Sr. Manager - Frd Non-Orals

14-17 years

Not Disclosed

Bangalore

10 Jan. 5, 2025

Job Description

Job Type: Full Time Education: PhD/MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr. Manager - FRD Non-Orals
Date: January 1, 2025
Location: Tandalja - R&D
Company: Sun Pharmaceutical Industries Ltd

Key Responsibilities:

Technical Expertise:

Provide technical guidance in the formulation design, process optimization, and characterization of liposomal drug products.
Solve complex formulation and manufacturing challenges using a science-driven approach.
Ensure adherence to global regulatory requirements (e.g., FDA, EMA) for liposomal generics.

Strategic Leadership:

Lead and manage R&D projects focused on liposomal formulations, ensuring alignment with organizational goals.
Develop strategies for the design, development, scale-up, and commercialization of complex generics, including liposomes.
Collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance, Manufacturing, and Marketing, to ensure project success.

Project Management:

Manage multiple R&D projects with accountability for timelines, budgets, and resource allocation.
Oversee technology transfer from R&D to manufacturing, ensuring robust and scalable processes.
Track progress against key milestones and provide updates to senior management.

Regulatory and Compliance:

Support the preparation of ANDA submissions for complex generics, including authoring and reviewing Module 3 documentation.
Ensure compliance with cGMP, GLP, and other applicable regulations during development activities.

Team Development:

Mentor and develop a high-performing R&D team with expertise in complex drug delivery systems.
Foster a culture of innovation, collaboration, and continuous learning.

Qualifications:

PhD/MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related fields.

Experience:

Minimum 14-17 years of experience in R&D for complex generics, with at least 5 years focused on liposomal formulations.
Demonstrated experience in developing and commercializing liposomal drug delivery systems.
Proven track record of successful ANDA filings for complex generics.

Skills & Competencies:

Deep understanding of liposomal technology, including formulation, characterization, and analytical techniques.
Strong knowledge of global regulatory guidelines and quality standards for complex generics.
Excellent project management, problem-solving, and decision-making skills.
Strong leadership, communication, and interpersonal abilities.

Key Performance Indicators (KPIs):

Successful completion of R&D milestones within defined timelines and budgets.
Number of successful ANDA submissions and approvals for liposomal generics.
Efficiency of technology transfer processes to manufacturing.
Development of innovative formulations and cost-effective processes.

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