Drug Delivery and Formulation Investigator, Long Activing Injectibles, ViiV
• Support pre- and post- development candidates by screening and developing robust drug product compositions for non-conventional sterile drug products, including but not limited to suspensions, hydrogels, emulsions, and controlled release implants
• Develop scalable manufacturing processes and evaluate terminal sterilization processes
• Work effectively with R&D pilot plant scientists and operators to manufacture drug product for clinical studies
• Author relevant sections of technical reports and regulatory documents
• Define the primary packaging and support stability and robustness assessment as appropriate for early stage projects
• Interact closely with internal partners in conducting PK/PD/Tox studies
• Contribute to scientific strategy to advance development candidates requiring non-conventional parenteral delivery
• Serves as a drug product representative in CMC technical meetings
• Identify and manage scientific business-relevant relationships and contract research programs
• Participate in due diligence assessment of new business development opportunities, as required
• Mentor fellow scientists on formulation design
• Ph.D. with a minimum of 4 years of industry experience and a Degree in Chemical/ Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field
• Knowledge of sterile drug product development reflected through industry experience
• Strong foundation in materials science or related field
• Strong written and oral communication skills
• A strong track record of publications in parenteral drug delivery
• A good understanding of GMP manufacturing and GMP compliance
• Hands on experience and thorough knowledge of laboratory/plant equipment to manufacture non-conventional sterile drug products through processes including wet grinding, micronisation, and homogenization. Knowledge should be reflected through industry experience
• A background in sterile drug product development (including non-conventional drug products) and process development reflected through industry experience and external publications
• Experience with terminal sterilization techniques
• Experience in authoring relevant sections of regulatory documents (eg. IND or IMPD)
• Proven ability to work effectively with and lead cross-functional teams
ViiV Healthcare is a pharmaceutical company specializing in the development of therapies for HIV infection that was created as a joint venture by Pfizer and GlaxoSmithKline in November 2009 with both companies transferring their HIV assets to the new company. At ViiV Healthcare our scientists are 100% dedicated to finding new ways to limit the impact of HIV on the 35 million people living with the virus.
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