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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.

 

KEY ACCOUNTABILITIES AND RESPONSIBILITIES:

• 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

shelf-life;

• 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

discussions;

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

actions;

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

preparations of responses to RfI;

 

SKILLS & COMPETENCIES:

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

regulations;

• 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

timelines;

 

EDUCATION, EXPERIENCE AND QUALIFICATIONS:

•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;