Scientist, Process Analytics, Synthetic Molecule Process Development

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); Vor Ort; USD 116.000 - 182.000; Vollzeit

Zusammenfassung

Takeda in Cambridge, MA seeks a Scientist for Process Analytics in Synthetic Molecule Process Development. You will lead analytic method development and off-line analytics for route scouting and optimization in drug substance projects.

Role involves planning and executing unit operation characterization and optimizing experiments, with cross-functional leadership and data-driven decision making involved throughout projects.

Qualifikationen

• Bachelor's degree or higher in a pharmaceutical science field; 5+ years industry experience for the BSc, 3+ with MS, 0+ with PhD.
• Strong background in modern analyses for small molecule pharmaceuticals (HPLC, GC, LC-MS) and related software.
• Able to troubleshoot issues, work cross-functionally, and manage multiple tasks.

Aufgaben

• Design and execute drug substance process development analytical activities including method development and impurity identification.
• Collaborate with process chemistry, analytical development and engineering for optimization and scale-up.
• Perform analytical testing (HPLC, LC-MS, GC, KF, NMR, XRPD, DSC, TGA, DVS) as needed.
• Identify IPC issues and develop suitable methods.
• Provide analytical support to troubleshoot processes and implement corrective actions.
• Support PAT and HTE initiatives for Process Analytics.

Kenntnisse

Analytical thinking

Problem solving

Teamwork

Communication skills

Organization

Knowledge sharing

Resource management

External involvement

Lab work

Literature searching

Ausbildung

Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science

Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science

PhD in chemistry, biology, pharmacy, engineering, or related pharmaceutical science

Tools

HPLC

GC

LC-MS

NMR

XRPD

DSC

TGA

DVS

Empower/Openlab

Jobbeschreibung

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientist, Process Analytics, Synthetic Molecule Process Development in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission.

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Scientist, Process Analytics where you will provide support for process chemistry and engineering efforts through specialized expertise in off-line analytical method development aimed at route scouting, optimizing reactions and understanding mechanisms for synthetic molecules. You will also provide theoretical and conceptual input to the design, development, and execution of research assignments for specific projects. Additionally, you will independently plan and execute most unit operation characterization and optimization experiments within their area of expertise and develop an awareness of unit operations in other areas. This role is responsible for significant or sole technical leadership within projects or complex studies, proactively identifying process or study issues and challenges, and proposing potential resolutions. As part of the Process Analytics (PA) Group for Synthetic Molecule Process Development (SMPD, Drug Substance (DS)), you will report to Head, Process Analytics, Synthetic Molecule Process Development.

How you will contribute:

• Design and execute drug substance process development analytical activities including phase-appropriate method development, preliminary isolation/identification of process impurities, understanding reaction kinetics/mechanism, and data management.
• Collaborate with drug substance process chemistry, analytical development and engineering to design and execute experiments for process optimization, scale-up, and technology transfer activities.
• Execution of analytical testing's for small molecule pharmaceuticals, such as HPLC, LC-MS, GC, KF, NMR, and solid state characterizations (XRPD, DSC, TGA, DVS) when needed.
• Identify critical in-process-control issues and develop appropriate IPC methods.
• Provide analytical support and expertise to troubleshoot process-related issues and implement corrective actions.
• Method development support for innovation and technology team, including support for Process Analytical Technology (PAT) and High throughput experimentation (HTE) teams.
• Analyze and interpret analytical data to assess process performance, identify trends, and make data-driven decisions to improve process efficiency and product quality.
• Stay updated on emerging trends and advancements in analytical chemistry, and process optimization methodologies.
• Identify opportunities for continuous improvement in analytical techniques, processes, and systems.
• Technology advancement: work cross-functionally to ensure continued innovation for the PA team and SMPD.
• Platform consolidation of analytical data so that chemists and engineers can easily access data, accelerate processing time, and integrate results.
• Contribute to complex/multiple projects or functional areas through leading or influencing others.
• Influence and support initiatives related to driving scientific and technical improvement within function and potentially cross-functionally.
• Ensure a productive and development-rich environment.
• Define more complex/novel approaches and methodologies to solving complex technical challenges.
• Identify vendors and build relationships to gain access to technologies as needed to deliver pipeline goals.
• Understand project timelines and deliverables and plan/coordinate project work accordingly with departmental, functional, and external stakeholders.
• Provide technical leadership to project teams within area of expertise.
• Contribute significantly and independently to project work which may include multiple projects within functional area.
• Review, interpreting and communicating data cross-functionally within CMC (Chemistry, Manufacturing & Controls) and project teams.
• Plan and implement resolutions to technical problems/issues.
• Independently design and execute experiments, and reports results.
• Responsible for integrating scientific/technical efforts around cross-functional issues.

Minimum Requirements/Qualifications:

• Bachelor's degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 5+ years relevant industry experience
• Master's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 3+ years relevant industry experience
• PhD in chemistry, biology, pharmacy, engineering, or related pharmaceutical science; 0+ years relevant industry experience
• Working knowledge of modern analyses for small molecule pharmaceuticals, particularly HPLC, GC, LC-MS, and associated analytical software and data processing platforms, such as Empower / Openlab
• Good understanding of synthetic organic chemistry
• Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and workable solutions.
• Teamwork -- Ability to work well in highly cross functional team environment and across global line functions.
• Communication Skills -Able to express oneself clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents.
• Organization – Exercises time management and prioritization skills and can successfully manage multiple tasks simultaneously.
• Knowledge Sharing: Ability to capture organizational knowledge; improve solutions, processes, and deliverables through information; improve information capital by contributing experience, theories, deliverables, and models for others to use.
• Resource Management - Ability to manage one's time within individual, departmental, and corporate goals, and timelines; management of internal and external resources (vendors).
• External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events.
• Able to interpret results of complex experiments and integrate data produced by other disciplines.
• Able to work in lab setting.
• Proficiency with utilizing typical literature searching techniques to solve technical problems.
• May require 5-10% travel.

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: $116,000.00 - $182,270.00 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

Legal disclaimer:

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.

Company Values and Commitment:

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda‑ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.