Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: Associate Scientific Manager - HC/JC/3482/2013
1. Proficient in writing, reviewing & consolidating ANDA filing documents which includes but not limited to - Literature and Patent search reports, Optimization protocols, Exhibit batch records, Scale up reports, DOE reports, etc.
2. Project-wise documentation of all the development activities, creating formats for data updating and release to stakeholders for their review & decision making.
3. Planning & Execution of scale up & registration batches at manufacturing sites for respective products along with requisite documentation & quality compliance like making MFC, MPR, stability protocols, sampling protocols etc.
4. Work closely with analytical managers to ensure analysis plan is finalized & communicated with timelines on day-to-day basis.
5. Basics of IVIVC, discriminatory media identification, bio-relevant media identification etc will be preferred. Basic understanding in pharmacokinetics & ability to understand BE data.
1.Propose a formulation development strategy with inputs from crosfunctional teams & execute it on time to ensure project moves swiftly without any delays.
2.Awareness of QbD based formulation development concepts like QTPP, CQA, CMA, CPP, CS, DOE, FMEA, etc
3.Familiarity with USFDA, EMA, MHRA, and ICH guidelines, and the regulatory requirements of various International Regulatory Agencies for 505(j) & 505B (2) filings.
4.Support the multiple formulation projects for regulated markets by day-to-day experimental planning & execution
5.Hands on experience in handling various equipments like RMG, FBP, compression machine, capsule filling machine, blister packing machine, roller compactor etc at both lab scale & manufacturing scale.
Experience: 7-10 Years
Education: M.Pharm, PHD Pharmaceutical Sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 17th Nov., 2013
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