Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient.
Post: Senior Scientist (Formulation-Analytical Development)
Job Description:
Individual will have a major role in the design, development, scale up and optimization of solid oral dosage forms, as per IND/NDA requirements for NCEs. Knowledge of drug discovery process and experience in manufacturing of clinical trial batches (Phase I, II and III) supplies would be valuable. Preparing Product development reports (PDR), Manufacturing instructions, Batch records, Cleaning verification report, EHS safety report, SOPs and Validation protocol/plan (for Clinical/Commercial manufacturing). Selection and assessment of raw materials and packaging material required for the formulation. Experience in development of DP analytical method development and material characterization techniques. Process scale up and technology transfer to other locations. Excellent communication, presentation skills and scientific/technical writing skills. Working with and updating cross-functional and cross-cultural teams across sites. Undertaking multiple projects, tasks and co-ordination within and outside the team.
Maintenance of laboratory as per the research specific regulatory requirements and if needed to meet cGMP/cGLP requirements. Training and mentoring of team members. Any other responsibilities delegated by Supervisor from time to time.
Candidate Profile:
Ph.D. with Pharmaceutics/ Pharmaceutical Sciences/ Analytical Chemistry preferred. M.Pharm/ M.Sc. with specialization in Pharmaceutics/ Formulation development/ Analytical chemistry accepted. 5-6 years with Ph.D. or 6-8 Years with M.Pharm/M.Sc. Experience in Formulation/ Analytical R&D from a reputed pharmaceutical company. Experience with development of solid oral dosage forms and liquid injectable drug products and their analytical support.
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Expert in formulation designing, development optimization, scale up of formulation and processes for solid oral dosage forms and injectables. Experience in working with NCEs, manufacturing of clinical batches (Phase I, II and III). Experience in safe handling of potent compounds. Knowledge of analytical development support for drug products
Additional Information:
Job ID: IN2762-3455-R
Experience: 5-6 Year
Industry Type: Pharma/Biotech/Clinical Research
Location: Hyderabad
Functional Area: F&D
End Date: 30th Nov, 2013
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