US Pharmacopeia-China Job Description

US Pharmacopeia-China Job Description

Job Title: Vice President, Biologics Reports to: General Manager, USP-China Site Head Effective: March 2013

Function of the Position: This is a supervisory leadership position located in Shanghai, China. The incumbent applies scientific principles and practical laboratory experience to lead the USP-China’s Bioanalytical & Microbiology (B&M) Laboratories and staff. He/She oversees day to day operations of the laboratories and interactions with other USP departments, promotes B&M Laboratory programs to recruit collaborative / core laboratories, brings the collaboration opportunities to closure; develops and maintains strategic contacts and collaborations to develop documentary standards and reference standards for biologics. The incumbent must have a solid understanding of biotech industry and related regulations as well as GMP/GLP requirements. Roles and Responsibilities: 

Responsible for ensuring that laboratories and scientists are aligned with the mission, goals, objectives and priorities of the organization. Manage laboratory activities related to standard setting in biotech, biological products and microbiology laboratory.

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Develops and maintains strategic contacts and collaborations with domestic and international core laboratories. Develops work plans and statements of work (SOW) for core laboratories; reviews data and manages interaction with core laboratories.

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Reviews the B&M Laboratory building plan and makes necessary recommendations based on existing and future testing needs.

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Develops and manages annual budgets, projects resources, capital, personnel needs for the organization, and operation and maintenance of B&M laboratories. Ensures that the B&M laboratories and biotechnology projects are staffed appropriately and that all personnel are managed trained and developed according to USP practices, policies and corporate values and meet the needs of the business.

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Helps develop SOPs and policies and ensures that SOPs and policies are implemented and communicated effectively and complied completely. Supports to improve the USP China Quality Management System.

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Reviews, edits and approves all reports from the B&M Laboratory program. Reviews as necessary test reports and USP Reference Standards Candidate Evaluation Packages (RSCEP), and obtains additional data as needed.

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Develops study designs for collaborative studies of new B&M reference standard materials.

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Directs and conducts research in pharmaceutical analysis relevant to public standards technology.

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Responsible for creating and managing Cell Banks to meet USP as well as external customer needs.

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Assists in the preparation of the US Pharmacopeia and the National Formulary (USP-NF) as a resource on scientific questions.

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Represents the B&M Laboratory program at various scientific meetings, and makes presentations at scientific meetings as appropriate. Page 1 of 2

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Assists in the development and implementation of safety projects impacting B&M Laboratory personnel.

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Participates in USP cross-functional teams as appropriate.

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Teach USP Pharmacopeial Education at training classes as appropriately.

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Performs other related duties as required.

Minimum Requirements: Ph.D. in biochemistry/cell biology/immunology or related field is required with at least 15 years of relevant experience in biotech industry, including demonstrated strong hands-on laboratory experience in bioanalytical and bioassay as well as people management experience. Must have 5 years of experience in a senior position or other equivalent leadership role. Must have comprehensive understanding of the science involved in the late stage development of recombinant therapeutic protein pharmaceuticals and reference materials; broad experience in the analysis of proteins and glycoprotein’s;. Extensive experience in the development of cell-based bioassays, microbiological assays and considerable experience in protein immunological tests. Experience with method qualification and validation. Proven leadership and staff management skills. Must be fluent in English and Chinese. Experience and Competencies: Experience with compendial methods is a plus. A basic understanding of the processes of the USP is desired. Some experience in the organization and facilitation of collaborative studies desirable. Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders. Demonstrated proficiency in leadership, management and staff development practices, tools, and methodology. Broad experience for research and development labs, in a multinational pharmaceutical company; having prior experience in setting-up new laboratory and thorough knowledge in implementing Quality Management Systems is desirable. Interactions within USP: Bioanalytical & Microbiology Lab Vice President Documentary Standards and Reference Materials, Chemicals Supervisory Requirements: Cell Biology, Bioanalytical, Vaccine and Microbiology Laboratory staff

For more information about USP and its standard setting activities, please visit www. usp.org. This is a newly created position. Initially there will be three lab groups reporting to this position including cell biology and Bioanalytical, vaccine and microbiology. Interested candidates please send your resume along with a cover letter to [email protected] and [email protected].

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