Talent.com
Head, Analytical Controls (Sr. Director)

Head, Analytical Controls (Sr. Director)

Takeda PharmaceuticalsLexington, MA, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

How you will contribute :

  • Lead and develop a global team of managers and scientists and their teams in the field of analytical controls and compliance
  • Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all project-related analytical control topics, development requirements and program milestones including global reporting
  • Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas : a) GMP review and control for analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems
  • Contribute to product development from Research to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge. Including the support of transfer of development assets from Research, main ownership starting at start of GMP activities until hand-over to the commercial organization.
  • Contribute to overall functional direction globally and represent function within CMC / Pharmaceutical Science and across the global Takeda organization.
  • Implement and execute externalization activities with external partners, facilitate development of execution plans for each, and ensure completion of agreed upon activities

Accountabilities :

  • Responsibility for people and group management
  • Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment
  • Build future leadership while mentoring direct reports and junior employees
  • Lead and implementation of wider cross-functional / cross divisional strategy and decisions and drives initiatives to completion.
  • Develops and manages strategies for regional and global departmental infrastructure, resources, projects, etc. in conjunction with senior staff and global line and function heads
  • Lead global CMC and Quality key initiatives and represent Pharm Sci to other cross functional stakeholder key initiatives
  • Analyze and synthesize concepts from diverse information and articulate
  • Develop and set vision and direction of departmental activities and infrastructure with specific focus but not limited to compliance, quality, systems and processes for AD and PS
  • In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current Good / Laboratory / Manufacturing Practice (cGMP, cGLP) regulations
  • Harmonization and standardization of AD but also PS processes, reporting, systems and documents in collaboration with Quality. Establishes and manages operational processes within the department / function.
  • Benchmarks current trends within industry for all areas within Analytical Controls also including strategic development and planning of system architecture in alignment and collaboration with partners and stakeholders e.g. GMS / GQ for company wide systems, IT and PSST for new solutions.
  • Look for external benchmarks that help to aid superior performance of products, processes and people
  • Manages complete line function responsibility for all departmental programs and initiatives
  • Demonstrates project oversight and leadership and cross-functional awareness to advance the line function regionally and globally
  • Directs, informs and applies outsourcing strategy for department in conjunction with senior staff and global line and function heads
  • Minimum Requirements / Qualifications :

  • Bachelor degree with 20+ years of experience
  • Advanced degree with 15+ years relevant industry experience
  • Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug products under cGMP's
  • Demonstrates effective project management skills
  • GMP and compliance experience required
  • Analytical method development experience required
  • Regulatory submission experience required with basic knowledge for regulatory guidelines
  • Global cultural awareness, manage inclusively
  • Familiarity with working in a global setting
  • Excellent command of English (all sites).
  • People managerial experience preferred
  • Team player with flexible personality but able to be persistent and assertive
  • Highly reliable, self-motivated, responsible and curious personality open to learn and develop and a pronounced desire for improvement
  • 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.

    #LI-KD1

    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 : Lexington, MA

    U.S. Base Salary Range : $208,200.00 - $327,140.00

    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-term incentives. 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

    Lexington, MA

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

    Job Exempt : Yes

    It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

    Create a job alert for this search

    Sr Director • Lexington, MA, US

    Related jobs
    • Promoted
    Director - Corporate Control Accounting

    Director - Corporate Control Accounting

    IberdrolaBoston, MA, US
    Full-time
    The base salary range for this position is dependent upon experience and location, ranging from : $175,000 - $219,000.This position is responsible for the direction and oversight of the accounting a...Show moreLast updated: 30+ days ago
    • Promoted
    Global Head, BioAnalytics, CMC Development

    Global Head, BioAnalytics, CMC Development

    SanofiFramingham, MA, US
    Full-time
    Global Head, BioAnalytics, Cmc Development.Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families.Y...Show moreLast updated: 15 days ago
    • Promoted
    Director, Procurement Chemical Analysis Division

    Director, Procurement Chemical Analysis Division

    Thermo FisherTewksbury, MA, US
    Permanent
    Work Schedule : Standard (Mon-Fri).Environmental Conditions : Office.How will you make an impact? The Director, Procurement Partner is the leader responsible for developing and driving the Procuremen...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Quantitative Analyst

    Director, Quantitative Analyst

    Fidelity InvestmentsBoston, MA, United States
    Full-time
    Develops, implements, and scales multi-asset, open-architecture, custom, investment solutions for intermediary clients, using Python, R, SQL, and other tools. Measures, monitors, and evaluates inves...Show moreLast updated: 6 days ago
    • Promoted
    Associate Director of Analytics

    Associate Director of Analytics

    VirtualVocationsWorcester, Massachusetts, United States
    Full-time
    A company is looking for an Associate Director - Analytics, Global Regulatory Affairs.Key Responsibilities Oversee the semantic layer and custom analytics capabilities in alignment with the Globa...Show moreLast updated: 2 days ago
    • Promoted
    Director of Analytics

