- Lead development and execution of regulatory Chemistry, Manufacturing, and Controls (CMC) biomanufacturing strategies for internal and partner programs of all development phases, including varied programs in gene and cell therapy (CGT), antibody bioprocessing (mAb/biAb), mRNA products, and complex biologics.
- Proactively identifies CMC/cGMP issues and implements appropriate regulatory strategies to mitigate CMC dossier, QP, import/export, and other biomanufacturing regulatory documentation risks.
- Acts as subject matter expert and maintains current knowledge of biopharmaceutical regulations and guidelines (FDA, ICH, EU Annex 1, and others as required) and keeps abreast of biopharmaceutical cGMP manufacturing regulatory environment changes.
- Oversees activities for meetings with FDA and other regulatory authorities and leads negotiations and interactions with regulatory authorities on CMC matters.
- Leads cGMP CMC regulatory intelligence activities, including proactive communication of regulatory CMC/GMP expectations to internal and external stakeholders (including partners, customers, program teams, and quality stakeholders) to execute program objectives in compliance with applicable regulations.
Who you are: - MS degree or higher from an accredited institution
- Minimum of 7 years experience working with global regulatory agencies and health authorities, including US FDA, EU EMA/Competent Authorities, and in other global regions
- Minimum of 7 years experience in Good Manufacturing Practices (GMP) for biological drug development, with significant Chemistry, Manufacturing, and Controls (CMC) and ICH module 3 experience with experience in cell therapy and gene therapy CMC preferred.
- Acts as a strong regulatory business partner that can engage with diverse cross-functional matric environments to develop regulatory strategy and drive deliverables.
It would be a plus if you also possess previous experience in: - Ability to work effectively in electronic document management systems, e.g., Veeva Vault.
- Demonstrated ability to handle multiple projects/deliverables simultaneously.
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Regulatory Affairs CMC Officer - Marlborough, United States - Danaher Corporation
Description
Be part of something altogether life-changingWorking 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. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Regulatory Affairs CMC Officer for Cytiva is responsible for leading CMC strategies for internal and partner programs.
This position is part of Global Regulatory Compliance in Marlborough and will be remote. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.
What you will do:
The salary range for this role is $120,000-$150,000. 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. We may ultimately pay more or less than the posted range. 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.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
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 [redacted] to request accommodation.
