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Job Description Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as the Head, Analytical Development (AD) in Pharmaceutical Sciences.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work towards excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver
Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
Objectives/Purpose:- P rovides leadership and expertise in physical/chemical, biopharmaceutical, biological and parenteral testing for the discovery and development of small and large molecules and other modalities and delivery mechanisms . This includes managing the resources and analytical strategies for development and testing a portfolio of development candidates across many modalities .
- Sets the strategic direction for the function including (including regulatory, technical, and financial strategies) and is responsible for the management of all CMC analytical testing a ctivities for the global R&D portfolio including the e stablish ment of GMP labs for release testing of clinical trial materials and management of a network of external development and testing providers.
- D eveloping R &D CMC analytical center s of excellence which will provide strategic analytical testing capabilities in line with Takeda's R&D portfolio from discovery to post approval . This position will also determine and support new areas of analytical science and related technologies for potential use in new methods .
- Ensures that analytical methods are properly validated for the stage of development, the analytical data that the methods generate d a r e reliable and compliant with regulatory authorities, and that the methods are ultimately transferable to commercial organizations around the world .
Accountabilities:- Accountable to the entire R&D Organization for providing high quality data that is reliable and will be used by R&D project teams to make critical decisions including go-no-go for projects based on the physicochemical, biopharmaceutical, pre-formulation and stability data provided.
- O verall strategic management, direction, and motivation of physical, chemical, biopharmaceutic and analytical testing professionals that are responsible for the advancement of R&D projects.
- O perate s across the global PS network and collaborate s with other functions both within and outside Takeda to meet PS , R&D and Takeda objectives .
- Provides GMP and GLP reliable testing methods and analytical testing data for IND/CTA to NDA/MAA submissions in countries across the world that will serve as the basis for marketing approval.
- Develops and implement s strategies to reliably control the quality of drug substances and products based on the current Good Manufacturing Practice (cGMP) regulations in collaboration with Takeda's quality organization.
- Develops and maintain s a competent organization that will encourage appropriate risk taking, empowerment and the development of individuals.
- Manages a 45+ oku yen analytical testing budget within the human resources required to perform the work to achieve the department's critical results .
- Provides input into the overall strategic plans of the Pharmaceutical Sciences organization and for the implementation of key decisions from the Pharmaceutical Science's Leadership Team into the normal activities of AD.
- Accountable for the performance and management of analytical testing sites across the major geographical regions and using these sites to efficiently meet the goals of PS , R& D and the commercial organizations.
- Leads effective and efficient outsourcing of GLP/GMP analytical testing and the implementation and sustainability of internal GLP/GMP testing in early development .
- Accountable for the development, implementation, and realization of the digital CMC testing strategy across the R&D testing organization including LIMS, PAT, RTR, Met hod Simulation, and other aspects of digital data from CMC testing
Dimensions and Aspects: Technical/Functional (Line) Expertise :
- Comprehensive understanding of the pharmaceutical industry and Analytical Development
- In-depth knowledge of US/EU/JP regulatory regulations and ICH requirements governing international pharmaceutical industries
- Experience d in development of analytical / bioanalytical programs and strategies for both early and late-stage product development
- Demonstrated experience with the preparation of analytical CMC sections of regulatory submissions
- Sets a high compliance standard and ensures that systems and resources are in place to ensure the activities of the laboratories (internal and external) are conducted in compliance with cGMP/GLPs, SOPs, good documentation practices, DEA regulations and safety standards and in accordance with corporate requirements. Ensures overall laboratory readiness for regulatory inspections (e.g., FDA, EMA and DEA) and internal audits.
Leadership: - Demonstrated ability to work across functions, regions, and cultures
- Enterprise level leadership with the ability to inspire, motivate and drive results
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can engender credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple comprehensible terms
- Executive leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Ability to develop and drive a Global Workforce and Talent strategy for all 200 + colleagues in the Global, Regional and Local organizations
Decision-making and Autonomy :
- Ability to make highly complex decisions that impact the enterprise
- Accountable for decision making for designated function (Analytical Development)
- Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution
- Accountable for designing and implementing vision and strategy for designated scope in alignment with organizational goals
Interaction :
- Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
- Ability to effectively implement R&D's partnership strategy
- Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
- Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions
Innovation : - Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
- Comfortable challenging the status quo and bringing forward innovative solutions
- Ability to take risks implementing innovative solutions, accelerating time to market
Complexity :
- Ability to work in a global ecosystem (internal and external) with a high degree of complexity
- Breadth of knowledge required across therapeutic areas, indications, and/or modalities
Education, Behavioral Competencies and Skills: - Bachelor's degree in chemistry, Biology, Analytical science, or related field . PhD preferred.
- Minimum of 15+ years of increasing responsibility and experience in pharmaceutical analysis, manufacturing, or laboratory environment
- Minimum of 10 years of analytical research experience in the pharmaceutical industry, including at least 3+ years of analytical laboratory management.
- At least 5+ years of Senior management experience in Analytical Development or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
- Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
- Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
- Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry
Additional Information: . click apply for full job details
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