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 Job Title: Senior Manufacturing Associate Location: Lexington, MA About the role: You will perform manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operate production equipment according to SOPs for producing clinical and commercial products. Will support engineering and validation activities. How you will contribute: You will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Responsibilities include: * Troubleshoot and escalate process related issues * Create work orders as needed * Initiate and document minor deviations * Execute critical, production operations * Informing management of events impacting schedule * request and execution of GMP documentation * Enter data in the Laboratory Information Management System (LIMS), MODA and other business systems * Review manufacturing documentation real time to ensure compliance * Coordinate sample preparation and testing * Propose and review document revisions * Accomplish work in a safe manner, notifying management of safety issues * Participate in tiered visual management system and support continuous improvement programs * You will manage equipment and support facility related projects What you bring to Takeda: * Requires a high school diploma and 4-6 years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience. * Biotech Certificate preferred Key Skills, Abilities, and Competencies Substantial understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered. * Will 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. * Full awareness of current Good Manufacturing Practices. * Proficient in Aseptic Technique * Experience with business systems such as, LIMs, MODA and other business systems * Will work holidays and overtime as required. * May be required to adjust work schedule to meet production demands. * Proficient in Aseptic Technique * 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). * All Internal Manufacturing, Materials Management, Technical Operations and Facilities Management with limited exposure to support groups (Validation, Quality Control, Process Development and Health, Safety & Environment. Vendor * May require interaction with equipment, technical and supply item vendors 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. Important Considerations At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: * May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection. * Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. * Work in a cold, wet environment. * Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. * Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. 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. #GMSGQ #ZR1 #LI-MA1 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. Hourly Wage Range: $22.55 - $35.43 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 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