Alexion Pharmaceuticals, Inc. · 1 day ago
Director, Injectable Drug Product Development,
New Haven, CT
Full-time
Onsite
Director/Executive
$175K/yr - $263K/yr
8+ years expAlexion Pharmaceuticals, Inc. is focused on developing unique injectable drug products for a diverse portfolio. The Director of Injectable Drug Product Development will lead formulation and process development, ensuring successful integration and manufacturing while mentoring colleagues and providing subject matter expertise for regulatory submissions.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Formulation and process development, product integration, and manufacturing of patient-centered, unique injectable drug products for Alexion's diverse portfolio from pre-clinical to successful licensure
Lead interface with Operations, CMC Project management, Clinical Development, Regulatory on life cycle management opportunities
Develop drug product delivery strategies through internal/external partnerships and product integration into drug/device combination products
Ensure tech transfer of Alexion's portfolio with specialized input on engineering solutions for equipment and processes
Review and develop drug product technology roadmap and manage important investments
Assist and mentor colleagues in a matrix team for efficient and successful drug product development and manufacturing in a phase appropriate manner
Partner with functions across Alexion to build the best strategies for developing products in Alexion's diverse portfolio
Provide subject matter expertise for preparing regulatory filings, regulatory interactions including inspections, audits and is accountable for the technical content of the relevant drug product sections of regulatory submissions
Work with the Head on the development on drug product development strategies within PDCS and with partners in Operations, Regulatory Affairs, and Commercial organizations
Devote considerable time and effort in developing colleagues and the requisite to achieve Alexion's growing R&D pipeline
Qualification
Required
Must have a BS or equivalent in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with relevant experience
You have number of years of drug product development experience in formulation and process development and technology transfer for mAbs, proteins, peptides, synthetics and genomic medicine products
At least 8 years of experience of direct experience developing approaches to allow drug product development for early and late-stage programs through licensure
At least 5 years of experience managing a team of scientists and engineers at different levels (directly or in a matrix team) Ensuring their career growth
Must be proficient in current approaches for formulation and drug product process development, manufacturing processes and equipment, and applying these to developing efficient approaches to ensure product licensure
Knowledge of high concentration protein formulation development, aseptic processes, to provide vial, prefilled syringe, cartridge presentations as liquid and lyophilization dosage forms is important
Knowledge of current regulatory guidelines and cGMP requirements is necessary
Benefits
A qualified retirement program [401(k) plan]
Paid vacation, holidays, and paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage following the terms and conditions of the applicable plans.
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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