Corporation Description
Merck Millipore is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, we collaborate with customers to confront the world's challenging human health issues. From research through development to production, our scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Merck Millipore is part of the Merck Group, a company with more than 40,000 employees in 67 countries that was generating total revenues of EUR 9.3 billion in 2010. Merck is the world's oldest pharmaceutical and chemical company with roots dating back to 1668.
We are currently seeking a (Sr.) Aseptic Technical Consultant & Regulatory Specialist.
Job Responsibilities
In our Global Biopharm Process Solution team and based on understanding of Aseptic technology and regulatory requirements and trends you will provide internal and external consultancy support to service development, operation as well as customers.
This job can be based either in Shanghai or Beijing.
You will :
Work as Aseptic technical consultant to leverage the expertise and support the business growth:
Demonstrate strong technical product expertise focused on a aseptic application area and act as a technical information source
Use strong practical expertise of customer operational environment in aseptic area to assist Sales, Field Marketing and other stakeholders to better understand the customer operational environment
Conduct in depth process reviews, bringing real value to the customer operations
Act as a key member in a trouble shooting situation. Define initial problem and assign to correct resource (time and people). Some project management of response.
Work in partnership with sales in customer interactions to position and present Merck Millipore offerings. Use ability to match customer pains with gains to aid the sales process
Have excellent competitive positioning knowledge and exploit this to assist Sales, Field Marketing and other Stakeholders to better understand competitive environment
Train relevant Stakeholders to the appropriate level of technical competence, for example (but not exclusively) Tech Service, Field Marketing, Sales Development
Take active role in the Chinese Regulatory Environment to built Regulatory Intelligence, cover the area of Aseptic Processing, Virus and Single Use Validation
Monitor and report on changes within relevant regulatory and compliance environment
Influence and Shape future guidance, regulations, and policy
Active engagement in relevant industry groups in Aseptic, Virus and Single Use products
Drive thought leadership initiatives and build up relationship with related regulatory agencies in terms of Aseptic processing, Virus validation and Single Use Validation
Develop and engage in regulatory consulting services for customers:
Process Compliance Reviews:
Response plans to findings
Product implementation strategies
Change control strategies and filings
Provide regulatory support to service operation:
Training and rollout of regulatory expertise to other functions and geographies
Provide relevant training to educate PS colleagues on regulations that drive our value proposition
Analyze available regulatory and compliance information
Master in Science and/or Engineering Discipline >5 years experience.
Fluent in Chinese & English (verbal and written) is required.
Professional Skills and Experience :
Experience of minimum 5 years in Biopharmaceutical Industry, extensive knowledge in biotechnology and biomanufacturing industry
Proven knowledge of cGMP/cGLP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, Aseptic processing and validation procedures
Experience working in a global, matrix environment
Strong regulatory background and ideally in a Consultant role
Experience in a customer facing role
Experience in quality and preferably in process validation
Personal Skills and Competencies:
Strong organizational and time management skills
Ability to train and educate others
Capable of selling to customers
Effective management by influence
Some experience in thought leadership
Ability to work in multi-cultural teams
Good listening skills with the ability to analyze and respond to given situations quickly and effectively
Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external customer/supplier relationships at all levels.
Ability to indirectly influence other organizations and cultures
Good understanding of Merck Millipore IT Systems, e.g. Oracle, Lotus Notes, Microsoft Suite (PowerPoint, Word, Excel)
Able and willing to travel frequently
In our Global Biopharm Process Solution team and based on understanding of Aseptic technology and regulatory requirements and trends it is highly required to provide internal and external consultancy support to service development, operation as well as customers and to fulfill the gap of Technical consultant in Aseptic business and the Regulatory gap of business.
Apply
Please send your CV and cover letter to zhzhao@shilinx.com.
