Manager, Instrumentation and Qualifications
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 15, 2023
Job Description:
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Job Description
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
No Phone Calls or Recruiters Please.
KB-LI
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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Cherry Hill , Manager, Instrumentation and Qualifications, Executive , Cherry Hill, New Jersey
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