preparation of Strategy for Development for non-infringing, complex generics, PARA-III &IV approach.
4.    Formulation design and product development of advanced drug delivery system and generic products.
5.    Expected to work with clients to lead and provide technical guidance of Pre-formulation, clinical formulation design, characterization and development and CMC activities.
6.    Preparation and review of R&D documents like MFC, MFR, BMR, BPR for Technology Transfer Dossier.
7.    Preparation and PDR for product filing with regulatory agencies by QBD principle
8.    Planning and execution of scale up and pilot BE study batches at manufacturing site.
9.    Evaluation of the B.E data and well versatile with Regulatory quires
10. Co-ordination with various departments in R&D like Regulatory Affairs, Analytical, Purchase and also in manufacturing locations like Production, Technology transfer group, QA Department, QC Department to collect the inputs required for successful completion of Development and Technology transfer of a Generic Product
11. Establishing In-house systems and procedures to ensure cGMP practices & regulatory requirements.
Skills:
1.    Excellent Interpersonal skills
2.    Influencing capabilities
3.    Good in communication and presentation
4.    Proactive, Confident and Assertive
Please share your CV only who is willing to relocate to Bangalore to shrikrishna.uk@cdymax.in, srikantha@cdymax.in, jagadeesh@cdymax.in,