Hiring for Research and Development manager NDDS for CRO company based at Ahmedabad

Job Description:

The job description is as below:

The R&D Manager - NDDS will lead formulation and development of novel drug delivery systems from concept to scale up and tech transfer ensuring compliance with regulatory and quality standards and alignment with business goals. The role requires strong scientific depth in NDDS team leadership and cross functional collaboration with QA RA manufacturing BD and marketing.

Key responsibilities
- Lead end to end development of NDDS formulations (e.g. sustained/ controlled release transdermal nano/colloidal systems injectables inhalation etc.) from preformulation to commercialization.
- Design and execute formulation and process development experiments DoE/QbD studies stability studies and scaleup/tech transfer to manufacturing.
- Prepare and review development reports product development dossiers technology transfer documents and CMC sections for regulatory submissions.
- Establish and optimize analytical methods in collaboration with the analytical team to support formulation development and stability.
- Evaluate literature patents and market/technology trends to identify new NDDS platforms line extensions and lifecycle management opportunities.
- Manage multiple R&D projects simultaneously define timelines deliverables and resources and track progress against milestones.
- Collaborate closely with cross functional teams (Regulatory QA Manufacturing Supply Chain BD Medical) to ensure smooth progression of projects.
- Ensure adherence to cGMP GLP data integrity and applicable regulatory guidelines (e.g. ICH USFDA EMA CDSCO as applicable).
- Develop and implement lab SOPs to ensure proper documentation and maintenance of development records and databases.
- Lead coach and develop the R&D NDDS team to drive a culture of innovation scientific rigor and continuous improvement.
- Identify and manage external partners (CMOs CROs academic collaborators technology providers) when needed.
- Support technical due diligence for inlicensing out licensing and co development opportunities in NDDS.

Qualifications
- / PhD in Pharmaceutics Pharmaceutical Technology or related discipline with strong focus on NDDS / advanced drug delivery.
- Typically 8-12 years of experience in formulation R&D in pharmaceuticals with at least 3-5 years specifically in NDDS and 2-3 years in a leadership/ managerial role.
- Demonstrated experience in developing at least a few NDDS products taken through scale up and regulatory submission/approval.
- Strong understanding of preformulation biopharmaceutics pharmacokinetics and QbD/ DoE approaches.
- Good knowledge of global regulatory expectations for NDDS CMC requirements and ICH guidelines.
- Proficiency in project management prioritization and stakeholder communication.
- Strong leadership people management problem solving and decisionmaking skills.

Key competencies
- Scientific and technical excellence in NDDS
- Strategic and innovative thinking
- Project and portfolio management
- Cross functional collaboration and communication
- Team leadership and talent development
- Quality compliance and documentation focus

For further details please call Megha on or you can share your candidature on