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Senior Manufacturing Associate

Takeda Pharmaceutical Company Ltd

This is a Full-time position in Lexington, MA posted June 8, 2021.

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 DescriptionJob DescriptionThis position reports to Day, 6:00 am – 6:30 pm, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may be required to work overtime.With limited supervision the Senior Manufacturing Associate will lead execution of critical, routine, and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs to produce clinical and/or commercial products. Will support engineering and validation activities.Responsibilities:70% – This individual 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* Execution of critical, routine, and non-routine production operations* Informing management of events impacting schedule request* Perform Batch Record, Log Book, and Form Prep request* Enter data in the Laboratory Information Management System (LIMS)* Record data into log books* Review manufacturing documentation real time to ensure compliance* Coordinate sample preparation and testing* Propose and review document revisions* Carry out work in a safe manner, notifying management of safety issues and risks* Participate in tiered visual management system and support continuous improvement initiatives15% – This individual will manage equipment and support facility related projects by* Participating in tiered visual management system and support continuous improvement initiatives* Initiating work orders* Act as subject matter expert for improvement projects* Perform scheduled cleaning of equipment* Assembly and disassembly of process equipment* Perform standardization of equipment* Support change over activities* Execution of equipment and process qualifications and validation15% – Working with supervision this individual will* Provide technical training for area personnel* Provide input on training material development* Meet and maintain training requirements* Develop and maintain personal development plan* Provide annual performance self-assessmentEducation and Experience RequirementsMinimum* High School diploma or Associate’s Degree in Life Sciences/Engineering field* 3 years of GMP Manufacturing experience* 4-6 years related industry experienceDesired:* Biotech Certificate preferredKey Skills, Abilities, and CompetenciesSubstantial 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* 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* Proficient in Aseptic Technique* Ability to work cohesively in a team environment* 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* 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)Complexity and Problem SolvingWorks on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making decisions* Limited to no supervision / instruction needed for routine task and minor direction for more complex/non-routine tasks.* Clear understanding of manufacturing processes and the ability to readily identify deviations in process, controls, and guidelines required.* Will be responsible for identifying, supporting, and implementing process improvementsInternal and External ContactsInternal* 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 vendorsOther Job Requirements* May require weekend or holiday off shift support as neededPlease 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.This Jobs posting excludes CO applicantsLocationsUSA – MA – Lexington – BIO OPSWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time