Analytical LCM Product Lead Biologics

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Job Description

While a primary location is identified for this role qualified internal candidates in Brooklyn Park Neuchatel Vienna or Zurich may also be considered subject to business needs role requirements talent availability and local legal requirements.

About the role:

• Biologics Portfolio LCM Analytical Oversight: Single point of accountability for all Analytical LCM Biologics programs. Direct people management of individual analytical LCM program leads to provide deep technical quality and regulatory insights that drive consistent and scientifically sound decisions.
• Owns and drives Analytical LCM Portfolio Program Strategies for Biologics programs: Deep understanding of individual biologics product control strategies working with individual biologics analytical LCM program leads to ensure all analytical LCM activities are covered and on track with clearly defined roles and responsibilities schedules and resources. Creates and maintains Analytical LCM program roadmaps and method risk registers in alignment with overall CMC program roadmaps and 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: Works 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 biologics analytical prioritization network strategy CMC biologics initiatives/roadmaps and analytical lab work resourcing.
• Tech Forward: Drives digital-forward analytical technology innovation and platform embedment in analytical methodology. Works in collaboration with key stakeholders from Pharm Sci to QC labs including Quality Regulatory and IT to pull the latest analytical methodology through into LCM control strategies.
• Strategic and technical people leader for biologics portfolio analytical development technical and product strategies roadmaps and initiatives. Embeds 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 Biologics including monoclonal antibodies bispecific/multispecific antibodies fusion proteins recombinant proteins/enzymes and antibody-drug conjugates (ADCs).
• Owner of the Analytical LCM Biologics Portfolio Strategy from late development through commercial. Maintains deep analytical engagement with and understanding of product control strategies. Works with individual Analytical LCM program leads to create and maintain overarching program plans that meet overall CMC program plans. Provides oversight of each programs Analytical LCM Roadmap and Method Risk Registers driving communication and proactive planning to ensure appropriate analytical control strategies are in place for the lifetime of the commercial product.
• Strong interface and communication with enterprise leaders across 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 of ALL biologics program-specific analytical LCM activities to ensure continuity of control strategies including methods regulatory filings justification of specifications tech transfer methods remediation planning process changes seamless supply and bridging of control strategies for reference standards and key materials. Serves as analytical change control and comparability strategy owner and is ultimately accountable for biologics program-related analytical plans and execution of activities.
• Coordination with Pharm Sci and Business Development to ensure incoming biologics 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 of biologics 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 biologics analytical LCM program plans in collaboration with Pharm Sci the QC lab network and other key stakeholders ensuring appropriate product control efficiency compliance and quality outcomes.

• Builds and maintains a strong enterprise leadership network internally and externally to drive sound technical biologics program strategies embedding AQbD new technology 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 Biochemistry Biology Biotechnology Chemistry Pharmaceutical Sciences or a related discipline (PhD preferred).

• Experience: 12 years in pharma/biotech with depth in Analytical Development and/or QC with emphasis on leading multiple biologics analytical programs in development and/or lifecycle management. Proficient across the breadth of biologics analytical technology applied to drug substance and drug product especially cell-based bioassay/potency methods separation sciences mass spectrometry and deep biophysical and biochemical characterization. Significant people and matrix leadership experience and accountability for strategy governance and delivery across multiple programs including BLA or MAA filings.

• Control strategy & filings: Demonstrated experience developing analytical and holistic control strategies and supporting regulatory submissions (IND/IMPD/BLA/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 biologics 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.

T he salary range displayed reflects the primary location associated with this posting. Compensation may vary for candidates considered in other locations. Where applicable location-specific salary ranges and compensation information will be provided in accordance with local requirements.

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 MAAUT - Wien - DC Tower CHE - Glattpark (Opfikon) - Zurich HQ CHE - Neuchatel USA - MN - Brooklyn Park

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