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Presentation Outline

Presentation Outline. Partnering with Shang Pharma/ Chem Partner. Introduction.

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Presentation Outline

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  1. Presentation Outline Partnering with ShangPharma/ChemPartner

  2. Introduction ShangPharma, the holding company of Shanghai ChemPartner Co. Ltd. and Shanghai ChemExplorer Co. Ltd., is one of the largest CROs (Contract Research Organizations) in China and provides a comprehensive portfolio of services to global pharmaceutical and biotech companies. We have a team of skilled scientists and a problem-solving culture that enable us to respond to our clients' toughest challenges. Headquartered in Zhangjiang Hi-Tech Park, Pudong New Area of Shanghai, ShangPharma currently has a staff of more than 1,600 scientists in virtually every discipline. Over 40% of our scientific staff have post-graduate degrees and all of our top scientific leaders have U.S. and/or European industrial experience in major international pharmaceutical and biotechnology companies. To keep up with the growing demands for R&D outsourcing, we are looking for experienced candidates who thrive in a paced research organization. Discover your future with us by sending your CV to: yzhou1@shangpharma.com For more job information about us, please visit: www.shangpharma.com; Phone:0086-021-51320001

  3. 1. Senior Director/ Director: Medicinal Chemistry Responsibilities: Lead the integrated projects. Be accountable for project deliverables and the quality of the drug discovery science. Requirements: Ph.D. with10 years or more of drug discovery experience. Track record of involvement in projects leading to development candidates. Project leadership skills a plus. Experience in managing CRO chemists is a plus. Working knowledge of biology and DMPK disciplines. Excellent communication and organizational skills. Mandarin useful but not necessary.

  4. 2. Senior Director/Director: Process Chemistry Responsibilities:  Have a strong record of accomplishment in process chemistry, including a track record of publications and patents demonstrating innovative and creative solutions to problems; demonstrated managerial skills; significant leadership experience; and should have good communication skills. Responsible for managing multiple scale-up or process teams, and providing supervision to pre-formulation and analytical support teams. Responsible for management and career development of a group of co-workers reporting directly to him/her. Communicate with customers and clients (English speaking) directly. Assist General Manager in developing business opportunities. Requirement: Ph.D. in Organic Chemistry and 8+ years of relevant experience, preferably in chemical process development. Demonstrated knowledge in chemical process research & development and scale-up. Strong leadership and interpersonal skills. Demonstrated managerial experience in leading large groups. Demonstrated project management skills, experienced in managing time-sensitive projects. Strong written and oral communication skills (both in both English and Chinese).

  5. 3. Analytical Lab Head Responsibilities:  Lead, mentor, and manage a group of analytical scientists to support early CMC development for customers. Define and optimize the work processes within the department, and coordinate cross-functional project teams to ensure the development services meet customers’ quality requirements and timelines. Participate in decision-making process with senior management on budgeting, planning, and implementation. Initiate, develop, and foster a long-term partnership with customers. Manage the daily operations and activities within the department. Provide training and technical guidance to scientists to ensure the quality of work and timely completion of projects as required. Be responsible for departmental performance and individual performance evaluations. Create, review, approve, and implement SOPs within the department. Maintain a safe and compliant work environment. Lead analytical groups in Fengxian site to support chemical development activities in both pilot plant and kilo-labs. Manage the daily activities including method development and validation, in-process control and routine sample analysis, review experimental results and reports, problem-solving, and teleconference with customers. Requirements:  Education in analytical chemistry, organic chemistry, or related disciplines. Have a degree of Ph.D. with 3 – 10 years, or M.S. with 10+ years of technical and managerial experience in pharmaceutical industry. Be familiar with overall pharmaceutical development process, cGMP and regulatory guidelines. Hands-on method development experience and in-depth knowledge of chromatographic techniques such as HPLC, LC-MS, GC, GC-MS, chiral separations, and chemical and structural characterizations. Have excellent communication and interpersonal skills. Fluent in Chinese and English.

  6. 4. Genomic/Bioinformatic Leader Responsibilities: Support and build in-house capabilities for the analysis and interpretation of large-scale data sets, including next generation sequencing data. Perform necessary computational and statistical analysis on genomic datasets (expression, copy number, mutation, epigenetic) acquired in collaboration with academic and industrial research institutes. Collaborate and work closely with biology teams to utilize genomic data in support of needs from clients, including assistance in data interpretation, correlation to PD and biology, formulating testable hypotheses, and advice on the design of experiments. Develop an internal searchable genomic database for cell lines and xenograft tumor models as part of ChemPartner’s biology knowledge database. Requirements: MS (+7 years experience), or PhD (+2 years experience) in Bioinformatics or related field plus work experience from a bioinformatics research environment. Knowledge and working experience in human disease biology, especially cancer, is highly desired. Strong communication skills and a successful track record of collaborating with cross-functional scientific teams. Experience in machine learning algorithms and their application to biological problems. Experience integrating publicly or commercially available genetic, genomic, and pathway/network datasets with novel experimental data. Extensive programming experience pertinent to analysis of large and diverse data sets. Knowledge of one or more of UNIX, R, C/C++, Java, Perl/Python, MySQL. Familiarity with Java/C/C++ platforms is a plus. Demonstrated skill in prioritizing multiple responsibilities and tasks; excellent organizational skills. Excellent verbal and written communication skills.

