Scientist II

Job Description

Working as part of the External Technical Services, the ideal candidate will be responsible for the technical aspects of Drug Product (Fill Finish)

manufacturing at Contract Manufacturing Organisation (CMO) sites.

·Act as subject

matter expert in for Drug product processes, including technology transfer,

process evaluation, problem solving and investigation.

·Work through

collaborate within the organization to drive for results

·Provide SME

input for IND, BLA and other technical documents for regulatory agency

submission in support of manufacturing process operated at CMOs.

·Provide

expertise in trouble shooting activities to support manufacturing either on

site or virtually

·Identify and

lead process optimization initiatives and address opportunities for efficiency

and capacity improvements in all areas of manufacturing

·international

travel may be required

Requirements

Qualifications

·Minimum of 5 years’ experience in providing technical support to Drug Product manufacturing (facility

design, technology transfer or routine cGMP manufacturing)

·Comprehensive

knowledge of formulation and aseptic fill finish unit operations and freezing

drying

·Good

understanding of cGMP requirements for commercial Drug Product manufacturing

·Experience of

technology transfers and scale-up

·Proven ability

to work independently and to build highly effective relationships both within

and external to the company

·Organised

analytical thinker with strong attention to detail

·Excellent oral

and written communication skills, including technical writing

·Experience of

working with CMOs would be a distinct advantage

Education

·Minimum

Bachelors’ degree in Engineering (Chemical, Biochemical) or related field.

Advanced degree would be an advantage.