Job opportunities

All vacancies

Principle Scientist CMC Analytical Development

Job description

Principle Scientist CMC occupies a key role supporting Chemistry, Manufacturing and Controls

(CMC) development for therapeutic antibodies, ensuring that projects are successfully transferred

to commercial phase. He/she excels in stakeholder management, drives internal and external

efforts towards lifecycle management of the commercial product QC related activities.



• Responsible to sets up of integrated CMC operational analytical plans with external service

providers (DS and DP manufactures and QC testing labs) and internal stakeholders; oversee the

execution of agreed commercial supply plan for outsourced QC testing;

• Close follow up of deviations, change controls, OOS investigations related to QC activities at

external vendors, in close collaboration with the DS and DP manufacturing and QA team;

investigate OOE/OOT release results including root cause investigations and impact

assessments on the process performance capabilities; initiates change controls

• Close follow up and distribution of critical reagents and reference standard inventories; initiate

replenishment in due time and in accordance to the regulatory submissions. Follow up of the

reference standard trending and stability programs;

• Establish and maintain a complete data repository of product quality via control charts of the

analytical critical quality attributes, as part of process performance evaluation

• Set up the annual stability plan, and follow up on stability data trending within the approved


• Follow up on the analytical method life cycle, transfer strategies, protocols and reports; and

analytical method performance trending across the multiple QC testing sites

• As a member of the CMC development team actively contribute to technical and strategic CMC


• Identify and track project critical path items ‐ identify risks, formulate and monitor corrective


• Prepare and review variations of global submissions for commercial products, support

preparations of responses to RfI;



• Thorough knowledge and experience with GMP and in depth knowledge of ICH and GMP


• Works independently within the scope of his/her assigned field and supports others;

• Keep abreast with relevant scientific and/or technical developments. Searches literature and

other sources independently and applies knowledge;

• Excellent organizational and coordination skills;

• Ability to go into detail whilst keeping the view on the overall project goal;

• Strong technical expertise combined with good project management skills and ability to

communicate effectively with internal and external stakeholders;

• Flexible attitude, capable of picking up the tasks that require attention;

• Quality conscious attitude;

• Experience and knowledge in the preparation of regulatory submissions and variations for

commercial programs;

• Able to operate in a dynamic surrounding of a fast growing biotech company with challenging




•PhD in chemistry, pharmaceutical sciences, bio‐engineering, or other discipline within

pharmaceutical/biotechnology sciences;

•Strong technical expertise in the field of biological drug substance and drug product

manufacturing, process and product characterization, analytical method; development and

validation; process validation and good understanding of statistics;

•Fluent in English, written and spoken;


Executive search


Minimum 2 years


Higher Education




Pharmaceutical industry



Job Type


Submit your CV

Please submit your CV through the form below and we will contact you shortly.

How can we help

Drop by for