Lead MSAT- FTO

Job Summary

We are seeking a candidate to ensure robustness in all manufactured products by overseeing process engineering, incident closure, and effective CAPA implementation. Responsibilities include reviewing equipment qualification, collaborating on risk assessments, and initiating improvements for safety and efficiency. The role involves leading Management of Change (MOC) processes, fostering cross-learning within the Process Engineering community, and developing common solutions for platform issues.

Roles & Responsibilities

• You will be responsible for ensuring the continual process robustness in all manufactured products at the site by incorporating expectations and actions in the process engineering team's LDM (Learning Development Matrix). 

• Your role includes overseeing the closure of incidents and investigations with effective CAPA, addressing root causes to prevent repeat incidents.

• Your role involves reviewing the qualification of equipment and cleaning procedures to ensure robustness and documenting learnings to create an organizational knowledge repository.

• Additionally, you will collaborate with cross-functional teams to conduct risk assessments for all production processes, considering process, personnel, and environmental safety. 

• You will recommend and support improvements, including actions such as P&ID (piping and instrumentation diagram and URS (User Requirement Specification) preparation, procedure development, and addressing safety risks.

• You will initiate Management of Change (MOC) and Pre-Startup Safety Review (PSSR) processes to ensure the fulfillment of recommended changes and enhance process safety. 

• You will be responsible for continuous improvements in quality, removal of bottlenecks in production capacity, batch cycle times, yield improvements beyond budgets, technologies, and waste reduction.

• You will be responsible for fostering cross-learning within the Process Engineering community under the MSAT (Manufacturing Science and Technology) umbrella. This involves actively participating in and driving opportunities for knowledge exchange that arise from being part of a larger fraternity. 

• Your role includes learning from experiences at other sites and sharing insights gained from associated sites.

• You will be responsible for developing common solutions for platform issues impacting multiple sites and creating best practices for the FTOs (Formulation Technology Organization--- Injectables). 

• Your role involves assessing opportunities and implementing changes related to scale-up and modifications in processes/equipment at various stages of product development.

• You will interact with cross-functional teams (CFT) and prepare risk assessments for any modifications or changes.

Qualification

Educational qualification: A Bachelor's degree in Chemical Engineering/B. Pharm/ M. Pharm or a related field; advanced degree (Master's or PhD) preferred

Minimum work experience:Approx 15-20 years of experience in Process Engineering, with a focus on continuous process improvement, robustness, and safety in pharmaceutical manufacturing ( Primarily in Injectable) 

Skills & attributes:

Technical Skills

• Strong knowledge on CIP/SIP and other SKID process application

*  Knowledge of working on complex Equipment ( High Pressure Homogenizer, Aseptic ANFD, SKID process Mfg processes, Microfluidizer, Homogenizer, Bead mill in aseptic methodology

* Knowledge on Sterile Filtration, Filling, Lyo

* Knowledge on Media fill strategy finalization.

* Capable to Review and/or prepare PID/FS/FDS etc

*Extensive knowledge of continual process robustness, equipment Installation & qualifications, cleaning procedures, and safety risks.

• Proven ability to oversee the closure of incidents and investigations with effective CAPA and addressing root causes to prevent repeat incidents.

• Strong focus on continuous improvements in quality, production capacity, batch cycle times, yield improvements, technologies, and waste reduction.

• Ability to develop common solutions for platform issues impacting multiple sites and preparing risk assessments for any modifications or changes.

• Proven experience in assessing opportunities and implementing changes related to scale-up and modifications in processes/equipment at various stages of product development.

*Behavioural skills

• Strong leadership skills to drive opportunities for knowledge exchange and implement changes for continuous improvement.

• Effective collaboration with cross-functional teams, fostering a culture of continuous learning and improvement.

• Analytical mind set for assessing risks, recommending improvements, and implementing changes in processes.

• Excellent communication skills for sharing insights, preparing risk assessments, and collaborating with diverse 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 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered

At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddy's 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. Reddy's why they come to work every day and they'll say, because Good Health Can't 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 we're 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