About the role:
You will execute all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, you may rewrite complex procedures or initiate new procedures as applicable. You will have enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. You will have technical and administrative competence to organize and lead production activities, including demonstrating leadership in cGMP compliance, and environmental health and safety skills. You will report to Supervisor, Manufacturing. This role could report to Albumin, Immunoglobin (IG), or the Fractionation department.
The hours for this position are 6:00AM - 6:30PM or 6:00PM - 6:30AM on a 2-2-3 schedule.
How you will contribute:
Prepare media and buffer solutions.
Operate Clean-in-Place (CIP) and Steam-in-Place systems.
Assemble and operate filtration systems.
Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers)
Monitor and record essential process parameters.
Complete all relevant paperwork following GDP/GMP guidelines.
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
Perform sampling using aseptic techniques.
Participate on Continuous Improvement Teams.
Mentor other team members.
Write and review important documentation.
Troubleshoot process problems and respond to process alarms.
Help with process/equipment validation and data analysis.
Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
Work in a team environment.
What you bring to Takeda:
Typically requires high school diploma or GED plus 2+ years of experience or Associates' degree or higher and 1+ years of related work experience
Knowledge of cGMP manufacturing.
Knowledge of basic laboratory and pharmaceutical production equipment including: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
Will apply quantitative analysis to analyze process performance.
You will be proficient in multiple mathematical disciplines and be able to work with both the metric and USA standards of measurement.
Knowledge of basic chemical and biological safety procedures.
Have experience with inventory management.
Experience handling pallet-jacks, pallet trucks, and forklifts.
Can carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
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:
Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
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.
May work in a confined space.
Work multiple shifts, including weekends, or be asked to work supplemental hours and holidays in support of project execution on an infrequent basis.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Ability to work in a clean room environment for extended periods of time.
Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.
Must be able to climb ladders and stairs while wearing special gowning.
May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
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.
This posting excludes Colorado applicants.
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.
USA - GA - Social Circle - Hwy 278