Associate Scientist, Process Analytical Method Development
Takeda
Summary
You will report to the Associate Director, Process Analytics Lead within Analytical Development organization. You will contribute to in-process method development activities for synthetic molecules (Small molecules, Oligonucleotides, Peptides) using liquid chromatography, gas chromatography, spectroscopy, Karl Fischer, and particulate matter testing. You will independently plan, execute, analyze, and report method development experiments to support product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. You will work with departmental and cross-functional partners to generate high-quality data, troubleshoot technical issues, and communicate results that support decision-making for synthetic molecule programs. This role does not include direct people management.
Job description
About the role
You will report to the Associate Director, Process Analytics Lead within Analytical Development organization. You will contribute to in-process method development activities for synthetic molecules (Small molecules, Oligonucleotides, Peptides) using liquid chromatography, gas chromatography, spectroscopy, Karl Fischer, and particulate matter testing. You will independently plan, execute, analyze, and report method development experiments to support product understanding, process development, comparability, stability, manufacturing readiness, technology transfer, and regulatory submissions. You will work with departmental and cross-functional partners to generate high-quality data, troubleshoot technical issues, and communicate results that support decision-making for synthetic molecule programs. This role does not include direct people management.
How you will contribute
- Independently design, develop, qualify and report fit-for-purpose, scientifically sound and high-throughput analytical methods for in-process testing of synthetic molecules under general direction.
- Work closely with in-process analytical testing team within synthetic molecule process development organization for seamless method transfer and life cycle management.
- Apply Analytical Quality by Design (AQbD) principles and phase-appropriate approaches for method development.
- Partner with Analytical Development, Quality, Compliance, and Stability teams to support method bridging, and transfer activities.
- Work with automation, digital and PAT subject matter experts to validate and integrate technologies and platforms into process analytical methods.
- Evaluate new tools, platforms, and vendor solutions for in-process analytics as needed.
Skills and qualifications
- Typically associate degree with 7+ years, bachelor's degree with 5+ years, or master's degree with 3+ years of relevant industry experience in analytical development for synthetic molecules.
- Previous hands-on experience working in a laboratory setting is required.
- Strong expertise and practical knowledge of one or more relevant analytical techniques for testing synthetic molecules during process development such as liquid chromatography (HPLC/UPLC), gas chromatography (GC/GC-MS), spectroscopy (FT-IR, NMR), Karl Fischer, and particulate matter testing, or related techniques.
- Ability to independently plan and execute experiments, analyze data, interpret results, and communicate conclusions to technical and cross-functional stakeholders.
- Ability to prepare and review technical documentation, including protocols, reports, data summaries, method documents, SOPs, and technology transfer materials.
- Demonstrated problem-solving skills, including the ability to troubleshoot technical issues, propose practical solutions, and escalate risks appropriately.
- Ability to work across departmental and cross-functional teams with an understanding of project timelines, deliverables, and data quality expectations.
- Understanding of data integrity principles, ELN/LIMS documentation, laboratory safety, and good documentation practices.
- Ability to manage multiple priorities with general direction while maintaining attention to scientific quality, timelines, and documentation standards.
- Ability to communicate technical information clearly in writing and in conversation, and to present technical information clearly to scientific and project stakeholders.
- Working understanding of AQbD principles & ICH guidelines.
- Experience with laboratory automation capabilities, such as liquid handlers, dispensers, SCARA robots, and mobile robots, is highly desirable.
- Experience with laboratory information management systems and other digital or AI tools is desirable.
Requirements
- Typically associate degree with 7+ years, bachelor's degree with 5+ years, or master's degree with 3+ years of relevant industry experience in analytical development for synthetic molecules.
- Previous hands-on experience working in a laboratory setting is required.
- Strong expertise and practical knowledge of one or more relevant analytical techniques for testing synthetic molecules during process development such as liquid chromatography (HPLC/UPLC), gas chromatography (GC/GC-MS), spectroscopy (FT-IR, NMR), Karl Fischer, and particulate matter testing, or related techniques.
- Ability to independently plan and execute experiments, analyze data, interpret results, and communicate conclusions to technical and cross-functional stakeholders.
- Ability to prepare and review technical documentation, including protocols, reports, data summaries, method documents, SOPs, and technology transfer materials.
- Demonstrated problem-solving skills, including the ability to troubleshoot technical issues, propose practical solutions, and escalate risks appropriately.
- Ability to work across departmental and cross-functional teams with an understanding of project timelines, deliverables, and data quality expectations.
- Understanding of data integrity principles, ELN/LIMS documentation, laboratory safety, and good documentation practices.
- Ability to manage multiple priorities with general direction while maintaining attention to scientific quality, timelines, and documentation standards.
- Ability to communicate technical information clearly in writing and in conversation, and to present technical information clearly to scientific and project stakeholders.
- Working understanding of AQbD principles & ICH guidelines.
- Experience with laboratory automation capabilities, such as liquid handlers, dispensers, SCARA robots, and mobile robots, is highly desirable.
- Experience with laboratory information management systems and other digital or AI tools is desirable.
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.