Validation Officer - Auckland

Transcription

1 Validation Officer - Auckland As New Zealand s largest privately owned Pharmaceutical company based in West Auckland we have one of the most modern pharmaceutical manufacturing and testing facilities in Australasia. Requirements: We are seeking a suitably qualified Lab Personals with a BSc or equivalent tertiary qualification and a minimum of 2 years experience in a GMP environment. Preference will be given to those individuals who have experience in Pharmaceuticals Analysis. Validation, including manufacturing, process and cleaning validations. Experience in software validations would be advantageous. Responsibilities are diverse and include: Review, approval and implementation of validation documentation. Assisting in the coordination of validation activities. Checking and approval of validation data and some samples. Candidates must be able to demonstrate: Excellent communication and interpersonal skills. A disciplined approach with attention to detail. Critical thinking. Confident problem solving and decision-making. A proven ability to meet deadlines. A strong commitment to team success.

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3 Director/ Senior Director Regulatory Affairs - US Provide regulatory strategy for development, presentation and review of scientific data to facilitate the registration of drugs, devices and facilities, and maintain them in compliance. Build, develop, and train a skilled regulatory affairs organization. Ensure the completion of all regulatory related goals and objectives as determined by project teams and corporate partners. Requirements You re someone who wants to influence your own development. You re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point. B.S. degree in Pharmacy, Chemistry, Biology, Microbiology or related field; advanced degree preferred. 10 to 15 years industrial experience in biologic, medical device, IVD and/or pharmaceutical with minimum 5+ years in a Regulatory Affairs position at the associate director or higher level. 5 to 7 years management experience in a medical device, IVD or pharmaceutical company. Demonstrated work experience in all phases of device or drug registration and approval, from pre- to post-launch. CMC section experience is essential. Professional and scientific interface established within both professional societies and particularly with the FDA/other governmental entities. Prior experience or exposure to ex-us registration processes and requirements. Must be able to interpret and apply government regulations, make decisions on complex issues, and communicate effectively. Excellent cross-functional team leadership and participation skills. Highly organized and detail-oriented. Results and goals oriented. Excellent written and oral communications. Excellent presentation skills.

4 MARKETING TRAINEE Turkey The Position: To take part in marketing activities after the rotation program. Who you are: You re someone who wants to influence your own development. You re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point. - To have a university degree (to be graduated in 2008) on Biology, Chemistry, Pharmacy, Molecular Biology & Genetics, Chemical Engineering, Industrial Engineering, Economics or Business Administration - To have 'Advanced' level of English - To have Advanced level of MS Office applications - To be able to work abroad for a definite period of time - To have a driving license

5 Medical Laboratory Scientist Description The National Testing Centre, LabPlus, Auckland City Hospital has a vacancy for a Medical Laboratory Scientist. This small highly specialised department provides national newborn baby metabolic screening, biochemical genetics and national antenatal serum screening. This position is full time and is for work in all laboratory sections. The hours of work are 40 per week between 7.00 am and 6.00 pm by agreement. Requirements: Qualifications - registered or registerable Medical Laboratory Scientist with the New Zealand Medical Science Board. Desirable skills and experience: biochemical genetics testing hplc and other analytical instrumentation newborn screening (dried blood spot) technologies immunoassays Delphic laboratory computer system Microsoft Office.

6 Senior Lipid Chemist - Wellington Integrated Bio-active Technology Industrial Research Limited is New Zealand s leading industrial scientific research organisation. Our role is to source or discover leading-edge technologies then develop them into practical, focussed commercial business opportunities. A senior scientist vacancy has arisen at our Gracefield site and represents an excellent opportunity to join an internationally renowned research and development team working on an exciting long-term project in the area of lipid chemistry and technology. Key responsibilities, knowledge and qualifications: lead and/or make significant and innovative contributions to research projects perform experimental work at laboratory and pilot scale perform project planning and project design experience in standard and advanced lipid analysis methods is essential PhD or equivalent in lipid chemistry, natural products chemistry, or a related field The successful applicant will possess: Strong aptitude for experimental Research & Development Understanding and demonstrated experience in lipid research at a minimum of a laboratory scale Good project planning, organisational and problem solving skills An ability to work independently and in a supervisory role as part of a team Good oral and written communication skills

