Scientist, Analytical Development Job Description
Scientist, Analytical Development Duties & Responsibilities
To write an effective scientist, analytical development job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, analytical development job description templates that you can modify and use.
Sample responsibilities for this position include:
Scientist, Analytical Development Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Scientist, Analytical Development
List any licenses or certifications required by the position: GMP, SOP
Education for Scientist, Analytical Development
Typically a job would require a certain level of education.
Employers hiring for the scientist, analytical development job most commonly would prefer for their future employee to have a relevant degree such as Master's and Bachelor's Degree in Chemistry, Biochemistry, Biology, Science, Pharmacy, Engineering, Biotechnology, Cell Biology, Molecular Biology, Education
Skills for Scientist, Analytical Development
Desired skills for scientist, analytical development include:
Desired experience for scientist, analytical development includes:
Scientist, Analytical Development Examples
Scientist, Analytical Development Job Description
- Lead a group of research associates to perform a wide range of analytical tests on mAbs and ADCs to support mAb and ADC process development activities
- Follow all safety rules and use adequate equipment in order to ensure your colleagues’ safety your own
- Performs independent hands-on experimental work utilizing mass spectrometry, liquid chromatography and other analytical techniques
- Provides project oversight, client interaction and scientific input
- Performs data analysis and interpretation, including structural elucidation and identification of unknowns
- Complies with all cGMP and safety requirements, operating procedures and company policies and procedures
- Prepares concise and well-written scientific reports
- Commitment to teamwork for solving problems and serving clients
- Develop, establish and validate analytical methods as assigned
- Develop and maintain working knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned analytical development tasks
- University degree in pharmacy, chemistry, biochemistry or other relevant scientific / technical discipline (desirable Ph.D
- Recognizes analytical test problems, can investigate problems and take appropriate steps to resolve and communicate issues
- Analytical experience focusing on biologics or biologics formulation related topics
- Hands-on analytical skills and problem-solving skills
- Industry relevant experience
- Polymer characterization experience is as a plus, not a must have
Scientist, Analytical Development Job Description
- Submit complete, documented, and legible reports of analytical testing
- May supervise employees and train and mentor junior level team members, although primary role is that of individual contributor
- Exhibit safety awareness and conduct laboratory operations and chemical disposal in a safe manner
- Maintain compliance with regulations at all levels strict adherence to standard operating procedures and cGMP’s as necessary
- Demonstrate professionalism, enthusiasm, dedication and productivity
- Use technical and regulatory knowledge and judgment to validate procedures to comply with internal SOPs and regulatory needs
- Develop efficient, selective analytical procedures for assigned compounds
- Possess laboratory skills that allow for the methods development and processing of samples of materials that are difficult to handle or analyze
- Devise improved procedures for existing projects, as required
- Submit complete, high-quality records of all experiments and observations
- The preferred candidate should have a fundamental knowledge of cGMP, strong technical skills in protein analytics, and excellent compliance and organizational skills
- The successful candidate must have a strong ability to work independently and effectively, handling multi-tasks spontaneously and meeting timelines efficiently and productively
- A strong understanding of protein chemistry, general protein analysis and characterization methods
- Proven record of method development, method qualification and technical transfer, and an ability to implement new methods and technologies and to use Design of Experiments approaches
- Expertise and knowledge of biopharmaceutical development to support and drive analytical CMC activities, including a thorough understanding of how molecular attributes and target quality profiles link to patient safety and efficacy
- Experience methods and technical reports, authoring sections/documents for regulatory submissions, and responding to regulatory questions
Scientist, Analytical Development Job Description
- Act as a technical consultant
- Evaluate new technologies to determine their applicability to vaccine assay development
- Interface with other scientists in a variety of technical disciplines including process development, formulation development, clinical operations, quality control, quality assurance, discovery, and manufacturing
- Represent Analytical Sciences at project team meetings and provide analytical support for antigen characterization in support of process development and establishment of analytical methods for potency testing of vaccines
- Documentation, reporting, and communication of results in electronic laboratory notebooks, technical reports, PowerPoint presentations, and oral presentations
- Resource planning and project forecasting with external CRO’s
- Good knowledge on biotech processes development and protein purification
- To conduct sample testing for lot release, in-process, stability and R&D samples
- Knowledge of common and specific software in use in analytical labs
- To ensure compliance to regulatory requirement, including instrument maintenance, personnel training, document drafting, review and archiving
- PhD with 5+ years or MS with 10+ years of industry experience in Analytical Chemistry or an allied chemistry discipline
- Bsc/Msc in biotechnology with 2-5 years in the biopharmaceutical industry
- Solid theoretical basis and hands-on experience in protein characterization
- Results-oriented with ability to work and deliver under pressure
- Excellent English (written, oral)
- Experience with analytical characterization of RNA and/or lipid nanoparticles is mandatory
Scientist, Analytical Development Job Description
- Has technical responsibility for more than one part of a domain of expertise
- Proposes development strategies for own domain of expertise (including investments, new technology and QA)
- Implementation of basic new and novel methods and techniques
- Validated analytical methods
- Study results and reports for the registration, complying with the ICH guidelines
- Development reports, for feasibility studies of new technologies
- Input to selection of analytical development strategies
- Project-overlapping advice
- Transfer of analytical methods to internal and/or external sites
- Manages research associate performing laboratory-based studies to support assay development
- Small molecule experience is required
- This individual will lead projects and will manage and supervise 1-3 junior scientists
- Responsible for development and refinement of analytical techniques appropriate for various development phases from IND, to first in human, through full commercialization
- Provide management with recommendations for development of CMC regulatory strategies that meet both FDA and EMA requirements and expectations at each stage of drug development, from Phase 1 through commercialization
- Lead identification and development of analytical techniques that improve characterization of products, process intermediates and other materials
- Ph.D./M.S./B.S
Scientist, Analytical Development Job Description
- Leads an assay development scientific meeting that has cross functional representation from Research, Clinical, Process Development and QC
- Provides scientific content for regulatory submission
- Interacts with CMOs and may be involved with assay transfer activities
- Writes, reviews and/or approves Technical Protocols, Method development and Qualification reports
- Ensures timely review of all data supporting technical studies
- Ensures laboratory equipment and instrumentation upkeep which include troubleshooting, PM/calibration/qualification as needed
- Directs and controls the activities of a functional area through supervision of research associates
- Provides leadership, motivation and career development of laboratory staff
- Provide continual development of analytical methodologies and control strategies to characterize cell-based products using techniques such as flow cytometry, PCR, fluorescence-based imaging other specialty instrumentation
- Design, execute laboratory experiments, analyze data, and author technical reports to support method development
- Doctorate, Master’s, or Bachelor’s degree with 10 years of relevant experience in Chemistry, Physics, or Biology
- Large molecule experience (peptides, proteins, carbohydrates, DNA/RNA, antibodies, ) is a plus
- High level of independence and the ability to handle multiple simultaneous projects
- Bachelors, or Masters Degree with major in Natural Science or Pharmacy
- Significant analytical industrial experience and proven ability to handle difficult, or unusual assignment
- Some knowledge of analytical testing requirements of biological manufacturing processes, analytical development of methodologies used to test biological products