At Dr. Reddy’s, a global pharmaceutical company, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.
Post: Associate Director/Director, External R&D
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
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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