Scientist I, Upstream Process Development

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:

Scientist I is responsible for developing, characterizing and supporting technology transfer of robust drug substance manufacturing processes for biologics. The ideal candidate will have in-depth of knowledge of principles and theories of cell line development, medium and feed development, cell culture processes, or bioseparations including chromatography, filtration, and precipitation. The candidate is expected to a lead team, perform detailed scientific research, execute experiments, analyze experimental data, and provide recommendations to improve efficiency of drug substance manufacturing. The Scientist I will lead and support development studies for biologics lifecycle management and yield improvement with use of process intensification.

You will be responsible for:

• Lead external projects to evaluate and implement new platform or technology to improve the efficiency for current work flow
• Lead small-scale model qualification and process characterization studies
• Develop and optimize robust and scalable drug substance manufacturing processes (upstream and downstream) for GMP manufacturing of biologics for clinical and commercial supply
• Lead process scale up evaluation and support process tech transfer
• Manage a group of associate scientists to support professional development
• Serve as subject matter expert for cell line/upstream/downstream processes across Alexion internal and external manufacturing network for clinical and commercial processes
• Author internal technical protocols and reports which may have strong interface with other technical functions, regulatory, and compliance

You will need to have:

• Strong ability lead cross functional teams
• A PhD in Biology/Chemistry/Chemical Engineering/Biological Sciences or related fields, MS with at least 8 years of experience, or BS with at least 10 years of experience in biotechnology/pharmaceutical industry
• Technical knowledge of cell line, upstream, or downstream process development for biologics
• The ability to troubleshoot small and large scale equipment used in upstream/purification processes in area of expertise, and to offer solutions is expected
• Scientific principles and concepts in the field of process development
• 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.
• Technical proficiency, scientific creativity, learning agility, and ability to collaborate with others

We would prefer for you to have:

• Experience using AKTA systems and unicorn software for purification development
• Strong verbal and written communication and interpersonal skills
• Working knowledge of regulatory guidelines related to cell line, upstream, or downstream development and process characterization including viral clearance and process validation
• Strong ability for people management
• Knowledge and use of statistical analysis, multivariate data analysis and DOE
• Experience in writing and reviewing process-related documents
• Experience in molecular biology, medium and feed development, aseptic techniques and bioreactor operation

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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 [email protected]. 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.