Manufacturing Associate

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Job Description

Job Title: Manufacturing Associate

Location: Lexington, MA

About the role:

With general supervision you will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operate production equipment according to SOPs for producing clinical and/or commercial products.

How you will contribute:

You will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the following

• Troubleshoot and resolve basic process related issues
• recognize and escalate deviation
• Execution of critical and routine activities in support of production
• Perform Batch Record, Log Book and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS) , MODA and or other business functions
• Review GMP documentation
• Sample preparation and testing
• Identify changes needed to documentation
• Participate in tiered visual management system and support CI initiatives

This individual will manage equipment and support facility related projects by

• Initiating work orders
• Assembly and disassembly of process equipment
• Perform scheduled cleaning of equipment
• Perform standardization of equipment
• Support change over activities

Staff Technical Training and Development

• Maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self-assessment on development plan

Complexity and Problem Solving

Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.

• Receive assignments in the form of objectives with goals and process to meet goals outlined. Work is reviewed by supervisor to measure meeting of objectives.
• Accomplishes tasks through direct operation of cGMP activities.
• Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff.
• Evaluate and elevates issues to senior staff.
• Identify process deviations, troubleshoots issues and identifies process improvements.

Internal and External Contacts

• All Internal Manufacturing, Materials Management. Technical Operations and Facilities Management with limited exposure to support groups (Quality Assurance, Validation, Quality Control, Process Development and Health, Safety & Environment)
• May require interaction with equipment, technical and supply item vendors.

What you bring to Takeda:

Essential:

• Normally requires a high school diploma and 2-4 years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience.

Desired:

• Biotech Certificate preferred

Key Skills, Abilities, and Competencies

Significant understanding of general aspects of the job with a broad understanding of the detailed aspects of the job.

• May be required to perform as a subject matter expert for equipment and/or systems
• 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.
• Will work holidays and overtime as required.
• May be required to adjust work schedule to meet production demands.
• Proficient in Aseptic Technique
• Ability to work cohesively in a team environment
• 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).

Other Job Requirements

• 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.

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
• Tuition reimbursement

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.

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.

#GMSGQ #ZR1 #LI-MA1

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