Manufacturing Senior Training Coordinator

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

As the Manufacturing Senior Training Coordinator, you will oversee the assignment and delivery of manufacturing training curriculums for new employees, provide hands-on instruction, and coordinate training events with supervisors. Assess the effectiveness of training, continuously improve materials in collaboration with quality and training groups, and perform personnel qualifications on critical operations such as aseptic technique and swab sampling. Maintain and report qualification status, address gaps, and support quality systems through CAPAs and Change Controls. Present the training process during audits and inspections, ensure regulatory commitments, manage the MABioOps training lab, advise on training competencies, and participate in interviewing manufacturing associate candidates as needed. You will report into the Manufacturing Manager.

How you will contribute:

• Assign appropriate curriculum to new employees and provide a detailed overview of the manufacturing portion of the training program
• In collaboration with manufacturing supervisors schedule training events to train manufacturing personnel
• Hands-on training of manufacturing staff
• Assess training effectiveness. Work with training and quality groups to continuously improve training materials and curriculum
• Perform qualification of manufacturing personnel on critical operations including but not limited to aseptic technique and swab sampling
• Provide detailed qualification status via training reports and identify any gaps or opportunities
• Support quality systems and implement action items stemming of CAPAs and Change Controls
• Present the training process during audits and inspections
• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas
• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force
• Ability to stand for 6 hours in a production suite
• Ability to climb ladders and work platforms
• Stooping or bending to check or trouble-shoot equipment operations
• Ability to work around chemicals (alcohols, acids & bases)

Minimum Requirements/Qualifications:

• ·Requires a high school diploma and 6+ years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing Experience
• Biotech Certificate and prior leadership experience preferred
• Experience with systems such as SAP, LIMS and TrackWise and lean operating principles is a plus
• Requires 5+ years of GMP Training experience. Experience coaching other Training Coordinators required
• Operational knowledge of upstream or downstream manufacturing including Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters, etc.
• Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMA) to ensure inspection readiness of department

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$70,000.00 - $110,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.