Synthetic Molecules 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.
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, MAU.S. Base Salary Range: $212,000.00 - $333,190.00 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. 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, MAWorker Type EmployeeWorker Sub-Type RegularTime TypeFull time
