Jobs
>
Vienna

    Head, Analytical Development - Wien, Österreich - Takeda

    Takeda
    Takeda Wien, Österreich

    vor 1 Woche

    Takeda background
    Ganztags
    Beschreibung

    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 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 activities for the global R&D portfolio including 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&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 generated are 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

    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, MA

    U.S. Base Salary Range:

    $321, $442,200.00

    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 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. 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. 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

    Locations

    Boston, MAAUT - Vienna - Kärntner Ring

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time
  • BOEHRINGER Ingelheim RCV GmbH & Co KG

    Scientist Analytical Development

    vor 4 Tagen

    BOEHRINGER Ingelheim RCV GmbH & Co KG Wien, Österreich

    **Die Stelle**: · Das Boehringer Ingelheim Regional Center Vienna verstärkt seine Aktivitäten am Standort Wien und sucht ab sofort für den Geschäftsbereich Biopharmaceuticals eine/n engagierte/n · **Aufgaben**: · - Leitende Mitarbeit an Entwicklungsprojekten für Boehringer Ingelh ...

  • Eurofins

    Scientist for Analytical Development

    vor 5 Tagen

    Eurofins Vienna, Österreich Ganztags

    Job Description · Job Description · For one of our teams based in Vienna we are currently looking to hire a Scientist with a focus on activities in Analytical Development. Your main responsibilities will include, but are not limited to: · Development of analytical methods for the ...

  • Eurofins

    Scientist for Analytical Development

    vor 6 Tagen

    Eurofins Vienna, Österreich Ganztags

    Job Description · For one of our teams based in Vienna we are currently looking to hire a Scientist with a focus on activities in Analytical Development. Your main responsibilities will include, but are not limited to: · Development of analytical methods for the quantification o ...

  • RBI

    Quant Developer – Portfolio Credit Risk Analytics

    vor 5 Tagen

    RBI Vienna, Österreich

    · Quant Developer – · Portfolio Credit Risk Analytics (f/m/x) · #full-time · (38.5h / week) · #viennaoffice · (1030) · #homeoffice · possible · Your role at RBI · Development and implementation of credit risk models for IFRS9 impairments, stress testing, and economic capita ...

  • Wella Company

    Business Partner Salon

    vor 2 Tagen

    Wella Company Wien, Österreich

    Function: Sales- Location: Vienna, 9, AT- Work Arrangement: Remote**Business Partner Vertrieb (w/m/d)** · **ÜBER WELLA** · Wella Company ist eines der weltweit führenden Kosmetikunternehmen, das sich aus einer Familie von Marken-Ikonen wie Wella Professionals, Sebastian Professio ...

  • TUI

    Partner Marketing Manager

    vor 1 Woche

    TUI Wien, Österreich

    **Trage den TUI smile in die Welt und lass die Träume unserer Kund:innen wahr werden** · Marketing ist deine Leidenschaft? Freude an vertriebsnahen Herausforderungen und Hands-On-Mentalität zeichnen dich aus? Dann bist du bei uns genau richtig Als Partner Marketing Manager (m/w/d ...

  • TUI

    Partner Marketing Manager

    vor 1 Woche

    TUI Wien, Österreich

    Trage den TUI smile in die Welt und lass die Träume unserer Kund: innen wahr werden · Marketing ist deine Leidenschaft? Freude an vertriebsnahen Herausforderungen und Hands-On-Mentalität zeichnen dich aus? Dann bist du bei uns genau richtig Als Partner Marketing Manager (m/w/d) t ...

  • International Atomic Energy Agency

    Information Analyst

    vor 2 Tagen

    International Atomic Energy Agency Wien, Österreich

    Information Analyst (Nuclear Material Accounting Analytics) (P / · Organization: SGIM-Declared Information Analysis Section · Primary Location: Austria-Vienna-Vienna-IAEA Headquarters · Job Posting: , 7:46:39 AM · Closing Date: , 4:59:00 PM · Duration in Months: 36 · Contract Ty ...

  • Takeda Pharmaceutical

    Associated Scientist Cmc

    vor 4 Tagen

    Takeda Pharmaceutical Wien, Österreich

    **Your Opportunities**: · - Development of analytical methods according to AQbD principles to support routine testing, process development and product characterization. · - Optimization and automation of HPLC methods · - Close collaboration with in-process analytics and other tea ...

