Analytical Specialist Injectable_ Biophysical characterization

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 highly skilled Analytical Scientist in to join our Research and Development team for Injectable Division for developing and validating analytical methods for injectable products for its bio physical characterization, ensuring compliance with the regulatory requirements, conducting literature reviews, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. This role demands a strong understanding of analytical principles, excellent documentation skills, and the ability to work effectively in a collaborative team environment. scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer.

Roles & Responsibilities

• You will be responsible for Biophysical characterisation data generation for peptide products along with reference products to demonstrate the sameness of the products.
• Preparation of sameness reports with in comparision with reference product with adequate method development and validations.
• Analytical method development and validation of injectable products for biophysical characterization of complex generics (peptides and polymers). 
• You will be responsible to perform the Drug Master File/Literature review and procure the relevant columns and standards in order to initiate the analytical method development. Stay updated with the latest literature and industry developments in the field.
• You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department.
• You will be responsible to execute analytical activities as per defined procedures, document the data and send the respective record of analysis to group leader/analytical expert for the review and release in order to provide the approved results to formulation team. 
• You will be responsible for analytical method development for drug products for various tests mentioned in the specification in order to analyse the product development batches for the prototype screening. 
• You will be responsible for analytical method validation activities at the manufacturing sites providing method development reports to verify the validation parameters and ensure the execution of method validation as per the regulatory requirement in order to provide the authentic analytical validation report for the regulatory filing. 
• You will be responsible for analytical method transfer to plant locations successfully in order to train the Quality Control (QC) team on the methods for the Exhibit and commercial batch analysis at plant.
• You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results.
• You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy.
• You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions.
• You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. 

Educational qualification: Masters or PhD in Science/ Organic chemistry/ Pharmaceutical Sciences

Minimum work experience:  7-15 years of experience in analytical method development

Skills & attributes:
Technical Skills

• Experience on analytical development of complex injectables such as Microspheres , peptides, protein bound nano particles and polymer based drugs for method development, validation and sameness data generation.
• Understanding on peptide characterisation for its primary, secondary, tertiary structures and higher order structures.
• Knowledge and Hands on Experience on molecular weight determination by using multi Angle Leaser Light scattering detector(MALS)
• Knowledge and hands on experience on CD, SV-AUC with UV and Interference optics.
• Knowledge on fibrillation studies for peptide formulation products using ThT end point/Kinetic studies
• Developing an orthogonal analytical method using HILIC chromatography for peptide products
• Have work experience on method development, validation and transfer.
• Understanding on Abbreviated New Drug Application (ANDA) filing requirements.
• Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.
• Proven experience in method validation and documentation in compliance with regulatory requirements.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.

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/#!/