Top 37 Alexion pharmaceuticals Jobs

Associate Director, Injectable Drug Product Technology Transfer
Alexion Pharmaceuticals,Inc. —New Haven, CT
- Management
- Bachelor of Science
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Scientist III, Injectable Drug Product Development
Alexion Pharmaceuticals,Inc. —New Haven, CT
- Microsoft Word
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- Bachelor of Science
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Development Scientist III, Analytical Development and Clinical Quality Control
Alexion Pharmaceuticals,Inc. —New Haven, CT
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Vice President, Head of Translational Medicine and Translational Science
Alexion Pharmaceuticals,Inc. —Boston, MA
- Medicine
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Alexion Pharmaceuticals,Inc. —Boston, MA
- $175,000 - $263,000 a year
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Associate Director, US Strategic Business Planning & Execution, Medical Affairs
Alexion Pharmaceuticals,Inc. —Boston, MA
- $150,098.40 - $225,147.60 a year
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Associate Director, Safety Scientist
Alexion Pharmaceuticals,Inc. —Boston, MA
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- Microsoft Word
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- 5 years
- Health insurance
- Dental insurance
Global Safety Program Lead/Sr Medical Director
Alexion Pharmaceuticals,Inc. —Boston, MA
- $280,895 - $421,342 a year
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Senior Director, Epidemiology
Alexion Pharmaceuticals,Inc. —Boston, MA
- $229,047 - $343,571 a year
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- 6 years
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- Analysis skills
- Paid holidays
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Director, U.S. HCP Marketing Strategy, HSCT-TMA
Alexion Pharmaceuticals,Inc. —Boston, MA
- $194,126.40 - $291,189.60 a year
- Office
- 8 years
- Bachelor's degree
- Paid holidays
- Health insurance
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Scientist II, LC Development, Biologics Analytical Development
Alexion Pharmaceuticals,Inc. —New Haven, CT
- Bachelor of Science
- Mid-level
- Analysis skills
Medical Director, Global Patient Safety
Alexion Pharmaceuticals,Inc. —Boston, MA
- $249,827.20 - $374,740.80 a year
- Nursing
- Medicine
- Microsoft Excel
- Health insurance
- Dental insurance
Senior Manager, US Medical Review
Alexion Pharmaceuticals,Inc. —Boston, MA
- $116,710 - $175,064 a year
- Medicine
- Office
- Doctor of Philosophy
- Health insurance
- Dental insurance
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Associate Director, Biostatistics
Alexion Pharmaceuticals,Inc. —Boston, MA
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- 3 years
Director, US Commercial IT Business Partner
Alexion Pharmaceuticals,Inc. —Boston, MA
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- 11+ years
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- Paid holidays
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Executive Medical Director, Clinical Development, Hematology, Nephrology, & Transplant, Cell Therapy
Alexion Pharmaceuticals,Inc. —Boston, MA
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Senior Director, Thought Leader Liaison Team Lead, Hematology & Nephrology
Alexion Pharmaceuticals,Inc. —Boston, MA
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Senior Medical Director, Clinical Development Rare Cardiology
Alexion Pharmaceuticals,Inc. —Boston, MA
- $280,895.20 - $421,342.80 a year
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- 7 years
- Internal Medicine
- Health insurance
- Dental insurance
Senior Medical Science Liaison, Rare Neurology, Midwest (IL/WI)
Alexion Pharmaceuticals,Inc. —Chicago, IL
- $174,455 - $261,682 a year
- Weekends as needed
- Hybrid work
- Clean driving record
- Bachelor of Science
- Clinic experience
- Health insurance
- Dental insurance
5d

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Associate Director, Injectable Drug Product Technology Transfer

Alexion Pharmaceuticals,Inc. -
New Haven, CT

Apply Now

Job Details

Qualifications

FDA submissions
Chemical engineering unit operations
New product introduction engineering projects
Product development project management
Management
Production data analysis
TrackWise
GMP
Chemical scale-up projects
Manufacturing facility experience
Production validation processes
Quality control data analysis
Pharmaceutical company experience
Technology transfer (scale-up process)
Pharmaceutical analysis
Mentoring
Data analytics
Leading team collaboration initiatives
Chemistry, manufacturing & controls
Communication with regulatory authorities for clinical trials
Sterile products production
Chemical new product development projects
Cross-functional team management
Cross-functional communication
Pharmaceutical manufacturing facility experience

Full Job Description

Location: New Haven, United States Job reference: R-253733 Date posted: 06/29/2026

This is what you will do:

The Associate Director will lead the development, characterization, technology transfer, and validation of sterile injectable drug products across a range of modalities including biologics, peptides, nucleic acids, and synthetic molecules. This role spans early-phase development through commercialization and includes responsibility for liquid and lyophilized formulations in vials, prefilled syringes, and cartridges. The successful candidate will serve as a technical subject matter expert (SME), providing strategic and hands-on leadership in process development, scale-up, manufacturing support, and regulatory submissions.

You will be responsible for:

Lead cross-functional teams in the design, execution, and oversight of injectable drug product technology transfers to internal and external GMP manufacturing sites.
Develop and implement robust, phase-appropriate technology transfer and process validation strategies, including risk assessments, FMEAs, and control strategies.
Oversee development and optimization of drug product unit operations such as freeze/thaw, mixing, sterile filtration, aseptic filling, lyophilization, stoppering, sealing, and visual inspection.
Serve as the technical lead during manufacturing campaigns, providing on-site support, troubleshooting, and decision-making in collaboration with Process Development, QA, and Operations.
Author and review technical documentation including batch records, validation protocols, change controls, deviations, and regulatory filings (IND, IMPD, BLA, MAA).
Monitor and trend process performance data; lead investigations and implement CAPAs as needed.
Collaborate with internal and external stakeholders to ensure alignment on timelines, deliverables, and technical strategy.
Lead or contribute to continuous improvement initiatives to enhance the efficiency and effectiveness of technology transfer and manufacturing support processes.
Stay current with industry trends, regulatory expectations, and emerging technologies in injectable drug product development.
Mentor junior staff and contribute to resource planning, budgeting, and departmental strategy.
Travel domestically and internationally (~25%) to support manufacturing site activities.

You will need to have:

Proven leadership in injectable drug product development and technology transfer, including experience with biologics and complex modalities.
Deep technical knowledge of sterile manufacturing processes and equipment, including single-use systems.
Strong understanding of GMP regulations, process validation, and regulatory submission requirements and supporting regulatory inspections as a technical SME.
Experience managing or mentoring technical staff and leading cross-functional project teams in direct or matrix teams through late-phase development and commercial product launches.
Proficiency with electronic quality systems (e.g., TrackWise) and data analysis tools.
Excellent communication, collaboration, and problem-solving skills.
Ability to work in GMP environments and travel as needed for manufacturing support.
Prior work with CDMOs and global manufacturing networks.
Familiarity with protein formulation, stability, and analytical methods.

Preferred Qualifications:

Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or Engineering with 8+ years of experience; M.S. with 12+ years; or B.S. with 15+ years in biopharmaceutical drug product development and manufacturing.
Lean Six Sigma or continuous improvement training

Date Posted

29-Jun-2026

Closing Date

19-Jul-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Apply Now

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alexion pharmaceuticals jobs

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