Takeda Pharmaceutical Hiring for Analytical Services Operations Sr. Manager (HYBRID) Job at Boston, MA Full Time

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Job Description

Job Title: Analytical Services Operations Sr Manager

Reports to: Stability Program Compliance Team Lead – Analytical Services

Location: Lexington, MA – HYBRID WORKPLACE POSITION

About the role:

• You will have responsibility for operational, technical, and compliance oversight for Global Oncology External Supply Small Molecule (OncESSM) Quality Operating Unit (OpU) Analytical Services stability testing performed at external service providers (contract test labs and manufacturing organizations; CTLs and CMOS) for small molecule, recombinant biologics, and cell therapy products as part of the global ASO function. This is an individual contributor role who has complete knowledge, and full understanding of stability program management.

• Partner with, and manage, relationships with external testing partners to ensure continuity of testing, investigations, and resolution of unexpected results and represent Takeda in interactions with providers.

• Grow analytical documentation, e.g. Stability Protocols, Annual Stability Reports, Product Shelf life analysis, and Technical documentation. Author regulatory sections and support responses to questions.

• Develop performance metrics and inspire the continuous improvement of activities within the ASO organization

• Lead product stability investigations of unexpected results to identify root-cause and develop corrective or preventive actions. Manage Quality Incident Management reports when needed.

• Work with OncESSM Quality OpU leadership to support the forecast of future spending, monitor variances, and lead improvements with financial benefit.

• Provide support to data analysis, data entry, purchase order creation/reconciliation, and financial oversight of third-party labs in the US and other regions by the third-party lab locations.

• Support compliance of testing network through participation in external provider audits, data review and data integrity verification, development of quality agreements and assures execution to requirements.

• Support regulatory filing and product APQR.

• 
  SCOPE: Individual Contributor position (No Reports).

How you will contribute:

The primary responsibilities of the position are focused on non-laboratory support of the Analytical Services stability functions. Primary activities would generally include data analysis, data trending, project, and testing coordination, inspection support, investigation lead; own stability protocols/shelf life reports, and statistical analysis of stability data to provide shelf life assessment.

• Be the deviation/ Lab investigation owners, and support Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help find closure.

• Provide assessment on product impact for temperature excursions during shipment, and analyze the need for product cycling studies to support shipment excursions.

• Perform statistical trending of stability data and provide important insights to the CMC team.

• Provide financial oversight of third-party labs to assure budget requirements are met and are accountable for the CTL financial processes execution (i.e. PO generation, invoice processing) of the Global OncESSM Analytical Services Operations (ASO) unit.

• Work with the OncESSM AS Stability Head, ASO Business Operations Lead and ASO Stability Lead to give feedback on financial estimates and assumptions.

• Manage stability study protocol development, and data reporting for OpU products as designated.

• Develop data summary and communication tools such as dashboards, reports, and product quality reviews.

• Evaluate business processes and propose and carry through continued improvement opportunities.

• Provide technical support to other Analytical Services activities as our needs arise.

• Maintain training records current and GMP compliance when conducting Takeda business.

What you bring to Takeda:

• Minimum Bachelor’s degree in a scientific discipline and 10+ years of industry experience OR 5+ years of industry experience with an advanced degree.

• Experience in the pharmaceutical industry R&D, Analytical, or QC laboratory environment and with pharmaceutical quality systems and an understanding of GMP, GLP, GDP, and ICH Q1A (R2). Experience with LIMS, Track wise, Veeva, Mosaic, and other relevant QMS systems.

• Must have an in-depth understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry, Mass Spectrometry, NMR, and other analytical techniques; broad experience in analytical investigations, handling of OOS, and OOT investigations.

• Experience handling stability studies of small molecule API and ADC/biologics; analytical laboratory, method execution, qualification, or validation of small molecule or biologics assays.

• Experience in statistical analysis of data and author shelf life reports; regulatory support, authoring dossier sections, and response to regulatory inquiries.

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application, and complexity of technical knowledge)

• Expertise in product stability study needed for commercial products.

• In-depth understanding of relevant pharmaceutical and device regulations in global markets and author stability sections in regulatory filings and answer responses to questions from multiple regulatory agencies.

• Experience in Pharmaceutical and Bio-Pharmaceutical Manufacturing (in particular small molecules and ADC Oncology products).

• General knowledge of Takeda’s strategy and our performance, and using that information to anticipate long-range planning for products.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Demonstrate technical leadership; provide technical guidance to team members and find solutions to technical and quality issues.

• Make quality risk-based recommendations improving CTL services.

• Operate across multiple regions, and cross-functionally.

• Collaborate with multiple departments within the company and with external vendors. Experience with companies outside Europe

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match charitable contributions

• Family Planning Support

• Professional development opportunities

• Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company to inspire and empowers you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time