Biocharacterization Scientist
Biocharacterization Scientist
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Job Description
Job Summary
We are seeking a dynamic and experienced Scientist in Bioassay of injectables to design and develop robust in vitro bioassay methods for peptide and small molecules and for biological characterization of Active Pharmaceutical Ingredient (API) and Finished products (FP) in generic drug development.
Roles & Responsibilities
- You will be responsible for comprehensive literature searches and strict adherence to guidelines for designing safety and efficacy/potency bioassays crucial for product development.
- You will be responsible to design & execute experiments with relevant documentation based on clear understanding of relevant Quality by Design (QbD) elements. Collect and interpret data from experiments conducted (cell based/biochemical/ELISA/binding assays) and interact with relevant experts to gain basic understanding of design and development considerations for successful technology transfer.
- You will be responsible to conduct method development and qualification and actively participate in tech transfer for validation of methods to QC sites. Ensure alignment with laboratory results and contribute to documentation for gate clearances.
- You will be responsible to test assigned samples and release data within defined timelines for developmental and laboratory batches..
- You will be responsible to prepare and compile regulatory documents including protocols and reports for filing and deficiency response requirements. Conduct stagewise drafting of documents in accordance with regulatory guidance.
- You will be responsible to maintain impeccable documentation practices adhering to good documentation principles. Develop Standard Operating Procedures (SOPs) Standard Test Procedures (STPs) study reports and other essential documents. Create comprehensive method development and validation protocols and reports.
- Cultivate scientific acumen and foster an innovation culture through rigorous study of scientific literature. Remain at the forefront of developments in the field and identify opportunities to apply new knowledge in consultation with subject matter experts.
Qualifications :
Educational qualification: MSc (Biotechnology/Biology) / M Pharm/M tech/ PhD.
Minimum work experience: 37 years of relevant industrial experience in in vitro bioassay methods cell based and biochemical assays and mammalian cell culture
Skills & attributes:
Technical Skills
- Hands on experience in Mammalian cell culture techniques and safety measures; cell banking and characterization.
- Ability to develop and validate in vitro bioassay method for small molecules and peptides to support biocharacterization of the product. Having experience of development and validation of 2 or more peptide/large molecule products will be of added advantage.
- Knowledge on cGMP and QMS will be a plus
- Exposure and proficiency in multiple bioassay techniques like ELISA/Binding assay/viability studies/complement assays/SPR/ colorimetric assays /FRET /Luminescence assays
- Familiar with usage of instruments like spectramax for assay development and data analysis softwares like Graphpad Prism and PLA3
- Keeping abreast of current developments and new techniques in the field of molecular biology cell biology and generic drug development..
- Strong knowledge of pharmaceutical generic drug development and familiar with regulatory requirements and guidelines for biological assays.
- Awareness of Good Manufacturing Practice (GMP) guidelines Standard Operating Procedures (SOPs) and internal systems related to own tasks & applies the same in daily operations effectively
- Behavioral Skills
- Excellent communication and interpersonal skills.
- Strong analytical and problemsolving abilities.
- Ability to work collaboratively with own team and crossfunctional teams.
- Excellent documentation practices and meticulous attention to detail.
- Willingness to take initiative where required and work proactively to achieve team goals.
Additional Information :
About the Department
Integrated Product Development Organisation
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 catalyse your career growth and professional development through personalised 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
Employment Type
Full-time
