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Head of Biosafety Testing Operations - China

Your Role:

You will have direct responsibility for all aspects of service delivery quality and performance, employees’ development and career progression, and performance improvement within BioReliance® Biotesting Operations.

 

The post holder will be initially, responsible for establishing a BioReliance® biosafety testing facility in the Shanghai area, and then the subsequent direction and leadership of the China Biosafety Testing business, with direct ownership for BioReliance® Operations, including: Logistics and Supply Chain; Clearance services; Biosafety testing laboratories; Support services; Facilities and engineering management.

Functions directly managed:

  • Biosafety Testing: Virology, Microbiology, Molecular Biology, and cell culture production (internal)

  • Viral Clearance Services, and virus production (internal)

  • Support services: Test Article Receipt, Inventory Management, Shipping and Receiving, Facilities & EHS, Quality Control, and Report writing

  • Engineering, Facilities, and Validation

  • Indirect responsibility for Quality Assurance and regional client support resources (Project Management, Orders Management, Development Services and commercials) in the China facility.

  • Total number of employees supervised (in organization): approximately 75.

  • Number of locations: 1 building in Shanghai.

 

Description:

  • Responsible for building the BioReliance® biosafety testing business in China, as the site head for Process Solutions Services (PSS), working in conjunction with Commercial Operations colleagues and group function business partners.

  • Lead the design, construction, validation, and commercial readiness of a BioReliance® biosafety testing facility in Shanghai.

  • Partner with Heads of Commercial Operations for APAC and China to develop regional/ country-specific business plans related to operational capability and capacity

  • Partner with the Vice President, Global Operations and the senior operations leadership team to set operational strategy from which business unit goals and objectives can be established.

  • Responsible for China site planning, setting revenue and profit targets.

  • Provides full budgetary preparation, compliance accountability for assigned functional areas and makes recommendations concerning long-range planning.

  • Maintains profit and loss for China Biologics Operations.

  • Makes final decisions on operational and administrative matters to ensure achievement of China site objectives.

  • Maintains and develops strong financial controls to drive optimization for pricing flexibility, revenue and gross margins.

  • Develops and maintains formal operational controls to ensure realization of business units and BioReliance® biosafety testing business objectives.

  • Directs and controls operational activities through a site management structure.

  • Ensures the timely and efficient delivery of high-quality services to customers within a highly scientific laboratory-based environment.

  • Creates and implements critical functional strategies securing competitive advantages in negotiating and setting revenues, business processes/systems, efficient laboratory workflow, cycle time reductions, supplier relationships and alliances, quality and compliance.

  • Act as a coach and mentor to all staff within the Operation, driving employee development and succession planning to recognize talent, whilst also ensuring headcount requirements are always managed to the needs of the business.

  • Develops and promotes a client focused, performance improvement philosophy throughout all operations consistent with competitive strategies.

  • Develops the Operations staff and infrastructure to achieve financial goals. Nurture an open culture which encourages healthy debates to reach the best outcome.

  • Coordinates effective training and safety for all site employees.

  • Drives both short and long goals and objectives for increasing revenue, improving operations, profitability, service, quality and compliance.

  • Establishes and maintains key contacts internally and externally including customers, suppliers, regulatory bodies, senior management domestically and internationally, corporate management, local government officials and community organizations.

 

Requirement:

Education:

  • A minimum of a Bachelor’s degree in a Life Science is required.

  • A Master’s degree in Life Science or Business Administration (or equivalent business experience) is preferred.

Experience:

  • Requires a minimum of 10+ years of relevant business experience, ideally balanced in biologics development and/ or manufacturing, supply chain discipline, quality and technical operations within a global, multi-site environment.

  • Recent experience with introducing IT/ automation platforms and systems into a laboratory environment focused on excellent service delivery to clients is preferred.

  • Relevant industry experience in a (GxP) pharmaceutical, biotechnical or medical device environment is required.

  • Experience within a regulated environment and ability to interact effectively with regulatory agencies in China is highly desirable.

  • Strong management experience with a demonstrated ability to lead and influence internal teams and individuals as well as critical external contacts is required. Significant, proven track record in staff and organizational development – coaching, counseling, team-building.

  • Strong negotiating skills required. As “voice of the expert”, provide effective communication and working relationships with customers.

  • Experience in building and designing organizations in a dynamic, growing environment.

  • “Flexible/ focused thinker” – ability to transition from the strategic to the tactical easily. Track record of delivering improved service to clients.

  • Experience with process improvement tools (Six Sigma, Lean, etc.).

  • Fluent in both Mandarin and English (fluency in reading, writing, speaking in both languages).

  • Ability to travel internationally to customers and other Merck facilities.

Job Requisition ID:  201132
Location:  Shanghai - all
Career Level:  E - Professional (10+ years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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