19 Senior Analytical Development Scientist jobs in Placements24

• Develop, optimize, and validate analytical methods for small molecules and biologics (e.g., HPLC, UPLC, GC, MS, ICP-MS, spectroscopy).
• Characterize drug substances and drug products to understand critical quality attributes.
• Develop methods for stability indicating assays and impurity profiling.
• Transfer analytical methods to QC departments and contract manufacturing organizations (CMOs).
• Troubleshoot analytical methods and instrumentation.
• Author method development reports, validation protocols, and validation reports.
• Provide analytical support for process development and manufacturing investigations.
• Stay current with scientific literature, regulatory guidelines (e.g., FDA, EMA), and industry trends.
• Collaborate effectively with internal and external stakeholders.

• PhD in Analytical Chemistry, Biochemistry, or a related field.
• Minimum of 5 years of relevant experience in analytical method development and validation in the pharmaceutical or biotechnology industry.
• Extensive hands-on experience with various analytical techniques, particularly HPLC/UPLC and mass spectrometry.
• Strong understanding of protein chemistry and characterization of large molecules (e.g., antibodies, proteins).
• Experience with ICH guidelines and regulatory expectations for analytical method validation.
• Excellent problem-solving, organizational, and written/verbal communication skills.
• Ability to work independently and as part of a collaborative team in a hybrid setting.
• Proficiency in data analysis and interpretation.
• Experience with CMC regulatory filings is a plus.
• Must be able to work from our facilities in San Francisco, California .

• Develop, optimize, and validate analytical methods (e.g., HPLC, GC, KF, UV-Vis, dissolution) for drug substances and drug products.
• Perform characterization studies on drug candidates, intermediates, and finished products to support development and regulatory filings.
• Investigate and troubleshoot analytical method deviations and out-of-specification (OOS) results.
• Transfer analytical methods to quality control (QC) laboratories and contract manufacturing organizations (CMOs).
• Author and review analytical development reports, method validation protocols, and validation reports.
• Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant ICH guidelines.
• Stay current with advancements in analytical technologies and implement them where appropriate.
• Provide technical leadership and mentorship to junior scientists within the analytical development group.
• Collaborate with formulation development, process chemistry, and regulatory affairs teams to ensure timely project progression.

• Ph.D. or Master's degree in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 6 years of relevant experience in pharmaceutical analytical method development and validation.
• Extensive hands-on experience with various analytical techniques, especially HPLC/UPLC, GC, and spectroscopy.
• Thorough understanding of GMP regulations and ICH guidelines pertaining to analytical development.
• Proven ability to troubleshoot complex analytical challenges and develop robust solutions.
• Strong scientific writing and oral communication skills.
• Experience with stability studies and setting specifications for drug products.
• Demonstrated ability to work effectively in a team environment and manage multiple projects simultaneously.
• Experience with QbD (Quality by Design) principles in method development is a plus.

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance package.
• 401(k) savings plan with company match.
• Generous paid time off and holiday schedule.
• Opportunities for professional growth, training, and conference participation.
• Access to state-of-the-art analytical instrumentation.
• A dynamic hybrid work model promoting flexibility and collaboration in **Richmond, Virginia**.
• Supportive team environment focused on innovation and quality.
• Employee wellness programs.

• Develop, optimize, and validate analytical methods for the characterization of small molecules and/or biologics, including raw materials, intermediates, drug substances, and drug products.
• Utilize a wide range of analytical instrumentation, such as HPLC, UPLC, GC, MS, NMR, FTIR, UV-Vis, KF, and dissolution apparatus.
• Perform forced degradation studies and stress testing to understand degradation pathways and elucidate impurity profiles.
• Investigate and troubleshoot analytical method issues, ensuring timely resolution and data integrity.
• Transfer validated analytical methods to Quality Control (QC) laboratories for routine testing.
• Prepare comprehensive method development reports, validation protocols, and validation reports.
• Contribute to the preparation of analytical sections for regulatory submissions (e.g., IND, NDA, BLA).
• Collaborate with formulation development, process development, and quality assurance teams to support product development initiatives.
• Stay abreast of new analytical technologies, scientific advancements, and regulatory guidelines.
• Mentor junior scientists and contribute to the scientific and technical growth of the analytical development group.

• Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related scientific field.
• Minimum of 5 years of relevant industry experience in analytical method development and validation within the pharmaceutical or biotechnology sector.
• Extensive hands-on experience with various analytical techniques and instrumentation, particularly HPLC/UPLC and MS.
• Proven expertise in method validation according to ICH guidelines.
• Strong understanding of GMP principles and regulatory requirements for analytical testing.
• Excellent data analysis and interpretation skills, including statistical analysis.
• Proficiency in scientific software and data processing tools.
• Strong problem-solving abilities and a systematic approach to investigations.
• Excellent written and verbal communication skills, with the ability to present complex technical information effectively.
• Demonstrated ability to manage multiple projects and work independently as well as part of a team.
• Experience with biologics analysis is a plus.

Our client, a leading innovator in the Pharmaceutical sector, is actively seeking a Senior Analytical Development Scientist to join their esteemed team in Chicago, Illinois . This role is integral to supporting drug product development through the creation and validation of robust analytical methods. You will be responsible for characterizing drug substances and products, ensuring their quality, safety, and efficacy. The ideal candidate will possess extensive experience with a wide range of analytical techniques and a deep understanding of regulatory requirements. This position presents a significant career opportunity within a scientifically advanced organization dedicated to improving patient outcomes. We foster a challenging and rewarding work environment, focused on scientific excellence and collaboration in the bustling city of Chicago .

• Develop, optimize, and validate analytical methods for the characterization of drug substances and drug products using techniques such as HPLC, GC, MS, UV-Vis, and KF.
• Perform method transfer activities to QC laboratories and external partners.
• Investigate and resolve out-of-specification (OOS) results and deviations.
• Support formulation development and manufacturing process optimization through timely analytical testing.
• Prepare method validation protocols and reports in accordance with regulatory guidelines (ICH).
• Characterize impurities and degradation products, establishing appropriate specifications.
• Maintain laboratory equipment and ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Collaborate with formulation scientists, process engineers, and quality assurance teams.

• Master's degree or PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• A minimum of 6 years of experience in analytical development within the Pharmaceutical industry.
• Proven expertise in developing and validating analytical methods for small molecules or biologics.
• Hands-on experience with a variety of analytical instrumentation and software.
• Thorough understanding of ICH guidelines and regulatory requirements for drug development.
• Excellent problem-solving, organizational, and data interpretation skills.
• Strong written and verbal communication skills for technical documentation and team collaboration.
• Ability to work independently and manage multiple projects simultaneously.
• Must be authorized to work in the US and available for an on-site position in Chicago, Illinois .

Our client offers a competitive compensation package and a comprehensive benefits program, including excellent health, dental, and vision insurance, a 401(k) retirement plan with company match, and generous paid time off. Opportunities for continuous professional development, including training and attendance at scientific conferences, are provided. Our client is dedicated to fostering a collaborative and growth-oriented work environment. Relocation assistance may be available for qualified candidates. Join a premier Pharmaceutical organization and contribute to the development of innovative therapies that improve global health.

A globally recognized pharmaceutical company is seeking a highly experienced Senior Analytical Development Scientist to join their cutting-edge laboratory in Cincinnati, Ohio . This role is crucial for developing, validating, and implementing robust analytical methods for small molecules and biologics throughout the drug development lifecycle. The successful candidate will apply advanced analytical chemistry techniques to characterize drug substances and products, ensuring their quality, safety, and efficacy. This is an exceptional opportunity to contribute to the advancement of novel therapeutics within a collaborative and scientifically driven environment. The position offers a hybrid work arrangement, allowing for a balance between essential in-lab work and flexible remote contributions, supporting productivity and well-being. Join our dedicated team in Cincinnati, Ohio , and play a vital role in bringing innovative medicines to patients worldwide.

• Develop and validate analytical methods (e.g., HPLC, GC, MS, spectroscopy) for the characterization of APIs and drug products.
• Perform method transfer to quality control (QC) laboratories and support regulatory filings.
• Characterize impurities, degradation products, and excipients using sophisticated analytical techniques.
• Conduct stability studies and analyze data to establish shelf-life and storage conditions.
• Troubleshoot analytical issues and optimize existing methods for improved performance and efficiency.
• Collaborate with formulation scientists, process chemists, and regulatory affairs.
• Stay current with industry trends, regulatory guidelines (ICH, FDA), and new analytical technologies.
• Author technical reports, method validation protocols, and contribute to CMC sections of regulatory submissions.
• Provide scientific leadership and mentor junior analytical scientists.
• Ensure compliance with GMP and GLP guidelines in all laboratory activities.

• Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, or a related field.
• Minimum of 5 years of hands-on experience in analytical method development and validation within the pharmaceutical industry.
• Extensive experience with various chromatographic techniques (HPLC, UPLC, GC) and mass spectrometry (LC-MS, GC-MS).
• Proficiency in spectroscopic techniques (UV-Vis, FT-IR, NMR).
• Strong understanding of physical characterization techniques (e.g., particle size analysis, dissolution).
• Familiarity with pharmaceutical development stages from early discovery to commercialization.
• Knowledge of regulatory requirements for analytical testing and submissions.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong written and verbal communication skills, with experience in technical report writing.
• Ability to manage multiple projects and work effectively in a team environment.

Our client provides a competitive salary commensurate with experience, along with performance-based incentives. Comprehensive benefits include medical, dental, and vision insurance, a robust 401(k) program with employer matching, and life insurance. We are committed to professional development and offer opportunities for further training, conference participation, and career advancement. Generous paid time off, including vacation, holidays, and sick leave, promotes work-life balance. Relocation assistance may be provided for suitable candidates moving to Cincinnati, Ohio . Join our team and contribute to the future of healthcare.

Our client, a rapidly growing biopharmaceutical company, is seeking a skilled Senior Analytical Development Scientist to join their advanced development team in Sacramento, California . This role is critical for the development and validation of analytical methods essential for characterizing drug substances and drug products throughout the development lifecycle. You will be responsible for designing, executing, and troubleshooting analytical studies, ensuring method robustness and compliance with regulatory standards. The ideal candidate will possess extensive expertise in a variety of analytical techniques, a strong understanding of pharmaceutical development, and a meticulous approach to scientific inquiry. This is an excellent opportunity to contribute to the development of innovative therapies and advance your career in a dynamic scientific environment. We are committed to scientific excellence and the highest quality standards.

• Develop, optimize, and validate analytical methods for raw materials, intermediates, and finished products.
• Utilize a range of analytical techniques, including HPLC, UPLC, GC, MS, KF, UV-Vis, FTIR, and dissolution testing.
• Characterize physical and chemical properties of drug substances and drug products.
• Troubleshoot analytical methods and instrumentation issues.
• Prepare analytical method validation reports, transfer protocols, and qualification documents.
• Collaborate with formulation development, process chemistry, and quality control teams.
• Contribute to regulatory filings by providing method descriptions and validation data.
• Maintain comprehensive laboratory records and ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

• M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline.
• A minimum of 5 years of experience in analytical method development and validation within the pharmaceutical or biotech industry.
• Extensive hands-on experience with relevant analytical instrumentation and techniques.
• Strong understanding of ICH guidelines and regulatory requirements for analytical testing.
• Proven ability to troubleshoot and optimize complex analytical methods.
• Excellent data analysis and interpretation skills.
• Strong written and verbal communication skills, with the ability to document scientific work clearly and concisely.
• Ability to work independently and manage multiple projects simultaneously.

Our client offers a competitive salary, commensurate with experience, and a comprehensive benefits package. This includes excellent health, dental, and vision insurance, a 401(k) plan with employer match, and generous paid time off. Opportunities for professional growth and development are actively supported. The Sacramento location offers a high quality of life and access to a thriving biotechnology ecosystem.

• Develop, optimize, and validate analytical methods for drug substances and drug products using techniques such as HPLC, GC, UV-Vis, KF, and dissolution.
• Characterize pharmaceutical products and intermediates to support formulation development and manufacturing.
• Perform stability studies and analyze data to determine product shelf-life and storage conditions.
• Troubleshoot analytical instrumentation and methods.
• Write method validation reports, SOPs, and other technical documentation.
• Collaborate with formulation development, quality control, and regulatory affairs teams.
• Ensure all analytical activities comply with GMP and relevant regulatory guidelines.
• Stay current with advancements in analytical chemistry and pharmaceutical sciences.
• Mentor junior scientists and provide technical guidance.

• M.S. or Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 5 years of experience in analytical development within the pharmaceutical industry.
• Hands-on experience with a variety of analytical techniques and instrumentation.
• Strong understanding of ICH guidelines and GMP requirements for analytical validation.
• Experience with method transfer and supporting regulatory filings is highly desirable.
• Excellent problem-solving, organizational, and time management skills.
• Proficient in data analysis and scientific report writing.
• Strong interpersonal and communication skills.