  7. 5. Project Leader: In Vitro Pharmacology Responsibilities: Work in a dynamic project team environment and be involved in in vitro assay development and compound screen testing in biochemical and cellular assays to select candidates and to elucidate mechanism of action. Requirements: Ph.D. or equivalent in Biology, Cell Biology, Biochemistry or a related scientific discipline. Minimum of 5 years of relevant laboratory experience. Oversea drug discovery experience in pharmaceutical or biotech industries is preferred. Good communication skill in English is a plus. Have experience in in vitro GPCR, kinase, non-kinase enzyme or transporter assays, and familiar with other techniques such as PCR, Western Blot, ELISA, cloning and cell line construction. Ability to use data processing software (Excel, Prism, etc). The ability to efficiently perform experiments, analyze data and draw conclusions, and effective problem-solving skills. An understanding of scientific principles and experimental design are critical. The incumbent will operate in a highly collaborative environment, and will require excellent organizational and communication skills. Proficiency in computer applications is a plus.

  8. 6. Leader for Non-Human Primate Cognitive Behavioral Group Responsibilities: Will be working with non-human primates (Cymologous and/or Rhesus monkeys). Will direct a team of scientists and be able to work independently in: experiment design, staff training, new model implementation and applying industry-acceptable statistical data analyses. Experience in the Neuropharmacology and behavioral models in some, or all, of the following areas: ·   cognitive behavioral models such as *CANTAB*-based ·     delayed non-matching-to sample, ·     spatial working memory, ·     paired-associated memory, ·     object retrieval tasks ·     Neurodegenerative diseases, ·     EEG, or microdialysis. Requirements: Some experience in stereotaxic neurosurgery and anesthesia are also desirable. Ability to communicate well verbally and to write research proposal and report drafts in English. Additional understanding of Chinese (verbal and written) will be an asset.

  9. 7. GLP and Non-GLP Bioanalysis Director Responsibilities: Responsible for developing, adapting and implementing methods and procedures for detection and quantification of analytes in biological samples; the individuals also are charged to seek out and apply new analytical technologies in a high throughput pharmaceutical research setting. Managing routine operations in laboratories and enforcing existing lab SOPs.                   Managing inter-department collaboration. Requirements: Ph.D. degree in Bioanalytical Chemistry/biochemistry.  Greater than 5 years of industrial experience in LC/MS-based bio-analysis to support drug discovery and development. For non-GLP bioanalysis, extensive hands-on experience in method development and routine trouble shooting; familiar with various LC/MS platforms, bioanalysis acceptance criteria and laboratory SOPs. For GLP bio-analysis, experience in method development and strong trouble shooting capability; familiar with regulatory requirement for regulatory filings; knowledge and experience in a GLP regulated environment.

  10. 8. Large Molecule Bioanalytical Director Responsibilities: Draft study proposal and quotation in response to clients’ requests. Lead team to design, develop, and validate the immunoassays, including but not limit to ELISA, MSD, Luminex, immunogenicity assay, etc. Lead team to analyze large molecule samples from pre-clinical or clinical studies using immunoassays. Draft study reports, including assay development report, validation report, sample analysis report, etc. Maintain close and effective communication with clients, report study progress in a timely manner. Troubleshoot and provide ongoing guidance to team members as needed. Participate client visit and present company’s capabilities in above mentioned areas as needed. Work as a general lab manager for large molecule BA lab. Work closely with QA to ensure the operation is in compliance to GLP requirement, including instrument 3Q and maintenance, personnel training, SOP drafting, other documentation, archiving, etc. Work closely with LIMS administrator to ensure the proper usage of LIMS in large molecule BA lab. Requirements: PhD with 5-8 years or MS with 8-12 years of relevant industrial experience, preferably in GLP setting. Hands-on and supervisory experience on immunoassay development, validation, and sample analysis. Direct experience with immunogenicity assays will be a significant plus. Must be able to work in a dynamic working environment and be multi-tasking. Good communication skill is a must have.

