Scientist, Analytical Job Description
Scientist, analytical
provides analytical chemistry based testing support to formulation development and drug product release, using standard platforms such as HPLC / UPLC, Capillary Electrophoresis, Biophysical (DLS) and spectrophotometric/ colorimetric endpoints.
Scientist, Analytical Duties & Responsibilities
To write an effective scientist, analytical job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, analytical job description templates that you can modify and use.
Sample responsibilities for this position include:
2+ years’ experience in analytical or preparative HPLC coupled with mass spectroscopy
HPLC/UPLC
GC
Perform routine complex analyses of raw materials, in-process, finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering
Perform Identification studies for unknowns in drug products using Raman, LC/MS, GC/MS, Raman
Interacting with subject matter experts to understand protocol development needs
Implementing, validating, and documenting automated analytical assays
Supporting other users of laboratory liquid handling instruments
Independently carry out innovative research in diverse areas such as profiling bioactive lipids and metabolites, pathway analysis, and targeted proteomics, in support of target identification, disease biology, and mechanism of drug action
Support medicinal chemists in compound identification and purification, instrument maintenance and repair
Scientist, Analytical Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Scientist, Analytical
List any licenses or certifications required by the position: GMP, SOP
Education for Scientist, Analytical
Typically a job would require a certain level of education.
Employers hiring for the scientist, analytical job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Chemistry, Science, Biology, Biochemistry, Pharmaceutical Sciences, Sciences, Chemical Engineering, Physical Science, Education, Biotechnology
Skills for Scientist, Analytical
Desired skills for scientist, analytical include:
GC
HPLC
Organic chemistry
Applicable regulatory authority
Biopharmaceutical classification system
KF
Compendia and ICH guidelines
Dissolution method development and testing
IVIVC / IVIVR
Scientific principles and basic understanding of applicable drug development regulations
Desired experience for scientist, analytical includes:
Work closely with biologists, DMPK scientists and pharmaceutical development scientists external collaborators
Remain conversant with the modern analytical literature and maintain a strong laboratory presence
Provide technical resource for Process Analytics methods remediation, evaluation and validation
Provides project support for new product development which requires a close working relationship directly with Customers suppliers
U.V
Excellent communication (oral and written), listening skills, interpersonal skills required
Scientist, Analytical Examples
1
Scientist, Analytical Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of scientist, analytical. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for scientist, analytical
- Work with research scientists to analyze results and troubleshoot any issues with products or lab instrumentation/equipment
- Plan testing protocols, analyze test data and write clear, concise technical reports with supportable conclusions
- Knowledge of automated workstation equipment
- Understand and conduct studies for method development/evaluation, validation, transfer and verification according to scientific justifications and current regulatory guidance (e.g., ICH, FDA, USP, EP)
- Prepare and review technical documents, including validation/transfer/verification protocols and reports, analytical test procedures, technical reports, analytical investigations, for review
- Demonstrate strong skills/expertise/high proficiency on two or more specific analytical techniques
- This position assists continuous improvement in innovation and technology and contributes a stronger IP position for BI
- Actively participates in root cause investigations on near misses and all incidents
- Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA
- Lead troubleshooting activities for established bioanalytical test methods (CE-SD, iCIEF) for process impurities used in development and release testing
Qualifications for scientist, analytical
- At least 2 years related experience such as analyzing data and/or building analytical models
- Conducts method qualifications and validations under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) International regulations
- Helps Troubleshoot, investigate, and resolve analytical testing anomalies and drives solutions to improve the Quality Control program through effective corrective and preventive actions
- Understanding of analytical chemistry calculations such as concentrations (%, ppm, µg/mL, etc), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis is required
- General computer literacy including use of Microsoft Word, Excel, and Power Point, is required
- Experience developing generic pharmaceutical products
2
Scientist, Analytical Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of scientist, analytical. 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
- Extensive experience in chromatographic techniques such as GC is essential
- Maintain control of all project related samples submitted to the laboratory
- Write and review methods, reports
- Perform housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition
- Manage responsibilities and work in an efficient manner to assure accurate and timely data reports
- Consult and work closely with supervisor regarding any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy
- Train on all the SOPs and company procedures on regular basis and remain up to date with the training curriculum
- Carries out lead responsibilities in accordance with the organization’s policies
- Analyze and interpret results in written and oral format in consultation with Principle Scientist and/or Sr
- Lead troubleshooting activities for established test methods used in development and release testing
Qualifications for scientist, analytical
