Associate Manager - Filling (Aseptic Filling)

About the role

Roche is hiring an Associate Manager for its Filling department in Shanghai. The role covers leadership and people management of the team, support for the filling manager, and hands-on operational oversight of aseptic filling production, including shift scheduling, batch records, equipment monitoring and aseptic operations.

Key responsibilities

• Build and retain an inclusive team, manage performance and development of team members, and help build a talent pipeline and succession plans.
• Own the site's daily SHE management, implement site SHE procedures and programs, and promote a safety culture.
• Support the establishment of an effective operation system aligned with Roche standards, including manufacturing systems, CCS strategy, and training and qualification systems.
• Help set up procedures for aseptic techniques and good aseptic practices, and lead the site aseptic training program so only qualified people manufacture GMP lots.
• Ensure team competency in vial washing, depyrogenation, filling and stoppering, crimping, and other tasks.
• Take part in new facility design and construction, including process design, equipment selection, URS review, FAT, SAT, IOPQ and APS.
• Arrange filling shifts, review batch records and deviations, and monitor and maintain filling equipment.
• Supervise aseptic operations, raise deviations and lead root cause investigations, and respond to regulator and global quality audits as SME.
• Lead annual aseptic operator qualification, provide on-the-job training, run validation activities such as APS, and take part in change control, operational excellence and IT systems such as SAP, MES, Veeva and Cornerstone.

Required profile

• College degree (Pharmaceutical / Biological preferred).
• 10+ years of operation experience in the injection pharmaceutical industry; MNC biopharma preferred.
• 3+ years of people management experience.
• Experience with aseptic filling facility projects, including design, commissioning and qualification; isolator filling line experience preferred.
• Fluent English communication skills preferred.

Required skills

• Strong knowledge of cGMP and pharmaceutical regulations, especially in the biological industry.
• Aseptic filling operations and GMP lot manufacturing.