Job Description

Job Title:
Manager 2 - Formulation Development - NON ORALS
Business Unit:
R&D1 Regulatory Affairs
Job Grade
G11A
Location
Vadodara
At Sun Pharma, we commit to helping you "Create your own sunshine"- by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."
:
1
Support literature/patent search & prepare summary report.
2
Execute pre-formulation and prototype experiments at lab-scale along with e/LNB reporting
3
Execute stability studies and supporting analytical method development & validation
4
Execute process scalability at plant and subsequent Exhibit / Clinical batches
5
Drafting of technology transfer and regulatory documents like MF, RA, FMEA, CC, PDR, PD & documents for DCGI submission like CT-11/17, Transfer NOC, etc
6
Prepare risk assessment report for elemental impurity, nitrosamine impurity and E&L
7
Execute data compilation, analysis and presentation preparation for senior management review
8
Resource Management and budget preparation - inventory management and procurement forecast
9
Assist in trouble shooting and provide suggestions for corrective and preventive actions
10
Red Flagging of issues at the right time. Highlighting Key Issues to reporting managers which impacts the Program timelines/deliverables
11
Prepare SOPs for laboratory equipment/instrument and support laboratory audits
12
Be a part of Equipment / Instrument Qualification activities in case of procurement of any new Equipment / Instrument and prepare/ review qualification documents.
13
Other accountabilities as applicable as per needs of dynamic business environment
NA
Job Requirements
Educational Qualification
Graduate : M.Pharma/ Ph.D in Pharmaceutics
Experience
Tenure : Minimum 8 years of experience
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Skills Required