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Job Description
About the role:
As a Senior Manufacturing Associate, you will perform 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 for the production of clinical and/or commercial products. Will support engineering and validation activities. You will report to Manufacturing Supervisor.
This is a night shift role, with working hours from 6:00 p.m. to 6:00 a.m. on a rotating 2-2-3 schedule, which includes working every other weekend.
How you will contribute:
Carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and form preps.
Troubleshoot and escalate process related issues; create work orders as needed; initiate and document minor deviations; initiating work orders.
Enter data in the Laboratory Information Management System (LIMS), MODA and other business systems; request and execution of GMP documentation.
Lead execution of critical, routine and non-routine production operations; inform management of events impacting schedule; review manufacturing documentation real time to ensure compliance.
Coordinate sample preparation and testing; propose and review document revisions; perform scheduled cleaning of equipment.
Carry out work in a safe manner, notifying management of safety issues and risks; participate in tiered visual management system and support continuous improvement initiatives.
Assembly and disassembly of process equipment; perform standardization of equipment; support change over activities; execution of equipment and process qualifications and validation.
Act as subject matter expert for improvement projects; will be required to perform as a subject matter expert for equipment and/or systems; provide technical training for area personnel; provide input on training material development; maintain training requirements and act as a qualified trainer as required; develop and maintain personal development plan; provide annual performance self-assessment.
What you bring to Takeda:
High school diploma and 4+ years of experience or an Associate's Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.
Biotech Certificate would be ideal.
Substantial understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered
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 computer skills.
Proficient in Aseptic Technique
Work cohesively in a team environment
Experience with business systems such as, LIMs, MODA and other business systems
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:
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.
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).
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.
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:
$23.56 - $37.02
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
Job Exempt
No
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
