Team member Sterile Operations

Roles & Responsibilities

• You will be responsible for Bio-complexity assessment and provide inputs for product selection for United States Europe and Emerging markets.
• You will be responsible for providing Biopharmaceutical based strategic support for assessing the feasibility and complexities of new product development conducting comprehensive gap analyses and ensuring alignment with regulatory requirements for successful market entry.
• You will be responsible for identification of bio relevant/bio discriminatory media/appropriate in-vitro tools based on Critical Material Attributes & Critical Quality Attributes for periodical Management reviews.
• You will be responsible to support in designing & guiding the team in modeling and simulation of available data using data Analytical Tools and Software.
• You will be responsible for risk assessment for granting approval for pilot bio studies and early bio-manufacturing through Best Available Technologies (BAT) meetings and phase gates.
• You will be responsible for managing the team and provide them the guidance and support in setting up their goals.
• You will be addressing regulatory queries Deficiency responses and guiding the Product Development Team.

Qualifications :

Educational Qualification

Masters in Pharma/ PhD in Bio-pharmaceutics or pharmacokinetics or Pharmaceutics/pharmacology

Minimum Work Experience

8-10 years of experience in Pharmacokinetics Biopharmaceutics and Pharmaceutics

Skills & Attributes Technical Skills

• Strong understanding of differentiated and innovative product design the strategic path to make the product bio success.
• Deep Knowledge on formulation design and performance of products in-vitro & in-vivo.
• Exposure to Pharmacokinetic-Pharmacodynamics (PKPD) Modelling & Simulation.
• Knowledge of Preclinical and clinical Pharmacokinetic Modelling.
• Experience in in-vitro-in-vivo correlation (IVIVC) and Mathematical Compartmental Modelling.
• Knowledge on analytical development clinical pharmacology preclinical regulatory understanding of regulated markets like United States Europe and Russia China India etc.

Behavioural Skills

• Excellent communication negotiation and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with Regulatory 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 for patients around the world.

We have end-to-end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. Serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets we offer innovative and generic products ranging from Active Pharmaceutical Ingredients (API) Oral Formulations Parenteral (Injectables Ophthalmics) and other dosages.

Our product development efforts drive a portfolio of more than 1000 products. Enabled by our robust R&D team consisting of over 200 scientists and functional experts including more than 150 doctorates we have filed 1071 patents and 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. Our benefits are on par with the best industry standards and include:

• 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 also as a means to help patients lead healthier lives.

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

Key Skills
Dhcp,Ethernet,Information Technology Sales,Customer Development,ITI
Experience: years
Vacancy: 1