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**Job Function: **
Non-Standard
**Job Sub Function: **
Non-Employee
Job Category:
Non-Standard
All Job Posting Locations:
Shanghai, China
Job Description:
Position
Scientific Experienced Engineer – External Supply Integration (ESI) Temporary role based in Shanghai, China — Primary responsibility: management of our main supplier in China
About the Department
Join the Global Pharmaceutical Product Development and Supply (PPDS) organization within Therapeutics Development and Supply (TDS) at Johnson & Johnson. PPDS drives development of innovative pharmaceutical dosage forms across our centers in the US, Asia and Europe. This temporary ESI role sits in the Pharmaceutical Supply & Engineering Sciences (PSES) organization and will be based in Shanghai, working closely with the global PSES and DP development teams (Beerse/Antwerp and other sites).
Role summary
We are hiring an External Supply Integration (ESI) Scientific Experienced Engineer to act as the PSES lead for clinical drug product manufacturing at our main supplier in China. The role’s primary focus is the day-to-day management, coordination and technical oversight of clinical manufacturing activities at that supplier, ensuring right‑first‑time introductions, robust tech transfers and ongoing supplier performance aligned with global GMP and project timelines.
Key responsibilities
- Serve as the single PSES point of contact and the primary technical lead for our main supplier in China, managing the supplier relationship and acting as the interface between the supplier and internal DP development, QA, regulatory and supply chain teams.
- Lead clinical manufacturing introductions and follow-up at the main supplier: drive readiness, execute and oversee tech transfers, validate processes for oral solids, liquids and parenterals, and ensure right‑first‑time outcomes.
- Coordinate manufacturing plant readiness, supply execution and operational oversight at the supplier site (including site visits and on‑site escalation).
- Manage supplier performance and risks: proactively identify critical‑path issues, lead corrective actions, and implement preventative process improvements.
- Prepare, review and approve manufacturing instructions, batch records and specifications in collaboration with internal stakeholders and the supplier.
- Support scale-up and transfer activities from pilot/internal sites to the supplier and onward to commercial manufacturing when applicable.
- Work cross‑functionally with development, quality, regulatory and supply chain to ensure compliance with GMP, regulatory expectations, and company standards.
- Facilitate communications and alignment across global teams to ensure smooth clinical supply operations and timely deliveries.
- Participate in supplier qualification activities and support supplier audits together with QA when required.
Qualifications
- MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering, or related discipline. Minimum of 2 years’ experience in GMP-regulated pharmaceutical development/engineering (clinical manufacturing/CDMO interactions preferred).
- Practical experience with oral solid dosage forms, liquids and/or parenteral products; familiarity with conventional and some innovative technologies (e.g., spray drying, extrusion, continuous manufacturing) and basic knowledge of process analytical technologies is desirable.
- Proven experience managing an external manufacturing partner (CDMO/supplier) in China or across the Asian region — demonstrated ability to manage on‑site activities and supplier performance.
- Strong knowledge of GMP and regulated environments; able to translate regulatory expectations into supplier actions and documents.
- Excellent project coordination, risk management and problem‑solving skills with a bias for action.
- Strong collaboration and influencing skills; experience working in international, cross‑functional teams.
- Fluent in English (written and spoken). Proficiency in Mandarin is strongly preferred.
- Willingness to travel 10-20% (including supplier site visits).
- Ability to work independently under tight timelines while maintaining quality standards.
**Required Skills: **
Good Manufacturing Practices (GMP), Process Validation, Regulatory Requirements, Supplier Management, Technical Transfer
Preferred Skills:
Drug Product Manufacturing, International Teamwork, Manufacturing Integration, Manufacturing Scale-Up, Supplier Qualification, Supply Management