Production Technical Engineer

• Hiring Manager: Linlin Zeng

• Location: Shanghai China

• 20% Remote working, 80% in the office and 20% of travel expected 

• Job type: Full time/ Fixed Term

• • Lead or participate in technological transfer projects for oral solid & liquid dosage form products, adhering to GMP and MAH requirements for technological transfer.
  • Develop detailed technological transfer plans, outlining critical steps, responsible parties, and timelines.
  • Provide technical training and guidance to the CMO factory to ensure successful technological transfer and product quality consistency.
  • Monitor key indicators and parameters throughout the technological transfer process to ensure transfer outcomes meet expectations.
• Production Plan Execution and CMO Factory Coordination:
  • Collaborate closely with the CMO factory to align oral solid & liquid dosage form production tasks based on the company's overall production plan and market demands, ensuring timely, quantitative, and qualitative completion of production tasks.
  • Coordinate and resolve issues encountered by the CMO factory during production to ensure smooth execution of the production plan.
• Process Control and Management:
  • Adhere strictly to the oral solid & liquid dosage form production process specifications, overseeing and guiding the CMO factory's production process to ensure compliance with standards and stable product quality.
  • Participate in process optimization and improvement efforts to enhance production efficiency and reduce costs.
• Equipment Management and Maintenance Supervision:
  • Monitor the CMO factory's routine maintenance, repairs, and troubleshooting of oral solid & liquid dosage form production equipment to ensure optimal operational status.
  • Assist the CMO factory in developing and implementing equipment maintenance plans in accordance with GMP requirements to elevate equipment management standards.
• Cost Control and Efficiency Enhancement:
  • Analyze the CMO factory's production cost structure, proposing and implementing cost control measures to minimize waste and losses.
  • Collaborate with the CMO factory to optimize production processes, improving efficiency and reducing unit product costs.
• Documentation Management and Compliance:
  • Handle the preparation, organization, and archiving of production-related documents pertaining to the CMO factory, ensuring completeness and traceability of production records.
  • Comply with national and local drug regulatory laws and GMP requirements to ensure the CMO factory's production activities are compliant.
  • Assist with the application and modification of drug registration, production licenses, and other documents related to the CMO factory.
• Continuous Improvement and Innovation:
  • Stay abreast of industry trends and technological advancements, exploring new technologies and processes with the CMO factory to enhance production efficiency and product quality.
  • Drive continuous improvement and innovation in production processes, proposing creative solutions to drive ongoing advancements in production management.

2.Contribute to the good Internal & External service& relationship

• Managing relationships with External Partners and Internal Stakeholders
• Organize cross-functional communication and discussion by collecting information from each function’s knowledge and expertise for moving the programs forward.
• Close collaboration with procurement in negotiation of cogs provided by new or existing CMO depending on the scope of projects & business

• Third-party manufacturers
• EM CHC International Operational Hub team (QA,RA, Finance, SC, Procurement)
• EM cross operational hub teams
• Legal
• China CHC GBU commercial team & other cross functional teams
• China Industrial Network & IA CHC International network

Knowledge And Skills:

Experience & knowledge:

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field.
• Proven experience in oral dosage form production management or process development
• Familiarity with technological transfer processes and regulatory compliance requirements for drug products.
• Knowledge of production planning, process control, and equipment management in pharmaceutical manufacturing.
• Strong analytical skills to identify and resolve production issues, with a focus on cost control and efficiency enhancement.
• Up-to-date with industry trends and a willingness to drive continuous improvement and innovation

Core competencies:

• Technological Transfer: Expertise in leading technological transfer projects, ensuring seamless knowledge transfer and product quality consistency.
• Production Management: Proficient in planning, executing, and overseeing oral solid & liquid dosage form production to meet company targets and market demands.
• Process Expertise: Deep understanding of production processes and compliance with GMP standards to ensure product quality and efficiency.
• Equipment Management: Skilled in equipment maintenance, repairs, and optimization to maintain optimal operational status and minimize downtime.
• Cost Control: Proficient in analyzing production costs and implementing cost-saving measures to enhance profitability.
• Regulatory Compliance: Familiarity with drug regulatory laws and GMP requirements to maintain compliance across production activities.
• Innovation & Improvement: Committed to staying up-to-date with industry trends, driving process improvements, and implementing innovative solutions to enhance production efficiency.

Formal Education And/Or Experience Required:

• Bachelor’s degree in Pharmacist, Engineering, Operations, or other similar relevant disciplines.
• At least 3 years of relevant experience in pharmaceutical oral dosage form production management or process development.

Knowledge And Skills Desirable But Not Essential:

• PMP Knowledge & certificate
• Experience with CMO management
• ICH guideline knowledge