Associate Scientist Ii, Analytical Development And Quality Control

31824
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
The Associate Scientist II position is a technical position conducting critical analytical testing to support the development of Alexion’s biotherapeutic candidates. Under supervision, this position is also involved in development and optimization of release and stability methods including process residuals, excipient analysis and physiochemical chromatography (size exclusion, ion-exchange, reversed phase, hydrophobic interaction, etc.) for clinical and commercial biotherapeutics. Participation in method validation and transfer or troubleshooting of methods to internal and external laboratories may also be required. In addition, this position is expected to interact with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups.
You Will Be Responsible For

• Develop and optimize custom (U)HPLC chromatographic methods to evaluate key quality attributes for therapeutic proteins (SEC, RP-HPLC, Ion-Exchange, HIC, etc.) under the supervision of LC team lead.
• Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams
• Perform other related duties as assigned.
• Participate in the operation, maintenance and troubleshooting of analytical instrumentation (e.g. UPLC, HPLC along with various detectors including RI, ELSD, FLR, UV).
• Follow and execute defined methods, SOPs. Under direct supervision, author SOPs, study plans, protocols, and method development reports.
• Ensure training is current for all job functions performed. Attend all required Company training.
• Work with various Research and Development teams to support transfer of analytical test methods for development and clinical support.
• Perform assigned analytical testing tasks in a timely manner to support the development and optimization of manufacturing processes, or analytical/characterization methods as well as stability and release testing for Alexion | AstraZeneca Rare Disease biotherapeutic candidates.

You Will Need To Have

• Ability to travel up to 10% to support on-site training and troubleshooting.
• B.S. or Master degree from an accredited university is required. Working experience in the pharmaceutical or biotech industry is preferred.
• 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 hoursPerform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records with a close attention to detail.
• Hands-on experience in (U)HPLC and general knowledge of protein chemistry. Eager to learn and ability to take initiative in problem solving and bring independent, scientific approach to method development.
• The individual in this position will be able to organize his/her own work on a routine basis with no supervision as well provide troubleshooting and investigative efforts.

We Would Prefer For You To Have

• The individual is expected to have several areas of expertise and is expected to collaborate within the laboratory.
• Engage in problem solving and non-linear thought, analysis and dialogue.
• A successful candidate will typically hold a BS. or M.S. degree in Chemistry, Biochemistry, or a biological science with 2+ years of relevant industry experience; or equivalent combination of education and experience.
• The individual is expected to recognize aberrant test and sample conditions and provide adequate guidance to team with an assessment of the circumstances and corrective action.
• Practical knowledge of method development and optimization for protein therapeutics is preferred.
• Knowledge of current regulatory guidelines and cGMP requirements.
• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods.
• High emotional intelligence, excellent interpersonal skills, and strong communication skills.

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.