Alexion Pharmaceuticals, Inc. · 2 hours ago
Associate Scientist IV, Clinical QC Analytical Development & Clinical QC
New Haven, CT
Full-time
Hybrid
Senior Level
7+ years expAlexion Pharmaceuticals, Inc. is focused on supporting patients with rare diseases. The Associate Scientist IV will be responsible for managing clinical stability and sample management for GMP activities while collaborating with various teams to ensure compliance and support product development.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Working in a demanding environment where product development supports unmet needs of patients with rare diseases
Responsible for cGxP operations in support of early stage - PIII biologics
Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records
GMP shipping and handling support for incoming shipments, receipt, inventory, sample management and gLIMS data entry
Clinical Stability laydown and sample aliquoting of drug substance and drug product material (bulk bag, vial, PFS, AI etc) for testing
Oversee and document all Laboratory Investigations (EQV) for Clinical QC
Manage the batch release and stability testing certificates (CoA/CoT)
Assist the compliance team with change controls, deviations, CAPA’s
Supervise and lead subordinates as needed
Ensure compliance to legal regulations and company policies
Represent Clinical QC-ADQC on cross departmental project teams and provide technical input as required
Perform testing for in-process, drug substance and drug product release and stability samples (i.e., Compendial: Protein Concentration, Appearance, pH, freeze-point/ vapor-pressure Osmolality, sub-visible particulate (LO) and device functionality testing as assigned.)
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
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
Review laboratory data and documentation as qualified and assigned by area management
Perform other related duties as assigned
Global role requiring domestic and international travel (up to ~5%)
Qualification
Required
A BS degree in Immunology, Biochemistry, Chemistry, Chemical Engineering, or related discipline from an accredited university
7+ years of relevant experience or equivalent combination of education and experience is required
In depth knowledge of GMPs and their application in the environment is needed
The individual in this position is expected to have an in depth understanding of the Biological Chemistry laboratory environment and be familiar with all laboratory equipment / instrumentation, procedures, and responsibilities
Understand and follow written procedures when conducting experiments and applying methods
Ability to 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 can 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
Preferred
Experience with Veeva Vault ECMS, ELN, gLIMS, Lean 6 Sigma
Experience with domestic and international shipping requirements
Company
Alexion Pharmaceuticals, Inc.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community.
1001-5000 employees
H1B Sponsorship
Alexion Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (49)
2024 (57)
2023 (51)
2022 (29)
2021 (27)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$5.8M2020-12-12Acquired
1999-02-12Post Ipo Equity· $5.8M
1996-02-29IPO
Leadership Team
Frederic Chereau
SVP, Strategy and Business Development
Imran Shakur
Director, IRT and Technology Lead
Recent News
bloomberglaw.com
2025-12-20
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