Regulatory and Validation specialist at Cytiva in Marlborough, Massachusetts

Job Description:

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Regulatory and Validation specialist, for the qualification of plastic components used in the manufacturing of pharmaceutical and biopharmaceutical drug products, is responsible for interpreting testing results from partner laboratories and creating comprehensive, customer-facing reports. This role requires a deep understanding of USP 665 guidelines and the ability to communicate complex information clearly and effectively.

This position is part of the Global Regulatory Compliance team and will be remote. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

• Interpret Testing Results: Analyze and interpret testing results from partner laboratories to ensure compliance with USP 665 and other industry recognized guidelines.


• Report Writing: Prepare detailed, customer-facing reports that clearly communicate testing results and compliance status.


• Compliance Monitoring: Stay up-to-date with the latest USP 665 guidelines and related recommendation from industry and ensure all testing and reporting processes adhere to these standards.


• Documentation: Maintain accurate records of all testing results and reports and provide support to customers regarding testing results and compliance queries.


• Identify regulatory risks and propose appropriate mitigations in collaboration with Regulatory and Validation Strategy team, employing global Cytiva standardized methodologies as appropriate.

Who you are:

• Bachelor's degree in Chemistry or a related field, PhD or Master's preferred


• Minimum of 3 years of experience in a laboratory or quality assurance role, with specific experience in extractables and leachables associated with polymeric materials.


• Excellent written and verbal communication skills.


• Ability to interpret complex data and present it in a clear, concise manner.


• Risk-based approach: experience with risk-based approaches in regulatory compliance and testing.

Preferred Qualifications:

• Experience working in a regulated industry (e.g., pharmaceuticals, biotechnology).


• Familiarity with other USP guidelines and regulatory standards.


• Ability to work effectively in electronic document management systems, e.g., Veeva vault is a plus


• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

The salary range for this role is $85,000-105,000 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

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.

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 applyassistance@danaher.com to request accommodation.

Apply Now