Alexion Pharmaceuticals Associate Scientist II, Analytical Development and Clinical QC in New Haven, Connecticut
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 Development Associate II is responsible for performing assigned experimental tasks to support the development and optimization of manufacturing processes or analytical/characterization methods as well as GMP stability and release testing for Alexion| AstraZeneca Rare Disease biotherapeutic candidates. The Development Associate II will work in collaboration with other members of Process Development and Analytical Sciences.
You will be responsible for:
Working in a fast-paced environment where product development supports unmet needs of patients with rare diseases.
Responsible for cGxP operations in support of early stage - PIII biologics manufacturing.
Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records.
Perform analytical methods with a focus on plate based assays; residual impurity (i.e., residual Protein A, residual HCP, resDNA), potency/activity binding assays and compendial testing for in-process, drug substance and drug product release and stability samples.
Aid in experimental studies, developing, optimizing, qualifying, or supporting manufacturing processes or analytical/characterization methods for biotherapeutic candidates
Write and review methods, SOPs, qualification and validation protocols and reports, and technical reports as assigned.
Compile data and information related to assay and instrument performance.
Recognize aberrant test and sample conditions and report to them to the area supervisor / manager.
Maintain knowledge of current scientific principles and theories and train other lab personnel as assigned in areas of competence.
Order, stock, and receive, label, log, and inventory laboratory supplies.
Assist with GMP shipping and handling responsibilities for incoming shipments, receipt and inventory as needed.
Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions.
Ensure training is current for all job functions performed. Attend all required Company training.
May be qualified and assigned to review laboratory data or documentation upon qualification.
Perform other related duties as assigned
Global role requiring domestic and international travel (5-10%)
You will need to have:
A successful candidate will typically hold a BS degree in Immunology, Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university with 2-5 years of relevant experience or equivalent combination of education and experience.
A successful candidate will typically have +2 years of experience working in a relevant laboratory setting
Knowledge of GMPs and their application in the environment is preferred.
Have a strong working knowledge of the Biological Chemistry laboratory
Understand and follow written procedures when conducting experiments and applying methods
Document procedures and data in peer-reviewed laboratory notebooks and/or LIMS
Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
The ability to communicate verbally and in a written format is required.
The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected
Communicate findings to colleagues within the group through presentations
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: 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:
Previous experience with Laboratory Information Systems (LIMS).
Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint as well as SAS JMP statistical software.
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 (https://careers.astrazeneca.com/) .