Dr. Reddy’s Laboratories, Princeton, NJ
We are seeking a highly talented senior level Analytical Chemist (Director Level) at Dr. Reddy’s in Princeton NJ. This position would be responsible for all analytical activities for the co-development of Inhalation, Nasal, Transdermal, Topical and Soft-gelatin ANDA products with global external development and manufacturing partners for the US market.
POSITION RESPONSIBILITIES
1. Working as part of project teams with Technical Directors and internal team members, accountable for all analytical activities for the co-development of inhalation, nasal, transdermal, topical and soft-gelatin products.
2. Review analytical reports which document analytical characterization, method development and release of formulated drug product, drug substance, intermediates, starting materials, and functional excipients to support generic formulation development at early stages, registration and manufacturing.
3. Support analytical activities (for example, method development/validation, method transfer, testing plans) at partner sites with emphasis on scientific excellence, quality, cost, compliance and, timeline. Provide critical thinking and scientific input in resolving project specific issues, and lead and conduct investigations internally if required.
4. Perform technical diligence and identify the gaps in the analytical capability at external partners. Work with external partners to identify action plans to address gaps and define risk mitigation plans.
5. Review analytical data and provide summaries to key stakeholders. Coordinate with internal functions (Intellectual Property, RA, DQA, etc.) to obtain necessary approval as a part of the phase-gate clearance for timely project progression.
6. Review and input into key analytical documentation at external partners including specifications, analytical methods, validation/testing protocols etc to ensure regulatory compliance and alignment with Dr. Reddy’s processes. Co-ordinate internal document review with key stakeholders (RA, DQA).
7. Ensure that work performed complies with current regulatory requirements and are in accordance with cGMP and GLP.
8. Provide technical expertise and guidance for the development of Dr. Reddy’s internal inhalation analytical capabilities at R&D and commercial testing sites.
9. Oversee both R&D stability programs and Analytical Quality Control group at partner sites in coordination with the AR&D team in India.
10. Help establish and maintain corporate stability policies, protocols and programs, both in-house and at contract laboratories, for developmental products. Work closely with the Global Manufacturing Senior Management to assure alignment across the Dr. Reddy’s organization, provide for efficient and effective use of stability testing capabilities, and optimize hand-offs and key interaction points between R&D and commercial operations.
11. Contribute to stability reports for regulatory submissions and provide input to project teams with regards to choosing and maintaining contract stability laboratories
QUALIFICATIONS:
1. BS with 20+ years, MS with 15+ years, or a PhD with 10+ years of experience in Analytical Chemistry, or equivalent. Must possess practical and theoretical knowledge equivalent to that required by the position. Must possess a broad knowledge of the theory, precedents, and practice of analytical chemistry.
2. Strong drug product background on various dosage forms (Inhalation, Nasal, Transdermal, Topical and Soft-Gelatin Capsules). Must have strong fundamental knowledge of analytical chemistry as it relates to drug development, preformulation, developability, including in-depth experience with chromatography and other core analytical techniques.
3. Key analytical skills: Method development/verification/validation for drug substance and drug products, method transfer, stability programs/testing, troubleshooting, inhalation product testing (delivered dose, cascade impactor testing)
4. Working knowledge of regulatory requirements for Regulated markets for inhalation, nasal, transdermal, topical and soft-gelatin products
5. Knowledge of cGMP’s, GLP and understanding of Quality by Design (QbD) principles in analytical R&D. Proficient in the application of GMP regulations to laboratory operations in general and QC and stability analyses in particular.
6. Demonstrated leadership skills and team working abilities in an matrix environment
7. Ability to work independently as well as to collaborate and influence others who are not in an reporting relationship
8. Good verbal and written communication abilities
Submit resumes to ashandler@drreddys.com
