Scientist, / II Job Description
Scientist, / II Duties & Responsibilities
To write an effective scientist, / II job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, / II job description templates that you can modify and use.
Sample responsibilities for this position include:
Scientist, / II Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Scientist, / II
List any licenses or certifications required by the position: GMP, HAZWOPER, GLP, MLS, MT, FRM, CFA, EH&S, OSINT, DABT
Education for Scientist, / II
Typically a job would require a certain level of education.
Employers hiring for the scientist, / II job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Science, Biochemistry, Education, Biology, Engineering, Microbiology, Molecular Biology, Life Sciences, Technical
Skills for Scientist, / II
Desired skills for scientist, / II include:
Desired experience for scientist, / II includes:
Scientist, / II Examples
Scientist, / II Job Description
- Independent, self-motivated scientist responsible for designing, executing and interpreting complex in vitro and in vivo experiments
- Expertise in antibody therapeutics is essential
- Knowledge of mouse tumor models (syngeneic, xenograft, patient-derived, genetic engineered models) and ability to supervise external in vivo PK, PD and efficacy studies is necessary
- Knowledge and expertise in target identification and validation is a plus
- Candidate will present data at internal and external meetings, write technical summaries for regulatory documents, patent applications and manuscripts
- Works effectively within a team structure to achieve project goals
- Represents R&D and BDAB via industry conference presentations and interacts with customers as needed
- Technical support for various methods and for procedures and processes requiring evaluation and judgment with the assistance of a Sr
- Perform manufacturing process, immunoassay optimization and testing procedures on routine and non-routine production work using a variety of equipment and instrumentation
- Prepare new and update existing procedures
- Meticulous technique in handling of nucleic acids
- Experience in the processing of clinical specimens for the recovery of nucleic acids, together with a strong background in microbiology, virology and/or clinical laboratory science is advantageous
- Experience in handling of infectious biological samples and working in a cGMP environment are desirable
- Understands the theory of measurement, sources of error, and comparative advantages of different methodologies
- Knowledge of diagnostic product development and instruments systems is essential
- Keeps abreast of laboratory results or current developments affecting assigned project or area of responsibility
Scientist, / II Job Description
- Communicate to peers in a timely fashion
- Compile, analyze data, and compose reports as required
- Apply expertise in drug metabolism and pharmacokinetics (DMPK) principles and translational QP and PKPD methodologies as studies move from preclinical to clinical phases
- Develop/code and validate mathematical PK/PD/Biomarker/Efficacy models to elucidate the quantitative PK/PD relationships in pre-clinical species
- Perform advanced troubleshooting for the related mathematical models independently
- Work with Clinical Pharmacology to assess the clinical potential for drug-to-drug interactions using physiology-based PK (PBPK) modeling tools (e.g., SimCYP)
- Demonstrate an astute understanding of the PK/PD and QSP field and the relevant literature
- Utilize pre-clinical data for human efficacious dose prediction
- Prepare peer-directed presentations for the internal scientific community
- Strong statistics/applied mathematics/computer science background is preferred
- Typically requires a BS degree, preferably in Microbiology, Molecular Biology, Virology, Immunology, Chemistry, Biochemistry, or Physics
- Minimum of 1 year of related analytical chemistry/biochemistry experience
- Experience in infectious disease research and clinical immunoassay development is desired
- Experience with basic protein purification, electrophoresis and chromatographic techniques including HPLC and FPLC purification of proteins and antibodies is a plus
- Experience in the clinical diagnostics/biotech industry preferred
- Typically requires BS degree, preferably in Microbiology, Molecular Biology, Virology, Immunology, Chemistry, Biochemistry, or Physics
Scientist, / II Job Description
- Perform pharmacokinetic analysis and provide timely data to project team
- Serve as an expert user for state of art LC/MS instrumentations such as Sciex Triple-TOF and API-6500 to tackle any emerging needs to support drug discovery efforts
- Provide help and guidance to junior scientists in maintaining instruments and trouble-shooting LC/MS methods
- Prepare DMPK study reports to support regulatory submissions of drug candidates
- Analyse project objectives on a Global Scale and develop technical plan to deliver (tasks, timeline, risk management plan, interlinkages)
