Biodel Inc Work Values

Daily Duties at Biodel Inc:

• Develop, conduct, and coordinate novel drug delivery research and dosage form design under cGMP controlled environment, provide guidance to junior scientific staff. • Developed oral rapidly dissolving and oral controlled extended release tablets using HPMC, mannitol, Carbopol by direct compression and wet granulation technologies. Resolved problems related to release profile, segregation issues, disintegration time and mouth feel through judicious selection of excipients. Related performed studies include development of generic products, hardness, friability, weight variation, content uniformity, LOD, tap density, bulk density, disintegration and dissolution testings. • Lead parenteral and topical drug delivery projects - Reformulate existing commercial products (generic) to achieve longer shelf-life and improved PKPD profiles. Formulated protein and small molecule parenteral products with improved stability, immediate and sustained plasma-concentration time profiles, optimum osmolality and pH. Specific studies include solubility, stability (ICH routine, intermediate and accelerated), effect of pH and zeta potential, excipient compatibility, reverse-engineering of commercials products using filters, development of lyophilized products, formulation-container compatibility, container-closure integrity, in-vitro release studies, permeation studies, mucoadhesion, swelling and / erosion and physicochemical characterizations of developed formulations. • Developed oral extended release mucoadhesive delivery systems (bi-layered tablets, Pluronic and Carbopol gels and patches) for small molecules and proteins having potential to act as extended release depot systems via alternative routes of administration such as buccal, ocular and nasal amongst others. • Apply DOE in formulation development, use statistical tools such as ANOVA, t-test, regression analysis in data interpretation. • Write extensive scientific reports for regulatory submissions (IND, NDA and 510K, 505(b)(2)). • Manage manufacture of batches in coordination with QC and Regulatory departments, contact vendors for chemicals, coordinate with CROs for outsourced analytical works, work with CMOs and CROs to oversee technology transfer and outsourcing work. • Develop protocols for research, stability studies and for validations of analytical methods, SOPs for equipments, test methods and manufacturing processes. • Coordinate with analytical scientists and Quality Control Department to complete testing of finished products in a timely manner. • Review batch records and QC data.

What they like about Biodel Inc:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

Tags

Senior Formulation Scientist, Research Scientist, Pharmaceutical Product Development Manager, Pharmaceutical Project Manager, Medical Director, Solid dosage form Parenterals Topicals

Skills

Lyophilization, HPLC, Particle Size / Zeta Potential Analyzer, ELISA, Differential Scanning Calorimeter , Microscopy, TGA, Spectrometry, Fusion Pro, Empower, Microsoft Project Management, MS Office

These are some of the questions we asked our climbers about their experiences with Biodel Inc: