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Job Title: Analytical Services Operations Manager
Reports to: Stability Program Compliance Team Lead
Location: Cambridge, MA
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 a full understanding of stability program management.
Directly 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.
Maintain analytical documentation, e.g. Stability Protocols, Annual Stability Reports, Product Shelf life analysis, and Technical documentation. Author regulatory sections and support RTQs.
Develop and compile and monitor performance metrics and guide continuous improvement of activities within the ASO organization
Lead product stability investigations of unexpected results to identify root- cause; define 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.
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 stability protocols/shelf life reports, and statistical analysis of stability data to provide shelf life assessment.
As the deviation/Lab investigation owner, support Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help bring 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; execution, and data analysis 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.
Be a valued partner by providing relevant decision support (e.g. what-if scenarios for decision-making).
Provide technical support to other Analytical Services activities as needs arise.
Maintain training records current and GMP compliance when conducting Takeda business.
Technical/Functional (Line) Expertise: Expertise in product stability study needs for commercial products. In-depth knowledge of relevant pharmaceutical and device regulations in global markets and author stability sections in regulatory filings and answer RTQS from multiple regulatory agencies. General knowledge, and 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: Demonstrate technical leadership. Provide technical guidance to team members. Find solutions to technical and quality issues. Make quality risk-based recommendations affecting CTL services, helping Takeda support its commitment to putting patients first and building trust with society. Operate across multiple regions, and cross-functionally. This includes leadership on improvement projects and providing guidance/training to junior staff. Collaborate with multiple cross-functional teams within the company and with external vendors. Experience with companies outside Europe
Decision-making and Autonomy: Make technical and quality decisions. Lead complex investigations and provide technical guidance to CMO and CTL. Fulfill requests for analytics to support Quality Councils. Escalate any analytical issues identified during the review of analytics provided by CTLs or during data trending.
Interaction: Key Stakeholders include: OncESSM ESQL, GMS, Regulatory Affairs, Supply Chain, Commercial organizations, R&D teams, Procurement, Internal Manufacturing sites, Manufacturing Sciences, Quality Systems, and Compliance. Work with partners, regulators, industry peers, and other Takeda quality units.
Innovation: A firm grasp of industry, scientific and regulatory trends. Demonstrate an understanding of priorities, goals, and project timelines. This includes understanding how Analytical Services stability activities affect the business. Propose improvement ideas for continuous improvement of business processes and quality. Lead improvement projects Demonstrate a good understanding of the analytical methodology. Can work through important conversations with the CTL with regard to financial process execution.
Complexity: Accountable for financial process execution supporting the Global OncESSM Quality OpU products. Support analytical activities at CMOs or CTLs for Takeda’s Oncology and Small Molecule commercial products.
What you bring to Takeda:
Essential Skills:
A minimum of a Bachelor’s degree in a science-related field of study with 10+ years of experience in the pharmaceutical industry
An Advanced degree with 5+ years experience in the pharmaceutical industry R&D, Analytical, and QC laboratory environment.
Knowledge of pharmaceutical quality systems and an understanding of GMP, GLP, GDP, and ICH Q1A (R2).
Documentation skills are required, including writing SOPs, technical papers, and investigations.
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.
Must have broad experience in analytical investigations, and handling of OOS, and OOT investigations.
Experience handling stability studies of small molecule API and ADC/biologics.
Experience in analytical laboratory, method execution, qualification, or validation of small molecule or biologics assays.
Experience in statistical analysis of data and author shelf life reports.
Experience in regulatory support, authoring dossier sections, respond to regulatory inquiries.
Matrix management experience.
Awareness of financial processes.
In-depth understanding of applicable regulations and guidance.
Proficiency in Microsoft tools
Fluent in written and spoken English.
Desired Skills:
Experience with LIMS, Trackwise, Veeva, Mosaic, and other relevant QMS systems.
Project management experience.
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 of 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. You may:
Work in a controlled environment requiring special gowning and wearing protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
Need to remove all make-up, jewelry, contact lenses, nail polish, and artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours.
Working around chemicals such as alcohol, acids, buffers, and Celite may require respiratory protection.
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.
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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.
Boston, MA
Employee
Regular
Full time
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