FierceBiotech and FiercePharma Jobs
Director Analytical Development - Virdante Pharmaceuticals, Inc.
Nov 07
Location: Cambridge, MACategories: All Categories
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Position Description
Virdante Pharmaceuticals is developing safer and more effective drugs for autoimmune and inflammatory diseases. Our products incorporate a proprietary “sialic switch” technology to improve the anti-inflammatory properties of antibodies. Virdante completed a Series A financing in 2008 with Clarus Ventures, Venrock Associates, MedImmune Ventures and Biogen Idec New Ventures. Virdante is located in Cambridge, MA.
We are seeking highly motivated individuals to join our rapidly growing team. This is an exciting opportunity to join an early stage company on the “ground floor” and grow your career with the company as a member of the core team. You will work both in-house and with our outsourcing partners to ensure delivery of CMC goals – all under challenging timelines. Successful candidates will possess the skills and knowledge to deliver results and an entrepreneurial spirit that fits with a rapidly moving small company. We are offering highly challenging and rewarding work in a small, dynamic, growing company. Please contact us if you are seeking to enhance your career and make invaluable contributions.
RESPONSIBILITIES:
•Play a lead role as Virdante’s analytical and quality thought leader for our clinical and commercial stage biopharmaceutical products.
•Develop and validate all analytical assays for release and stability of biopharmaceutical products, and support internal process development efforts for clinical stage biopharmaceuticals.
•Lead all analytical development efforts in collaboration with our technical and manufacturing partners, as well as lead quality control efforts relating to outsourced GMP release and stability testing of clinical products.
•Contribute to the CMC sections of regulatory documents, for all aspects of supporting bioprocess development, and for technology transfer to GMP manufacturing.
QUALIFICATIONS:
•Ph.D. degree in analytical chemistry, biophysical/biochemical sciences, pharmaceutical sciences or a related field with a minimum of 5 to 8 years experience in supporting bioprocess development of therapeutic proteins or monoclonal antibodies and at least 3 years of supervisory experience.
•Proven leadership in developing, qualifying and transferring product release assays and stability indicating assays for recombinant glycoprotein and antibody therapeutics is essential.
•Prior hands-on experience in developing HPLC methods for quantitative glycan analysis and characterization is critical. A solid understanding and knowledge of carbohydrate chemistry and related bioanalytical techniques is essential.
•Demonstrated experience in glycoprotein characterization techniques, carbohydrate and peptide mapping, especially in the use of mass spectrometry for structural characterization of glycans is highly desirable.
•Experience in contributing to CMC sections of regulatory documents as well as establishing product specifications and regulatory agency interactions are highly desirable.
