BioSpace
Manufacturing Lead Associate - Nights
BioSpace, Lexington, Massachusetts, United States, 02173
Job Description
As Manufacturing Lead Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You oversee floor operations to ensure safety, aseptic operations and compliance with cGMPs. Ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well‑managed transfer of process changes and improvements to floor operations. Provide support to integrate best practices into manufacturing. You will report to Manufacturing Supervisor. How You Will Contribute
Primary contact for troubleshooting, issue resolution or escalation; create and follow up on work orders; communicate daily scheduling and staffing plans, including reallocation of staff for breaks, lunch, and training. Provide oversight and execution of all routine and critical operations, including commissioning and validation activities; monitor material consumption and coordinate all material deliveries. Ensure documentation (forms, logbooks, form preps, batch records) is complete, reviewed, and meets good documentation practices; communicate schedule changes as needed; responsible for floor inventory. Recommend and implement process changes, improvements and safety or ergonomic improvements; ensure work is carried out safely, reporting safety issues and risks. Initiate deviations or investigations of various complexities; work with cross‑functional teams to identify root causes, implement corrective actions, and complete GMP investigation/CAPA action items. Assist supervisor, engineer, or facilities with investigations; revise and author SOPs and batch records; communicate any quality issues or concerns to Supervisor and QA. Responsible for interviewing candidates; provide performance feedback; address minor personnel issues promptly and escalated major issues to the supervisor. Ensure staff compliance with relevant SOPs, batch records, form preps, and safety guidelines; act as a role model, subject matter expert (SME), and resource for staff; ensure safe work practices and behaviors. What You Bring To Takeda
Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering with 5 years of GMP Manufacturing experience. Biotech Certificate and prior leadership experience would be ideal. Experience with systems such as SAP, LIMS and TrackWise would be ideal. Perform manufacturing and sampling operations using aseptic technique. Operational knowledge of Clean‑in‑Place (CIP) and Steam‑in‑Place (SIP) systems and general production equipment such as autoclaves, water baths, pH/Conductivity meters, etc. Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department. Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure. In the absence of the supervisor, they are the person of authority. Expected to act on behalf of the supervisor while on the floor. Prior experience or exposure to standardization and measurements utilizing bench‑top equipment, aseptic processing, cell culture inoculation and scale‑up processes, use of bioreactors and centrifuges in the growth of cell cultures, process automation and SAP Enterprising Resource Platform. Important Considerations
Work in a controlled environment requiring special gowning and protective clothing. Remove all makeup, 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. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. Flexibility to work according to the production schedule. 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 troubleshoot equipment operations. Ability to work around chemicals (alcohols, acids & bases). 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. Compensation and Benefits Summary
Location: USA - MA - Lexington - BIO OPS Hourly wage range: $27.60 - $43.37. Employees may be eligible for medical, dental, vision, 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time, paid vacation, and short‑term incentives. 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.
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As Manufacturing Lead Associate, you will deliver leadership and excellence in manufacturing processing and scheduling to meet site demands. You oversee floor operations to ensure safety, aseptic operations and compliance with cGMPs. Ensure efficient use of material and equipment and assign personnel in the execution of daily operations. Provide technical support through interactions with support groups to ensure accurate and well‑managed transfer of process changes and improvements to floor operations. Provide support to integrate best practices into manufacturing. You will report to Manufacturing Supervisor. How You Will Contribute
Primary contact for troubleshooting, issue resolution or escalation; create and follow up on work orders; communicate daily scheduling and staffing plans, including reallocation of staff for breaks, lunch, and training. Provide oversight and execution of all routine and critical operations, including commissioning and validation activities; monitor material consumption and coordinate all material deliveries. Ensure documentation (forms, logbooks, form preps, batch records) is complete, reviewed, and meets good documentation practices; communicate schedule changes as needed; responsible for floor inventory. Recommend and implement process changes, improvements and safety or ergonomic improvements; ensure work is carried out safely, reporting safety issues and risks. Initiate deviations or investigations of various complexities; work with cross‑functional teams to identify root causes, implement corrective actions, and complete GMP investigation/CAPA action items. Assist supervisor, engineer, or facilities with investigations; revise and author SOPs and batch records; communicate any quality issues or concerns to Supervisor and QA. Responsible for interviewing candidates; provide performance feedback; address minor personnel issues promptly and escalated major issues to the supervisor. Ensure staff compliance with relevant SOPs, batch records, form preps, and safety guidelines; act as a role model, subject matter expert (SME), and resource for staff; ensure safe work practices and behaviors. What You Bring To Takeda
Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering with 5 years of GMP Manufacturing experience. Biotech Certificate and prior leadership experience would be ideal. Experience with systems such as SAP, LIMS and TrackWise would be ideal. Perform manufacturing and sampling operations using aseptic technique. Operational knowledge of Clean‑in‑Place (CIP) and Steam‑in‑Place (SIP) systems and general production equipment such as autoclaves, water baths, pH/Conductivity meters, etc. Knowledge of cGMP's and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department. Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure. In the absence of the supervisor, they are the person of authority. Expected to act on behalf of the supervisor while on the floor. Prior experience or exposure to standardization and measurements utilizing bench‑top equipment, aseptic processing, cell culture inoculation and scale‑up processes, use of bioreactors and centrifuges in the growth of cell cultures, process automation and SAP Enterprising Resource Platform. Important Considerations
Work in a controlled environment requiring special gowning and protective clothing. Remove all makeup, 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. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. Flexibility to work according to the production schedule. 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 troubleshoot equipment operations. Ability to work around chemicals (alcohols, acids & bases). 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. Compensation and Benefits Summary
Location: USA - MA - Lexington - BIO OPS Hourly wage range: $27.60 - $43.37. Employees may be eligible for medical, dental, vision, 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time, paid vacation, and short‑term incentives. 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.
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