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:

Working for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.

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: