Global pharmaceutical concern is seeking candidates whose function is 'End-to-End) and applies to all biological drug projects, development and/or manufactured internally and externally. You will provide scientific technical leadership, ensuring the focus on scientific excellence in maintained within the DPD/CMC teams.
Developing and implementing the global DPD strategy and plan per product, in line with the overall strategy and plan as outlined by the CMC tea, enabling the CMC team to optimise the science within DPD. The successful candidate will ensure alignment and endorsement of this strategy within the DPD function.
Developing clear beneficial DPD objectives aligned with the DPD and CMC strategy, and effectively communicating the strategy and objectives within the DPD team as well as to other stakeholders.
Working with the senior functional leaders of Drug Product Development and the CMC Leader to ensure rapid identification and resolution of problems.
Delivering an improved focus on the scientific rigor within the CMC teams and within DPD, ensuring consistent scientific excellence and scientific quality standards are met.
Driving the Target Product Profile agreement & deliverables in partnership with the CMC leader, the Supply Chain, Marketing, and the Compound Development Team.
Delivering the clinical and commercial formulations and manufacturing processes, meeting the manufacturing performance, cost, and process robustness needs, in line with Quality by Design principles.
Ensuring complete, consistent, comprehensive, high quality submission clinical and marketing dossiers.
Optimising the DPD development methodology, where possible making use of standard technology platforms, accelerating development timelines, and streamlining the technical transfer process.
A Master's degree or PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy with 3 years of experience required.
Demonstrated competency and experience in biologic drug product development within the pharmaceutical industry.
Effective communication skills and demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites required.
Demonstrated experience in scale up of manufacturing processes and technical transfer of projects into commercial manufacturing in preferred.Drug Product Development experience is preferred.
Experience in vaccine, gene, and/or cell therapy product development preferred.
Please visit our website, www.Manpower.co.za to submit your CV directly or to view other jobs.
Please note that only shortlisted candidates will be contacted. If your profile is not shortlisted, we will place your CV on our database and contact you as soon as a suitable position does become available. You are welcome to contact us to discuss other job opportunities.
ManpowerGroup SA is the global leader in contingent and permanent recruitment workforce solutions. We provide the agility businesses need with a continuum of staffing solutions. By leveraging our trusted brands, we have built a deeper talent pool to provide our clients access to the people they need, faster. We effectively assess and develop skills, keeping our associates ahead of the curve, so they can get the jobs done each time, every time. ManpowerGroup SA was established in the South Africa in 1999, and today works with organisations in both the public and private sectors, ranging from small and medium-sized enterprises, to multi-national organisations. ManpowerGroup
SA has a network of 7 local branches and is a subsidiary of ManpowerGroup, with a worldwide network of nearly 4,000 offices in over 80 countries and territories. ManpowerGroup SA is Level 1 BBBEE certified.