Polymorph Screening - API Lead

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. 

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary
We are seeking a dynamic and experienced Lead in Polymorph SCreening - Process Engineering for invention/discovery of pharmaceutically acceptable novel forms that are commercially viable for Active Pharmaceutical Ingredient & formulation development within product portfolio strategy to enable Abbreviated New Drug application (ANDA). 

Roles & Responsibilities

• You will be responsible to review the Intellectual Property (IP) landscape & work along with Intellectual Property (IP) /Portfolio team to define the solid-form strategy for the products.
• You will be responsible to guide team in polymorph screening studies using various techniques using crystal engineering concepts
• You should be able to evaluate & utilise predctive tools for efficient experimental design
• You will be responsible for enabling the team in interpreting the solid-form characterization data and Provide advanced characterization to confirm the novelty as needed.
• You will be selecting and evaluating the appropriate solid-form for drug product development in partnership with pre-formulation team. And also assessing & providing the toxicological aspects of the solid forms.
• You will be responsible for knowledge transfer on solid-form for process scale-up and enabling team for filings and optimizing the process.
• You will be participating in Periodic reviews with Portfolio, Intellectual Property (IP), Product Management and Active Pharmaceutical Ingredient leadership on prioritization and strategy.
• You will facilitate faster regulatory approvals, review screening reports meticulously, ensuring proper documentation. You will be responsible to obtain regulatory acceptance for novel forms, particularly in the case of solvates or co-crystals.
• You will be responsible to provide comprehensive guidance to teams for responding to regulatory authorities' and customers' queries pertaining to polymorph for both new development and existing commercial products.
• You will be responsible for Research/ Intellectual Capital Development & Publication. Support intellectual capital development related to products and processes.
• You will be responsible for team building and identify skill gaps and facilitate/conduct/nominate for appropriate internal or external training programs. 

Educational qualification- PhD (Chemical Engineering)/PhD (Chemistry)/PhD(Pharmaceutics)/M.Sc (chemistry) with specialization or experience in solid-state chemistry & polymorph screening

Minimum work experience-12 years of work experience (after PhD) in crystallization/solid-form screening

Skills & attributes – 
Technical Skills-

• Experience in polymorph screening/development of at least 15 products.
• Should be well versed with polymorph characterization, molecular modelling & experimental tools for novel forms discovery.
• In depth knowledge of crystal engineering concepts, advanced solid-state characterization, knowledge of novel technologies related to polymorph screening.
• Sound understanding of Active Pharmaceutical Ingredient (API) polymorph development and Intellectual Property related to polymorphs. 
• Exhibits ability to effectively utilize quantitative predictive tools ex: molecular modelling to design experiments to discover novel forms.
• Basic understanding of Chemistry, API development, Analytical operations and Regulatory Affairs.
• Experience of at least 3 years in guiding & mentoring individual/teams in specific functional area.

Behavioral Skills- 

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.
• Mentor, coach team members
• Good Negotiation Skills and Influencing skills.
• Commitment to Learning & Coaching/mentoring

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 at https://careers.drreddys.com/#!/