• Develop, optimize, and validate analytical methods for the characterization of biologics, including proteins, antibodies, and vaccines.
• Perform routine and non-routine analytical testing to support drug development, formulation, and stability studies.
• Utilize a wide range of analytical techniques such as HPLC, UPLC, CE, MS, ELISA, SPR, and spectroscopy.
• Troubleshoot analytical instrumentation and method-related issues, implementing effective solutions.
• Prepare detailed analytical method development reports, validation protocols, and reports.
• Ensure all analytical activities are conducted in compliance with GMP, GLP, and relevant regulatory guidelines.
• Collaborate closely with formulation development, process development, and quality control teams.
• Contribute to the preparation of regulatory submissions (e.g., IND, BLA, NDA) with relevant analytical data.
• Mentor junior scientists and provide technical guidance.

• Ph.D. in Chemistry, Biochemistry, Analytical Chemistry, or a related life science field.
• Minimum of 5 years of relevant industry experience in analytical development, preferably with biologics.
• Extensive hands-on experience with a variety of analytical techniques relevant to protein characterization (HPLC, MS, CE, SPR, etc.).
• Proven experience in method development, optimization, and validation according to ICH guidelines.
• Strong understanding of protein structure, function, and degradation pathways.
• Familiarity with GMP/GLP environments and regulatory expectations.
• Excellent problem-solving abilities and meticulous attention to detail.
• Strong written and verbal communication skills, with the ability to present complex data clearly.
• Experience in the **San Francisco, California** biotech cluster is highly valued.

Join a leading pharmaceutical company renowned for its commitment to developing life-changing therapies. Our client is actively seeking a highly experienced Senior Analytical Development Scientist to contribute to their state-of-the-art laboratories in Madison, Wisconsin . This role is critical in developing and validating robust analytical methods for small molecules and biologics throughout the drug development lifecycle. You will be responsible for designing, executing, and troubleshooting a wide range of analytical techniques to ensure product quality, stability, and regulatory compliance. The ideal candidate possesses a strong theoretical and practical understanding of analytical chemistry, extensive experience with various analytical instrumentation, and a proven ability to lead method development projects. This is a fantastic opportunity to work with cutting-edge technologies and contribute to the advancement of novel pharmaceutical products.

• Develop, optimize, and validate analytical methods (e.g., HPLC, UPLC, GC, MS, ICP-MS, KF, UV-Vis, Dissolution) for drug substances and drug products.
• Characterize impurities, degradation products, and other critical quality attributes of pharmaceutical compounds.
• Troubleshoot and resolve analytical method issues, ensuring data integrity and reliability.
• Support regulatory filings by preparing method validation reports, validation protocols, and other relevant documentation.
• Collaborate closely with formulation development, manufacturing, and quality control teams to ensure seamless integration of analytical activities.
• Stay current with scientific literature, emerging analytical technologies, and regulatory guidelines (ICH, FDA, USP).
• Contribute to the transfer of analytical methods to QC laboratories and external partners.
• Mentor junior scientists and provide technical guidance on analytical challenges.
• Actively participate in scientific discussions and contribute to project strategy.

• Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 6 years of experience in pharmaceutical analytical development, with a strong emphasis on method development and validation.
• Extensive hands-on experience with a variety of analytical instruments, particularly HPLC/UPLC, GC, and Mass Spectrometry.
• Proficiency in method validation according to ICH guidelines and regulatory requirements.
• Strong understanding of pharmaceutical development processes and quality systems.
• Experience with small molecules and/or biologics characterization is essential.
• Excellent problem-solving skills, meticulous attention to detail, and strong organizational abilities.
• Effective written and verbal communication skills for technical reporting and cross-functional collaboration.
• Proven ability to manage multiple projects and prioritize effectively in a dynamic environment.

Our client provides a highly competitive salary and an extensive benefits package aimed at supporting employee health, financial security, and professional advancement. This includes comprehensive medical, dental, and vision insurance, a robust retirement savings plan with employer matching, generous paid time off, including vacation, sick days, and holidays, and dedicated opportunities for continuous learning and career growth. Relocation assistance may be provided for candidates relocating to Madison, Wisconsin . We are committed to cultivating a stimulating and inclusive work environment where scientific excellence is valued and rewarded.