Some opportunities happen only once in a lifetime – like a job where you have the chanceto 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:
QC Senior Specialist-Stability is responsible for developing and maintaining the Stability Programme for all commercial products (internally and externally managed) and ensures that all activities are fully in compliance with cGMP standards, regulatory commitments and Alexion Standards and Protocols. The QC Senior Specialist-Stability is responsible for performing key quality tasks.
You will be responsible for:
Primary duties of the position are focused around non-laboratory support of the QC stability function.
Primary activities include but are not limited to:
- Management of stability programs for all products or designated products, as applicable.
- Enrolling biologics lots into stability studies in LIMS at Alexion, according to stability protocols.
- Includes registrational stability studies (Process Validation Runs, site-specific stability studies, temperature excursion stability studies, annual enrollment lots and for-cause lots).
- Enrolling lots into stability studies at contract management organizations according to stability protocols.
- Issuance of stability samples requests in accordance with Alexion procedures and communicating with planning, QA, Technical services and relevant internal and external stakeholders to ensure that sample requests are issued in a timely manner.
- Writing and approving stability protocols.
- Ensuring that stability pulls are conducted on time and that metrics for pull adherence are reported via Stability Review Board.
- Writing and approval of stability study reports (e.g. study completion reports).
- Stability data analysis, data trending/statistical analysis and presentation of same via Stability Review Board and other relevant forums.
- Input into the stability sections of regulatory filings, responses and submissions.
- Input to and authoring of the stability section of annual product quality reports.
- Lead and manage investigation activities related to the stability program and implementation of appropriate CAPAs.
- Change management activities in accordance with Alexion procedures.
- Act as stability SME for Health Authority Inspections.
- Identify and implement continuous improvement programs as appropriate.
- Mentoring and training of Stability Specialists, Stability Analysts and QC staff as required.
You will need to have:
- Degree in chemistry or biological science with a preference for Analytical Chemistry or Biochemistry with a minimum of 7 years’ experience in a related role within the Pharmaceutical/Biotechnology Industry.
- Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.
- Experience in the use of Electronic Document Management and Quality Management Systems (e.g. Trackwise) is required.
- The duties of this role are generally conducted in an office environment with some infrequent lab-based activity. As is typical of a primarily 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; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. 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.
We would prefer for you to have:
- Previous hands-on experience managing stability programmes in a GMP environment is strongly preferred.
- Ability to work well both independently and in a team environment.
- Excellent communication, interpersonal and organisational skills.
- Ability to prioritize work and multitask with significant autonomy.
- Conducts work in compliance with cGMPs, ICH guidelines and safety and regulatory requirements.
- Project management and project team leadership.
- Takes a structured, analytical approach to problem solving.
Alexionis 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. Furtherinformation about Alexion can be .
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 lackthereof, sex, sexualorientation, 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 aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.