Global Regulatory CMC Strategy Lead
Dormont Manufacturing Co
Dormont Manufacturing Co in Norwood, Kentucky, is seeking an Associate Director, Global Regulatory, to lead CMC activities for various products. You will develop regulatory strategies in alignment with business objectives. The role requires extensive experience in the pharmaceutical industry, particularly in Biologics and CMC regulations. This position offers competitive salary and comprehensive benefits, supporting your well-being and work-life balance. #J-18808-Ljbffr Dormont Manufacturing Co
- ...seeking an experienced candidate to manage a team of CMC experts. You will oversee regulatory activities and ensure high-quality CMC... ...regulations. The role includes developing regulatory strategies and leading submissions. #J-18808-Ljbffr Dormont Manufacturing...Regulatory
$130.8k - $209.4k
...a Stability Leader to support mRNA programs in Norwood, Kentucky. This position requires defining stability strategies and analyzing data to ensure regulatory compliance. The ideal candidate should have a degree in life sciences and extensive experience in stability programs...Regulatory$224.9k - $404.6k
...for managing a team of CMC experts that prepare and... ...correspondence and regulatory applications. This position... ...to oversee the product strategy for all the products in their portfolio and lead and support all... ...volunteer days, sabbatical, global recharge days, and a discretionary...RegulatoryPermanent employment- Moderna is hiring a Stability Leader to define and lead stability strategies across a diverse mRNA portfolio in Norwood, Massachusetts. You will oversee stability protocols, align with global regulatory standards, and partner with various teams to ensure robust shelf-life...Regulatory
$142.5k - $256.5k
...Work with exceptional global teams on a broad pipeline... ...-appropriate stability strategies across a diverse mRNA... ...into actionable program, regulatory, and supply decisions.... ...What You’ll Do Define and lead phase-appropriate... ...within cross‑functional CMC team structures. Experience...RegulatoryPermanent employmentWork at officeWork from homeWorldwide$130.8k - $209.4k
...Sciences & Technology (AS&T) based at their Norwood, MA site. The role involves overseeing analytical method strategies and providing technical support for regulatory submissions. The ideal candidate will hold a Bachelor’s degree in a relevant field and possess over 8...RegulatoryFull time$130.8k - $209.4k
...Work with exceptional global teams on a broad pipeline... ...-appropriate stability strategies across a diverse... ...actionable insights that inform regulatory, supply, and lifecycle... ...‑related planning. Lead or support investigations... ...in cross‑functional CMC teams within a matrixed...RegulatoryFull timeWorldwide- ...Manufacturing Co in Norwood, KY, is seeking an Associate Director, Sterility Assurance. This role leads the Contamination Control Strategy ensuring compliance with regulatory standards in aseptic manufacturing. The candidate will work closely with cross-functional teams...Regulatory
- Dormont Manufacturing Co in Norwood, Kentucky, seeks a senior HVAC Engineer to lead design for energy-efficient systems. This role demands over 10 years in HVAC engineering and a commitment to sustainability through innovative practices. You will mentor junior engineers...
$109.2k - $174.6k
...troubleshooting guidance, and material/control strategy inputs to manufacturing sciences, CMC, and Quality partners as needed.... ..., manufacturing troubleshooting, regulatory‑supporting documentation, or phase... .... That’s why our US benefits and global well‑being resources are designed...RegulatoryPermanent employmentWork from home$130.8k - $209.4k
...Sciences & Technology (AS&T) - CMC based at their Norwood,... ...Manager, AS&T - CMC Lead will provide technical expertise... ...transfer, and lifecycle strategies for analytical methods across a global network. The ideal... ...have a strong background in regulatory submissions, analytical...RegulatoryPermanent employmentFull time$142.5k - $256.5k
...Process Development to lead upstream/fermentation process... ..., cell banking strategy, scale-up/scale-down, process... ...transfer, and CMC support. The successful... ...characterization summaries, and CMC/regulatory sections as needed.... ...days, sabbatical, global recharge days, and a discretionary...RegulatoryPermanent employment$142.5k - $256.5k
...seeking an Individual to lead host strain, vector, and expression system strategy for E. coli-based production... ..., development summaries, CMC-supporting documentation, and regulatory responses as needed. Serve... ...s why our US benefits and global well‑being resources are...RegulatoryPermanent employmentFull timeWork from homeRelocation$142.5k - $256.5k
...medicine. Work with exceptional global teams on a broad pipeline and... .... In this role, you will lead Moderna’s INT logistics operations... ...and communicate with senior CMC Management in a dynamic, cross... ...to the nature of the work and regulatory requirements, only individuals...RegulatoryPermanent employmentWorldwide$158.6k - $285.5k
