Associate Director, LM Bioanalytical Services

Transcription

1 Associate Director, LM Bioanalytical Services Overview: Responsible for leading method development, method validation/qualification and sample testing in large molecule bioanalytical service group, with immunogenicity testing and other antibody related testing focus. Responsibilities: Supervise personnel associated with bioanalysis in large molecule BAS group. Ensures optimum personnel performance through leading by example, motivation and performance recognition. Responsible for evaluating new technology in the field of large molecule bioanalysis, which include but not limited to PK, ADA, NAb, Biomarker and other antibody related analytical testing. Prepares high quality reports and study summaries for management and sponsors. Functions as a study director, principal investigator, or project coordinator including serving as a primary contact for sponsors. Responsibilities include planning and supervising more complex and exacting research studies. Actively participate in lab operation efficiency improvement efforts and promote team work and collaboration. Maintains effective cost control within the LM bioanalytical group through implementation and maintenance of efficient and effective work scheduling coupled with creative and well thought out study planning and design. As a department management team member, assists site top managment for overall functions and operation in bioanalysis and other departments. Ensures compliance with company safety policies, practices, and procedures in order to maintain a safe work environment and minimize or eliminate injury. Maintains close professional contact with updated regulatory guidance and industry developments in all critical analytical areas to ensure that laboratory functions operate at state-of-the art level and are compliant with all pertinent Good Laboratory Practices (GLP). Qualifications: Experience / Training / Education: Ph.D. degree in biology, biochemistry, molecular biology, immunology, or equivalent 10 years of relevant experience in large molecule bioanalysis, drug development, or equivalent 3-5 years of people management experience Any similar combination of education and experience

2 Knowledge / Skills / Abilities: Expert knowledge of biological sciences Expert knowledge of commonly used scientific concepts, practices, and procedures within large molecule analytical/bioanalytical field Expert in immunoassay and other relevant techniques for large molecule analysis, in addition to appropriate regulatory guidelines A thorough understanding of the services provided by CROs Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Excellent interpersonal skills Ability to research and evaluate applicable types of data and research results Computer skills: skilled at internet research, MS Word, Excel, Outlook, PowerPoint, and Watson LIMS. Microsoft Project knowledge a plus Ability to work under pressure of multiple projects and deadlines Ability to effectively prioritize workload and manage changes in direction Ability to work in a team environment Familiarity with and adherence to regulatory guidelines consistent with site requirements Physical Requirements: Must be able to work in an office environment with minimal noise conditions Must be able to work in Lab setting with exposure to biohazards /Chemicals Must be able to wear appropriate PPE Must be able to work in environment with variable noise levels Ability to stand /Sit/walk for long periods of time Ability to crouch, bend, twist, and reach Clarity of Vision Ability to identify and distinguish colors Must be able to perform activities with repetitive motions Ability to climb Ladders / Stairs employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

3 Associate Scientist I- Metabolism Overview: Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small & large molecule Bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. XBL is seeking an Associate Scientist I - Metabolism to join our Drug Metabolism Department. employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Responsibilities: With minimal supervision after training, individual performs routine laboratory techniques (e.g. biological sample processing, HPLC analysis, in vitro metabolism incubations, drug and drug interations, radiolabel isotope 14 C and 3 H handling.) Receive specific instructions on assigned task and expected results. Maintain research notebooks in a well-organized manner. All necessary documentation is recorded. Perform routine calculations, tabulate and record results. Prepare standard solutions used in the laboratory. Prepare accurate data summary with minimal supervision. Maintain and calibrate laboratory equipment. Assume responsibility for technical accuracy of work. Learn and enhance technical knowledge of pharmaceutical areas, metabolism chemistry, and/or environmental. Comply with all safety rules, practice good housekeeping, and maintain safe workplace without supervision. Understanding of Good Laboratory Practices and EPA, FDA, or other regulation pertaining to the study. Promote implementation and compliance with XBL safety policies, practices, and procedures in order to maintain a safe work environment and minimize or eliminate injury. Other duties as assigned. Experience / Training / Education: Bachelor s degree in chemistry, biology, or a related discipline 0-2 years of relevant experience, or equivalent Any similar combination of education and experience