    Director of Analytics

    VirtualVocationsLowell, Massachusetts, United States
    Full-time
    A company is looking for a Director of Analytics & Performance Measurement.Key Responsibilities Design and deploy advanced optimization models for marketing spend allocation Develop and maintain...Show moreLast updated: 30+ days ago
    • Promoted
    Director of Toxicology

    Director of Toxicology

    VirtualVocationsDorchester, Massachusetts, United States
    Full-time
    A company is looking for a Director, Toxicology to lead drug development efforts from preclinical stages to clinical trials. Key Responsibilities Oversee IND-enabling activities including pre-clin...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Quantitative Analyst

    Director, Quantitative Analyst

    Fidelity Investments Inc.Boston, MA, United States
    Full-time
    Develops, implements, and scales multi-asset, open-architecture, custom, investment solutions for intermediary clients, using Python, R, SQL, and other tools. Measures, monitors, and evaluates inves...Show moreLast updated: 27 days ago
    • Promoted
    Senior Director, Analytical Development

    Senior Director, Analytical Development

    BiogenCambridge, MA, US
    Full-time
    Senior Director And Head Of Analytical Development For Small Molecules & Antisense Oligonucleotides.As the Senior Director and Head of Analytical Development for Small Molecules & Antisense Oligonu...Show moreLast updated: 30+ days ago
    • Promoted
    Director of Quality Control

    Director of Quality Control

    Strand TherapeuticsBoston, MA, US
    Full-time
    Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.Building on the idea...Show moreLast updated: 30+ days ago
    • Promoted
    Associate Director / Director, Technology Transfer

    Associate Director / Director, Technology Transfer

    AsimovBoston, MA, United States
    Full-time
    The (Associate) Director, Technology Transfer will play a pivotal role in delivering biologics cell line development (CLD) campaigns for our customers and successfully transferring Asimov processes...Show moreLast updated: 6 days ago
    • Promoted
    Global Category Manager, Analytical Services

    Global Category Manager, Analytical Services

    Takeda PharmaceuticalsCambridge, MA, US
    Full-time
    Global Category Manager (GCM) Analytical Services.The Global Category Manager (GCM) Analytical Services at the Associate Director level, plans and leads category projects for a clearly defined su...Show moreLast updated: 10 days ago
    • Promoted
    Senior Director TM Controller & PoL Applications

    Senior Director TM Controller & PoL Applications

    Infineon Technologies AGBoston, MA, United States
    Full-time
    Director TM Controller & PoL Applications, you will be the Technical interface to R&D and customers, support technical Go-to-Market activities, provide technical customer support on application and...Show moreLast updated: 2 days ago
    • Promoted
    Director, Internal Audit

    Director, Internal Audit

    EntegrisBillerica, MA, United States
    Temporary
    Here at Entegris, we use advanced science to enable technologies that transform the world, and we are seeking employees who have the drive to continue that mission. Vice President of Internal Audit ...Show moreLast updated: 2 days ago
    • Promoted
    Associate Director of Data Analysis

    Associate Director of Data Analysis

    VirtualVocationsLowell, Massachusetts, United States
    Full-time
    A company is looking for an Associate Director, Data Analysis.Key Responsibilities Manage multiple analytic projects, ensuring deadlines are met Support stakeholders by translating challenges in...Show moreLast updated: 3 days ago
    • Promoted
    • New!
    Head of Solutions Engineering

    Head of Solutions Engineering

    SanofiCAMBRIDGE, MA, United States
    Full-time
    Sanofi is building the pharmaceutical industry's first AI-powered operating system—and we need a Head of Solutions Engineering (a Technology Principle) to make it happen. You'll lead a specialized t...Show moreLast updated: 8 hours ago
    • Promoted
    Quantitative Project Director

    Quantitative Project Director

    VirtualVocationsLowell, Massachusetts, United States
    Full-time
    A company is looking for a Project Director / Senior Project Director for a temporary role with full-time hours and potential to become a regular staff employee. Key Responsibilities Independently m...Show moreLast updated: 2 days ago
    • Promoted
    Pioneering Medicines : Director, Analytical Development

    Pioneering Medicines : Director, Analytical Development

    Flagship PioneeringCambridge, MA, US
    Full-time
    Director, Analytical Development.We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner. Pioneering Medicines, an initiat...Show moreLast updated: 23 days ago
    • Promoted
    Director, US Pricing & Access Analytics

    Director, US Pricing & Access Analytics

    Grifols Shared Services North America, IncBoston, MA, United States
    Full-time
    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1...Show moreLast updated: 5 days ago
    • Promoted
    Associate Director, Analytical Development

    Associate Director, Analytical Development

    VertexBoston, MA, US
    Full-time
    Associate Director, Analytical CMC Strategy.Vertex Pharmaceuticals is seeking a highly motivated, collaborative, and innovative Associate Director specializing in analytical CMC strategy to provide...Show moreLast updated: 30+ days ago