Danaher Corporation
Manager, cGMP Quality Control
Danaher Corporation, Coralville, Iowa, United States, 52241
Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.
IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality Control cGMP located in Coralville, IA and will be indicate whether position is on-site. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.
In this role, you will have the opportunity to:
The Manager, cGMP Quality Control supervises the internal and external Quality Control resources to result in reliable execution of raw materials testing, in-process testing, product release testing, and facility environmental & equipment monitoring to support Operations activities. Products include single guide RNA and donor DNA for therapeutic use.
Support, maintain, and execute cGMP production facility analytical methods for testing of nucleic acid therapeutics, to include capillary electrophoresis, mass spectrophotometry, endotoxin, compendial testing with contract testing laboratories and various other methods, both compendial and custom.
Specify, design, and execute testing for environmental monitoring of facility and equipment cleaning verification.
Author and execute standard operating procedures (SOP’s) and validation procedures (IQ/OQ/PQ) for facility and production quality control methods.
In collaboration with the Facilities and Maintenance Manager, assist in managing housekeeping services with respect to specific services to maintain environmental control of clean production and laboratory areas
Monitor, analyze, and improve Quality Control infrastructure using internal and external QC resources in order to reduce operating expenses, facilitate growth, and minimize downtime
Interface, support, and collaborate with other departments (Quality, R&D, Finance, etc.) and external vendors to ensure reliable operation of Genomics Medicine QC. Lead daily management to drive sustainable, continuous improvements in Safety, Quality, Productivity, On Time Delivery, and materials management.
The essential requirements of the job include:
BS in related science or engineering required
Minimum of 5 years of experience with Quality Control in a GMP environment is required.
Minimum of 2 years of experience as a team lead or people leadership required.
Strong knowledge and experience with 21 CFR 210 & 211 and ICH Q7 is preferred.
Preferred Skills
Experience performing method validation is required. Experience writing validation protocols is preferred.
Experience performing method development or optimization is highly preferred.
Ability to encourage and facilitate cooperation, teamwork and pride.
Ability to communicate effectively with all levels of staff and management in both written and verbal format.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
#LI-LCS
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality Control cGMP located in Coralville, IA and will be indicate whether position is on-site. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.
In this role, you will have the opportunity to:
The Manager, cGMP Quality Control supervises the internal and external Quality Control resources to result in reliable execution of raw materials testing, in-process testing, product release testing, and facility environmental & equipment monitoring to support Operations activities. Products include single guide RNA and donor DNA for therapeutic use.
Support, maintain, and execute cGMP production facility analytical methods for testing of nucleic acid therapeutics, to include capillary electrophoresis, mass spectrophotometry, endotoxin, compendial testing with contract testing laboratories and various other methods, both compendial and custom.
Specify, design, and execute testing for environmental monitoring of facility and equipment cleaning verification.
Author and execute standard operating procedures (SOP’s) and validation procedures (IQ/OQ/PQ) for facility and production quality control methods.
In collaboration with the Facilities and Maintenance Manager, assist in managing housekeeping services with respect to specific services to maintain environmental control of clean production and laboratory areas
Monitor, analyze, and improve Quality Control infrastructure using internal and external QC resources in order to reduce operating expenses, facilitate growth, and minimize downtime
Interface, support, and collaborate with other departments (Quality, R&D, Finance, etc.) and external vendors to ensure reliable operation of Genomics Medicine QC. Lead daily management to drive sustainable, continuous improvements in Safety, Quality, Productivity, On Time Delivery, and materials management.
The essential requirements of the job include:
BS in related science or engineering required
Minimum of 5 years of experience with Quality Control in a GMP environment is required.
Minimum of 2 years of experience as a team lead or people leadership required.
Strong knowledge and experience with 21 CFR 210 & 211 and ICH Q7 is preferred.
Preferred Skills
Experience performing method validation is required. Experience writing validation protocols is preferred.
Experience performing method development or optimization is highly preferred.
Ability to encourage and facilitate cooperation, teamwork and pride.
Ability to communicate effectively with all levels of staff and management in both written and verbal format.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
#LI-LCS
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.