4 Staff Scientist Overview: Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small & large molecule Bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. XBL is seeking a Staff Scientist I - Metabolism to join our Drug Metabolism Department. employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Responsibilities: Prepare dose formulation for animal dosing and perform dose formulation analysis. Plans and carries out experiments and associated research assignments, e.g. biological sample processing, in vitro/in vivo metabolism studies, metabolite profiling and identification, drug and drug interactions, etc. Handle radio-labeled materials (e.g., 3 H, 14 C). Efficient time management to complete the assigned task May act as study director/principal investigator. Operates and/or oversees the operation of equipment to acquire experimental data. Compiles, calculates, plots, and analyzes, and with experience, interprets data; records and maintains data in accordance with accepted standards and practices. Assumes responsibility for technical accuracy of work. Thorough understanding of Good Laboratory Practices and EPA, FDA, or other regulations pertaining to the study. Promotes implementation and compliance with XBL safety policies, practices, and procedures in order to maintain a safe work environment and minimize or eliminate injury. Maintains and enhances technical expertise and knowledge of environmental, metabolism chemistry, and/or pharmaceutical areas. Identifies safety hazards and initiates corrective action. Assists in the safety training for subordinates and/or less experienced staff. Assists in training Associate Scientist, Assistant Scientist, and Laboratory Assistant. Collaborate with other scientists in a team to support metabolism studies.

5 Other duties as assigned. Qualifications: Experience / Training / Education: Bachelor s or MS degree in chemistry, pharmaceutical, or a related discipline 5-7 years of relevant experience with advanced responsibilities in research and development, or equivalent Any similar combination of education and experience Knowledge / Skills / Abilities: Experience with formulation and radioisotope handling (e.g., 3 H, 14 C). Experience and knowledge of in vivo and in vitro metabolism. Basic knowledge of commonly used scientific concepts, practices, and procedures within a biological or chemical R&D laboratory setting Highly motivated with excellent communication and organizational skills Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Effective interpersonal skills Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint Ability to work under pressure of multiple projects and deadlines Ability to effectively prioritize workload and manage changes in direction Ability to work in a team environment Familiarity with and adherence to regulatory guidelines consistent with XBL requirements employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

6 Research Scientist I- Metabolism Overview: Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small & large molecule Bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. XBL is seeking a Research Scientist I - Metabolism to join our Drug Metabolism Department. employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Responsibilities: Identification of drug metabolites using liquid chromatography-tandem mass spectrometry, NMR, and other analytical methodologies. Elucidation of metabolic pathways involves the identification and quantification of metabolites in biological matrices (e.g., blood, plasma, excreta) using HPLC with radioactivity detection and/or LC-MS/MS. Conduct in vivo and in vitro metabolism studies. Conduct LC-MS/MS analysis and interpretation. Handle radio-labeled materials (e.g., 3 H, 14 C). Serve as Study Director/Principal Investigator. Implements new techniques and instrumentation to improve technical operations. Prepares scientific reports that document the analytical results and interpretation for the identification of drug metabolites. Authors scientific papers, which are published in peer reviewed journals, and presented in scientific meetings. Collaborate with other scientists in a team to support metabolism studies. Knowledge of in-vitro and in-vivo drug metabolism processes and related bioanalytical techniques. Qualifications: Training / Education: Ph.D. degree in a chemical, pharmaceutical, or equivalent Post-doctoral experience is desirable Any similar combination of education and experience Experience / Knowledge / Skills / Abilities: Experience in structural characterization and identification of drug metabolites using LC/MS/MS. Experience and knowledge of in vivo and in vitro metabolism.

7 Experience with radioisotope handling (e.g., 3 H, 14 C) biochemical techniques is a plus. Experience and knowledge in design of NMR experiments, operation, and data interpretation as applied to identification of unknowns is a plus. Experience and knowledge in agrochemical and animal health areas is a plus. Ability to learn quickly and effectively in a dynamic laboratory environment Ability to follow instructions and research plans with limited supervision Ability to work in a team environment Ability to understand and adhere to regulatory guidelines consistent with XBL requirements Basic knowledge of commonly used scientific concepts, practices, and procedures within a biological or chemical R&D laboratory setting Highly motivated with excellent communication and organizational skills Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Effective interpersonal skills Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint are desirable employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

8 Research Scientist BA Overview Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small molecule Bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. XBL is seeking a Research Scientist to join our Bioanalytical Department. Responsibilities: Develop and validate animal health bioanalytical assays using LC-MS/MS. Perform bioanalytical sample testing for PK/TK studies. Perform extraction of plasma, tissue samples, LC-MS/MS instrument operation, maintenance and troubleshooting. Trained in SOPs. Write method development and bioanalytical report. Present experimental results. Working with other scientists in studies. Solid understanding in analytical chemistry. Expert in chromatography, solvent, buffer, and reagent preparations and applications. Must possess strong Analytical Chemistry skills; LC-MS (API4000 or 5000 preferred), Shimadzu HPLC systems, and troubleshooting. Experience in LC-MS/MS, bioanalytical assay development, validation, and sample testing. Experience in dose formulation assay development, validation, and sample assay by LC/MS and LC/UV. Experience with radioisotope handling (e.g., 3 H, 14 C) biochemical techniques is a plus. Must possess experience in Good Laboratory Practice (GLP) and have a thorough understanding of any industry, FDA, or other applicable regulatory guidance pertaining to the conduct of bioanalytical activities. Qualifications: Experience / Training / Education: Ph.D. degree in chemistry, biology, or a related discipline, or equivalent 1-2 years of relevant laboratory experience in LC-MS/MS bioanalysis, or M.S At least 5 years of relevant laboratory experience Any similar combination of education and experience Knowledge / Skills / Abilities: Knowledge of commonly used scientific concepts, practices, and procedures within pharmacology or animal science field Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Effective interpersonal skills

