Development Scientist II, Analytical Development and Clinical QC (ADQC) New Haven, Connecticut,[...]
Alexion Pharmaceuticals, Inc.
- # Development Scientist II, Analytical Development and Clinical QC (ADQC)New Haven, Connecticut, United States of AmericaApply NowFind out how well you match with this job**This is what you will do:**This Development Scientist II will be a key team member in Alexion’s External Analytical Development and Quality Control group. This position is responsible for maintaining the highest standard of quality and compliance of external quality control testing (GMP) laboratories. This candidate will be responsible for initiation and ownership of laboratory investigations (LIRs) through strong liaison with external contract laboratories and change controls relevant to ADQC biologic programs. The candidate will ensure timely, compliant, and high-quality delivery for LIR closure to enable the generation of final release CoAs. The role will work closely with internal Quality Assurance, Compliance, Analytical Development and Stability teams to ensure product to patients.**You will be responsible for:*** 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**You will need to have:*** A successful candidate will have 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.**We would prefer you to have:*** 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.**Date Posted**09-Aug-2026**Closing Date**03-Sep-2026
- J-18808-Ljbffr Alexion Pharmaceuticals, Inc.
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Development Scientist II, Analytical Development and Clinical QC (ADQC) New Haven, Connecticut,[...] in Brooklyn, NY vacancy
- Alexion Pharmaceuticals, Inc. is seeking a Development Scientist II for the External Analytical Development and QC group in New Haven, CT. You will own laboratory investigations (LIRs) with external labs and drive timely, compliant closure to generate final release CoAs...Suggested
- BioCT Innovation Commons seeks a Development Scientist II to join the External Analytical Development and Quality Control group. You will ensure GMP-compliant external QC testing and own laboratory investigations with external labs to enable timely release CoAs. You will...Suggested
$80.8k - $118.75k
Product Development Scientist II - Oral Products Job Description Job Alerts Link Job Title: Product Development Scientist II - Oral Products Req... ...student loan repayment assistance, attend a conference, or gain a new certification with professional development stipends...SuggestedRemote workFlexible hours- ...transforming your career. Process Development Senior Scientist What you will do Let’s do... ...of programs from Ph II/III clinical trials to marketing... ...collaborate cross functionally with analytical and drug product... ...ability to explore and develop new approaches to further...SuggestedFlexible hours
$135k
YipitData is the leading market research and analytics firm for the disruptive economy and most recently raised $475M from... ...for. About The Role: We\'re looking for a Product Development Associate to join our New Product Development (NPD) team. This role is ideal for...SuggestedWork at officeRemote workVisa sponsorshipFlexible hours- ...products, programs, and services that unlock new value for consumers and strengthen the... ...manufacturers Responsibilities Leverage analytical and financial analysis skills to assess... ...experience in retail-focused product development, offer/channel strategy, marketing or related...Work experience placementLocal area
- ## IT Product Developer II, III, IVApplylocations: OK Tulsa - Headquarters: Relocation... .... This role goes beyond traditional development—you will work closely with stakeholders across... ...advances in AI and continuously learning new methodologies* Other duties as assigned##...Work at officeRelocation
- ...Freenome, we are seeking a Senior Development Scientist I to help grow the Freenome... ..., verify, and validate clinical-grade assay technologies for... ...working with ctDNA/cfDNA as an analyte in NGS workflows. Proven... ...and highly motivated to learn new skills and comfortable...Local areaFlexible hours
- ...Altasciences. About The Role The Scientist, LCMS is assigned to projects... ...training (can include method development, validation or sample... ...validation and production studies for clinical and non-clinical studies in... ...When applicable, provide QC support on studies assigned to...Temporary workRemote workFlexible hours
- Sanofi is seeking an mRNA Analytical Development Scientist in Waltham, MA to drive LC-MS characterization for mRNA vaccine development, release, and stability studies. You will work within the Analytical Sciences team, collaborating across CMC and bioprocess groups to...
- Freenome is seeking a Senior Development Scientist I to advance our multiomic platform, developing clinical-grade assay technologies and transferring robust NGS-based workflows into high-throughput production. You will lead experiments, collaborate with engineers, data...
- Amgen Inc. is seeking a Process Development Senior Scientist to define quality attributes and advance analytical methods for protein therapeutics. You will develop LC-MS/MS based workflows, characterize modifications such as glycosylation and oxidation, and optimize chromatography...
$86.32k - $129.48k
...Senior Engineer supports the development, validation, and implementation... ...develop, validate, and implement new or improved test methods;... ...multidisciplinary activities, analytical evaluation, statistical analysis... ...testing strategies, or Class II medical device product registrations...Local area- Amgen is hiring a Process Development Senior Scientist to lead development, characterization, scale-up... ...processes to advance programs from Ph II/III through regulatory submission. You... ...-functional team with bioprocessing, analytical and regulatory colleagues, expanding...
