Graduate level degree in biological sciences or related subject required. Ph.D. highly preferred with equivalent expertise required. Must have a minimum of 8 years of relevant analytical experience with biologics, several of which must be in a management position.
• Strong knowledge of biologics manufacturing and analytical methodology as well as ICH, cGMP, eMEA and JP guidelines as they pertain to the manufacturing of monoclonal antibody based therapies required.
• Prior contract manufacturing project management experience is highly preferred. Propr experience with manufacturing from pre-IND through phase 3 of commercial production is highly desired
• An understanding of project accounting and financial concepts is also required since this individual will participate in budgeting, tracking and financial decision making for multiple drug development programs.
• A hands-on, proactive stance is essential with willingness and ability to assist all team members to achieve corporate goals
• Excellent interpersonal skills are mandatory, in addition to analytical problem solving, the ability to set priorities and achieve goals; strategic thinking, energy, enthusiasm and an entrepreneurial mindset.
• The ability and willingness to travel (domestic and international) approximately 20% of the time is required.
Posted On -
2/26/2014 4:47:38 PM
• BS/BA in Life Sciences or equivalent.
• Minimum of 5 years’ experience in the implementation, validation and administration of a LIMS including computer system lifecycle management, change management, script writing and execution and pertinent regulations (e.g. 21 CFR Part 11).
• Minimum 5 years’ experience in FDA or equivalent regulated industry, biotechnology or pharmaceutical, performing Quality Assurance functions related to material disposition; including material specifications, batch record review, SOPs and Certificates of Compliance (or Analysis).
• Working knowledge of TrackWise and SAP.
• Effective written and verbal communication and organizational skills.
• Strong working knowledge of cGMPs.
Posted On -
2/26/2014 4:44:53 PM