including biophysical characterization and formulation development of a wide range of protein drug modalities. A general understanding of protein chemistry and/or the ability to run biomedical assays in a laboratory is preferred. Experience with electronic record keeping and data software, like electronic lab notebooks, End Note, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.
), as well as MS Word, Power Point, Excel/Graph Pad, Visio, and Adobe Pro, would be an advantage. Responsibilities With some supervision, design and execute development studies for Alexion medicals' clinical drug candidates and commercial products,
characterizing protein drug conformational and colloidal stability using industry standard methodology (e. g. circular dichroism, differential scanning fluorimetry, analytical ultracentrifugation, size-exclusion chromatography, etc.
) Previous experience using in-silico modeling software (e. g. MOE) is desirable. Can prioritize multiple assigned tasks and projects. The ability to work independently as well as part of the team is essential. Perform data analysis as well as author technical reports and or relevant sections of clinical and commercial regulatory filings on the executed studies for the Alexion drug product candidates Become current with the literature about drug product manufacturing
processes, manufacturing equipment and single use systems as well as associated global regulatory expectations Actively participate in department and team meetings including assuming ownership and delivering on assign action items.
Develop presentations for meetings with internal and external stakeholders with some supervision. Requirements BS in Chemistry, Biochemistry, Chemical Engineering, medical Sciences or relevant Engineering/Life Sciences field with 2+ years of experience or MS degree with 1+ years is required Scientific and practical knowledge of protein biochemistry and/or drug product process development is preferred. Previous experience in biotherapeutics development as well as a general knowledge of c GMP and Quality expectations is preferred.
Understanding of the biotherapeutics drug formulation development and analytical tools used to test formulations is a plus. Ability to take initiative in problem solving and finding solutions to scientific challenges is preferred. The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential. Excellent interpersonal skills are required, as is the strong ability to communicate effectively. The duties of this role are generally conducted in a lab environment.
As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging Date Posted 21-Jul-2023 Closing Date 29-Dec-2023Alexion 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, interaction, interactionual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact xyz X@. Alexion participates in E-Verify.
in-depth of knowledge of filtration, column/membrane chromatography, tangential flow filtration, other protein purification methods, and scale-up. Experience with process characterization using DOE and associated data analysis is also desired. The candidates will perform detailed scientific research, execute experiments, analyze experimental data, and provide recommendations to improve efficiency of process workflows, and enhance robustness while ensuring regulatory compliance.
The Scientist I will work closely with other functions within the drug substance process development group and will also work routinely with other groups within Process Development and Clinical Supply (PDCS), Research,
Global Operations, Quality (QA), Regulatory (RA) and external vendors. They will have the opportunities to innovate, collaborate and present scientific progress, both internally and externally.
The successful candidate must also have mature team-working behaviors and organizational awareness and insight. You will be responsible for: Leading biologics downstream process development to design and conduct studies to deliver high process yield, robust, and scalable processes for support GMP manufacturing of biotherapeutics. Serving as a technical expert in protein purification, process characterization, and process scale-up with cross-functional teams and during technical transfer activities
Advancing downstream platform process with innovations, and championing creative process improvement initiatives backssing and proof-of-concept demonstration of new technologies and ideas and their implementations to support technology advancement to improve process efficiency, reduce the COGs, and process yield while maintaining high product quality.
Leading technical projects and routinely managing the work of others to facilitate technical milestone deliverables. Authoring technical protocols, reports and peer-reviewed external journal articles; presenting scientific findings at scientific conferences You will need to have: A Ph D in Biochemistry/Chemistry/Chemical Engineering or related fields, MS with at least 8 years of experience, or BS with at least 10 years of experience in biotechnology/medical industry Experience and scientific understanding of the principles of the purification of proteins or viral vectors from mammalian and/or microbial cell lines.
Great ability to plan, design, execute, analysis and document all stages of downstream process development Must have demonstrated technical proficiency, scientific creativity, strong leadership, advanced problem-solving skills, and strong capability to collaborate and innovate with others Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors Good oral and written communication skills are essential with experience in writing and reviewing technical reports The duties of this role are generally conducted in a lab environment.
As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have: Technical proficiency with laboratory automation and high throughput technologies: such as AKTA Avant, AKTA Crossflow, TECAN, etc. Knowledge and the use of statistical analysis, multivariate data analysis and DOE Demonstration of expertise in column chromatography for protein purification and filtration technologies Critical thinking and strong troubleshooting and investigation skills; Good record of scientific achievement (presentations, publications, patents, etc.
) Strong interpersonal, verbal, and written communication skills Strong dedication and passion for process sciences #LI-JR1#LI-HYBRID Date Posted 21-Jul-2023 Closing Date 29-Dec-2023Alexion 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, interaction, interactionual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Alexion provides reasonable accommodations to meet the needs of candidates and employees.
To begin an interactive dialogue with Alexion regarding an accommodation, please contact xyz X@. Alexion participates in E-Verify.
