# Associate Director, Injectable Drug Product Technology Transfer

**Company**: Injectable Drug Product Development
**Location**: New Haven, Connecticut, United States of America
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Manufacturing
**Industry**: Healthcare

**Apply**: https://astrazeneca.eightfold.ai/careers/job/563877690541547?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_2cf2aeb2-c06

## Description

This role involves leading the development, characterization, technology transfer, and validation of sterile injectable drug products across a range of modalities. The successful candidate will serve as a technical subject matter expert, providing strategic and hands-on leadership in process development, scale-up, manufacturing support, and regulatory submissions.

Key responsibilities include:

- Leading cross-functional teams in the design, execution, and oversight of injectable drug product technology transfers to internal and external GMP manufacturing sites.

- Developing and implementing robust, phase-appropriate technology transfer and process validation strategies, including risk assessments, FMEAs, and control strategies.

- Overseeing development and optimization of drug product unit operations such as freeze/thaw, mixing, sterile filtration, aseptic filling, lyophilization, stoppering, sealing, and visual inspection.

- Serving as the technical lead during manufacturing campaigns, providing on-site support, troubleshooting, and decision-making in collaboration with Process Development, QA, and Operations.

- Authoring and reviewing technical documentation including batch records, validation protocols, change controls, deviations, and regulatory filings (IND, IMPD, BLA, MAA).

- Monitoring and trending process performance data; leading investigations and implementing CAPAs as needed.

- Collaborating with internal and external stakeholders to ensure alignment on timelines, deliverables, and technical strategy.

- Leading or contributing to continuous improvement initiatives to enhance the efficiency and effectiveness of technology transfer and manufacturing support processes.

- Staying current with industry trends, regulatory expectations, and emerging technologies in injectable drug product development.

- Mentoring junior staff and contributing to resource planning, budgeting, and departmental strategy.

- Traveling domestically and internationally (~25%) to support manufacturing site activities.

## Skills

### Required
- injectable drug product development
- technology transfer
- process development
- scale-up
- manufacturing support
- regulatory submissions
- GMP manufacturing
- sterile filtration
- aseptic filling
- lyophilization
- visual inspection
- batch records
- validation protocols
- change controls
- deviations
- regulatory filings
- process performance data
- CAPAs
- continuous improvement
- industry trends
- regulatory expectations
- emerging technologies

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