Lead process development activities for therapeutic antibodies
Manage team of scientists in development and small-scale manufacturing
Develop innovative manufacturing solutions for new and existing biological products
Maintain good LCM of the current approved products
Perform process characterizations studies (e.g. viral and impurity clearance studies, chromatography resin reuse, process limit evaluations)
Support the scale up and transfer of manufacturing processes from CMC to GMP production
Provide specialized technical CMC input to project teams and support the Operations group on with significant manufacturing investigations and CAPAs
Compile and/or assist Regulatory in compilation of CMC sections of all regulatory filings
Provide expert advice with agency interactions, as required
Support setting of CMC budgets and ensure adherence to this budget throughout the financial year
Provide due diligence support for in
and out-licensing products as required
Ensure projects are delivered on time, in-line with all relevant guidelines, to budget, and in line with business needs
Complete additional tasks considered necessary to meet business and customer requirements as indicated by the Line Manager
To adhere to SERB’s policies on health, safety and workplace policies
Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with SERB values.

Bachelor’s Degree with a sound technical background or relevant equivalent experience
5 Years+ experience in pharmaceutical biologics development and manufacturing, with experience in antibody manufacture desirable
Experience of managing vendors desirable
Excellent understanding and hands–on working knowledge of chromatography, cGMP, quality and regulatory requirements for clinical and commercial manufacturing
Demonstrated ability to successfully manage outsourced manufacturing and analytical contractors.

CMC Process Development Manager

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