7 Hamilton Technical Product Manager Based in Europe, working as part of the commercial team to develop and support customers' and partners' science and protocols/workflow. Requirements include good knowledge of DNA extraction and detection, B.Sc. or PhD level in Biology or associated science skills are required. Technical Directors Based in San Diego, working as part of the commercial team to develop and support customer and partnership relationships as well as working on the new product development pipeline and specification. Extensive knowledge of DNA extraction and detection, B.Sc. or PhD level in Biology or associated science and three - four years business experience required. Scientist Be a key member of an expanding science team by leading R&D programs aimed at launching new products promptly and effectively. Work with the development team in solving customer/ collaborator problems or issues and to provide project management assistance to the R&D Leadership/ Team. Experience: Minimum qualification of an MSc in a biological sciences discipline. Knowledge and experience of common DNA manipulation techniques such as DNA extraction and PCR, and excellent record keeping and organizational skills.

8 PURPOSE OF POSITION Protein Separation Unit Supervisor Christchurch The position of Production Supervisor is a front line leadership position, responsible for the leadership and supervision of all aspects of the Proteins Separation Unit; ensuring the skilled manufacturing team completes their tasks in an efficient, safe, and compliant manner. The position requires full hands on application, involving the Team in all aspects of task completion. RESPONSIBILITIES Works with the team members and Export, Production Planning and Purchasing department (E.P.P.P) to establish, review, and execute a production schedule consistent with master schedule requirements for products. Coordinates team resources to ensure the most efficient use of time and materials. Organises and maintains production schedules on a daily, weekly and longer term basis to ensure: Implements and monitors process changes as required. Any plant or process changes or modifications must be discussed and approved with the Site Manager and other relevant parties (including but not limited to QA Officer / Project Leader) prior to implementation. Only on approval are the modifications to be implemented and appropriately actioned. Ensures adherence to quality standards established in process documents. Continually strives to improve product quality through the establishment of more effective or efficient manufacturing processes and quality testing. Effectively communicates the importance of total quality to the members of the team. Establishes and maintains individual training programs for staff. Trains staff using appropriate SOPs and batch sheets to the standard expected for ISO PERSONAL ATTRIBUTES AND SKILLS REQUIRED Education Requires a Bachelors degree in a technical field or the equivalent knowledge and experience. A major in Protein Biochemistry is preferred. Experience Requires a minimum of 2 years relevant work experience in a team leadership role with proven ability to handle process, business and personnel issues independently.

9 Research Technician Applications are called for the post of research assistant in the Fetal Physiology and Molecular Neuroscience Group at the Depts of Physiology and Anatomy with Radiology, at Auckland University. The applicant should have extensive experience in histological, immunohistochemical, western blotting and in situ hybridization techniques, and experience in laboratory based teaching. The ideal applicant will have a BSc or Masters degree involving neuroscience research. Person Specification Qualifications: The ideal applicant will have a BSc or Masters degree involving neuroscience research. Experience: The applicant should have extensive experience in histological, immunohistochemical, western blotting and in situ hybridization techniques, and experience in laboratory based teaching. Attributes and Skills: Attention to detail Good group member

10 Pathway Therapeutics Ltd Research Technician (in vitro screening) - Auckland Pathway Therapeutics is a newly formed company that seeks to develop inhibitors of phosphatidylinositol 3-kinases as a new therapy for cancer. We are seeking an enthusiastic self-motivated person to be part of the multidisciplinary team undertaking this exciting research programme. This position would suit a self motivated individual who is able to work independently within a team research environment to enable the team to achieve research milestones. The candidate must have an appropriate science degree or equivalent qualification, be well organised, have good verbal and written communication skills, good computer skills, and be meticulous in record keeping. This position will require some work outside normal working hours. You will have experience in drug screening, cell based biochemistry and enzyme assays. Knowledge of cancer biology is desirable. Full training will be given in all procedures as required. The position is based in the Department of Molecular Medicine and Pathology at the University of Auckland's Faculty of Medical and Health Science campus at Grafton. The role is full time and funded by a research contract.

