Associate Director/Director, External R&D in Dr. Reddy’s lab
Post: Associate Director/Director, External R&D
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Job Description:
* Manage projects at the partner site with an emphasis on scientific excellence, quality, cost, compliance and timelines
* Provide an objective overview of the product and/or portfolio selected for co-development, prepare development strategy (jointly), identify technology requirements, review the IP landscape, formulate the filing strategy, define a regulatory pathway, and assess manufacturability and the commercialization process
* Perform technical diligence and provide input to BD about partner’s capabilities and experience
* Provide critical thinking and scientific input in resolving project specific issues
* Coordinate with functions (IP, RA, DQA, etc.) internally to obtain necessary approval as a part of the phase-gate clearance for timely project progression
* Keep current on emerging technologies to support business objectives while providing technical leadership to ensure that products are developed, filed and launched on time
* Conduct project reviews at periodic intervals, identify milestones in jeopardy and suggest recovery actions
* Ensure availability of consistent documentation for formulations, analytical methods and the manufacturing process for tech transfer and turnkey projects
* Ensure progress updates are available on time, shared, and reviewed with the top management
* Ensure that work performed complies with current Regulatory requirements and are in accordance with cGMP
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Candidate Profile:
* M. Pharm. or Ph.D with 10 to 12 years of experience in the generics industry with a good understanding of the pharmaceutical product development process for filing in regulated markets (US and EU)
* Demonstrated experience with various dosage forms, drug delivery technologies and complex generics development
* Experienced in using project management tools for project management, planning and decision making
* Working knowledge of Regulatory and IP requirements for regulated markets
* Knowledge of cGMP’s and an understanding of Quality by Design (QbD) principles in product development
* Demonstrated leadership skills and team working abilities in a matrix environment
* Ability to collaborate and influence others who are not in a reporting relationship
* Demonstrated ability to think laterally, outside the box
* Ability to convey a sense of urgency and persist in face of difficulties
* Ability to speak directly and clearly
* Thorough understanding of Generics product development process for regulated markets (U.S and EU)
* Strong scientific and technical understanding in the areas of drug delivery technologies, various dosage forms, scale-up and, technology transfer
* Proven track record of successful ANDA flings including PIV and FTF opportunities
* Experience in managing outside projects
* Excellent communication skills, both written and oral
* Demonstrated ability to influence internal and external stake-holders and, the ability to work in a matrix environment
* A winning “get things done” attitude and approach
Additional Information:
Experience: 2-5 years
Location: Bridgewater, NJ
Education: M.Pharm, PhD
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Job Number: 2225584
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