About the role:
The Manufacturing Lead Operator supports all current and future processes in production in B8 Purification which may include small, mid or large-scale manufacturing, while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the direction of the supervisor, they must help establish daily shift priorities, and then communicate and delegate tasks to safely accomplish those priorities. They are expected to make Safety, Quality, and Production decisions. You can apply their subject matter expertise and their understanding of the capabilities and performance of their team members to quickly assess important issues. You will escalate all relevant information and be prepared to recommend appropriate actions. They are expected to be communicate all important information to their respective teams and communicate the appropriate shift-to-shift updates through all applicable communication tools and at shift handoffs. In addition to being fully accountable in production processes, you may help problem solve in other areas. They are expected to participate in both departmental projects and quality working teams. You will be a delegate to the supervisor and may conduct departmental activities in their absence. They fully understand the regulations and may make recommendations according to their interpretations. They have a high level of technical and administrative knowledge to perform complex troubleshooting tasks on manual and automated equipment, and they may assist during the transfer of new processes/methodologies into the manufacturing area. Manufacturing Lead Operators are expected to serve as a mentor and set the example for all team members since their team will interpret that behavior as acceptable. They must display the appropriate conduct, compliance, cleanliness, and culture while promoting Takeda's focus on Patient, Trust, Reputation, and Business.
How you will contribute:
Follow all safety rules, SOPs, cGMP, work rules and other company policies and programs.
Complete relevant paperwork following GDP/GMP guidelines.
Perform hands-on execution of manual and automated manufacturing operations. Equipment may include: Centrifuges, Filter Presses, Ultrafiltration, Tangential Flow Filtration and Nanofiltration systems, CIP/COP, Chromatography and material handling devices. Manual activities include weighing and addition of chemicals, paste suspension, equipment cleaning, room cleaning, equipment assembly/disassembly, transfer panel connections, titrations and other activities.
Train and maintain standards to be proficient in multiple product lines and support various areas within the manufacturing suites.
Interface and Navigate through the DeltaV, Programmable Logic Controller (PLC), and Electronic Batch Management (EBM) systems to respond to process events, changes, and tasks
What you bring to Takeda:
Must have demonstrated and leadership skills and be able to lead a team effectively.
Experience exercising proper judgment with regards to Safety, Quality, Compliance, and Production decisions.
In-depth process knowledge of related manufacturing techniques and specialties.
Correct GDP type errors in the electronic systems (DeltaV, EBM, PLC, etc.)
Trend data in DeltaV and EBM systems for investigations and process deviations
Proficient in DeltaV and EBM to a level that aligns with the your responsibilities and standard operating procedure (SOP) guidance
Familiarity with pharmaceutical production equipment including centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place).
Knowledge of basic chemical and biological safety procedures.
Requires high school diploma and a minimum of 6 years related experience, or Bachelor with minimum of 4 years related experience. College degree in Science or Engineering discipline.
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.
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.
Must be able to lift, push, pull and carry up to 50 lbs.
Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift.
Must be able to climb ladders and stairs while wearing special gowning.
May require bending, twisting, reaching, and/or squatting motions to perform certain tasks.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.
Will work in a cold, wet environment.
Must be able to work multiple shifts, including weekends.
Must be able to work overtime as required. (only for non-exempt positions)
May be required to work in a confined area.
Some Clean Room and cool/hot storage conditions.
Base Salary Range: $56,000 to $80,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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.Locations
USA - CA - Los AngelesWorker Type