Specialist- Process MSAT

Job Summary
We are seeking a dynamic and experienced Team Lead in Process Development to lead and guide the Injectable Process development team in areas of Quality by Design (QbD) Process selection Scale Up and Technology transfer to Manufacturing Science & Technologies (MSAT)/ Formulation Technology Organisation (FTO)/ Contract Manufacturing Organisation (CMO) and ensure product development leads to development of robust manufacturing process throughout the clinical phases and commercial product life cycle

Roles & Responsibilities

Technology Transfer Troubleshooting & Continuous Improvement

• Prepare review and approve technical protocols reports SOPs and product impact assessments related to product lifecycle management (LCM).
• Initiate review and approve change controls incidents and risk assessments related to validation and qualification activities.
• Coordinate with cross-functional teams (Production QA QC) for execution and documentation of new products scale-ups and transfers.
• Lead technology transfer activities for new products scale-ups line transfers and site-to-site commercial batches for injectable products.
• Support investigations for non-conformances (Incidents OOS OOT Market Complaints) through root cause analysis and impact assessments.
• Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals.
• Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving.
• Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs).

Cleaning Validation: Prepare and review cleaning validation documents including protocols reports master plans and assessments.

Analytical Support:

• Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance.
• Evaluate and introduce new analytical technologies to resolve technical issues perform proof of concept and support HPT initiatives.

Subject Matter Expertise: Serve as the subject matter expert for fill-finish processes ensuring robust and compliant operations.

Knowledge Sharing & Talent Development

• Facilitate knowledge sharing through discussions training sessions and invited talks to build analytical competence.
• Support talent acquisition and induction processes to ensure recruitment of qualified personnel.

Qualifications :

Educational qualification- Master in Pharma/ Ph.D in Pharma

Minimum work experience- 10-12 years of Experience and at least 6 years of experience in Drug product tech transfers & operations support (DP-MSAT)

Skills & attributes  
Technical Skills-
Handled various forms of injectables which includes dry powders lyo products and liquid injections. 
Knowledge of the technology transfers from site to site and R&D to operations.
Knowledge in Six Sigma Lean Techniques
Knowledge about Good Documentation practices (GDP) and Good Manufacturing Practice (GMP).
Behavioural Skills- 
Excellent communication and interpersonal skills.
Strong analytical and problem-solving abilities.
Ability to work collaboratively with own team and cross-functional teams.

Additional Information :

About the Department

Integrated Product Development Organisation

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages

Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :

No

Employment Type :

Full-time