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Senior Scientist require @ Hetero Biopharma

Senior Scientist require @ Hetero Biopharma

Hetero Biopharma Ltd.

R&D – Clinical Bio Analytical Lab

Designation : Senior Scientist

Experience : 8 Yrs. to 10 Yrs.

Education Qualification : M.Sc. life sciences / MTech biotechnology

Job Location : Hyderabad (Telangana)

Job Description
Current opening is for large molecule clinical bioanalytical laboratory. The candidate should have extensive hands on experience on bioanalytical techniques for estimation of large molecules like therapeutic proteins and monoclonal antibodies, assessment of immunogenlclty and biomarker analysis in clinical samples. He/she should also be Well versed with current regulatory guidelines for Bioanalytical methods, and Quality systems as per GLP practice. Prior work experience in a clinical bioanalytical laboratory / GLP certified clinical CRO lab is required, prior people man¬agement skills will be advantage. Knowledge on statistical analysis Is preferable but not an absolute requirement. This role will be evaluated by the innovation, scientific rigor, ownership and accountability to design and implement PK and immunogenicity assessment strategy to support various programs cross-different modalities.

Job Responsibilities
•  To develop and validate bioanalytical methods and conduct sample analysis for various clinical analysis as per study requirements.
•  Should be able to trouble shoot and mentor team members.
•  Contribute to study reports and regulatory submission activities.
•  Drafting SOPs related to bioanalytical methods and QA systems.
•  Perform other bioanalytical work as assigned based on project and Company needs
•  Take part in general bioanalytical laboratory operations including: maintenance of equipment, ordering lab supplies.
•  To collaborate with the other functions / departments as required to ensure that the efficiency and quality of work meets with organisational needs.

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Last date: 30th September, 2020

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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