Technical Services Supervisor 技術服務主任

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Job Summary:

Supervisor of Technical Services Department, responsible for supporting new project evaluation, product transfering, production process validation, the operation and maintenance of process and improvement of manufacturing process.

Responsibilities:

• Coordinate and ensure timely execution of Validation Master Plan activities, including process performance qualification, aseptic process simulation, cleaning validation, and related validation tasks, while maintaining compliance with regulatory requirements.
• Assist in client communication, technology transfer documents preparation, batch execution and project tracking activities to meet project milestones and address real-time changes.
• Support the development and implementation of effective site procedures for qualification, validation, technology transfer, and process improvements in alignment with industry standards and company policies.
• Set performance metrics for the technical service team, monitor progress against objectives, and report updates to management.
• Collaborate with the technical team to identify and implement solutions for technical issues and recommend process improvements based on experimental results, regulatory standards, and business goals.
• Conduct investigations into deviations or technical issues in commercial production and provide technical guidance to resolve root causes effectively.
• Organize and deliver formal and informal training sessions for team members to ensure continuous development and compliance with regulatory expectations.
• Assist in preparing budgets and resource plans for technical service activities and ensure alignment with department goals.

Preferred Qualifications:

• Bachelor's degree in Pharmacy, Chemical Engineering, Biotechnology or related science discipline and over 3 years of related experience.
• Technical writing skills of GMP documents.
• Proven track record of process development, process optimization, and technology transfer experience.
• Ability to work with cross functional teams and meet performance commitments.
• Speaking and writing skills in both English and Mandarin.