Senior Director, Protein Characterization

This is what you will do:  

This Senior Director of Product Characterization, which is part of the Analytical Development & Quality Control group which is one fuctional group of Product Development and Clinical Supply team, leads Alexion’s efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics by physical and chemical means. This position will manage and oversee extensive product and impurity characterization and degradation pathway analysis for Alexion’s non-clinical, clinical and commercial stage products.  This position supports CMC by providing characterization summaries and comparability assessment/evaluation reports. This position leads the support efforts for Alexion’s Research, Cell Culture, Purification, Quality Control/Quality Assurance and Manufacturing with techniques available in protein characterizations, comparability, force degratiodation and CQA determination core facility.  

 

You will be responsible for:  

• Lead physicochemical characterization efforts for all stages of products  

• Establish phase-appropriate product degradation pathways for Alexion’s drug candidates 

• Design and execute product comparability assessment and comparability evaluation in a phase appropriate manner to support process changes  

• Design and execute product force degradation in a phase appropriate manner to support comparability and fullfill regulatory requirement.  

• Perform CQA assessment to ensure the desired product quality and support analytical control strategy  

• Lead product and impurity characterization for Alexion’s drug substance and drug product. Alexion’s product characterization laboratories are equipped with state-of-art instruments.  

• Provide characterization support to Research groups within Alexion 

• Provide reference standard characterization analysis for commercial or early stage products 

• Maintain appropriate compliance within area of responsibility with regards to current SOPs, instrument qualifications and training.  

• Represent the area functions as required during audits by agencies and internal/external auditors 

• Establish systems within area of responsibility to ensure compliance, good lab practices and work 

You will need to have: 

• Strong protein characterization skills are required demonstrated expertise in a wide range of protein analysis is required 

• Experience and expertise in complying with CMC requirements in product characterization is required 

• In depth understanding of protein degradation pathways is a must 

• In depth understanding of product comparability assessment and evaluation is required 

• Excellent written and verbal communication skills and demonstrated ability to work effectively in cross functional teams are required.  

• Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  

• Extensive experience in drafting and reviewing relevant CMC sections for regulatory filing is required. 

• Experience in corresponding with regulatory authorities is required 

• Ability to represent Alexion Pharmaceutical’s interests, objectives and policies in a responsible manner is required 

• Explore and assess new analytical tools and enhance the internal toolbox for protein characterization.  

• Identify and Lead Technical development initiatives to expand the Group’s capabilities 

• Act as a champion and represent the ADQC team in project team meetings and participate in data presentations and cross-functional collaborations with the opportunity to serve as mentor of project leads 

• Demonstrated leadership and managerial skills are a must. A minimum of 8 years’ management experience in a relevant function is required.   

• A PhD in biochemistry or related disciplines with a minimum of 15 years’ work experience in the pharmaceutical/biotechnology industry is required 

We would prefer for you to have: 

• Compliance experience in characterization laboratories and analytical area is preferred 

Date Posted

18-Jun-2024

Closing Date

30-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status