Manager, Instrumentation and Qualifications - Now Hiring

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Manager, Instrumentation and Qualifications

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manager, Instrumentation and Qualifications in our Cambridge, MA location.

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 realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for 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.

As part of Lab Operations, you will report to the Associate Director, Lab Operations and will work with Facilities, IT, Quality, EH&S, Finance, Procurement, and multiple externals including Service Providers and Supply Vendors.

POSITION OBJECTIVES:

• Provide equipment and inventory management services to the Process Development and Pharmaceutical Science department.
• Responsible for independently scheduling and organizing the installation, operational and performance qualification (IQ/OQ/PQ) activities of all laboratory equipment.
• Perform regular maintenance on GxP and non-GxP equipment.
• Troubleshoot equipment issues in conjunction with end users to resolve issues or coordinate the repair with internal teams or vendors.
• Manage equipment services including repairs, calibrations, qualifications, software/hardware upgrades for lab equipment.
• Responsible for independently scheduling and managing end user requests for utility upgrades, modifications, and installations.
• Manage equipment database information, including maintaining database for equipment moves, new equipment arrivals, equipment decommissioning.
• Responsible for ensuring compliance, performing documentation review, implementing, and managing workflows related to all laboratory equipment.
• Partner with R&D Quality to ensure compliance standards are met and sustained. Ensure Pharmaceutical Sciences is audit ready in partnership with R&D QA.
• Optimization of calibration and maintenance methodology including generation, review or revision of SOPs around instrumentation in collaboration with Quality Assurance.
• Lead or participate on projects and teams related to capital equipment purchases and lab moves.

POSITION ACCOUNTABILITIES:

• Knowledge of Empower, Blue Mountain RAM or similar qualified CMMS system desired.
• Experience in Pharma / GMP / FDA regulated industry and working with validated systems.
• Familiarity with laboratory and analytical instrumentation including but not limited to HPLC/UPLC, GC. MS, NMR, and other process chemistry equipment.
• Ability to learn and administrate new platforms and software applications.
• Strong organizational and communication skills, with an attention to detail. Ability to express one’s self clearly and concisely within team.
• Documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to upper and direct management. Can think strategically during critical activities.
• Strong team member with demonstrated ability to work collaboratively with others.
• Demonstrated ability to manage projects independently, as well as project teams.
• Independent and self-motivated individual. Works well in a cross functional team environment.
• Ability to own and manage departmental finance and budget justification.
• Analytical and Problem Solving Skills: Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information.
• Project Management: Able to initiate, manage, plan, execute, control, and close concurrent validation projects within given timelines.
• Requires in-depth interactions with scientists and quality specialists from various departments and external vendors.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Bachelors degree in Chemistry, Instrumentation, Facilities, Engineering, or related Pharmaceutical Science; 8 years relevant industry experience •Masters degree in Chemistry, Instrumentation, Facilities, Engineering, or related Pharmaceutical Science;  6 years relevant industry experience,   •Knowledge of IQ (installation qualification) / OQ (operational qualification) / PQ (performance qualification).

Base Salary Range: $ $101,500- $145,000, based on candidate professional experience level.  Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.   

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

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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.