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.
The Stability Program Specialist is part of the Quality Assurance, Therapeutics Gene Editing department located in Coralville, Iowa and will be on-site at our Therapeutics Manufacturing facility. 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:
- Write, execute, and maintain stability protocols, reports and SOPs in support of the stability program, including review and implementation of regulatory requirements for the stability program.
- Coordinate with Quality Control management for scheduling of stability sample analysis and organizing shipments to off-site laboratory facilities (as needed).
- Ensure data is evaluated, including the creation, review and trending of data, to meet customer, industry and regulatory requirements and presenting data in graphical form and reports provided to customers
- Assist in the preparation of documents for and provide support during customer and/or regulatory audits.
- Performs other duties as assigned.
The essential requirements of the job include:
- Bachelor’s degree in a scientific field
- Minimum 1-2 years of experience in a regulated environment or GMP compliant environment (Pharmaceutical, Medical Device, OTC Drug, Cosmetic, etc.)
- Experience with basic statistical analysis, and related interpretation of stability data
It would be a plus if you also possess previous experience in:
- Experience working in a quality control laboratory or quality assurance role a plus.
- Working knowledge of regulatory guidance for stability storage and testing, desired
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.
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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.
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 [email protected] to request accommodation.
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What We Do
For over 35 years, IDT has been enabling genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, with the most advanced synthesis, modification, purification, and quality control capabilities available.
Through our founder's dedication to innovation, the highest standards of quality, and deep genomics expertise, IDT has evolved from a leading oligo manufacturer to a genomics solutions provider supporting areas such as NGS, CRISPR, SynBio, and PCR. With these core efforts, IDT teams have been helping to drive science forward with increased quality, efficiencies, and unmatched customer service.
Today, technology is evolving faster than ever before. Scientists leading the transition from basic to translational research face new challenges with securing the custom solutions necessary to advance their research out of the lab and into the clinic. These emerging barriers have slowed down critical discoveries with potentially profound impacts on human and ecological health.
To help overcome these obstacles and push the boundaries of technology, we've expanded production facilities and capabilities to include GMP and cGMP manufacturing grades. These additions provide customers with a genomics solutions partner capable of supporting the entire research journey. Combined with a renewed collaborative agility, members of our organization and strategic partners are positioned to contribute to the greatest genomic breakthroughs of our time—guiding more effective vaccines, addressing world hunger and climate change, and driving new diagnostics and therapeutics for complex diseases.
As we look to the future, our mission—accelerating the pace of genomics—honors our legacy and represents our commitment to the pursuit of new ideas to help us realize our shared vision of enabling researchers to rapidly move from the lab to life-changing advances.
For more information, visit www.idtdna.com.
