Head, Analytical Development (AD)
Boston, MassachusettsBoston, Massachusetts| Vienna, Austria
- Job Level: Senior
- Travel: 5-10%
The Pharmaceutical Sciences (Pharm Sci) organization is an integral part of global R&D at Takeda, translating science into therapeutic products for patients. When you join Pharm Sci, you become part of a team dedicated to bringing our products to life for our patients through innovation, dedication and talent while minimizing environmental impact.
We work as a member of Takeda’s Global Program Team (GPT) and take full ownership of Chemistry, Manufacturing & Control (CMC) activities — driving product development from bench to bedside.
The Pharm Sci team focuses on executing and enhancing business processes and partnering with key stakeholders and industry leaders to boldly deliver an increasingly complex portfolio. Always looking through a sustainability lens to protect our planet, we are embracing new ways of working, excelling in our data and digital transformation, building differentiated capabilities (CMC Acceleration), delivering innovative medical devices, and advancing an inclusive, innovative culture.
It is an exciting time to be in Pharm Sci. Join our journey and change the lives of patients!
Boston, Massachusetts| Vienna, Austria
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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:
Provides leadership and expertisein physical/chemical, biopharmaceutical,biological andparenteral 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 activities for the global R&D portfolioincluding the establishment of GMP labs for release testing of clinical trial materials and management of a network of external development and testing providers.
Developing R&D CMC analytical centers of excellence which will provide strategic analytical testing capabilities in line with Takeda’s R&Dportfolio 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 generatedare 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.
Overall strategic management, direction, and motivation of physical, chemical, biopharmaceutic and analytical testing professionals that are responsible for the advancement of R&D projects.
Operates across the global PS network and collaborates 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 implements 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 maintains 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, Method 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
Experienced 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:
Pharmaceutical manufacturing and packaging
Active pharmaceutical ingredient manufacturing
Packaging materials
Printed commodities
Analytical laboratories
Approximately 15% travel is required.
Domestic and international flights with overnight stays required
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy
Takeda is proud in its commitment of 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.
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
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:
Boston, MAU.S. Base Salary Range:
Kristin Test
$0.00 - $0.00The 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.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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, MAAUT - Vienna - Kärntner RingWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeThe heart of our work
Leading with innovation
Our pipeline
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
Jobs for you
- Associate Scientist/Principal Scientist, Process Engineering, Pharmaceutical Science Fujisawa, Japan Category: Sales
- 25卒新卒採用 ー シンセティックモレキュール・プロセスデベロップメント(SMPD)研究員 Fujisawa, Japan Category: Sales
- Head, Analytical Development (AD) Boston, Massachusetts, Vienna, Austria Category: Pharmaceutical Sciences
- Associate Director Process Engineering Fujisawa, Japan Category: Manufacturing Engineering
Join our talent community
Get customized job alerts sent right to your inbox. Plus, get the latest in company news and other important resources by signing up for our talent community.