Manufacturing Associate I

JOB DESCRIPTION:

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Manufacturing Associate I at our Lexington, Massachusetts Manufacturing Site.

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 a Manufacturing Associate I working on the team, you will be empowered to help increase quality and service to both internal and external clients. In this role, you will contribute to Takeda’s mission by helping to build a better tomorrow for our patients and their families.

With general supervision the individual will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps.

SHIFT:

• Days, 12-hours rotating

PRIMARY RESPONSIBILITIES:

Primary responsibilities include the following:

80%

• Troubleshoot and resolve basic process related issues

• recognize and escalate deviation Execution of critical and routine activities in support of production

• Perform Batch Record, Log Book and Form Prep requests

• Enter data in the Laboratory Information Management System (LIMS) , MODA and or other business functions

• Review GMP documentation

• Sample preparation and testing

• Identify changes needed to documentation

• Participate in tiered visual management system and support CI initiatives

• Complete required training on time

10%

This individual will manage equipment and support facility related projects by:

• Initiating work orders

• Assembly and disassembly of process equipment

• Perform scheduled cleaning of equipment

• Perform standardization of equipment

• Support change over activities

• Execution of equipment and process qualifications as well as validation

10%

Staff Technical Training and Development

• Maintain training requirements Develop and maintain personal development plan

• Provide annual performance self-assessment on development plan

EDUCATION & EXPERIENCE REQUIREMENTS

• Normally requires a high school diploma and 2-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience

• Biotech Certificate preferred

Key Skills, Abilities, and Competencies

Significant understanding of general aspects of the job with a broad understanding of the detailed aspects of the job:

• May be required to perform as a subject matter expert for equipment and/or systems

• The individual is proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures

• Possess excellent communication and troubleshooting skills

• Full awareness of current Good Manufacturing Practices

• Proficient computer skills

• Will work holidays and overtime as require

• May be required to adjust work schedule to meet production demands

• Proficient in Aseptic Technique

• Ability to work cohesively in a team environment

• 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.

OTHER JOB REQUIREMENTS

• May require weekend or holiday off shift support as needed Please be aware that this position is considered “Essential Personnel.” This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary. To ensure “Essential Personnel” are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event). These details will be provided by management prior to any potential inclement weather situation.

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.

USA - MA - Lexington - BIO OPS

Employee

Regular

Full time

Job ID R0027080