  • Hookipa Pharma

    Data and Information Architect

    vor 2 Tagen

    Hookipa Pharma Wien, Österreich

    Date: Jul 21, 2023- Location: Wien, AT**About HOOKIPA**: · HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify target ...

  • REWE International IT

    Web/app Analyst

    vor 12 Stunden

    REWE International IT Wien, Österreich

    Company Description · In our RIAG IT unit in Vienna, we bundle the entire technological development of all online activities of REWE International AG. We want to become the leading provider of online solutions in all of the markets that are relevant to us. Make history with us in ...

  • mySugr

    Business Analytics Intern

    vor 1 Woche

    mySugr Wien, Österreich

    Full-Time, Paid Internship: 4-6 months (Vienna)_ · Diabetes is a pesky monster — and that's putting it mildly. If you're serious about helping us face it head on, come join us · For a behind-the-scenes look, check out our Monster Culture blog and Roche code4life to see what makes ...

  • Gitmax

    Data Modeler

    vor 1 Woche

    Gitmax Wien, Österreich

    We are seeking a highly skilled and experienced **Data Modeler** to join our team. · This role will involve collaborating closely with business stakeholders, data engineers, and business analysts to design and implement data models that support our procurement analytics objective ...

  • Erste Group Bank AG

    Data Scientist

    vor 4 Tagen

    Erste Group Bank AG Wien, Österreich

    Erste Group was founded in 1819 as the first Austrian savings bank and today it is one of the largest banking groups in Central and Eastern Europe (CEE). As an attractive employer, Erste Group offers interesting career opportunities in an international environment.- Group Financi ...

  • Moody's

    Product Manager

    vor 1 Woche

    Moody's Wien, Österreich

    Moody's is a global integrated risk assessment firm that empowers organizations to make better decisions. · **Team/Department Description: Product Team, Moody's Analytics GmbH Austria** · We are seeking a highly motivated, personable individual to join our team as Product Manager ...

  • International Atomic Energy Agency

    Satellite Imagery Analyst(P3)

    vor 1 Woche

    International Atomic Energy Agency Wien, Österreich

    Satellite Imagery Analyst(P / · Organization: SGIM-State Infrastructure Analysis Section · Primary Location: Austria-Vienna-Vienna-IAEA Headquarters · Job Posting: , 3:05:47 AM · Closing Date: , 4:59:00 PM · Duration in Months: 12 · Contract Type: Temporary Assistance - Regular ...

  • Valneva

    Scientist Assay Development Austria

    vor 1 Woche

    Valneva Wien, Österreich

    **Your Responsibilities** · - Coordination and performance of work in Department with primary focus on: biochemical, molecular biological and immunological assay development · - Guidance of Research Assistants and support in efficient distribution of workload (knowledge transfer, ...

  • Hotel Sacher

    Digital Marketing Manager:in

    vor 1 Woche

    Hotel Sacher Wien, Österreich

    **YOUR TASKS** · - Digital Marketing Strategy: Develop and implement comprehensive digital marketing strategies aligned with the hotel's objectives and target audience. Identify opportunities and trends to enhance brand positioning and drive revenue growth. · - Website Management ...

  • Moody's

    Product Manager

    vor 1 Woche

    Moody's Wien, Österreich

    Moody's is a global integrated risk assessment firm that empowers organizations to make better decisions. · We are seeking a highly motivated, personable individual to join our team as Product Manager. As a Product Manager, you will be a vital member of Product Team responsible f ...

  • International Atomic Energy Agency

    Internship - Imagery Science and Analytics

    vor 3 Tagen

    International Atomic Energy Agency Wien, Österreich PraktikumSHIP

    Internship - Imagery Science and Analytics - (TAL-SGIM · Organization: SGIM-State Infrastructure Analysis Section · Primary Location: Austria-Vienna-Vienna-IAEA Headquarters · Job Posting: , 2:39:22 AM · Closing Date: , 4:59:00 PM · Duration in Months: 12 · Contract Type: Intern ...