11 Director, Regulatory Affairs - San Diego Description Proacta is a privately-held drug discovery and development company with offices in San Diego, CA and Auckland, New Zealand. The Company is developing a new generation of cancer drugs that uniquely target physiological attributes of solid tumors. Currently, Proacta is seeking a qualified candidate for the position of Director, Regulatory Affairs in San Diego, reporting to the Chief Executive Officer. Overview This role will oversee the global regulatory strategies and activities for drug development from candidate selection, through preclinical and clinical phases in the development, registration, and commercial marketing of the Company's products. Responsibilities include, but are not limited to: Participate vigorously in defining the business, clinical and regulatory strategy for each drug candidate Ensure preparation and completeness of regulatory filing from all areas (CMC, preclinical, clinical) Interface with regulatory authorities in US, New Zealand, and Australia Maintain current knowledge and expertise of new and revised regulations and guidelines of the regulatory environment in the US, New Zealand, and Australia, including ICH guidelines Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans Coordinate the completion of expedited safety reports ensuring reports are complete and compliant with all applicable regulations where clinical studies are being conducted Requirements Bachelor's degree in scientific discipline or health-related field Minimum of seven years pharmaceutical experience, with five years of hands-on regulatory affairs experience; international experience is a plus Regulatory Affairs Certification desirable Oncology experience highly desirable Evidence of active participation in the successful writing, assembly and acceptance of major regulatory submissions (INDs, NDAs) and supportive amendments or supplements Previous regulatory agency interactions (e.g. pre-submission meetings, EOP2, etc.) Perform job duties with minimal guidance Knowledge and understanding of ICH/GCP Strong oral and written communication skills, along with good organizational and planning skills are a must Must be willing to travel

12 [ Medical Science Liaison II - BioOncology - S. Cal Drug Devt - Med/Clin Affairs The Genentech, Inc. Medical Science Liaisons (MSL) function as field based members of the Clinical Science Organization. MSLs are scientifically trained professionals with strong clinical and / or scientific backgrounds. MSLs are expected to facilitate and implement the clinical strategies of Development through: * Facilitation of the Investigator Sponsored Trial program * Facilitation Genentech sponsored trials * Scientific presentations (advisory boards) Job Duties/Responsibilities: General: *Adhere to corporate compliance in all activities, including those related to clinical trials, scientific presentations, and responses to unsolicited requests for information. *Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings. Clinical Trials: support clinical trial programs within the team s therapeutic area as appropriate, including, but not limited to the following. *As the primary point of contact for I trial investigators and sites, effectively coordinate, facilitate, and monitor studies ensuring timely review, initiation, completion of trials, and publication of study results. *Evaluate, review and recommend revisions to IST protocols in support of clinical and scientific questions relative to the products *Manage timelines of publication plans in specific therapeutic areas *Identify, develop, maintain and build advocacy with potential investigators *Provide input into study design and site selection for Genentech sponsored trials Qualifications: Education, Experience, Knowledge and Skills: *Advanced Clinical / Science degree required (e.g. MSN, Pharm.D, PhD, MD). *Minimum 2 years clinical experience in relevant therapeutic area required. *Experience in clinical / scientific trial development and / or trial management preferred *Pharmaceutical / biotech industry experience preferred. *Demonstrated high quality interpersonal and communication skills including presentation skills. *Good computer skills including proficiency with Microsoft Word, PowerPoint, and Excel. *Willingness to travel extensively, typically between 50% and 75% of the time.

13 Senior Research Associate - Medicinal Chemistry South San Francisco, CA Description Responsibilities: We are seeking a Senior Research Associate in the medicinal chemistry department who will be responsible for the design and synthesis of biologically active small molecules. Qualified individuals will participate in our small molecule drug discovery efforts as part of a multi-disciplinary project team. Requirements: B.S. or M.S. in chemistry and 8 years minimum experience in synthetic organic chemistry environment. Demonstrated expertise in multi-step synthesis, purification and structural characterization of organic compounds directed towards the evaluation of therapeutically relevant targets; proven ability to participate in compound design guided by target SAR analysis, structural insights and ADME information. Ability to effectively communicate and discuss scientific results in interdisciplinary research teams.

