Principal Scientist, Process Research, Synthetic Molecule Process Development, Pharmaceutical Sciences Full-time

Principal Scientist Synthetic Molecule Process Development

About Takeda

“Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We're looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company's founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

About Synthetic Molecule Process Development

Role and responsibility of Synthetic Molecule Process Development (SMPD) is process research and development of synthetic Drug Substance (DS) including small molecules, peptides, and oligonucleotides from pre-clinical to NDA and tech-transfer to commercial manufacturing division. Also, SMPD manufactures and supplies DS to non-clinical and clinical studies with suitable quality.

SMPD is searching for a Principal Scientist in our Process Research group. This experienced scientist leads process chemistry activities for synthetic small molecule early-stage development (i.e. pre-clinical stage up to Ph2 start), serving as a key SMPD representative within global cross-functional teams. This role designs phase-appropriate and scalable synthetic processes, oversees development and manufacturing activities including CDMO collaborations, prepares regulatory documents for IND and RTQ, and drives progress toward project milestones through scientific expertise and effective project management while contributing to overall CMC strategy execution. The role may support internal/external technical transfers and/or patent applications by preparing technical documents.

Accountabilities

• Leads all or part of the SMPD efforts on a program and represents SMPD in cross-functional meetings.
• Plays an important role as a subject matter expert in a global cross-functional project team and collaborates with other functions in support of the development and implementation of an overall CMC strategy.
• Actively builds necessary cross-functional and cross-site relationships in support of early-stage development.
• Independently develops and executes plans (e.g. timelines, budget, resource allocation, work package prioritization, risk assessment, etc.) for early-stage process research and development as well as non-GMP/GMP preparation of gram-to-kilogram quantities of small molecule APIs, intermediates, impurities, and reference standards, and/or manages such activities at CDMOs.
• Designs scalable synthetic processes for synthetic small molecule DS and phase-appropriate strategies for process optimization with a primary focus on early-stage development.
• Analyzes and interprets scientific data independently and solves synthetic chemistry problems.
• Establishes metrics and has accountability for progression of process chemistry-related activities against project goals; regularly determines deadlines and objectives.
• Prepares drug substance-related regulatory documents for IND and RTQ.
• As necessary, prepares experimental procedures for patent applications and scientific reports as well as tech transfer documents in support of SMPD internal program transfer and collaborations with CDMOs.

Education, Experience, Knowledge, Competencies and Skills

Education

• Ph.D degree in organic chemistry and 3+ years of industry experience in the fields of process chemistry or M.S. degree in organic chemistry and 9+ years of industry experience in the fields of process chemistry.
• Additional study or post-doctoral research experience abroad is preferred.

Experience and Knowledge

• Expert understanding of a wide range of synthetic organic chemistry, including reaction mechanistic aspects and synthetic route design (retrosynthetic analysis), paired with excellent laboratory skills.
• A high level of proficiency in multi-step synthesis, purification, and characterization of complex organic molecules using the latest techniques.
• Experience with synthetic route scouting, DS process development, and scale-up manufacturing under cGMP. Experience in leading DS process research & development for early-stage assets (pre-clinical/Ph1) is highly valued.
• Experience in managing DS development and manufacturing activities at external CDMOs.
• Experience in the use of technologies (e.g. flow chemistry, photo redox chemistry, Process Analytical Technologies (PAT) such as FT-IR, NIR, FBRM, UV-vis, etc., automation, artificial intelligence, kinetic modeling, etc.) and an interest in application to early-stage development programs are preferred.
• Knowledge of regulatory requirements in ICH and experience with authoring and reviewing CMC documentation for IND is preferred.

Competencies and Skills

• Leadership – Identifies opportunities and demonstrates initiative towards the accomplishment of department/function goals and objectives.
• Problem-Solving – Ability to troubleshoot critical issues or problems using appropriate information and determine causes and possible solutions.
• Communication – Communicates complex information clearly and engagingly; documents issues and/or concerns concisely with colleagues; asks for and provides the right amount of information to meet the needs of management, direct reports, and project teams; adjusts communication style as appropriate for the audience; proactively and effectively communicates with stakeholders and management; technical writing skills to support authorship and approval of internal technical documents.
• Teamwork – Must have a collaborative mindset to build a network of relationships with people in a variety of functions and roles; leverages formal and informal networks to accomplish goals; promotes shared responsibility for getting things accomplished across our organization.
• Technical – Subject matter expertise in one or more specific scientific area(s) of organic chemistry as well as multi-step synthesis of pharmaceutically active ingredients.
• Resource Management – Ability to manage timelines as well as individual, departmental, and project goals; effective management of internal and external resources (CDMOs).
• Development/Growth – Possesses self-awareness and a learning-oriented mindset with a desire to continually build and grow leadership, management, and technical skills to elevate personal, team, and organizational performance and capabilities.

Language Requirements

• Must have good written and verbal communication skills in both Japanese and English.

Travel and Other Requirements

• Some domestic and international travels to internal meetings or external vendor/CDMO sites may be necessary.
• Ability to participate in early-morning and/or late-evening tele/video conferences.

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.
• Salary Increase: Annually, Bonus Payment: Twice a year
• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
• Flexible Work Styles: Flextime, Telework
• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company's discretion.
• It is possible the department and workplace may change at the company's discretion.

Locations

Fujisawa, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time