Full-Time
Development Scientist 2
Analytical Development and Clinical QC, Analytical Development and Quality Control
Posted on 5/12/2026
Alexion
5,001-10,000 employees
Global biopharmaceuticals focusing on rare diseases
No salary listed
New Haven, CT, USA
In Person
On-site in New Haven, CT; travel up to 10%.
 Biology & Biotech (1) |
|---|
- strong mental acuity with high attention to detail and ability to maintain accuracy in documentation and processes
- Excellent analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis
- A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance, and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations
- Strong proficiency in quality management systems and effective communication skills for interacting with cross-functional teams
- Strong proficiency with MS Word, Excel, PowerPoint
- Ability to bend, reach and stand, with lifting to 15 pounds and carrying over short distances
- Ability to travel up to 10%, if needed
- Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands on biological analytical development experience in pharmaceutical industry
- Responsible for generating and/or mirroring, reviewing, providing assessments, and driving ownership of LIRs to close out Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results with structured root cause analysis, impact assessment, and/or corrective/preventive actions (CAPAs)
- Design investigational testing plans ensuring compliant closure of all testing related investigations within the quality system
- Lead and/or facilitate cross-functional meetings with quality assurance to ensure structured investigation alignment
- Create plans, track, and present timelines to meet established targets, goals, and objectives
- Perform review of analytical data to ensure expected assay performance
- Identify opportunities for improvement in systems and make recommendations for effective changes to ensure compliance with cGMP
- Strong presentation skills
- Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
- Knowledge of pharmaceutical/biotechnology manufacturing process
- Database management / statistical analysis (e.g., JMP, Tableau, SAS) with proficiency in Microsoft SharePoint and/or BOX
Alexion focuses on discovering, developing, and selling therapies for rare and ultra-rare diseases by targeting the complement system. Its drugs, such as Soliris and Ultomiris, inhibit C5 to block inflammatory cascades, while Strensiq and Kanuma treat metabolic and lysosomal disorders. The company combines in-house R&D with acquisitions to expand its portfolio and leverages AstraZeneca’s global scale to reach patients. Its goal is to improve outcomes for patients with rare diseases and bring these therapies to international markets at premium pricing.
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Boston, Massachusetts
Founded
1992
Simplify's Take
What believers are saying
- ALXN2220 Phase 3 success in ATTR-CM addresses $500M+ peak sales opportunity with no approved amyloid-depleting competitor.
- VOYDEYA and Ultomiris label expansions capture previously untreated patient subsets, extending core franchise revenue streams.
- LogicBio acquisition expands genomic medicine pipeline, diversifying beyond complement-mediated disorders into gene therapy markets.
What critics are saying
- Soliris/Ultomiris biosimilar entry 2026–2027 erodes $6B+ annual revenue; patent cliff creates 40–60% revenue cliff post-2028.
- ALXN2220 Phase 3 failure eliminates $500M+ opportunity; cardiac safety signals halt program in 18–30 months.
- Complement inhibitor commoditization: five rival C3/C5/Factor D inhibitors compress pricing 15–25% by 2027, fragmenting PNH franchise.
What makes Alexion unique
- Pioneering complement cascade expertise translates into first-mover advantage across PNH, aHUS, NMOSD rare indications.
- Integrated AstraZeneca scale enables global commercialization and manufacturing capabilities unmatched by pure-play biotech competitors.
- Patient-centric clinical trial design with real-world evidence frameworks addresses rare disease regulatory complexity systematically.
Help us improve and share your feedback! Did you find this helpful?
Your Connections
People at Alexion who can refer or advise you
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Health Savings Account/Flexible Spending Account
Unlimited Paid Time Off
Flexible Work Hours
Remote Work Options
Paid Vacation
Paid Sick Leave
Paid Holidays
Hybrid Work Options
Stock Options
Company Equity
401(k) Retirement Plan
Mental Health Support
Wellness Program
Gym Membership
Phone/Internet Stipend
Home Office Stipend
Professional Development Budget
Conference Attendance Budget
Training Programs
Tuition Reimbursement
Professional Certification Support
Mentorship Program
Parental Leave
Family Planning Benefits
Fertility Treatment Support
Adoption Assistance
Childcare Support
Elder Care Support
Relocation Assistance
Employee Referral Bonus
Meal Benefits
Commuter Benefits
Legal Services
Employee Discounts
Company Social Events
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↓ -1%"Week in RARE provides advocates a unique opportunity to participate in multiple events in one place to maximize their time, travel, and potential to gain benefits from their participation."
Schlieren-based startup, Neurimmune, which develops drug candidates for central nervous system (CNS) and related protein aggregation diseases, has, in collaboration with its partner Alexion, advanced its drug candidate ALXN2220 into phase 3. This marks a significant step in the company’s journey to addressing the serious clinical condition ATTR-CM. Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, systemic clinical condition that leads to progressive heart failure and high rate of fatality within four years from diagnosis. Despite recent advances in slowing disease progression, there is currently no treatment available to deplete cardiac ATTR amyloid and revert cardiac dysfunction. Schlieren-based startup, Neurimmune, which develops drug candidates for central nervous system (CNS) and related protein aggregation diseases including Alzheimer’s disease, amyotrophic lateral sclerosis, frontotemporal dementia and ATTR cardiomyopathy, is currently testing a drug candidate, ALXN2220 (formerly NI006), a human antibody targeting ATTR Cardiomyopathy. In 2022, Neurimmune entered into an exclusive global collaboration and license agreement with Alexion, AstraZeneca’s Rare Disease group, for ALXN2220. Neurimmune is responsible for completion of the phase 1b clinical study on behalf of Alexion, with Alexion incurring certain trial costs. Aside from the phase 1b trial, Alexion is responsible for further clinical development, manufacturing, and commercialization as ALXN2220. The two companies have now initiated the phase 3 of the DepleTTR-CM clinical study to assess the efficacy and safety of ALXN2220 for the treatment of ATTR-CM
WILMINGTON, Del.--(BUSINESS WIRE)--VOYDEYA™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).1 VOYDEYA is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care ULTOMIRIS® (ravulizumab-cwvz) or SOLIRIS® (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor.2,3. The approval by the US Food and Drug Administration (FDA) was based on positive results from the pivotal ALPHA Phase III trial. Results from the 12-week primary evaluation period of the trial were published in The Lancet Haematology.2. Bart Scott, MD, Professor, Division of Hematology and Oncology at the University of Washington Medical Center, and Professor, Clinical Research Division at Fred Hutchinson Cancer Center, said: “The approval of VOYDEYA offers this small subset of PNH patients an add-on therapy designed to address EVH, while maintaining disease control with ULTOMIRIS or SOLIRIS. Terminal complement inhibition with ULTOMIRIS can address the life-threatening complications of PNH, building on the efficacy and safety of SOLIRIS established over nearly 20 years.”
WILMINGTON, Del.--(BUSINESS WIRE)--ULTOMIRIS® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).1. The approval by the US Food and Drug Administration (FDA) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were published in the Annals of Neurology.2 In the trial, ULTOMIRIS was compared to an external placebo arm from the pivotal SOLIRIS® PREVENT clinical trial. ULTOMIRIS met the primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee. Zero relapses were observed among ULTOMIRIS patients with a median treatment duration of 73 weeks (relapse risk reduction: 98.6%, hazard ratio (95% CI): 0.014 (0.000, 0.103), p0.0001).2
Sebelipase alfa (Kanuma®▼) recommended by NICE as the first treatment for infants with ultra-rare Wolman Disease. . Kanuma, an enzyme replacement therapy, is the first medicine to be recommended for this life-threatening condition in infants under two years old