Job Description

Position Overview

We are seeking a highly motivated and experienced

Project Manager

with a strong background in

new chemical entities (NCEs), pre-formulation, and formulation development

. The ideal candidate will manage cross-functional drug development projects from early discovery through clinical development, ensuring timely execution, compliance, and alignment with strategic goals.

Key Responsibilities

Lead and manage projects involving

NCE development

, from pre-formulation through formulation and process development. Develop, monitor, and maintain project timelines, budgets, and resource allocation. Collaborate with

R&D, Analytical, Regulatory, Quality, and Manufacturing teams

to ensure seamless project execution. Oversee

pre-formulation studies

, including solubility, stability, excipient compatibility, and solid-state characterization. Guide

formulation development activities

for oral, injectable, or other dosage forms. Ensure compliance with

cGMP, ICH, and regulatory guidelines

throughout project execution. Identify potential risks, develop mitigation strategies, and proactively resolve project-related challenges. Prepare and present project updates, progress reports, and technical data to senior management and stakeholders. Serve as the primary liaison between internal teams, external partners, and CRO/CMO collaborators. Drive continuous improvement in project management processes and contribute to organizational best practices.

Qualifications

Master's or Ph.D. in

Pharmaceutics, Pharmaceutical Sciences, Chemistry, or related field

. 7+ years of experience in

pharmaceutical R&D

, with proven expertise in

pre-formulation and formulation development

. Strong understanding of

drug development lifecycle

, from discovery to clinical trials. Experience in managing cross-functional teams and external CRO/CMO partners. Excellent knowledge of

analytical techniques

, stability studies, and biopharmaceutics. Demonstrated ability to manage multiple projects, set priorities, and deliver results on time and within budget. Strong leadership, communication, and organizational skills. Familiarity with regulatory submission requirements (IND, NDA, ANDA, IMPD) is a plus.

Preferred Skills

Experience with

oral solid dosage forms, injectables, or biologics formulation

. PMP certification or formal project management training. Experience with

QbD (Quality by Design)

and

DoE (Design of Experiments)

approaches in formulation development.
Job Type: Full-time

Pay: ₹1,200,000.00 - ₹1,600,000.00 per year

Experience:

NCE development: 4 years (Required) Pre-formulation studies: 4 years (Required) formulation development activities: 4 years (Required)
Work Location: Remote

Speak with the employer

+91 9492565398