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Director, QC Microbiology and Contamination Control

Employer
Takeda
Location
Lexington, Massachusetts, US
Salary
Competitive
Closing date
May 20, 2021

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Sustainability, Biology
Salary Type
Salary
Employment Type
Full time
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Job Description

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. The individual is directly responsible to maintain labs in an inspection-ready, GMP-compliant state as well as support the introduction of new technology to improve sustainability and compliance.

Additionally, the role provides leadership for developing, maintaining, and supporting all aspects of the environmental/utilities monitoring and contamination control programs for commercial and clinical drug substance manufacturing.

In this role, the individual will drive accountability to deliver to targets for commercial and clinical testing of defined site-based and external programs, collaborate on continuous improvement (CI) activities, engage with peers across the sites to influence daily operations, and progress lean lab initiatives.

This position requires demonstrated leadership, as well as operational experience in a cGMP setting.

The role requires direct leadership and management of individuals, including goal setting, performance feedback, skills development, and mentoring.

Job Summary/Operations Involvement:

Responsible for the successful operation of activities of major significance to the organization. Ensures that overall budgets, schedules, and performance standards are realistically set and attained.

Discretion/Latitude:

This is a key leadership role in the Quality organization. Accordingly, it includes a high degree of autonomy and empowerment to achieve organizational goals. Individuals in this role are expected to be highly proficient in cGMP expectations related to QC Microbiology / Contamination Control as their decisions will have a significant impact on the overall success of functional, division, or company operations.

Impact:

Decisions would affect the financial, employee, or public relations posture of the company.

Responsibilities:
  • Oversight of daily laboratory operations, including tiered board attendance and governance activities: 25%
  • Oversight of the site's programs related to contamination control (cleaning and disinfection, traffic and gowning, utilities, etc.): 25%
  • Collaboration with peers in Quality organization to support major events and programs (OOS, AIQ, Data Integrity): 10%
  • Direct management of individuals, including goal setting, performance feedback, skills development, and mentoring: 20%
  • Other - Participate in training, development, and improvement activities: 20%
  • Responsible for developing, maintaining, and supporting all aspects of Environmental Monitoring program in support of GMP Biologics Manufacturing Operations.
  • Responsible for developing, maintaining, and supporting all aspects of Contamination Control 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, Manufacturing Sciences, and Quality Assurance.


Education and Experience Requirements

Essential:
  • Minimum of a bachelor's degree in a scientific discipline and 15 or more years related experience in a Biotech environment, esp. Quality Control laboratory preferred.
  • Demonstrated ability to solve problems, drive improvement, and develop plans and advance to completion on time and in full.
  • Prior people management experience
  • Strong relevant experience in executing, developing and managing QC Microbiology and/or EM Programs in cGMP biotech and/or pharmaceutical environments.
  • Strong knowledge of cGMPs and regulatory expectations
  • QC laboratory experience
  • Knowledge of quality systems
  • Excellent communication, interpersonal and organizational skills
  • Strong business acumen (Operations, productivity, continuous improvement)

Desired:
  • Microbioloy Related Degree, preferred
  • Experience or training in continuous improvement / operational excellence


Key Skills, Abilities, and Competencies

Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following values:

  • Integrity
  • Fairness
  • Honesty
  • Perseverance


  • Excellent communication, interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Ability to prioritize work and multitask.
  • Conducts work in compliance with cGMPs, safety and regulatory requirements


Complexity and Problem Solving:
  • Solve routine problems of moderate to significant scope and complexity following established policies and procedures.
  • Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
  • Builds stable working relationships internally.


Internal/External Contacts:
  • The role is directly accountable to the MA Biologics Operations Quality Head
  • Key internal partners include the personnel in the broader site and global Quality organization, Manufacturing, Manufacturing Sciences, Validation, Facilities and Engineering.
  • External: interacting with vendors as needed, and regulatory agencies.


Other Job Requirements

Routine travel is not expected, but periodic opportunities for training and development may require limited travel.

The following physical abilities are required in order to fulfill the job duties:
  • Ability to work around chemicals as an observer only. The role is not expected to perform actual lab operations.
  • Ability to wear basic personal protective equipment such as gloves, gowning, and eye protection while in laboratory areas.
  • Ability to walk and stand for periods of time.


Location and Salary Information:

This job posting excludes CO applicants.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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