Scientist, Analytical Development Job Description
Scientist, analytical development
provides technical support in the lab performing HPLC, KF, dissolution, troubleshooting, and method development for small molecule.
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:
Be involved in method development and qualification, GMP material release by following procedures, comparability studies, impurity analysis using HPLC, fluorescence detection, CE-SDS, SDS-PAGE, and mass spectrometry
Conducts scheduled preventive maintenance and qualification of equipment (i.e., MS, HPLC, ) and software
Design experimental plans to address specific program issues
Interpret, analyze, and manage data
Adhere to cGMP’s in all work practices, when required
Review peer's work
Review revisions to procedures as needed
Write and disseminate technical data summaries and reports
Coordinate activities of outside resources such as consultants
Develop technical strategies to meet customers technical and business needs
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:
GC
HPLC
Biopharmaceutical classification system
KF
Dissolution method development and testing
IVIVC / IVIVR
Scientific principles and basic understanding of applicable drug development regulations
Applicable regulatory authority
Compendia and ICH guidelines
Organic chemistry
Desired experience for scientist, analytical development includes:
Broad experience (at least 3 years) in pharmaceutical analytical development or quality
Strong background in spectroscopic analyses, such as FTIR, RAMAN, NIR, FBRM, , and chemometrics modeling applied to drug substance and drug product characterization and manufacturing is highly desirable
MS in Chemistry/Biochemistry, or related field with 1 year of industry laboratory experience
Ability to transfer knowledge to others via training or mentoring of staff
MS with 3-5 year experience
Experience with bioanalytical techniques such as SDS-PAGE, CE-SDS, ELISA, Cell-based bioassays, BIAcore, cIEF/icIEF
Scientist, Analytical Development Examples
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Scientist, Analytical Development Job Description
Job Description Example
Our innovative and growing company is looking for a scientist, analytical development. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for scientist, analytical development
- 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
Qualifications for scientist, analytical development
- 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
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Scientist, Analytical Development Job Description
Job Description Example
Our growing company is hiring for a scientist, analytical development. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for scientist, analytical development
- 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
Qualifications for scientist, analytical development
- 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
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Scientist, Analytical Development Job Description
Job Description Example
Our innovative and growing company is hiring for a scientist, analytical development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for scientist, analytical development
- 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
Qualifications for scientist, analytical development
- 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
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Scientist, Analytical Development Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of scientist, analytical development. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for scientist, analytical development
- 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
Qualifications for scientist, analytical 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
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Scientist, Analytical Development Job Description
Job Description Example
Our innovative and growing company is looking for a scientist, analytical development. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, analytical development
- 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
Qualifications for scientist, analytical 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