Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manufacturing Specialist in our Brooklyn Park, Minnesota facility.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manufacturing Specialist working on the Biologics Manufacturing team, you will be empowered to provide technical support to GMP manufacturing and lead Continuous Improvement efforts, and a typical day will include:
•Provide technical support of GMP manufacturing operations and staff; write and revise supporting documentation, perform training, implement new/improved procedures, materials, and equipment.
•Lead and support continuous improvement efforts to streamline the manufacturing process, reduce waste, maximize safety, and improve process yield, efficiency, and compliance.
•Coordinate investigation efforts and resolution of deviations; perform root cause analysis; coordinate implementation of corrective/preventive actions.
•Conduct and document detailed investigations, track exceptional events, change proposals, and audit responses.
•Lead, participate, and/or collaborate with cross-functional teams to determine root cause(s), implement appropriate corrective/preventive actions related to equipment, process, and compliance, including facility support and external vendors.
•Contribute to implementation of new equipment, systems, and procedures; assess impact of new regulatory guidelines on current practice, initiate document change proposals; assist with training and auditing as appropriate.
•Analyze and trend data to aid in the development and/or revision of department processes and procedures.
•Analyze technical problems to contribute to development of new or modified processes involving manufacturing operations.
•Participate in special projects as necessary; serve as manufacturing liaison to other departments and sites.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
•Bachelor’s degree, (scientific or engineering degree preferred) with a minimum of four years in a biologics manufacturing setting.
•Basic scientific understanding of biology/microbiology and chemistry/biochemistry and strong technical understanding of how they apply to the manufacturing process.
•Knowledge of cell culture, purification, and/or media/buffer production.
•Strong technical knowledge of manufacturing equipment operation, maintenance, and changeover; as well as commissioning, validation, and troubleshooting.
•May have more specific skill sets in areas depending on need/opportunity; aseptic technique, clean room management, column packing, bioreactor operation, chromatography, etc.
• Strong verbal and written communication skills across multiple functional areas.
•Computer skills, including PowerPoint, Word, Access, and Excel. Ideal candidate will have proficiency in mathematics, word processing, technical writing, and spreadsheet management.
•Knowledge of basic chemical and biological safety procedures.
•Must have passion to innovate and drive for solutions.
•Must have excellent planning and organizational skills.
•Must display personal accountability for results and integrity.
•Must have uncompromising dedication to quality and relentless focus on rapid and disciplined action.
•Must have respect for individuals and the diverse contributions of all.
•May be required to stand, operate manufacturing equipment, computer equipment; and may be required to wear personal protective equipment (PPE) such as safety shoes, safety glasses and/or hearing protection.
•May be required occasionally to lift, push, or pull up to 50 pounds during handling of production equipment and/or materials.
•May be required to climb occasionally (use of stepladders/stairs in production areas, or stairwells in work campus).
•May be required to bend, kneel, or crawl rarely when troubleshooting production equipment.
•May be required to stand and walk frequently and/or for extended periods while overseeing production activities.
•May be required to drive rarely to attend offsite meetings and/or training.
•May be required to use hearing occasionally when listening for production and equipment alarms.
•Occasional movement of head/neck while using computer applications and handling of production equipment and materials.
•May be required to perform visual inspection of production equipment, materials, and activities.
•May be required to perform occasional overhead reaching during handling of production materials/files/supplies.
•On rare occasions, travel may be required to offsite meetings or training event.
WHAT TAKEDA CAN OFFER YOU:
•401(k) with company match and Annual Retirement Contribution Plan.
•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.
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.