Posted to MedZilla on 3/25/2019

Takeda Pharmaceuticals

US-MA, Associate Director Quality Control Microbiology SR0032311-MZ


Primary Duties:

This position will lead the management and operations of the Quality Control Microbiology Laboratory including support of raw materials, validation, in-process and product testing. In addition, the role provides leadership for developing, maintaining and supporting all aspects of the environmental monitoring and utilities monitoring programs for commercial and clinical drug substance manufacturing.

The Associate Director QC Microbiology directs the work of laboratory management and engages with test and support functions to ensure the timely release of test results.

The position will drive compliance with CGMPs and SOPs and represent the function in the inspection / audit process. In addition, this role will participate in operational excellence initiatives and drive continuous improvement in the microbiology laboratory.

The position requires demonstrated leadership, as well as operational experience in a Quality Control laboratory setting.

Responsibilities include:

  • Training, coaching, and mentoring the QC laboratory team and develop effective performance objectives to monitor performance.
  • Reporting on laboratory metrics and identifying new metrics focused on monitoring for potential issues and continuous improvement.
  • Responsible for overall QC Microbiology GMP operations in support of Biologics Manufacturing Facility.
  • Direct supervisory and lead technical staff with responsibilities for all laboratory personnel and individuals.
  • Responsible for developing, maintaining and supporting all aspects of Environmental Monitoring program in support of GMP Biologics Manufacturing Operations.
  • Provide technical support for validating/qualifying systems including CIP/SIP processes, water and clean air production and distribution systems, cleaning/gowning and personnel practice; provide expert input with cross-functional teams to include personnel from QC, Manufacturing, Technical Services, and Quality Assurance.
  • Responsible for laboratory support of product testing (bioburden, endotoxin, and bacterial identifications).
  • Manage capital, contract services and personnel budgets for areas of responsibility.
  • Establish systems to maintain cGMP compliance across areas of responsibility with regards to current SOPs, validation/qualifications, and training. Identify and implement best practices across areas of responsibility.
  • Represent the area functions as required during audits by external agencies and auditors, as well as by internal auditors.
  • Establish systems across areas of responsibility to ensure compliance, good lab practices and efficiency.
  • Review SOPs, protocols, policies, and reports.
  • Manage / support continuous improvement and lean lab projects.
  • Interact with Manufacturing, QA and other departments as required to meet objective; interact with business partners and technical representatives as required to meet objectives.


60%: Management duties, overseeing cGMP microbiology in support of biologics manufacturing

20%: Regulatory and/or inspection support, initiating/completing quality systems, such as change control or CAPA

20%: Involvement in special projects, such as overseeing and evaluating improvements to LIMS systems and other quality management systems

Education and Experience Requirements

  • Requires a bachelor s degree and a minimum of 10 years of relevant QC experience and at least 5+ years of supervisory experience.
  • Microbiology related degree is preferred.
  • Strong relevant experience in executing, developing, and managing QC Microbiology and EM programs in cGMP biotech and/or pharmaceutical environments.
  • Excellent communication, interpersonal and organizational skills.
  • Track record of conducting work in compliance with cGMPs, safety and regulatory requirements.
  • Strong business acumen (Operations, productivity, continuous improvements)

Other Job Requirements

Travel between MA sites may be required.

The following physical abilities are required in order to fulfill the job duties:

  • Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
  • Ability to work around chemicals (if working around the laboratories)
  • Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
  • Ability to walk and stand for periods of time

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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