Analytical LCM Product Lead Synthetic Molecules

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

• Synthetic Molecules (SM) Portfolio LCM Analytical Oversight: Single point of accountability for all Analytical LCM Synthetic Molecule Programs. Direct people management of individual analytical LCM program leads to provide deep technical quality and regulatory insights to drive consistent and scientifically-sound decisions.
• Owns and drives Analytical LCM Portfolio Program Strategies for Synthetic Molecule (SM) Programs: Deep understanding of individual synthetic molecule product control strategies and works with individual SM analytical LCM program leads to ensure all analytical LCM program activities are covered and on track with clearly defined roles and responsibilities schedules and resources. Works to create and maintain Analytical Program LCM roadmaps and method risk registers in alignment with overall CMC program roadmaps. Provides direct line-functional leadership for all Analytical LCM Program representatives ensuring consistent scientific direction portfolio prioritization capability building and clear accountability for program deliverables.
• Analytical LCM Functional & Enterprise Leader working in strong collaboration and communication with the Analytical LCM Portfolio leader other Analytical LCM Modality leads MSAT Manufacturing Leads Pharm Sci Analytical QC sites and internal and external analytical labs and services to align on ways of working synthetic molecules analytical prioritization network strategy CMC synthetic molecule initiatives/roadmaps and analytical lab work resourcing.
• Tech Forward: Driving towards digital-forward analytical technology innovation and platforming embedment in analytical methodology. Working in collaboration with key stakeholders from PharmSci to QC labs including quality and regulatory and IT to pull-through the latest analytical methodology into LCM control strategies.
• Strategic and technical people leader for small molecule portfolio analytical development technical and product strategies roadmaps & initiatives. Embed AQbD and risk-based thinking in method development qualification/validation and lifecycle management to improve robustness reduce investigations and accelerate tech transfer and comparability.

How you will contribute:

• Single point of accountability for the global Analytical LCM portfolio of Synthetic Molecules including traditional synthetic molecules peptides oligonucleotides and linker payloads for ADCs.
• Owners of Analytical LCM Synthetic Molecules Portfolio Strategy from late dev commercial. Deep analytical engagement and understanding of product control strategies. Works with individual Analytical LCM program leads to create and maintain overarching program plans to meet overarching CMC program plans. Oversight of each program Analytical LCM Roadmap and Methods Risk Registers and driving communication and proactive planning ensuring appropriate analytical control strategies are in place for the lifetime of the commercial product.
• Strong interface & communication with enterprise leaders in MSAT Analytical MSAT manufacturing Pharm Sci Quality Regulatory GSQ QC sites and IT to ensure program plans and needs are well integrated and resourced into existing and future control strategies.
• Accountable for the integrated planning for ALL analytical synthetic molecule program-specific LCM activities to ensure continuity of control strategies including methods regulatory filings justification of specs tech transfer methods remediation planning process changes seamless supply and bridging of control strategies for reference standards & key materials for a program analytical change control and comparability strategy owners. Ultimately accountable for analytical synthetic molecule program-related plans and execution of activities.
• Coordination with Pharm Sci & BD on integration of incoming synthetic molecule program analytical strategies are consistently pulled through into commercial lifecycle management. Ensures analytical LCM plans and methods have appropriate quality management across the network including standards training and inspection readiness expectations for data integrity and documentation practices.
• Oversight on synthetic molecule program method risk registers to monitor method performance and proactively implement measures to ensure products and methods remain in control for the lifetime of use.
• Partner with QA QC Manufacturing/MSAT Regulatory CMC Supply Chain Pharm Sci and IT to ensure submission-ready analytical sections inspection readiness and governance for change control and lifecycle management.
• Contributes to driving analytical technology innovation into the synthetic molecule analytical LCM program plans in collaboration with PharmSci and QC lab network and other key stakeholders that ensures appropriate product control efficiency compliance and quality outcomes.

• Builds and maintains strong enterprise leadership network internally and externally to drive sound technical analytical synthetic molecule program strategies embedding AQbD new technology and risk-based thinking in methods development qualification/validation and lifecycle management to improve robustness reduce investigations and accelerate tech transfer and comparability.

Minimum Requirements/Qualifications:

• Education: BS/MS in Chemistry Biochemistry Pharmaceutical Sciences or related discipline (PhD preferred).
• Experience: 12 years in pharma/biotech with depth in Analytical Development and/or QC with emphasis on leading multiple synthetic molecule analytical programs in development and/or lifecycle management. Proficient across all synthetic molecules analytical technology applied to API and drug product especially separation sciences and dissolution. Significant people and matrix leadership experience and accountability for strategy governance and delivery across multiple programs including NDA or BLA filings.
• Control strategy & filings: Demonstrated experience developing analytical control strategies holistic control strategies and supporting regulatory submissions (IND/IMPD/BLA/NDA/MAA) including specifications/justifications stability and comparability strategies.
• AQbD / validation & lifecycle: Strong understanding of ICH expectations and practical execution of AQbD risk-based validation/verification robustness and method lifecycle management.
• Analytical platforms & informatics: Strong technical oversight across key analytical modalities and enabling systems (CDS/LIMS/ELN) including standardization and qualification in regulated environments.
• Analytical development breadth: Understanding of analytical development supporting discovery through manufacturing and regulatory submissions.
• Regulatory support: Experience supporting regulatory submissions and approval processes.
• Scientific leadership & stakeholder management: Strong communication/collaboration; able to manage complex priorities and stakeholders.
• Platform modernization: Track record modernizing analytical platforms or scaling new ways of working.

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:

Lexington MA

U.S. Base Salary Range:

$212000.00 - $333190.00

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 actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits please click here .

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

Lexington 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.

Required Experience:

Senior IC