Tech Lead Oral Solids Soft Gel

Job Summary:

We are looking for an experienced Technical Lead in the Oral Solids Formulation Research & Development Department. This role encompasses new product ideation successful product introduction formulation & process development technology transfer and securing product approvals and launches. Working collaboratively with various crossfunctional departments including Portfolio Business & Marketing Supply Chain Analytical Research & Development IPR Regulatory Clinical & BE teams is essential for successful product development within established timelines ensuring timely product filings approvals and launches and thereby bolstering organizations initiatives to promote innovation.

This role emphasizes enhancing scientific capabilities and developing a pipeline of highvalue products for markets in the US Europe Canada Japan and other emerging regions. It involves leading a team of research scientists dedicated to the formulation development of Oral Solid and Liquid Dosage Forms. Responsibilities include overseeing formulation design preformulation studies stability testing scaleup and technology transfer processes. The team will primarily focus on soft gelatin capsule technologybased products for global markets. The ideal candidate is someone currently overseeing a team of research scientists in a similar capacity.

Roles & Responsibilities:

• Team Leadership: Lead the assigned OSD formulation development team to create a unique and valuable product portfolio. Responsible for setting goals for oneself and team members in line with the organizations objectives and facilitating skill development within the team.
• Technical Leadership: Provide technical direction to define the project scope finalize development strategies and manage the entire process from product introduction to launch. Ensure a seamless transition from product selection to development and facilitate effective communication between crossfunctional teams for successful project management. Implement strategies for highquality product development through innovative dosage form design. Stay informed on trends in new product ideation technologydriven innovations and unmet medical needs. Utilize digital tools in product development and data analysis. Oversee the development of oral solid dosage forms like tablets and capsules including preformulation studies formulation design stability testing scaleup & technology transfer processes to create robust and bioequivalent products. Must be proficient in understanding the chemical and physical properties of APIs and excipients concerning formulation and drug delivery as well as familiar with analytical methods and instruments to characterize APIs and dosage forms. Collaborate with various cross functional teams such as Manufacturing Quality Assurance Quality Control and Occupational Safety for smooth and effective product execution at the site. Should have experience in developing complex solid oral dosage forms like Osmotic Drug Delivery Systems Extended Release & Delayed Release matrix and pellets based dosage forms Spray Dried & Hot Melt Extrusion ASD based products ExtrusionSpheronization based products TabinTab press coated technology based dosage forms Suspension / Powder layering technology based dosage forms SMEDDS based dosage forms and Suspension / Solution filled soft gelatin capsules. Product development should be carried out as per principles of Quality by Design Quality Risk Management and apply statistical design of experiments wherever applicable.
• Product Management: Evaluate product and process complexity innovation potential and development challenges defining the product strategy in line with company goals. Conduct thorough literature reviews to gather relevant scientific data. Facilitate the application process for obtaining import licenses for reference products BE NOCs and manufacturing site licenses. Develop and optimize formulations for immediate and modifiedrelease oral solid dosage forms. Ensure logistical readiness for smooth product execution and technology transfer. Coordinate with API manufacturers CROs and CMOs. Work with the Global IP team to examine IP constraints review patent summaries and propose noninfringement strategies for formulation design. Collaborate with the Regulatory team to address submission requirements conduct gap analyses and ensure submission quality. Perform detailed risk assessments and work with crossfunctional teams to mitigate potential risks. Proficiently draft highquality technical and regulatory documents. Address regulatory agency queries within deadlines to obtain timely product approvals. 
• Safety & Compliance: Ensure product development operations adhere to organizational safety norms following Good Laboratory Practices (GLP) and strictly following mandatory compliance practices enforced

Qualifications :

Educational qualification: Ph.D. / MS or M.Pharm Pharmaceutics 

Minimum work experience: M.Pharm with 14 20 years of experience in Generic Formulation Research and Development (or) Ph.D. with 10 to 16 years of experience

Skills & attributes:  

• Should exhibit situational leadership have excellent communication interpersonal & project management skills.
• Effective planning and high level of performance orientation.
• Strong strategic thinking attention to details perseverance analytical and trouble shooting abilities.
• Good at networking collaborating influencing & be assertive.
• Strong in building & leveraging relationship to facilitate organizational objectives 

Additional Information :

About the Department

Integrated Product Development Organization                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused 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 catalyze your career growth and professional development through personalized 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 !/ 

Remote Work :

No

Employment Type :

Fulltime