Associate Director, Injectable Drug Product Technology Transfer

New Haven, CT - USA

Monthly Salary: Not Disclosed

Posted on: 23 hours ago

Vacancies: 1 Vacancy

Job Summary

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

03-Dec-2025

Closing Date

23-Dec-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.

Required Experience:

Director

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 t...