Assistant General Manager – Formulation R&D Full Time

Job Title: Assistant General Manager – Formulation R&D

Location: Thane

Reporting To: VP – FRD

Team Structure: 5-6

Experience Required: 16-18 yrs

Qualification: M.Pharm

Working Days: 5 days a week

About Inventia Healthcare:

Inventia Healthcare is a pioneer in pharmaceutical development and manufacturing, with over 40 years of expertise in Oral Solid Dosage (OSD) forms. Our global presence spans 45 countries with over ten international facility approvals. Backed by Platinum Equity, we continue to innovate and grow with a strong R&D base in Thane and manufacturing in Ambernath.

Job Description:

• Manages multiple projects through teams in own area of operation and ensures completion of projects within budgets and stipulated timelines
• Monitors progress and tracks project schedules and priorities; coordinates with other departments for any additional support required and resolves any outstanding issues.
• Identifies areas of product and process improvement for the design and development of dosage forms and their manufacturing process
• Finalizes specifications for raw materials, intermediates and finished products
• Reviews of the analytical results
• Provides technical assistance to team members and coordinates with other departments (e.g. Analytical Research, IPR, Regulatory, Corporate Quality) on various aspects of product development methods
• Reviews and monitors work of team periodically to ensure adherence to set timelines and meet the regulatory requirements (e.g. ICH, EDQM, US FDA etc)
• Identifies team members to represent the department and be a part of the cross functional technology transfer team
• Coordinates transfer of new products from development to production, through established procedures and ensures validity of supporting documentation. Coordinates with Analytical Research team to ensure smooth transfer of technology to the respective manufacturing units
• Provides troubleshooting support during product scale-up or production to manufacturing team/ client
• Reviews and monitors work of team periodically to ensure adherence to set timelines, plans, GLP norms and safety
• Reviews and ensures completion of necessary project related documentation.
• All activities to be executed in compliance and as per SOP’s applicable.

Qualifications & Skills:

1. Expertise in handling multiple products of different nature like Extended release formulations including Pellets, OROS, Reservoir devices, Delayed release, Immediate release products etc.
2. Experience in handling FTF products, 505b (2) along with ANDA etc.
3. Thorough understanding of basics of product development like regulatory guidance’s (US/EU/Brazil/Canda etc.), process optimization and cost-effective formulation development etc.
4. Expertise in preparation of all filing documents as per country specific requirements like product development report, understanding of QBD/DOE, specifications etc.
5. Capability to handle and balance team in all fronts for smooth functioning
6. Expertise in coordinating and communicating with cross functional teams for expedition of product activity.