14 Sr Manager, Bus Development South San Francisco, CA *Business Development is seeking a Sr. Manager to join their Immunology Group, which focuses on identifying promising drug candidates in the areas of autoimmune diseases and disorders, inflammatory conditions, infectious diseases, and cancer immunotherapy. *The successful candidate will be responsible for sourcing new opportunities and leading initial evaluations, advanced due diligence reviews, term sheet discussions and contract negotiations for deals and collaborations that are consistent with the company's business objectives. * Responsibilities will include close collaboration with internal cross-functional stakeholders to implement and refine the BD Immunology strategy, actively seeking out opportunities that are consistent with that strategy, coordinating due diligence activities, performing financial analysis to value opportunities, negotiating with potential partners, and making presentations and recommendations to senior management. * The BD Sr. Manager will work with various departments in the company, such as Finance, Research, Exploratory Clinical Development, Clinical Development, Manufacturing and Commercial to assess the technical merit and strategic fit of licensing opportunities relative to Genentech's existing portfolio. Requirments: *An MD in rheumatology, pulmonology or other relevant field is required. *An MBA, JD and/or significant business experience in the industry, are also required. *The position requires significant negotiation experience, strong interpersonal skills, superb oral and written communication skills, analytical capabilities, and team leadership experience. *The successful candidate must have a demonstrated history of successfully leading project teams or strategic corporate initiatives and have a strong background in biotechnology and/or pharmaceutical drug development. *Previous experience in business development licensing and/or negotiating agreements is preferred. *The person selected must be skilled at presenting findings and recommendations to senior management. *The successful candidate should also have an established network of contacts in key academic institutions, biotechnology and pharmaceutical companies.

15 Hospital Sales Representative - Australia You'll be influencing key Infectious Disease (Hepatitis C) and Gastroenterology Physicians. Forming part of an experienced and highly successful hospital sales team, you'll be attending and facilitating meetings with Doctors both locally and interstate. Your territory includes Brisbane South, Gold Coast and regional areas; Lismore, Northern NSW, Rockhampton, Townsville and Mackay. Taking responsibility for the performance of your territory, you will be achieving goals based on sales targets, tailoring customer plans and developing and maintaining your sales business plan. Your track record as a pharmaceutical sales specialist and ability to build productive relationships with key medical professionals will enable your success in this role. Who you are: You re someone who wants to influence your own development. You re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point. Sharing our passion for pioneering products, you'll find yourself at home here, working with like-minded people looking to make their mark. Degree qualified in science, you'll have outstanding communication and organisational skills. With a willingness to travel in QLD and Northern NSW, you won't be the only one going places, your career will be too.

16 Technician - Applied Plant Pathology Hawke s Bay This full time position provides technical support within a team undertaking a combination of applied and fundamental research on the detection, biology and control of microorganisms responsible for diseases in horticultural crops. The range of responsibilities includes isolation and culture of microorganisms, plant propagation, trial management and the analysis of data collected in the field and laboratory. As a minimum, you ll have a BSc (or equivalent technical experience) in horticulture, microbiology, plant science or similar. Practical experience of field and/or laboratory-based plant pathology or microbiology is preferable. A driver s licence is required. ACCOUNTABILITIES: 1. Execution and/or management of applied disease control trials in fruit crops 2. Field and laboratory data collection and analysis 3. Isolation and culture of micro-organisms 4. Propagation and maintenance of plant material 5. Assistance in the preparation of client reports and delivery of client presentations 6. Assistance in the preparation of scientific papers and presentations 7. General maintenance and housekeeping of plant pathology laboratories. PERSON SPECIFICATION Professional Knowledge and Skills: 1. Ability to work independently as well as in a team environment 2. Flexibility to work on a range of different pathogen/crop host combinations in both the glasshouse and the field 3. Ability to work in sterile culture and microscopy techniques 4. An organised and methodical approach to tasks and commitment to effective project management 5. Relevant computing skills including word processing, spreadsheets, graphical and statistical packages 6. Effective verbal and written communication skills 7. Ability to plan work schedules to meet agreed deadlines 8. Ability to operate within recognised safety standards to ensure personal and team safety

