Associate Scientist, Process Analytical Method Development

Takeda; Cambridge (MA); Vor Ort; USD 104.000 - 163.000; Vollzeit

Zusammenfassung

Takeda in Cambridge, MA is seeking an Associate Analytical Development Scientist to design and qualify high-throughput methods for in-process testing of synthetic molecules using HPLC/UPLC, GC/GC-MS, FT-IR/NMR, and Karl Fischer.

You will independently plan experiments, analyze data, and report results to support process development, comparability, and regulatory submissions, while partnering with Quality, Compliance, Stability, and Manufacturing teams.

Qualifikationen

• 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 analytical techniques such as HPLC/UPLC, GC/GC-MS, FT-IR/NMR, Karl Fischer, and particulate matter testing.
• 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 tech transfer materials.
• Demonstrated problem-solving skills, troubleshooting, and risk interpretation.
• Ability to work across departments with regard to timelines, deliverables, and data quality.
• Understanding of data integrity, ELN/LIMS documentation, safety, and good documentation practices.
• Ability to manage multiple priorities while maintaining scientific quality and timelines.
• Clear written and verbal communication of technical information to stakeholders.
• Working understanding of AQbD principles & ICH guidelines; experience with automation and AI tools is highly desirable.

Aufgaben

• Independently design, develop, qualify and report fit-for-purpose analytical methods for in-process testing of synthetic molecules.
• Collaborate with in-process testing teams for seamless method transfer and life-cycle management.
• Apply AQbD principles and collaborate with QA, Compliance, Stability to support transfer activities and tool integration.

Kenntnisse

HPLC/UPLC

GC/GC-MS

FT-IR/NMR

Karl Fischer

AQbD

ICH guidelines

Laboratory automation

ELN/LIMS

Data analysis

Cross-functional collaboration

Ausbildung

Bachelor’s degree

Master’s degree

Associate degree

Tools

LIMS

Automation platforms

AI tools

SCARA robots

Jobbeschreibung

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 interpret risk 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Cambridge, MA

U.S. Base Salary Range:

$103,500.00 - $162,690.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.