- Evaluation and interpretation of scientific and analytical data
- Evaluation of prototype samples including for product stability, product safety and transit
- Compilation of reports as appropriate and recommendation of actions to the project team
- Has a working knowledge of the quality systems applicable to the design and quality assessment of medical devices BS EN 13485, method development, method
- Conduct Laboratory Analysis (unsupervised) and all facets of the job efficiently, accurately and within agreed budget and timelines, as and when required
- Contribute to productive teams working to achieve the agreed results, within the laboratory and with customers and such that agreed financial goals with respect to income, expenditure and overall contribution are achieved
3
Scientist, Analytical Job Description
Job Description Example
Our innovative and growing company is looking for a scientist, analytical. 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
- Liaison with affiliates and external partners to drive impactful innovation in nutrients test methods
- Implement technical exchange with internal &external labs
- Management of general lab processed required for day to day efficient operation and ensure compliance to all applicable safety and quality system requirement
- Work with a diverse range of global organizations across multiple therapeutic areas
- Be part of a rapidly developing, multi-disciplinary team who are
- Dedicated to partnering with our clients to develop quality candidate molecules
- Supportive of each other every step of the way
- Work in our newly appointed laboratories based on a countryside science park close to Cambridge city centre
- Receive a fair financial package – which includes generous company pension contributions and the option for private medical and dental insurance
- The ability to learn and understand new procedures in a short space of time
Qualifications for scientist, analytical
- Requires a PhD in Chemistry, Biochemistry, or Bioengineering
- Self-motivating and ability to work independently
- Provides support and coaching to subordinate employees in the areas of training, planning, and work assignment
- Well-organized, self-motivated, hard-working and detail-oriented individual able to work successfully in both a team/matrix environment independently
- Requires a PhD in Chemistry, Biochemistry, or Bioengineering and a minimum of 3 years relevant experience, preferably in a cGMP environment
- The successful candidate will hold a degree in Chemical or Life Sciences from an accredited university and wil have one to seven years' experience in analytical methods development in a small molecule product environment
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Scientist, Analytical Job Description
Job Description Example
Our company is hiring for a scientist, analytical. 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
- Conduct instrumental analyses according to written procedures such as LC, GC, IC, LC-MS, and/or GC-MS
- Ability to work both closely with other team members from various disciplines the ability to work independently when needed
- Assist with the development of new procedures and methodologies (based on prior established techniques at this site) to develop solutions to solve scientific/technical problems of limited scope
- Plans and executes validation of analytical methods
- Performs analytical methods and simple analytical tests, including dose formulation analysis
- Documents results in electronic laboratory notebooks, laboratory information systems and performs second scientist review of data
- Compiles data for reports and presentation - may interpret data and draw conclusions
- May author chemical stability and deviation memos, analytical methods, validation summaries, and standard operating procedures
- Liaises closely with Safety Assessment to support development timelines
- May be involved on cross functional and global teams
Qualifications for scientist, analytical
- BS in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 5-8 years related lab experience
- MS in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 5 years related lab experience
- Completed training as technician in chemistry or chemistry related field with track records on current analytical methodologies
- Also desirable is basic understanding of GMP experience in pharmaceutical development activities
- Understand analytical chemistry calculations such as concentrations (%, ppm, µg/mL, etc), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis
- BS/MS in Chemistry or related science field
5
Scientist, Analytical Job Description
Job Description Example
Our growing company is hiring for a scientist, analytical. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for scientist, analytical
- Adhere to safety and regulatory requirements
- Transfer new products from R&D to Manufacturing
- Responsible for sustaining products
- Conduct exploratory research for new ion chromatography hardware or consumables with improved performance
- You will be responsible for the analytical assessment of mammalian cell culture based biopharmaceutical molecules
- You provide the corresponding section of high quality submission documents for CTAAs and MAAs
- As analytical team member you play an important role in internal and external projects
- You also take care for technical and scientific evaluation and implementation of new analytical technologies, instruments and methods in analytical development
- Review lab notebooks and reports
- Perform a variety of tasks associate with tobacco product testing in a high=throughput laboratory
Qualifications for scientist, analytical
- Professional/academic achievement in Chemistry or a related physical science at Masters, MPhil or PhD level
- Experience in HDX-MS or Host Cell Protein analysis is a plus
- Proficiency in mass spectrometry related softwares, such as Xcalibur, MassLynx, MassHunter, Proteome Discoverer, Mascot, Empower, ChemStation, Abilities in computer programming a plus
- Familiarity with GLP/GMP concept
- Work requires five years of research experience
- Excellent oral and written communication skills strong computer skills