- Collaboration across Regions for Global Platform Solutions
- Independently prepares detailed project plans, including risk matrix, contingency plans and design of experiments
- Work with teams to plan and design experimental methods to achieve technical objectives identify and solve problems in experimental design, materials and operational processes
- Interface with other departments (Marketing, Product Management, R&D, Licensing, Business Leads and Development, Legal, Quality, Technical Service and Manufacturing) to coordinate product development and improvement
- Direct and control the activities of multiple projects
- Maintains current knowledge of major technological and scientific developments in relevant fields
- Minimum of 2 years of directly related scientific experience
- Performing testing accurately and precisely
- Responding to routine inquiries from management, employees and regulatory agencies
- BS degree in a statistics, engineering, mathematics, computer science, physics, operations research field (MS or PhD strongly preferred)
- Some related work experience in predictive modeling and data mining
Scientist, / II Job Description
- Strong technical writing skills as evidenced by the ability to prepare technical reports, product transfer documents, clear and effective manufacturing protocols and SOPs
- Excellent organizational skills with the ability to effectively evaluate, prioritize, and lead multiple projects, and to work under pressure with strict attention to deadlines and details
- Responsible for B-cell enrichment and automated antibody screening
- Initiates and completes routine procedures in an independent and efficient manner
- Proposes and implements new technologies based on science overall understanding of drug discovery process
- Functioning as a Research Scientist develop, perform, and troubleshoot analytical laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics, techniques include, but not limited to, electrophoresis (CE, IEF, PAGE), chromatography (HPLC, UPLC, IC), and spectrometry (UV/Vis, Fluorescence)
- Generate draft/final protocols for studies in conjunction with the sponsor and internal departments (research staff, client services, et al.)
- Function as contact for the planning and execution of Sponsor interaction related to proposal management, research and method development, and for the design, scheduling, conduct and reporting of studies
- Assist in oversight of laboratory and mentor technical staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance
- Review, interpret, analyze, evaluate, and present data on assigned studies, with minimal assistance from senior scientific staff
- Expertise in using Python, Java / C++, or other programming languages, with R, Matlab or similar machine learning tools
- Minimum of Associates Degree with five year related experience required
- Bachelor degree preferred, preferably in Life Sciences, Bio/Biomedical Engineering, or related
- Proficiency in a range of techniques used in molecular biology including nucleic acid extraction and amplification is required
- Experience in processing of clinical specimens for the recovery of nucleic acids is required
- Experience in handling of infectious biological samples and working in a regulated environment is required
Scientist, / II Job Description
- Provide scientific and technical guidance within Biologics to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct
- Manage or assist with improvement projects
- 40% Answer business problems and questions by using appropriate statistical techniques on available data
- 10% Communicate findings to business owns and IT managers
- 25% Develop models in using Statistical and Mathematical tools (R, SAS, Matlab or similar tools)
- Perform hands on analytical testing for method development, validation or transfer routine stability testing in a QC environment as needed
- Perform routine testing of stability samples, reviewing and approving raw material and finished product procedures
- Training and assisting R&D and QC laboratory personnel in troubleshooting test procedures during method transfers and as needed
- Generate and review R&D laboratory investigation reports as needed
- Generate and review method validation protocols and reports as needed
- Independently conducts literature searches and summarizes data obtained
- Industry experience developing quantitative molecular assays and integration on automated platforms is strongly preferred
- Familiarity with CLSI guidelines and data analysis techniques used to validate quantitative assay performance is strongly preferred
- Ability to recognize and protect proprietary information as it relates to project, formulas and ingredients
- General beverage knowledge, including beverage industry trends/updates, ingredients, beverage physical/chemical attributes, beverage stability, QA/QC, process, packaging, sensory, nutrition
- Ability to handle multiple projects and ensure successful completion