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Associate Director CMC

Mumbai, MH
Job Code:
  • Manufacturing & Production
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Job Details

THE POSITION Prepares global CMC development plans in collaboration with line functions and the head of EPD Drug Product Development. Leads CMC activities for DPD together with team(s) of functional representatives from various departments across the division and external parties. Serves as a CMC spokesperson for DPD-CMC functions and ensures information flow amongst the project primarily Brand teams, TA strategy teams and various line functions, and informs management of plans, risks and progress through regular communications. Builds relations and works with Clinical, Regulatory, Operations, Quality, and Commercial organizations and external parties. Develops, implements and follows reviews lessons learned; establishes success criteria and metrics at the beginning of a project; uses metrics to manage and communicate project accomplishments Creates new ideas and drives ideas in process from idea to green housing; liaises with other functions to build business cases. Performs and stimulates technology scouting.CORE JOB RESPONSIBILITIESResponsible for planning and controlling assigned budgets (capital, projects, functional) ensuring that budget targets are met also in conjunction with external service providers.Takes CMC Team leadership, development and execution of the project strategy and is accountable for the budget and overall CMC quality of the assigned projects.Represents the team at the project (brand) team meetings, and informs CMC Management of plans, risks and progress through regular communications.Ensures high quality science, technology and deliverables, ensuring compliance with respective regulatory and quality requirements.Reviews and develops contracts with external parties like TPMs, consultants, academia and obtains resources from Abbott internal functional areas.Presents and meets customers on national level; identifies opinion leaders, presents to PC on a regular basis.Demonstrates a strong personal capacity for learning new aspects of the business and encourages others to do the same.Presents at scientific conferences mainly at global level; constantly provides presentations and up-dates to brand team.POSITION ACCOUNTABILITY / SCOPEReports directly to the head of the Drug Product Development department and is member of project/brand teams.Is accountable for success of assigned CMC part development projects and transfer to MS&T.Key contributor for successful filings of high quality CMC dossiers and approval of products.This position has a significant impact on the end results for successful completion of the assigned project.MINIMUM EXPERIENCE / REQUIREMENTSUniversity Exam in natural sciences (e.g. pharmacy, chemistry, biotechnology, food chemistry), Masters Degree at least 6 years of experience within different CMC functionsPhD Degree and 4 years experience within different CMC functions.
Degree: Ph.D. (Doctorate)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 6-11


Drug Regulation | Formulation | Quality Assurance/ Control
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