Manager

Glenmark Pharmaceuticals; Mumbai; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Glenmark Pharmaceuticals seeks a Manager - Project Management to lead techno-commercial R&D projects that are in-licensed, co-developed and tech-transferred to CDMOs for US markets. The role includes managing launches and alliances, with a focus on cross-functional collaboration.

The candidate should have 10–12 years in R&D/regulatory roles, with exposure to US/EU regulatory processes, and experience in complex NDDS platforms. MBA preferred, PMP a plus, based in Andheri, Mumbai.

Qualifications

• Must have 10–12 years of experience in R&D/Regulatory related roles with exposure to technology, product assessments and commercial aspects.
• Experience with US/EU Regulatory environments; complex technology platforms (NDDS) advantageous.
• Exposure to BD and/or Alliance management would be an added advantage.

Responsibilities

• Lead techno-commercial evaluation of new product opportunities, technology platforms, CDMO’s and CRO’s.
• Provide technical inputs on drug development, CMC, non-clinical and clinical aspects for complex generic products.
• Define, establish and implement the Project Management process for the portfolio and manage budgets to meet milestones.
• Project manage CMO & tech-transfer projects; prepare RFPs, contracting, execution and tracking.
• Manage new product launches for partnered products with end-to-end visibility and timely execution.
• Alliance management of IL/CDMO partners.

Skills

Project management

Analytical skills

Communication skills

Education

Bachelor in Pharma/Biotech

MBA

PMP certification

Tools

Project management tools

Job description

Job Description

Designation: Manager - Project Management

Office Location: Andheri, Mumbai

Position description: Primarily responsible for project managing generic / complex generic R&D projects that are in-licensed, co-developed & tech-transferred to CMO’s, manage new product launches and alliances for US market.

Primary Responsibilities

• Primarily a techno-commercialrole for project managing generic / complex generic projectsfor USmarket. Lead techno-commercial evaluation of new product opportunities, technology platforms, CDMO’s, CRO’s.


• Provide technical inputs on drug development, CMC, non-clinical & clinical aspects for complex generic products -: in-house & licensed (in/out).


• Understand, communicate and provide perspective on the views of external experts / regulatory agencies, relevant to the project’s development strategy - highlight risks and risk mitigation strategies.


• Define, establish & implement the Project Management process for the said portfolio; establish Project review mechanisms & conduct of project within approved budgets - ensure successful completion of project milestones as per project plans.


• Project manage CMO & tech-transfer projects - Techno-commercial evaluation of CMO/CDMO/CRO; Preparing RFP, Contracting, Project execution & tracking.


• Manage new product launches for partnered products - Provide end to end visibility of launch plans to all stakeholders and ensure timely execution of plans.


• Alliance management of IL/CDMO partners.

Educational Qualifications

Minimum of a Bachelor Degree in Pharma/ Biotech preferably with an MBA. PMP certification is an added advantage.

Required Work Experience

• Must possess experience of 10 - 12 years in R&D / Regulatory related roles with good exposure to technology, product assessments, commercial aspects, etc.


• Must have exposure to US/EU Regulatory environment, experience in complex technology platforms (NDDS) will be an advantage.


• Exposure to BD and/or Alliance management would be an added advantage.

Key Interfaces

External

Licensing partners, CMO/CDMO, Consultants, Design houses, Contract Manufacturers, Regulatory Consultants, Clinical Consultants.

Internal

R&D, Regulatory affairs, Clinical Services, QA, BD & Portfolio team.

Required Knowledge & Skills

Understanding of drug development across R&D/ Manufacturing/ Clinical aspects.

Good analytical & communication skills.

Project Management tools & Techniques.