Associate Director Quality Control Microbiology at Takeda in Social Circle, GA
Job Description About the role:
As the Associate Director, Quality Control Microbiology, you will manage, plan, direct and evaluate all activities and staff of the Microbiology Department in the Quality Control Laboratory to ensure the safety and reliability of Takeda products, and to comply with Quality and Regulatory requirements. You will work with manufacturing and product support teams to ensure product safety through Testing of Raw Materials, Critical Systems, Environmental Monitoring, Utilities, In-Process Intermediates and Finished Drug Products. You will support Quality Control Initiatives to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant goals. You will make essential decisions to disposition raw materials, in-process and finished product testing results for release and identify potential risks associated with laboratory operations and lead teams to resolve lab issues. You will be a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits. You will report directly to the Head of Quality Control. How you will contribute:
Support regulatory filings, submission review and data analysis Provide the Microbiology group long term goals, general policies and management guidance based on business directions and goals. Provide Quality Laboratory management guidance to policies based on business directions and goals. Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines); develop policies to implement these requirements for laboratory operation. Ensure compliance with testing procedures, specifications and company policies. Prepare the department for internal and external authorities. Be a Quality representative for the lab and partner with investigators and customers. Work with manufacturing teams in functions that impact production, solve problems, improve quality, increase efficiency, produce cost savings, and provide new product support. Lead and supporting complex investigations and trending laboratory results. Improve operating mechanisms to ensure that non-conformances (OOLs, OOSs, and CAPAs) are completed in an effective. Manage guidance on creation, changing and issuance of lab related documents. Assure a safe and non-discriminatory working environment for employees. Develop and manage operating budget for lab/ teams. Ensure employees are trained and audited. Make appropriate staffing recommendations. Evaluate performance through performance appraisals and ensure employees have development plans. Mentor and develop strong team. Work with internal subordinate superiors and senior groups. Identify and manage continuous improvement projects with objective of achieving quality, reliability and cost improvements. Drive continuous improvement understanding to all laboratory levels. Manage the process of evaluating new technology for the lab and subsequent validation. Manage assay troubleshooting, trending and supporting complex investigations Hire and retain great talent; develop, coach and provide challenging work for team members; support the career development of their employees both within their current position as well in situations where employees move on to different roles within the Shire organization; manage performance and differentiate compensation and development; plan for future recruiting needs; improve performance Knowledgeable about Quality Laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs. (Strong emphasis and experience in Microbiology). What you bring to Takeda:
Typically requires bachelor's degree in chemistry, biological science or other related technical field. 8
years of related experience with 3
in a management role. Manage complex projects, resolve complex issues, critical problem solving. Develop and mentor a large team of employees. Knowledgeable about Quality Laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs. (Strong emphasis and experience in Microbiology). Have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP. Strong leadership, project and people management skills, and ability to make critical decisions. Experience with the Biopharmaceutical business or industry. of individuals and teams. 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. Must be able to lift, push, pull and carry up to 15 lbs. 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 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. 5% Travel 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.
Salary Range:
$100K -- $150K
Minimum Qualification
Engineering Management, Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
As the Associate Director, Quality Control Microbiology, you will manage, plan, direct and evaluate all activities and staff of the Microbiology Department in the Quality Control Laboratory to ensure the safety and reliability of Takeda products, and to comply with Quality and Regulatory requirements. You will work with manufacturing and product support teams to ensure product safety through Testing of Raw Materials, Critical Systems, Environmental Monitoring, Utilities, In-Process Intermediates and Finished Drug Products. You will support Quality Control Initiatives to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant goals. You will make essential decisions to disposition raw materials, in-process and finished product testing results for release and identify potential risks associated with laboratory operations and lead teams to resolve lab issues. You will be a representative for the Quality Laboratory during Regulatory Inspections and Customer Audits. You will report directly to the Head of Quality Control. How you will contribute:
Support regulatory filings, submission review and data analysis Provide the Microbiology group long term goals, general policies and management guidance based on business directions and goals. Provide Quality Laboratory management guidance to policies based on business directions and goals. Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules and guidelines); develop policies to implement these requirements for laboratory operation. Ensure compliance with testing procedures, specifications and company policies. Prepare the department for internal and external authorities. Be a Quality representative for the lab and partner with investigators and customers. Work with manufacturing teams in functions that impact production, solve problems, improve quality, increase efficiency, produce cost savings, and provide new product support. Lead and supporting complex investigations and trending laboratory results. Improve operating mechanisms to ensure that non-conformances (OOLs, OOSs, and CAPAs) are completed in an effective. Manage guidance on creation, changing and issuance of lab related documents. Assure a safe and non-discriminatory working environment for employees. Develop and manage operating budget for lab/ teams. Ensure employees are trained and audited. Make appropriate staffing recommendations. Evaluate performance through performance appraisals and ensure employees have development plans. Mentor and develop strong team. Work with internal subordinate superiors and senior groups. Identify and manage continuous improvement projects with objective of achieving quality, reliability and cost improvements. Drive continuous improvement understanding to all laboratory levels. Manage the process of evaluating new technology for the lab and subsequent validation. Manage assay troubleshooting, trending and supporting complex investigations Hire and retain great talent; develop, coach and provide challenging work for team members; support the career development of their employees both within their current position as well in situations where employees move on to different roles within the Shire organization; manage performance and differentiate compensation and development; plan for future recruiting needs; improve performance Knowledgeable about Quality Laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs. (Strong emphasis and experience in Microbiology). What you bring to Takeda:
Typically requires bachelor's degree in chemistry, biological science or other related technical field. 8
years of related experience with 3
in a management role. Manage complex projects, resolve complex issues, critical problem solving. Develop and mentor a large team of employees. Knowledgeable about Quality Laboratory operations and government regulations pertaining to pharmaceutical manufacturing labs. (Strong emphasis and experience in Microbiology). Have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP. Strong leadership, project and people management skills, and ability to make critical decisions. Experience with the Biopharmaceutical business or industry. of individuals and teams. 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. Must be able to lift, push, pull and carry up to 15 lbs. 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 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. 5% Travel 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.
Salary Range:
$100K -- $150K
Minimum Qualification
Engineering Management, Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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