Hyderabad

Support the Quality vision and mission for Amgen India aligned with Amgen’s mission to serve patients. Support Amgen India Quality Team Lead in the development and implementation of a multi-year Quality technological plan aligned with Amgens standards and overall strategic imperatives.

Exposure to aseptic process activities, aseptic techniques, aseptic filling and sealing activities, and media filling activities. Experience in operating autoclaves and terminal sterilizers. Preparation of autoclave loads, loading and unloading of autoclaves and sterilizers

The selected candidate is supposed to make her, his team and work in the core animal biotechnology areas wing. In addition to their own research programme, she, he is expected to provide support, collaborate to other research projects at NIAB and put efforts towards institute building. 

Knowledge of FDA, cGMP, ICH, DMF guidelines for regulatory submissions. Hands on experience in CMC submissions, supplemental applications. Experience working on labels will have added advantage. Excellent written and verbal communication skills; experience in Regulatory Affairs of Finished dosage formulations mainly for USFDA, EU. M Pharmacy / M. Sc. / B Pharm

Research experiences in cell culture, viral assays and handling small animals mice will be preferred; Four years Bachelors degree in natural or agricultural sciences, masters degree in natural or agricultural sciences, BVSc, B.Pharma or Bachelors in Technology or Medicine from a recognized university or equivalent.

In this role, the Senior Scientist-I will work on isolation, purification of known and unknown impurities, compounds by preparative HPLC and characterization of molecules using various analytical technique. Prepare, execute, and complete IQ/OQ/PQ of new instruments. Indent the required glass ware, chemicals, and columns for the ARD projects.

Seeking a dynamic independent and experienced Research Associate in Clinical Management for processing, reviewing and receiving clinical data and records and from therapeutic groups as well as internal and outside investigators. Ensuring accurate, timely, and consistent data reaches the clinical teams and other groups. Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research

Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.

Adult stem cell derived exosomes, A cell-free therapy for glaucoma. Experience in animal models for evaluating preclinical safety, pharmacokinetics and efficacy will be preferable. Candidates with GPAT or equivalent exams will be given a preference. Candidate must be interested in learning new concepts, tools, and techniques.