Manager, cGMP Quality Control

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. Job Title: Manager, cGMP Quality ControlLocation: Coralville, IAThe 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 nucleic acids and proteins for therapeutic use.Support, maintain, and execute cGMP production facility analytical methods for testing of nucleic acid and protein therapeutics, to include capillary electrophoresis, mass spectrophotometry, endotoxin, and various other methods, both compendial and custom.

Support, maintain, and coordinate compendial testing with contract testing laboratories under cGMP.

Execute product stability testing programs in coordination with Quality Assurance.

Specity, 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.

Lead quality system improvements related to Quality Control.

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.

Effectively communicate Genomics Medicine QC needs using a team approach to accomplish goals and objectives of the business

Supervise and direct staff, including employee hiring, training, evaluations, and discipline.

Observe, document and coach associates’ performance to enable them in their career path.

Demonstrate and uphold behavior consistent with the Danaher Core Behaviors and deliver the Integrated DNA Technologies experience to customers and other business associates

Utilize Danaher Business Systems (DBS) tools to improve QC, while championing an environment of teamwork and associate engagement.

Lead and engage employees during Kaizens to drive continuous improvements.

Maximize the performance of value streams by implementing and sustaining lean principles to meet customer requirements

Performs other duties as assigned.

Education, Licensure, Certification, Registration

BS degree in science or engineering

Professional Experience

Minimum of 5 years of experience with Quality Control in a GMP environment is required. Strong knowledge and experience with 21 CFR 210 & 211 and ICH Q7 is preferred.

Minimum of 2 years of experience in a people leader role is preferred

Experience performing method validation is required. Experience writing validation protocols is preferred.

Other Knowledge, Skills, and AbilitiesAbility 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.

What We Offer:Shift Differentials (Extra Compensation for less traditional shifts)

Generous Paid Time Off Accruals

16 Hours PAID Volunteer Time Off

11 Paid Holidays

Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates

401(k) with Company Match

Medical, Dental, and Vision Insurance Options

Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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. If you’ve ever wondered what’s within you, there’s no better time to find out.