Production Technical Engineer
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- 上海
Job Title:Production Technical Engineer, External Manufacturing CHC China
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
At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.
Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.
We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.
To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.
About the job
Primary Purpose: To lead and oversee the efficient and compliant production of oral dosage form products through CMO factories, ensuring timely delivery of high-quality products that meet market demands and regulatory requirements.
- Lead technological transfer projects, ensuring successful transfer and product consistency.
- Coordinate with CMO factories to execute production plans, resolving operational issues for smooth execution.
- Monitor and manage production processes, ensuring adherence to GMP standards and process specifications.
- Collaborate on process optimization, cost control, and equipment maintenance to enhance efficiency and reduce costs.
- Participate in quality monitoring, identifying, and addressing abnormalities to maintain product quality.
- Manage production documentation, ensuring compliance with regulatory requirements.
- Stay updated on industry trends, driving continuous improvement and innovation in production processes.
Main responsibilities:
- 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
V – MAIN PROFESSIONAL RELATIONSHIP
- 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
About you
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
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