17 Clinical Coordinator Canada Montreal Job Description: As a Clinical Coordinator, your main responsibilities will consist of the following: In collaboration with Clinical Project Managers and / or Clinical Specialists, ensure coordination of local clinical activities such as Clinical Trials, Clinical Programs, Health Management initiatives and Special Access Programs; in full compliance with Standard Operating Procedures (SOPs), Local Working Procedures (WPs), Good Clinical Practice (GCPs) and any applicable Health Canada requirements. Interact and communicate with external customers (Health Care Professionals, Investigators, Study Coordinators, Contract Research Organizations) regarding Clinical Project requirements (eg. Product Monograph requirements, Clinical trial documentation, Data Collection Form completion, Study Material needs etc ). Ensure timely follow-up of Clozaril patient compliance to comply with Health Canada requirements. Ensure the transfer of all safety, clinical and problematic situations to the Clinical Specialists and / or Clinical Project Managers. Process the reporting of all Serious Adverse Events received according to Novartis standards. Coordinate the process for contracts / clinical trial agreements and oversee tracking of project budgets. Ensure proper filing and tracking of project related documentation. Provide and maintain technical/practical training, support, and/or assistance to both external and internal project database users. SKILLS: Communication skills - Must apply interpersonal skills in order to properly communicate and understand customer needs specific to Health Management & Clinical programs. Computer Skills - Strong computer skills, with the ability to quickly adapt to different software. Able to work quickly and efficiently on the project relevant computer programs, thus properly interpreting the information exchanged with customers. Training Skills - Must be able to train remote customers on Health Management program procedures and the use of relevant tools (i.e. web-based systems). Flexibility - Adapts schedule in times of heavy workload, with the ability to multitask. Minimum requirements University degree or other post secondary education certificate is a definite asset Superior organizational and time management skills A minimum of 4-5 years relevant experience Excellent communication skills, both oral and written Fluently bilingual (written and spoken) Demonstrates attention to detail

18 Job Description: Cellular Assay Development Technician Switzerland Basel As part of the cellular biomarker group we are currently looking for a highly motivated Biomarker Scientist who will conduct experiments and manage the technical lab activities. The person will be responsible for: Development and validation of innovative cell based assays with special focus on flow cytometry, proliferation assays, receptor occupancy assays, and other related technologies for the measurement of cellular biomarker Development and validation of immuno-assays: single ELISA and multiplex based assays (Luminex, MSD,..) Implementation (sample measurement) of validated biomarker assay in clinical studies and pre clinical studies. Design, perform and oversee experiments in assigned projects with minimal supervision. Provide input for data evaluation, interpretation and for relevant conclusions Oversee assay development and implementation at CROs Contribute to write reports in form of tables, graphs, etc. Minimum requirements Complete education as laboratory technician with 1-3 years industry experience or University degree (without PhD.) and industry experience. Understanding, knowledge and experience in flow cytometry, cell based assays, immuno-assay (ELISA, Multiplex) techniques, and relevant laboratory tools and procedures. Basic knowledge in immunology and cell biology Analytical thinking and willingness to accept responsibility. Computer skills (Excel, Word, PowerPoint, Softmax pro, DIVA, CellQuest,..) Good oral and written communication skills in English.

19 Clinical Research Scientist - China Job Description Assists Medical Advisor in determining the feasibility of conducting the clinical trial and prepar-ing relevant documents. Takes an active role in the internal project management group in working closely with medical advisor, drug registration officer and brand manager. Responsible for the identification of potential investigators and clinical sites. Coordinates Regulatory Authority and Ethics Committee applications and approvals Responsible for study drug management, including the distribution of trial supplies, including trial medications. Liaises with local depot to ensure timely and reliable trial materials distribution and accountability. As the key responsible person of Novartis for projects that is contracted out to 3rd party (e.g. CRO) to implementation, ensure the projects to be conducted according to GCP and Novartis relevant SOPs. Develops trial subject recruitment strategies and plans. Assists to organization of investigator meetings and chairs regular internal trial management meet-ing. Ensures all SAEs are appropriately reported within the time frame required by GCP, the protocol and the SOPs and coordinate communication with local CS&E. Provides monthly trial progress report to relevant stakeholders Ensures the investigator payments are processed according to trial budget plan. Assists investigator to ensure the accuracy and completeness of TMFs when trial close. Minimum requirements: BS or higher degree with medical or pharmacological background Fluent English (oral and written).

