Analytical scientist , API Plus

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.

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AREAS OF RESPONSIBILITY (AOR) Header
Definition
IN ORDER TO, what results1Dossier filing support (FDF Model) 
Identify the gaps in data requirements as per the filing country regulatory checklist.
Prepare the necessary documents required for filing specific to API plus Markets. (e.g., Specification, STP, validation documents etc.).
Connect with respective cross functional teams to collect the data required for the submission in order to successful filing of dossiers.

2Analytical method transfer Prepare the list of analytical requirements in advance in the identified technology transfer projects.

Provide onsite or off-site analytical support to partners to resolve technical issues and challenges for smooth Analytical method transfer. 

Provide the guidance to PMO team member, for arranging the right standards to the partner.

3Deficiency support Prepare the responses for regulatory deficiencies at the earliest possible time.
                                  
Perform the experiments required to address the deficiencies.

Modify the Analytical documents as per the country or Regulatory agency requirement.

Collect the raw data and label as per regulatory requirement in order to address the deficiencies.4Technical Management a. Provide the technical data / documents / information to address the queries related to analytical section.

b. Identify the technical gaps and alert the concerned stake holders in time to avoid the last-minute surprises and help to derive mitigation plans.

C. Build the relationship with cross functional team and keep updated with lead country analytical deficiencies.
 
D. Perform the experiments required to address the challenges raised by the partners which they had undergone during their execution5Support for Predeal assessment a. Collect the information related to Analytical, manufacturing, stability, packing, regulatory, commercial etc. to support the pre-deal evaluation.
b. Gather the data to address the customer queries raised during the deal discussions.
 

MINIMUM REQUIREMENTS       

Education & Experience B. Pharma (5-8 years), M. Pharma ( 2-5 Years), M. Sc. (5-8 Years) Business Understanding In-depth understanding of the dossier filing requirements of API PLUS markets and technical knowledge for successful filing. Knowledge Behavioral Skills: Chromatography and spectroscopy knowledge; Other chemical analysis experience.
Knowledge on ICH guide lines.
Communication skills,
Presentation skills,
Influencing skills and
Decision making skills