Job Title: AD/Director, External Manufacturing & MS&T
Job Number: 25215
Location: Lexington, MA
The Associate Director / Director of External Manufacturing and Manufacturing Sciences & Technology (MS&T) will be responsible for ensuring our manufacturing processes and equipment are fit for purpose and that Drug Substance (DS), Bulk Drug Product (BDP), and Finished Drug Product (FDP) are manufactured and released through our CMO partners according to phase appropriate GMPs as needed to meet clinical demand. Planning and oversight of Tech Transfer activities to ensure accurate translation of Process Description requirements into CMO Batch Records and SOPs will also be a primary focus. Additional responsibilities will include: oversight of equipment commissioning and validation activities to ensure a phase appropriate validated state is maintained; assistance with developing and implementing a QbD system to enhance process and analytical knowledge; and providing process engineering support for tech transfer and process scale-up; providing manufacturing and technical support to facilitate CMO issue resolution, deviation / investigation closure, and final product disposition.
- Act as primary liaison with CMOs to ensure product manufacturing meets demand needs for DS, BDP, and FDP. This will include production demand planning, Person-in-Plant, Executed Batch Record review and issue resolution, deviation / investigation support and closure, and support of final product disposition by QA.
- Oversee and ensure success of Tech Transfer (TT) activities from Translate to CMO partners. This will include drafting Requests for Proposal, vendor identification, evaluation, and selection, development of a comprehensive TT plan and schedule, ensuring accuracy of the Process Description, review of Batch Records and SOPs for alignment with the Process Description, review of Material Specifications, review and approval of raw material / consumables procurement plans, and coordination with Analytical Development on analytical method transfer / qualification / validation.
- Lead and oversee equipment commissioning and validation activities and ensure ongoing validated status of process equipment in accordance with the VMP. Provide oversight of technical changes and lead end-to-end change control management related to technical issues, working cross-functionally as required.
- Assist with the development and implementation of a QbD system to further process understanding for Translate’s products, facilitate trending and assessment of process parameters and quality attributes in order to set operational limits, specifications, and ultimately design space as products progress through clinical development, lead risk process / material / supplier assessments, and utilize relevant process data to enhance risk-based supplier management.
- Provide process engineering support for TT and process scale-up activities. Assistance with hands-on execution of process development activities and demonstration batches may also be required.
- Review and audit of CMO invoicing prior to approval for payment. Prepare campaign summary reports as required.
- Assume additional responsibilities as assigned.
- 10-15 years of relevant experience in the biopharmaceutical industry.
- BS / MS in Engineering (preferred) or Life Sciences.
- Experience in technical/process development and process/technology transfer, focused on biologics or ATMPs
- Experience and demonstrated proficiency in global GxPs, industry guidance (esp., ICH Q6 – Q12) and compliance with the same.
- Experience in CMO search, selection, and management
- Experience lead cross-functional teams to perform root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, CAPA-studies).
- Excellent communication skills and ability to provide clear, candid, and transparent descriptions of CMC/technical tasks, issues, schedule challenges, and proposed solutions
- Results oriented and demonstrates a focus on achieving (business) results.
- Demonstrated ability to facilitate project team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.
- Familiar with current issues and Regulatory requirements related to manufacturing using single use equipment for drug substance and drug product production.
- Ability to travel (U.S./ Int’l) 25-50% of time, particularly when production campaigns are being done.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.