$40 - $46 per hour
mRNA Process Development Senior Scientist Full-time Compensation: USD 40 - USD 46 - hourly The work... ..., providing a unique range of analytical testing services to clients across multiple... ...sciences and in the support of clinical studies. We are seeking a process development...Hourly payFull timeMonday to Friday- ...transforming your career. Process Development Principal Scientist What you will do Let’s do this. Let’... ...formulation, process development, and/or analytical characterization, with experience in... ...manufacturable drug products for clinical development in a fast‑paced...
- ...providing a unique range of analytical testing services to clients across... ...and in the support of clinical studies, as well as having an... ...global presence in Contract Development and Manufacturing Organisations... ...positive attitude Ability to learn new techniques, perform multiple...Permanent employmentFull timeContract workMonday to Friday
$84.9k - $100k
...? Join the Mizkan America Research & Development as an R&D Scientist! We’re looking for a talented individual... ...What You\'ll Do: Design and develop new product formulations, lead portfolio... ...of Design of Experiments (DOE) and analytical/sensory testing methods. Working knowledge...Temporary workWork at officeLocal areaShift work$164.61k - $201.19k
...impact innovative abrasives. Leveraging new technologies to develop novel, high-performance... ...3M’s proprietary position through development of intellectual property. Utilizing good... ...DOEs (design of experiments) and use of analytical techniques in experimentation. Record of...Full timeH1bRelocation packageFlexible hoursNational Black MBA Association
Brooklyn, NY3 days ago$99k - $121k
...healthcare company, pioneering new technologies to... ...organization of scientists, engineers, and physicians... ...NGS), population-scale clinical studies, and state-of-... ...Engineer - Software Development Engineer - Artificial... ...development techniques. Strong analytical and problem-solving...Full timeTemporary workWork at officeLocal areaFlexible hoursShift work$182.5k - $208.3k
...voice of the customer internally - identifying new capabilities, defining product features, and working closely with development teams to get those features incorporated;... ...Statistics, Economics, Operations Research, Analytics, Mathematics, Computer Science, Computer Engineering...Full timePart timeLocal areaCapital One National Association
Brooklyn, NY23 hours ago- ...your job. Join TI's Advanced Technology Development organization, focused on state-of-the-art... ...Bench testing and collect data Develop new test capability using parametric analyzers... ...device physics and reliability Strong analytical and programming skills (Python, MATLAB etc...Local area
Texas Instruments
Brooklyn, NY23 hours ago $90 per hour
...breakthrough data transport and acceleration technology is ushering in a new era of connectivity and capabilities in the vehicle and at the... ...concept to silicon to the future of mobility. Head of Product Development Engineering Summary: The Head of Product Development...For contractorsFlexible hours$88.6k - $133k
...globally.Role OverviewWe are seeking a highly motivated Product Development Scientist to join our R&D team in Valhalla, NY in a unique dual-... ...implementation. Partner with cross-functional areas like Regulatory, Analytical, Micro, Supply Chain, Marketing, Sensory, etc. to deliver...Full timeWork at officeWorldwideMonday to FridayUnilever
Hoboken, NJ2 days ago- Penn State University is seeking a Part-Time Research and Development Engineer for the Applied Research Laboratory in State College, PA. The role supports ARL engineers in experimental testing and data analysis, with a focus on vibration and acoustic data. Required: a Bachelor...Part timeFor contractors
$126.07k - $170.56k
## Process Development Sr ScientistApplyremote type: On Sitelocations: US - California - Thousand... ...your career.**Process Development Sr Scientist**## **What you will do**Let’s do this.... ...and optimizes state-of-the-art analytical tools to guide that development. The Pivotal...Flexible hours- ...seeking engineers with a track record of new product launch, service introduction and... ...features and functionality. As an Aviation Development Engineer, you will be responsible for the... ...must be a (i) U.S. citizen or national, (ii) U.S. lawful, permanent resident (aka...Permanent employmentWeekend work
$108k - $153k
...technologies to address a patient’s unmet clinical needs.It’sour driving force to help... ...generation medical devices by driving supplier development, validation, milestone builds, and... ...technologies and production strategies to support new products, improve operational efficiency...Contract work- Natera is seeking a Scientist to join the Early Cancer Detection product development team in California. The role focuses on process optimization and product verification... ...the oncology portfolio within a fast-paced clinical setting. The candidate should have strong...
$169k - $303k
...Location Type Onsite Department Product Compensation Product Manager, Developer Platform via Greenhouse Location San Francisco, CA • New York, NY • United States Employment Type Full Time Location Type Onsite Department Product Compensation Not disclosed About the role...Minimum wageFull timeLocal areaRemote workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Development Scientist II, Analytical Development and Clinical QC (ADQC) New Haven, Connecticut,[...]. Be the first to apply!
Related searches
- method development scientist Brooklyn, NY
- development engineer Brooklyn, NY
- engineering leadership development program Brooklyn, NY
- product development engineer Brooklyn, NY
- r&d engineer Brooklyn, NY
- engineering development program Brooklyn, NY
- analytical development scientist Brooklyn, NY
- research and development engineer Brooklyn, NY
- supplier development engineer Brooklyn, NY
- sr. process development engineer Brooklyn, NY