Manufacturing Manager

Job Summary:

In charge of Manufacturing Department, develop implementation to reach objectives set by Company and government on Quality, productivity and Customer service.

Responsibilities:

[Organization & people development]

1. Directs the efforts of management personnel responsible for the production of licensed products to ensure conformance with all regulatory requirements, cGMPs and company policies, procedures and product strategies.

2. Set individual objectives and development plan for subordinates, and establish succession plan.

3. Recruitment, selection, training, coaching, retaining, promotion, termination and performance management for department personnel in leadership and critical roles.

4. Evaluate the organizational requirement and allocate resources to achieve the business targets.

5. Meets with cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources, reset direction and maximize effective interactions and functioning.

[Business]

1. Interprets and sets the site strategic direction for current and future facilities, product and process improvements. Provides support for new and existing products by overseeing new process development and associated in-process testing, new assay development and launch planning.

2. Support and co-lead Quality Council and other groups to support existing production and future product and product enhancement, through problem investigation and the experimental evaluation of product and process quality to ensure the meeting of Customer commitments.

3. Develops, evolves and implements master site plan that is in alignment with overall goals of Tech Operation.

[Compliance & Quality] To comply the company Quality standard, US FDA, EU EMA, Taiwan GMP regulation and PIC/S requirement:

1. Ensures that cGMP and safety training for all site personnel is conducted in a timely, efficient and complete manner in order to meet regulatory compliance requirements.

2. Ensures plant operations are in compliance with corporate standards as well as federal regulations including; cGMP, GLP, OSHA, etc.

3. Formulates overall manufacturing policies and strategies to ensure consistency and compliance of manufacturing procedures. Interprets, oversees and ensures the implementation of corporate global policies, site and business specific guidelines and manufacturing SOPs.

[Site Functions]

1. Develops operating budgets for labor and capital expenditures that are consistent with short and long-term site master plans.

2. Directs and oversees the maintenance of appropriate costing of goods and margins in order to minimize unnecessary costs and meet regulatory compliance requirements.

[Cost effective manufacturing]

1. Budget and control the production expenses.

2. Identify the opportunities and lead the team to initiate and implement of productivity improvement project.

3.Budget and control the capital expenditure for production.

[Evaluate and Optimize utilization of the plant capacity]

1. Develop the annual Capacity Plan to meet the business demand.

2. Review the monthly capacity and utilization.

Qualification and Requirements:

• Major in Manufacturing Management, Manufacturing Engineering or Pharmacy preferred and a minimum of 10 years experience in pharmaceutical manufacturing. Or Master's degree and a minimum of 6 years experience in pharmaceutical manufacturing or related industries. Or Ph.D with 3 years experiences.
• Needs to meet mentioned qualification above plus a remarkable performance and/or extra experience.
• Solid oral dosage, Gel, Ointment and Nanoparticle Oral Suspension experience required.
• Experience in equipment qualification, process validation, manufacturing and technical transfer is desired.