9 Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint Knowledge of Laboratory Information Management System (LIMS) Knowledge of Data Acquisitions and Operating Software as Analyst, MassLynx. Up-to-date knowledge of Bioanalytical techniques in method development and sample analysis of analyte and its metabolites in biological matrices. Ability to work under pressure of multiple projects and deadlines Ability to effectively prioritize workload and manage changes in direction Ability to work in a team environment Familiarity with and adherence to regulatory guidelines consistent with XBL requirements

10 Job Description Job Title: Reports to: Location: Exempt/Non-exempt: Department: Postdoctoral Research Associate Group Leader or Above Plainsboro, NJ Exempt Large Molecule BAS Primary Duties and Responsibilities: Knowledge of large molecule bioanalysis processes and related bioanalytical techniques such as ELISA, PCR, FACS, Automation, cell-based assay, enzyme activity assay, etc. Design and perform large molecule PK, biomarker, and immunogenicity method (ADA and Nab) development, validation, and sample analysis. Perform bioanalytical analysis and data interpretation of large molecule PK quantitation, immunogenicity assay results, enzyme activity, PCR and other relevant assay. Prepares protocols and reports. Collaborate with other scientists in a team to support large molecule studies. Knowledge of pharmacokinetics, immunogenicity, and biomarker studies, and enzyme kinetic analysis. Experience and knowledge of Good Laboratory Practices (GLP). Highly skilled in conducting research, data interpretation, report writing, and verbal communication. Proven track record of analytical method development (ELISA, cell-based assay, PCR). Relevant industrial experience will be an advantage. Experience / Training / Education: Ph.D. degree in immunology, molecular biology, biochemistry, cell biology or equivalent 1-3 years of relevant research experience, or equivalent, is desirable Any similar combination of education and experience

11 Knowledge / Skills / Abilities: Basic knowledge of commonly used scientific concepts, practices, and procedures within a biological or chemical R&D laboratory setting Highly motivated with excellent communication, organizational and interpersonal skills Well organized, detail oriented, and adaptable to changes Effective oral and written communication skills Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint are desirable Ability to learn quickly and effectively in a dynamic laboratory environment Ability to follow instructions and research plans with limited supervision Ability to work in a team environment Ability to understand and adhere to regulatory guidelines consistent with WuXi AppTec requirements employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

12 Post-Doc In Bioanalytical Division Responsibilities: XenoBiotic Laboratories, Inc. (XBL), a GLP-regulated Pharmaceutical Development Contract Research Organization located in central NJ, is seeking an experienced Post-Doc with expert knowledge of Bioanalysis of analytes and its metabolites in biological matrices. The position requires a solid background in Chemistry, method development, method validation utilizing various techniques, LC-MS/MS, and the use of Laboratory Management System (LIMS) in regulated environment.. XBL has a long history of providing high quality science and data related to our Sponsors nonclinical, clinical pharmaceutical, and animal health programs involving new candidate drugs in development as well as agrochemical-related programs. The successful individual selected for this position will be able to: Develop, validate and provide guidance in sample analysis of drug candidates in various biological matrices. Perform trouble shooting of the assay and provide guidance to the Principal Investigators (PIs) in resolving analytical problems in timely fashion. Prepares scientific Method Validation Plan (MPV) and Sample Analysis Plans (SA). Collaborate with other scientists in a team effort to complete all the bioanalytical assignment on time under a tight schedule to meet the timelines for the Sponsors Qualifications: The ideal candidate for this position will have a Ph.D. in Chemistry, Biochemistry or a related field with an equivalent combination of education and experience that provides the knowledge, skills, and abilities to perform the job requirements. Experience with small molecule LC-MS/MS analysis and interpretation. Experience in method development utilizing various techniques Experience in unitizing liquid handlers for sample analysis and aliquotting. Knowledge of various plat forms of MS/MS as Analytst and MassLynx Experience and knowledge of Good Laboratory Practices (GLP). Highly skilled in conducting research, data interpretation and report writing. Knowledge of utilizing Laboratory Information Management System (LIMS). Relevant industrial experience will be an advantage. Experience in trouble shooting LC-MS/MS equipment. Experience in trouble shooting analytical methods on timely fashion Candidates must be detail-oriented with strong problem-solving skills and a collaborative, teamoriented approach; computer proficient in a Windows environment; and possess superior interpersonal, presentation, communication, and organizational skills.

