Are you ready to lead a team that makes a difference in the lives of patients? As a Senior Manager in Analytical Development and Quality Control at Alexion, you will manage a team responsible for conducting and managing stability studies for our clinical products pipeline! You will set shelf-life and filing strategies for INDs and BLAs, align data availability with the CMC team, and coordinate timelines for regulatory filings. Collaborate with internal functions such as Product Development, Clinical Supply, Quality Assurance, Quality Control, Global Tech Operations, and Regulatory Operations. Implement stability processes, strategies, and systems while establishing partnerships with external organizations for stability sample storage and testing. Manage stability data compilation, data management with advanced tools, trending/interpretation, expiry/shelf-life, and provide audited data for regulatory filings.
Accountabilities
- Manage a group of stability analysts and operational staff in setup, execution, and reporting of clinical and commercial stability studies within Alexion’s internal analytical network
- Interact with key team members across Analytical Development and Clinical QC, External Quality Control, Quality Assurance, Regulatory Affairs, and external counterparts in Alexion’s provider network to assure that Alexion’s clinical and commercial stability programs support the development and commercialization of safe, effective drugs
- Manage stability standards, procedures and workflows pertaining to set up and execution of cGMP-compliant stability studies for drug substances, drug products and placebos for all the modalities including synthetic, biologics and AAV products
- Hire, mentor, and develop staff and lead all aspects of Stability job roles for training
- Participate in cross-functional process development teams representing clinical stability for input into sample plans and assess CC for introduction of new molecules
- Act as subject matter expert on issues and items related to scientific, regulatory and compliance aspects of stability
- Manage CMOs and external storage vendor(s) to obtain approved stability protocols and applicable quotes
- Manage stability protocol approvals, data compilation, verification, trending, reporting and investigation of atypical/OOS/OOT results for stability studies performed at internal and external analytical providers
- Manage and analyze all the stability data with advanced and/or automated tools/software
- Manage Change Controls, Deviations, CAPAs and serve as stability SME to provide assessments as required
- Provide Stability assessments for LIRs in support of testing/laboratory investigations, shipping or storage deviations and facilitate cross-functional meetings as required
- Manage data audit and verification for release and stability testing performed by CMOs and internal test labs
- Coordinate CoAs and CoTs generation
- Perform all job functions in compliance with cGMPs and maintain accurate and legible records
Essential Skills/Experience
- PhD with 5 years, MS with 7 years, or BS with 10 years of experience in biologics development, characterization, analytical development, quality control or quality assurance
- 3 years team managing experience
- Thorough understanding of global GMPs pertaining to drug development, especially biologics
- Expert understanding of application of current guidance on statistical evaluation of data. Strong working knowledge of statistical packages used for trending and forecasting of stability data (SAS JMP, MiniTab, SLIMS)
- Prior experience managing stability programs for clinical phase products
- Prior experience in managing or coordinating outsourced analytical and/or stability programs
- Ability to interact with Quality Control groups, Quality Assurance and PDCS members
- Able to navigate external vendor sites and portals for data extraction and review
- Able to communicate findings to colleagues within the group through presentations
- Laboratory Information Systems (LIMS) is necessary
- Thorough understanding of global GMPs pertaining to drug development, especially biologics
- Understanding of application of current guidance on statistical evaluation of data
Desirable Skills/Experience
- Small molecule drug development or commercial product analytical testing or stability
- Advanced/automated tools for data management and analysis
- The ability to independently contribute and coordinate the generation of procedures, protocol and reports pertaining to test methods
- Knowledge of current regulatory guidelines and cGMP requirements
- Engage in problem solving and non-linear thought, analysis, and dialogue
- High emotional intelligence, excellent interpersonal skills, and effective communication skills
- The individual is expected have deep understand of stability assays and the data generated from the laboratory
When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At Alexion, AstraZeneca Rare Disease, we are driven by our mission to serve patients. Our work is led by their lived experiences which guide our actions. We know our patients by name; we meet their families. Our commitment is unwavering as we tackle the toughest challenges for them. Join us to grow in a rapidly expanding portfolio within a supportive culture that values innovation, connection, and patient-centricity.
Ready to make an impact? Apply now!
Date Posted
06-Mar-2025
Closing Date
10-Jun-2025Alexion 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 provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.