20 Expert Publication Writer - India Description To prepare high quality manuscripts, abstracts and other communication tools (slide presentations, posters etc.) for publishing in indexed scientific/medical journals or for presentation in scientific/health Authority meetings. To liaise globally with internal and external contributors, including authors & Key Opinion Leaders, Novartis publication managers and external editorial teams. To assist in publication planning and communication strategies in therapeutic areas. Minimum requirements PhD in Life Sciences/Applied Biology MD in Internal Medicine/ Pharmacology MBBS, MPharm, MSc by Research Additional Requirements: Publications in indexed journals/ high quality scientific writing, including previous writing experience in safety documents (including narratives) and clinical study reports (CSRs) Relevant experience (at least 2-3 years) in leading pharmaceutical/research companies, including medico-marketing, or academic/research institutions Disease/Therapeutic area expertise Excellent communication and project management skills

21 Laboratory Technician - Wellington Mesynthes is a tissue regeneration company developing novel scaffolds to stimulate tissue repair. Its primary pipeline is being developed from a proprietary scaffold derived from a unique form of extracellular matrix which elicits a strong regenerative response. We are seeking to appoint a full time Laboratory Technician reporting to the Scientific Director. The candidate will join a small research team focused on the development and commercialization of extracellular matrices. This hands on position will develop, implement and execute designated research activities for research projects as part of the research team. The position requires a high level of technical competency, self-motivation and independent thought. There is scope within the research program for professional and skills development. Requirements The ideal candidate will possess a BSc (Hons) or equivalent, and possess 3 to 5 years academic or industrial experience in a research laboratory setting. Skills in biochemical techniques including (but not limited to) Western blot, ELISA, dot-blot, immunohistochemistry, mammalian tissue culture are required. Additional skills in the preparation, implementation and working under quality assurance systems (e.g. GLP, GMP) are desirable. Computer competence, as well as, excellent oral and written communication skills are expected.

22 Scientists - Palmerston North Description Are you passionate about seeing your ideas turned into commercial products? See your ideas from infancy to implementation working with our team of recognised experts developing novel dairy ingredients for cheese, beverage, nutrition bar, cultured, and snack food applications. Focussed on design and modification of dairy proteins, you will apply your understanding of chemistry and physics to these ingredients and the food systems they go into. As New Zealand's biggest company and the world's largest exporter of dairy products our commitment to innovation has developed into an international reputation for leading-edge R&D. We have opportunities for highly qualified Food Scientists, Engineers and Technologists to join our team in Palmerston North. Food Technologist (Cheese) Be part of a team developing new ways of making cheese products and designing new protein ingredients that are valued by our global cheese ingredient customers. It's exciting and challenging work with a product that is in high demand by a dairy conscious world. Process Engineer / Food Technologist (Cultured Foods) Be part of a team actively designing and developing milk protein ingredients that provide texture solutions in cultured food applications. Your ability to draw on scientific knowledge and link it with your product development and processing expertise will be critical to develop value propositions for our customers. Applications Technologist (Beverages) Be part of a team that works on market leading protein ingredients for beverages. This is not milk as you know it! These are new mainstream sports beverages that the world's largest beverage companies want us to develop. Food Scientist / Food technologist (Snacking & Convenience) Be part of a team developing the next generation protein ingredients for nutrition bars and betterfor-you snack foods. We need your scientific brain to help us unravel the complexity of intermediate moisture foods and translate this knowledge into the ingredients and products of the future.

23 Toxicologist- Bangalore, India Qualifications: Hands-on experience in designing and directing GLP tox and/or safety pharmacology studies involving protein and/or small molecule drug candidate. Ph.D. with 4+ years in toxicology preferably from industry. Knowledge and experience in regulatory submission is highly desirable Self-motivated, attention to detail, dedication to quality, and willingness to learn Ability to work independently and interdependently in a supportive multi-functional team setting. Working knowledge of GLP regulations Demonstrated in vivo experience Highly developed medical writing skills Responsibilities Design, conduct and carry out preclinical safety/toxicology and other preclinical studies Coordinate, supervise, and manage contract GLP toxicology and safety pharmacology studies Responsible for protocol generation, initial selection and negotiation with CROs, study monitoring, data collection and analysis, and report writing/drafting Assist preparation of preclinical portion of regulatory submissions such CTD, BLA and IND. carrying out risk assessments on potential new drugs to see they are safe to test on humans; assessing whether the benefits of the drug outweigh the risks; carrying out work on cells and tissues before tests are carried out on animals and then humans.