...solutions. Travel to support global project execution could... ...as the overall project lead or technical lead... ...across INT and broader CMC Proactively identify risks... ..., develop mitigation strategies, and communicate... ...nature of the work and regulatory requirements, only individuals...RegulatoryPermanent employmentFull timeFor contractorsWork at office$89.9k - $143.8k
...to electrical system design, maintenance strategy optimization, and continuous improvement... ...work. That’s why our US benefits and global well‑being resources are designed to support... ...law. Due to the nature of the work and regulatory requirements, only individuals who...RegulatoryPermanent employmentFull timeFor contractors$121.6k - $194.5k
...medicine. Work with exceptional global teams on a broad pipeline and... ...Senior Engineer I, you will lead the technical execution of... ...integrity while meeting stringent regulatory, data integrity, and... ...Design and implement automation strategies for cell handling workflows (...RegulatoryPermanent employmentFull timeWork at officeWorldwide$130.8k - $209.4k
...solutions. Partner closely with CMC, GSC, Digital, and Enabling... ...Enablement & Value Realization Lead structured identification of... ...the primary integrator across Global Supply Chain, CMC, Finance, SAP... ...to GxP, financial, and regulatory requirements. Leadership & Autonomy...RegulatoryWork from home$109.2k - $174.6k
...technical expertise within the Global Engineering Technical... ...specifications and automation strategies meet performance, quality, and... ...). Experience supporting or leading cross-functional technical projects... ...the nature of the work and regulatory requirements, only individuals...RegulatoryPermanent employment$142.5k - $256.5k
...site’s Contamination Control Strategy (CCS) program. This role ensures... ...activities are aligned with regulatory expectations, operational... ...Authorities of the Position Lead and maintain the Contamination... ...timely, and aligned with site and global quality system requirements....RegulatoryPermanent employment- ...facility's compliance with cGMP standards. Your role involves executing qualification activities, authoring documentation, and ensuring regulatory compliance within our manufacturing ecosystem. The ideal candidate has a B.S. in Engineering and 2-5 years of validation...Regulatory
$114.8k - $157.85k
Dormont Manufacturing Co is seeking an Employee Relations Manager to foster positive employee relations and ensure compliance with labor laws in Norwood, Kentucky. This role involves managing performance processes, conducting investigations, and advising management on employee...$74k - $118.4k
...advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real... ...documentation, and collaborate cross‑functionally to maintain regulatory compliance and operational readiness. This is a highly...RegulatoryPermanent employmentFull timeWorldwide- Collins Engineers, Inc is seeking a highly motivated Senior Team Leader to manage inspection tasks and teams. This role is based in Norwood, Kentucky, with some local travel involved. The successful candidate will have 12+ years of experience in structural inspections, ...Work at officeLocal areaRelocation
$45 - $50 per hour
Dormont Manufacturing Co is seeking a full-time Physical Therapist for its Norwood Towers Post Acute facility. This role allows you to lead therapy for post-acute rehab in a supportive in-house team environment with no corporate red tape. You will have the opportunity for...Hourly payFull time- CDK Global is seeking a Critical Situation Leader based in Norwood, OH. The role focuses on managing case escalations and ensuring customer communication during significant outages. Ideal candidates will have strong client services experience and the ability to analyze...Remote job
$84k - $134.1k
...paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown Savings and... ...in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (...RegulatoryPermanent employmentFull timeApprenticeshipWorldwideShift work$121.6k - $194.5k
...deliver reliable and compliant robotics systems. Travel to support global project execution could be up to 25% during critical phases.... ...in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (...RegulatoryPermanent employmentWork from home$142.5k - $256.5k
...user requirements, safety expectations, and applicable regulatory standards. Here’s What You’ll Do Lead the design and optimization of HVAC and mechanical... ...energy efficiency, reliability, and compliance with global standards. Serve as the subject‑matter expert (SME) in...RegulatoryPermanent employmentFull time- ...remote role requires outstanding leadership and healthcare or medical sales experience. Responsibilities include directing sales strategies, leading a team of Regional Sales Managers, and ensuring compliance with company policies. The position offers a competitive salary,...Remote job
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