Job description
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
In this role the candidate will research, design, and execute scientific studies to enable the drug product (DP) process development, characterization, and clinical manufacturing of parenteral/injectable biologic products. The candidate will support various aspects of DP development including formulation development, analytical/biophysical characterization, and process development. A general understanding of protein chemistry and/or the ability to run analytical assays in a laboratory is preferred.
Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as MS Word, PowerPoint, Excel/GraphPad, Visio, and Adobe Pro, would be an advantage.
You will be responsible for:
- With some supervision, design and execute development studies for Alexion pharmaceuticals’ clinical drug candidates and commercial products, characterizing protein drug stability and comparability using industry standard methodology (e.g. SE-UPLC, icIEF)
- Previous experience with statistical analysis (e.g., JMP) 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.
You will need to have:
- BS in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or relevant Engineering/Life Sciences field with 0-2 years of experience
- 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 cGMP 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
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Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion 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, 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 has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.
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