Method Development Scientist
A scientist responsible for developing, validating, and implementing methodologies for experimental and analytical procedures, often in pharmaceuticals or biotechnology.
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Sample Job Descriptions for Method Development Scientist
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
The Junior Method Development Scientist will be responsible for assisting in the development and validation of analytical methods, supporting research and development activities in a laboratory setting. They will work under the guidance of senior scientists to design experiments, analyze data, and contribute to scientific reports and publications.
Required Skills
- Strong analytical and critical thinking skills.
- Proficiency in using laboratory software and equipment.
- Effective verbal and written communication skills.
- Time management and organizational abilities.
- Basic understanding of statistics and data analysis.
Qualifications
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
- Understanding of analytical techniques such as HPLC, GC, MS, and spectroscopy.
- Familiarity with regulatory requirements and guidelines related to analytical method development.
- Strong problem-solving skills and attention to detail.
- Ability to work effectively in a team and communicate scientific results.
Responsibilities
- Assist in developing, optimizing, and validating analytical methods for drug substances and drug products.
- Conduct literature searches and gather relevant information to inform experimental designs and methodology.
- Carry out analytical experiments and document findings in lab notebooks and databases.
- Collaborate with cross-functional teams to support research and development projects.
- Ensure laboratory equipment is maintained and calibrated according to standard operating procedures.
- Participate in the preparation of scientific reports, presentations, and publications.
Intermediate (2-5 years of experience)
Summary of the Role
The Method Development Scientist is responsible for developing, validating, and implementing analytical methods to support research and development projects. This role involves working closely with research and quality teams to ensure the accuracy and efficiency of analytical techniques.
Required Skills
- Strong analytical and problem-solving capabilities.
- Proficiency with analytical instrumentation and software.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
- Keen attention to detail and commitment to high-quality results.
- Time management skills with the ability to handle multiple projects simultaneously.
Qualifications
- Bachelor's or Master's degree in Chemistry, Biochemistry, or a related field.
- 2-5 years of experience in analytical method development and validation, preferably in a pharmaceutical or biotechnology environment.
- Familiarity with regulatory guidelines and Good Laboratory Practices (GLP).
- Proven track record of developing methods for HPLC, GC, LC-MS, or other analytical techniques.
- Experience with statistical analysis and design of experiments (DOE).
Responsibilities
- Design and execute method development experiments for analytical testing.
- Validate new methods in accordance with industry standards and regulatory guidelines.
- Prepare detailed documentation, including standard operating procedures (SOPs) and method validation reports.
- Collaborate with cross-functional teams to resolve methodological issues and enhance analytical capabilities.
- Conduct literature reviews and stay updated on industry trends and advancements in analytical methodologies.
- Provide technical guidance and training to junior staff and technicians.
- Ensure laboratory equipment is calibrated, maintained, and functioning optimally.
- Analyze data, interpret results, and present findings to stakeholders.
Senior (5+ years of experience)
Summary of the Role
We are seeking a seasoned Method Development Scientist with a strong background in analytical chemistry and experience in developing and validating analytical methods for pharmaceuticals. The ideal candidate will have a track record of innovation, problem-solving, and leadership in a laboratory setting.
Required Skills
- Exceptional problem-solving and critical thinking abilities.
- Strong leadership and project management skills.
- Excellent communication and interpersonal skills.
- In-depth understanding of statistical data analysis and its application in method validation.
- Proficiency with laboratory information management systems (LIMS) and data analysis software.
Qualifications
- Ph.D. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- Minimum of 5 years of experience in analytical method development within the pharmaceutical industry.
- Proven experience in a wide range of analytical techniques such as HPLC, GC, MS, and spectroscopy.
- Experience with regulatory submissions and knowledge of ICH guidelines.
- Strong publication record in peer-reviewed journals.
Responsibilities
- Lead the design and development of robust analytical methods for drug substance and product analysis.
- Optimize and validate analytical procedures to meet regulatory requirements.
- Collaborate with cross-functional teams to support preclinical and clinical development.
- Manage method transfer to quality control and external partners.
- Prepare and review technical documents, including validation reports and sections of regulatory submissions.
- Mentor junior scientists and provide scientific guidance.
- Stay current with industry trends and advancements in analytical chemistry.
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