13 We offer a comprehensive salary and excellent benefits plan. For immediate consideration please forward your resume with salary requirement to: hr@xbl.com XENOBIOTIC LABORATORIES, INC. We are proud to be an equal opportunity employer. EEO M/F/D/ employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

14 Pathologist Overview: We are seeking a veterinary clinical pathologist to actively contribute to projects from target selection/validation through to late stage toxicology studies. The successful candidate will contribute to the selection and efficacy/safety assessment of biologic and small molecule therapeutics. The candidate must be ACVP certified. Expected travel to Suzhou Responsibilities: Perform the complex microscopic evaluation and interpretation of tissue sections from animals exposed to test materials and correlate these findings with necropsy, organ weight and clinical pathology findings. Author comprehensive pathology narrative reports of microscopic, gross, and clinical pathology findings, while meeting report deadlines. Supervise necropsies and provide scientific guidance to necropsy technicians to ensure accuracy and compliance with protocols and SOP s. Communicate the significance of pathologic findings to study directors, clients and other individuals. Participate in histopathology consultations and peer reviews with other pathologists Attend pre-initiation and/or pre-necropsy meetings. Perform internal peer reviews of in-house toxicology reports that include interpretations of Anatomic Pathology data. Work with laboratory scientists and other experts to design protocols and generate impactful data and interpretations on target selection and expression, therapeutic efficacy, early safety assessment, issue resolution, pathobiology mechanisms and biomarker studies. Responsible for management of medical technologists at laboratories Establishing seamless interaction between clinical pathology scientists and immunobiologists. Mentor the laboratory staff in their growth and career development, and assure quality laboratory results. Analyze and integrate datasets from nonclinical studies and programs in support of drug discovery and development. Responsible for representing and reporting interpretations and making recommendations and decisions for project teams in a collaborative environment. Qualifications: Skills & Abilities Ability to evaluate tissue sections from animals, including the interpretation of histomorphologic findings for each tissue of every animal, as well as selected special stains and procedures. Ability to formulate pathology tables by direct entry of all histomorphologic findings into a computerized data collection system.

15 Ability to conduct necropsies and recognize, describe and interpret findings at necropsy. Ability to provide scientific guidance and feedback to histology technicians to correct artifacts and prevent reoccurrence of technical problems, and to ensure accuracy and compliance with protocols, SOP s and client expectations of quality histotechnology. Excellent verbal and written communication skills. Excellent interpersonal skills. Experience in toxicologic pathology desirable. Strong communication skills, proven negotiating skills and be a team player Education & Professional Experience DVM/VMD degree or equivalent Formal pathology residency or graduate studies (i.e. MS, PhD) at an institution in which the training of veterinary pathologists is a primary function Must be Board certified by the American College of Veterinary Pathologists. Experience 5+ years of experience in a biotechnology or pharmaceutical company. employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

16 Associate Quality Assurance Specialist Overview: Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. XBL is seeking a Associate Quality Assurance Specialist to work in a GLP regulated research environment. employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability Responsibilities: Primary Duties and Responsibilities: Maintains a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and any other related Regulations which may apply to XBL activities. Evaluates current laboratory practices. Recommends changes or modifications to laboratory procedures in order to facilitate compliance with GLP standards. Conducts audits (protocol/plan, raw data, and final report audits for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated) and in-lab critical phase inspections of any GLP-regulated study performed at the laboratory for conformance to the final protocol/plan, SOPs, and relevant GLP regulations. Conducts inspections of laboratories/facilities Conducts audits of employee training files. Prepares written records of all inspections and audits. Submits findings to the study director,and/or principal investigator (or laboratory supervisor, when appropriate) and management, indicating deviations from or conformance with GLPs, protocol/plan, methods and SOPs. Reports periodically to QA management regarding quality issues and status of inspection/audit activities. Assists in reviewing, writing, and maintaining up-to-date SOPs and controlled documents for the QA unit. Updates the master schedule as required by GLPs. Other duties as assigned by QA management Qualifications: Experience / Training / Education: Bachelor s degree in biology, chemistry, or related field.

17 At least 2 years of experience in QA or QC, with focus on bioanalytical Familiarity with Good Laboratory Practice standards and experience working in a GLP regulated research environment. Any equivalent combination of education and experience Knowledge / Skills / Abilities: Knowledge of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and commonly used concepts, practices, and procedures within GLP QA field Must work well with numbers Detail-oriented and highly organized Effective oral and written communication skills Excellent interpersonal skills Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, SharePoint and PowerPoint Ability to multitask and work under pressure of multiple projects and deadlines Ability to effectively prioritize workload and manage changes in direction Must be able to record and keep essential records for a regulated environment Familiarity with and adherence to regulatory guidelines consistent with XBL requirements