Head of Global Microbiology Management

Employer
Takeda
Location
Lexington, Massachusetts, US
Salary
Competitive
Posted
Jul 20, 2021
Closes
Aug 05, 2021
Ref
2322652566
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
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Job Description

OBJECTIVES/PURPOSE:
  • Leads, owns and drives strategic global (multi-site, multi-product) microbiology/aseptic pro-grams across Takeda facilities
  • Leads and develops a team of global microbiology experts
  • Drives standardization and harmonization between the manufacturing sites and provides train-ing/ capability building throughout the Takeda network
  • Leads and/or supports microbiological investigations and technical support and provides on-site or remote inspection support


ACCOUNTABILITIES:
  • Management of global procedures on environmental monitoring and critical utilities, microbiological control, cleanroom management and design, microbiological methods and validations, sterilization and aseptic processing controls (process simulations), disinfectant efficacy studies, micro assessment for raw materials, media/buffer, and excipients
  • Ensures alignment of Takeda´s network regarding global microbiological/aseptic standards and compendial requirements
  • Leads Microbiological Control Programs/Strategy
  • Leads and/or support Microbiological Investigations (on-site or remotely)
  • Leads Global Communities of Practice (CoP) meetings to share Best Practices and Lessons learned throughout the network
  • Provides technical support to Takeda´s sites regarding microbiology/aseptic related challenges
  • Responsible for assessing critical CMO/CTL deviations
  • Responsible for providing micro/aseptic related support regarding submission and responses to authorities
  • Responsible for internal and external Audit Support (pre-, during and post inspections) on-site or remotely
  • Leads external engagement in microbiology/sterility assurance/cleanroom management related forums and Benchmark industry trends/standards (e.g., BPOG/PDA/ECA/Industry forums)


DIMENSIONS AND ASPECTS:
Technical/Functional:
  • Profound knowledge and experience in microbiology laboratory, aseptic practices and techniques, also in a manufacturing setting, including topics like construction of new manufacturing sites
  • Experience to drive microbiological control gap assessments at the sites
  • Experience in microbiological investigations,
  • Knowledge regarding disinfectants/disinfectant agents and new developments on the market
  • Experience with Quality Management Systems preferable in an FDA and EMEA regulated manufacturing setting
  • Thorough knowledge of applicable regulations and standards including ISO 14644, ISO 9001, ISO 13485, FDA CFR Parts 210, 211, 600, 820 and International GxPs
  • Experience in providing audit support


Leadership:
  • Develops and leads global strategic microbiological/aseptic programs across all Takeda facilities
  • Leads/drives other global strategic initiatives and improvement projects
  • Ability to lead multi-facility team members
  • Experience in managing change
  • Excellent negotiation and influencing skills
  • Excellent communication and presentation skills projects
  • Representing Takeda in the industry and as needed with authorities (e.g. during inspections and/or calls/meetings with authorities)
  • Good computer skills, proficient writing, organization and presentation skills


Decision-making and Autonomy:
  • Ability to set priorities and to support facilities throughout the global network
  • Experience in makings decisions according Quality Risk Management


Interaction:
  • The role interacts routinely with all sites and all functions across the Takeda network through the CoPs, by supporting projects and microbiological investigations, conducting training's, responding to facility questions and needs, etc.
  • Frequently interacts with companies other than Takeda, such as manufacturers of rapid microbiological methods, of disinfectant, and cleanroom equipment/tools suppliers, training providers, etc.
  • Interaction with different Health Authorities in the course of inspections as needed
  • Interaction with industry as member of different forums, liked BPOG, Austrian Pharma Cercle, as presenter at different events, like seminars, etc.


Innovation:
  • Scientific knowledge to identify new developments regarding microbiological control and cleanroom cleaning/disinfection and to share new perspectives and best practices throughout the network
  • Excellent knowledge sharing skills
  • Experience in providing training's and workshops for all levels
  • Experience to drive/support digitation programs, such as EM LIMS


Complexity:
  • Ability to manage complex, global (multi-site, multi-product) programs/projects and initiatives
  • Multi-cultural considerations and knowledge of site-specific needs are essential for the successful implementation and maintenance of the different initiatives as well as global procedures


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / experience:
  • Masters in microbiology or biology or biotechnology
  • A minimum of 15 years of experience working in a GMP-environment in the pharmaceutical industry is required
  • A minimum of 10 years experience in a microbiology laboratory or comparable, such as in a sterility assurance function are required


Core Competencies / Skills:
  • Strong analytical and problem-solving skills
  • Experience with investigational trouble shooting,
  • Experience in managing projects in a global environment
  • Excellent influencing skills


Leadership Behaviors:
  • Demonstrates strategic enterprise thinking to find innovative ways to serve patients, and build trust, reputation and our business
  • Creates the environment that inspires and enables people to move the organization forward
  • Focuses on the few priorities that matter most and delivers superior results
  • Elevates the capabilities of the organization for now and the future


Live the TAKEDA-ISM:
  • Putting the patient in the center
  • Building trust with society
  • Reinforcing our reputation
  • Developing the business


Location and Salary Information: This job posting excludes CO applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time