AstraZeneca · 2 months ago
Associate Director, Injectable Drug Product Technology Transfer
US - New Haven - CT
Full-time
Onsite
Lead/Staff, Director/Executive
8+ years expAstraZeneca is seeking an Associate Director for Injectable Drug Product Technology Transfer to lead the development and validation of sterile injectable drug products. This role involves overseeing technology transfer processes, providing technical leadership, and ensuring compliance with regulatory standards throughout the product lifecycle.
BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
Qualification
Required
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
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
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
H1B Sponsorship
AstraZeneca 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
2021 (2)
2020 (11)
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
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