24 Drug Metabolism Scientist - China Description Develop in vitro drug metabolism assays including protein binding, liver microsomes, hepatocytes and other cell culture based assays Design and conduct in vitro drug metabolism studies to support various drug discovery and development projects Compile and interpret experimental data and preparation of protocols and study reports Maintain high level of professional expertise through familiarity with English scientific literature Prepare SOPs participate in establishment of in-house laboratory, safety, quality and GLP compliance programs Required Skills Hands-on technical skills in enzyme and cell culture based assays Strong knowledge in enzymology is highly desired Good interpersonal, communication, multi-tasking and presentation skills Able to troubleshoot procedures. Track record of exercising initiative, must possess the ability to examine data and solve problems and make decisions Qualification A Ph.D. or M.S. in chemistry, biochemistry or related field Experience2 or 5 years experience, respectively

25 Scientist-Molecular Biology - US As part of a multi-disciplinary team including Product Research, Product Development and Operations, the successful candidate will contribute to process development and transfer of consumable products to manufacturing. In this role he/she will: - Produce prototype development reagents according to research design. Assist in development of design verification test plans to stated requirements and specifications. Implement and execute testing using PCR, real time PCR and sequencing instrumentation and software. Analyze data and communicate results in both oral and written form. Requires a Bachelor's Degree (chemistry, biochemistry, molecular biology) with 4 years of industry experience or a Master's Degree with 2 years of industry experience Experience in product development and commercialization, quality systems, report writing & documentation skills are essential. Demonstrated scientific expertise with sample preparation, PCR, RT-PCR, real time PCR, sequencing and good general molecular biology skills are required. Familiarity with Production and Manufacturing systems, ISO regulations and QSR systems as well as assay optimization using Design of Experiment (DOE) and statistical analysis are desired. Knowledge of standard computer skills, data analysis, and good communication skills are expected.

26 Project Coordinator-US Bio-Rad Laboratories, Inc. ranks among the top five life science companies worldwide, and maintains a solid reputation for quality and innovation. It develops, manufactures and markets a complete range of laboratory products used for research in molecular biology, biochemistry, microbiology, genetics, immunology, and chemistry. The group serves a growing base of customers in academic and biotechnology research, and in the pharmaceutical industry. Recently, the group introduced new products for use in the areas of DNA amplification, proteomics, and food testing, three fields in which Bio-Rad remains at the center of discovery. Requirements: BA/BS is required. Minimum 0-2 years project management or working in new product development of Gene Expression reagents or instruments. Project coordination experience in new product development desired. Good communication skills. Ability to work with teams and conduct meetings and manage project coordination activities. Skilled in use of and reporting from project management systems such as MS Project. Proficient in Word and Excel, and ERP system. Strong team player, energetic, willing to work closely with Project Managers and R&D management. Must require minimal supervision. Duties and Responsibilities: Coordinate activities between R&D, System Integration and Manufacturing to introduce new reagents and instruments. Determine project timeline and scope. Work with project manager to assess product needs and resources, maintain documentation to support the new product development SOP's. Facilities team meetings and follow-up on action items. Routinely inform key stakeholders of project milestones, plans, status, and decisions through regular reporting and communication. Maintain easily accessible, easily understood project documents in electronic/print format.

27 Senior Scientist Supervisor Assay Development - Australia The successful applicant will be a self-motivated individual, expected to interact broadly across the entire R&D organisation. In this position you will be responsible for directing the department s assay development strategies and applying your analytical skills to support the technical development of release assays appropriate for the stage of development. You will have a significant scientific track-record and be capable of providing expert advice and guidance. You will be responsible for the direction and the quality of results of a small unit of scientists to design or adapt assay methods for investigating the target protein during scale-up, manufacturing, formulation and stability studies of the final product. This is a specialised position, requiring expert knowledge in assay development for protein or peptide applications. Experience in the rapid development, qualification and validation of HPLC, ELISA and other assays for proteins are a necessity. A working knowledge of other biochemical techniques, e.g. electrophoretic or enzyme activity methods, or experience in plasma-derived proteins would be of advantage. In addition, experience managing the outsourceing of assay development to contract facilities would be an advantage. Requirements The successful applicant will possess a PhD or equivalent qualification in Sciences, e.g. Biochemistry/Immunology, or other relevant discipline with a focus in Analytical Sciences. At least 5-years experience with a significant involvement in assay development, preferably with a link to the biotechnology industry.