Alexion Pharmaceuticals,Inc.
Director, Protein Characterization
Alexion Pharmaceuticals,Inc., New Haven, Connecticut, us, 06540
Location:
New Haven, United States
Job reference:
R-208423
Date posted:
09/05/2024
This is what you will do:
The Protein Characterization group, part of the Analytical Development & Quality Control team, leads Alexion’s efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics. 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. It supports CMC by providing characterization summaries and comparability assessment/evaluation reports, leading support efforts for Research, Cell Culture, Purification, Quality Control/Quality Assurance, and Manufacturing with techniques available in protein characterization.
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 assessments and evaluations in a phase-appropriate manner to support process changes.
Design and execute product force degradation studies to support comparability and fulfill regulatory requirements.
Perform CQA assessments to ensure the desired product quality and support the analytical control strategy.
Lead product and impurity characterization for Alexion’s drug substance and drug product.
Provide characterization support to Research groups within Alexion.
Provide reference standard characterization analysis for commercial or early-stage products.
Maintain compliance with current SOPs, instrument qualifications, and training.
Represent the area functions during audits by agencies and internal/external auditors.
Establish systems to ensure compliance and good lab practices.
You will need to have:
Strong protein characterization skills with demonstrated expertise in a wide range of protein analysis.
Experience in complying with CMC requirements in product characterization.
In-depth understanding of protein degradation pathways.
In-depth understanding of product comparability assessment and evaluation.
Excellent written and verbal communication skills and ability to work effectively in cross-functional teams.
Proficient cross-company communication, cultural sensitivity, and partnership in interactions.
Extensive experience in drafting and reviewing relevant CMC sections for regulatory filings.
Experience in corresponding with regulatory authorities.
Ability to represent Alexion Pharmaceutical’s interests responsibly.
Explore and assess new analytical tools to enhance the internal toolbox for protein characterization.
Identify and lead technical development initiatives to expand the Group’s capabilities.
Act as a champion for the ADQC team in project meetings and participate in data presentations.
Demonstrated leadership and managerial skills with a minimum of 8 years’ management experience in a relevant function.
A PhD in biochemistry or related disciplines with a minimum of 15 years’ work experience in the pharmaceutical/biotechnology industry.
We would prefer for you to have:
Compliance experience in characterization laboratories and analytical areas.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment, as well as work authorization and employment eligibility verification requirements.
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New Haven, United States
Job reference:
R-208423
Date posted:
09/05/2024
This is what you will do:
The Protein Characterization group, part of the Analytical Development & Quality Control team, leads Alexion’s efforts to support new molecule manufacturability assessments and characterization of its biotherapeutics. 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. It supports CMC by providing characterization summaries and comparability assessment/evaluation reports, leading support efforts for Research, Cell Culture, Purification, Quality Control/Quality Assurance, and Manufacturing with techniques available in protein characterization.
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 assessments and evaluations in a phase-appropriate manner to support process changes.
Design and execute product force degradation studies to support comparability and fulfill regulatory requirements.
Perform CQA assessments to ensure the desired product quality and support the analytical control strategy.
Lead product and impurity characterization for Alexion’s drug substance and drug product.
Provide characterization support to Research groups within Alexion.
Provide reference standard characterization analysis for commercial or early-stage products.
Maintain compliance with current SOPs, instrument qualifications, and training.
Represent the area functions during audits by agencies and internal/external auditors.
Establish systems to ensure compliance and good lab practices.
You will need to have:
Strong protein characterization skills with demonstrated expertise in a wide range of protein analysis.
Experience in complying with CMC requirements in product characterization.
In-depth understanding of protein degradation pathways.
In-depth understanding of product comparability assessment and evaluation.
Excellent written and verbal communication skills and ability to work effectively in cross-functional teams.
Proficient cross-company communication, cultural sensitivity, and partnership in interactions.
Extensive experience in drafting and reviewing relevant CMC sections for regulatory filings.
Experience in corresponding with regulatory authorities.
Ability to represent Alexion Pharmaceutical’s interests responsibly.
Explore and assess new analytical tools to enhance the internal toolbox for protein characterization.
Identify and lead technical development initiatives to expand the Group’s capabilities.
Act as a champion for the ADQC team in project meetings and participate in data presentations.
Demonstrated leadership and managerial skills with a minimum of 8 years’ management experience in a relevant function.
A PhD in biochemistry or related disciplines with a minimum of 15 years’ work experience in the pharmaceutical/biotechnology industry.
We would prefer for you to have:
Compliance experience in characterization laboratories and analytical areas.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment, as well as work authorization and employment eligibility verification requirements.
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