  11. 9. Director/Senior Director in Mammalian Cell Culture Process Development • Responsibilities: • Involve in the development and characterization of recombinant cell culture processes from cell line generation to bench scale production.  This important role requires biological and engineering expertise to develop cell lines and optimize the processes that will ultimately be suitable for cGMP production.  • In addition, the responsibilities will include the development of technologies to enhance the cell line and cell culture expression platform. • Requirements: • Ph.D. in a scientific discipline (Chemical Engineering, Biochemical Engineering, Biology or related field) with 2+ years or MS with 4+ years of relevant experience in the pharmaceutical /biotechnology industries in protein expression, mammalian cell culture and cell line development in an industry setting. • Direct experience with and knowledge of the design, optimization and scale-up of mammalian cell culture processes is a necessity.  Experience with mammalian cell culture process development and process transfer for clinical or commercial manufacturing of biopharmaceutical product(s) highly preferred. Process validation and cGMP experience is desirable. • Extensive hands-on experience with mammalian cell line development is required. Experience in applying standard molecular biology techniques to create expression vectors and to clone gene of interest would be a strong advantage. • Must be highly motivated, have excellent organizational and communication skills.  Must be able to work independently and as part of a multi-disciplinary team and committed to high quality work. • Must be able to generate detailed written records of the work accomplished in a timely manner.

  12. 10. Director/Senior Director, Biologics Process Development • Responsibilities: • The Process Development group designs, optimizes, scales and transfers highly productive mammalian cell culture processes for mAb development programs. • We seek a highly motivated professional to establish and lead the Process Development group within Chempartner Biologics. This individual will have responsibility for cell culture, purification and formulation of antibody products. • In addition, the candidate will participate in and lead interdisciplinary project teams, develop timelines and project goals, and present project updates. • As a senior leader, the candidate will specify and purchase instruments, set priorities for and supervise direct reports, and ensure that the group runs smoothly and is responsive to the needs and changing priorities of the department. • Requirements: • Basic qualifications are a Ph.D. in biochemistry, cell biology, chemical engineering or related discipline with a minimum of 10 years of combined post-doctoral and/or industrial experience. • Qualifications include substantial experience in using DOE to design high-productivity upstream or downstream processes for mAbs and knowledge and experience improving processes while maintaining comparable glycoprotein product quality. • A demonstrated leadership ability and strength in scientific analysis and creativity, as supported by publications, knowledge of ICH guidelines and experiences in contributing to CMC sections of regulatory submissions, and experiences guiding and motivating PhD-level staff are essential. • Excellent written and oral communication skills and supervisory experience are also required.

  13. 11. Biacore Scientist • Responsibilities: •  Hands-on scientific expertise and problem solving skills in Biacore analysis. • Co-ordinate with project teams to streamline the sample characterization process. • Performs Biacore instrumentation routine maintenance. • Fully document all protocols and results in notebook and compose summary report. • Requirements: •  Working knowledge and expertise in Biacore technique. • Proven hands-on skills in the performance of molecular interaction analysis. • Strong organization and communication skills, and ability to work within a team environment. • Ph.D, or BS/MS 2+ years of related experience in industrial or academic settings. • The individual must have proficient knowledge and expertise in Biacore and other techniques analyzing molecular interaction and binding kinetics.  • Experience working in an GLP environment, as well as practical knowledge in bioanalytical assays is desirable.   • The qualified candidate must be a highly motivated individual with proven skills in verbal and written communication and teamwork. • Proficient in English.

  14. 12. Director in Therapeutic Antibody Development  • Responsibilities: • Be responsible for generating monoclonal antibodies using various lead generation technologies, screening for binding, and carrying out initial characterization, in order to advance therapeutic antibody discovery programs from targets to selected lead  Ab candidates.  • Generate therapeutic monoclonal antibody candidates by hybridoma (using human immunoglobulin transgenic mice, wild strain mice, etc.), phage display, from single B cells of immunized mice, etc. • Perform the screening for selecting antibody candidates by using target-specific or cell-based binding assays. • Perform expression and conventional purification of antibodies, antibody fragments, or fusion proteins. • Characterize lead antibody candidates. • Maintain accurate and comprehensible written records, write clear reports and presentations. • Ready to adapt new technologies, and use them in research projects.  • Requirements: • Master's or Ph.D in Molecular Biology, Bio-Engineering, Cell Biology or a related field. • A minimum of 3 years of related work experience. • Demonstrated expertise and hands-on experience in the generation of therapeutic monoclonal antibody candidates by one or more of the following techniques: hybridoma (using human immunoglobulin transgenic mice, wild strain mice, etc.), phage display, or from single B cells of immunized mice. • Familiarity with a variety of cell-based functional antibody assays. • Well-organized and able to carry out several projects simultaneously; • Pre-clinical antibody project management experience is highly desirable.

  15. 13. Head of Compound Management and Assay Operations We are seeking an experienced and highly motivated biologist to head compound management and in vitro assay operations in our company. A candidate should have a Ph.D. degree in biological sciences with at least 2 years work experience or M.S with at least 5 years working experience in screening and assaying compounds in pharmaceutical or biotech companies. Experience in high-throughput screening of compounds, assay development and assay automation, compound dilution and liquid handling systems, as well as expert computing skills are highly desired. Previous experience in compound management is a plus but not required. In addition, strong organizational and leadership skills are required for taking this position.

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