CMC Scientist EMR-40

CMC Scientist EMR-40

09 Nov
|
Camargo Pharmaceutical Services
|
Montréal

09 Nov

Camargo Pharmaceutical Services

Montréal

We are Camargo. A preferred drug development partner on a mission to better the lives of those around us. We are passionate about accelerating access to medicines that address global patient needs, enhance quality of care and improve health outcomes. Culture is at the heart of what we do. We believe in building meaningful connections, showing gratitude, and thinking differently to blaze new trails. We’re always looking for great people to join us on the journey.



We know that with the right employee experience and dedicated support, our team can achieve anything! We have cultivated an amazing internal culture that starts from the moment you apply at Camargo and continues throughout your career with us.

We invest in your personal and professional development and celebrate a community of inclusion that focuses on our values and our connections with one another.



We are seeking a CMC Scientist to utilize in-house and external resources to support execution of product development plans in alignment with project strategies and goals and collaborate with the Development and Regulatory Sciences team to research, write, edit and format technical and regulatory documentation required by clients, project partners and Regulators. This position supports strategic assessment of the pharmaceutical and regulatory viability of product development opportunities in coordination with other technical functions within Development and Regulatory Sciences. We are seeking candidates with experience in drug or biologics development, including analytical, formulation and/or process development in GxP environments



Responsibilities:





- Independently prepares regulatory documents such as meeting request documents, meeting package documents, INDs, NDAs and other regulatory documents.

- Participates as required in meetings between the Sponsor and the FDA or other regulatory agencies in support of CMC aspects of client’s projects.

- Assists with the management of product development projects such as objective, material requirements, study plans, costs, timing, regulatory strategy and human resource requirements.

- Works with CDMOs to establish and execute procedures for development

- of control strategies for new and existing products. Actively participates in resolution of quality issues. Support development studies using quality risk management techniques.

- Writes and/or reviews research, development, manufacturing and analytical documentation such as comparability protocols, development reports, master batch records, and compounding procedures. Supports establishment of finished product and in-process specifications.

- Works with cross-functional team to determine, review and adhere to project timelines, objectives and deliverables.

- Ensures that cGMP requirements are met through document review and/or technical audits and process monitoring at sites of manufacture, as needed.

- Keeps abreast of scientific and regulatory developments that could impact ongoing and potential projects and improve subject matter expertise

- Submits weekly time report per company policy.





Who You Are:





- Advanced degree in Pharmacy, Chemistry, Engineering or related field plus 2 to 3 years of relevant industry experience or BS in the same fields plus 5 to 7 years’ experience.

- Participation in or leadership of analytical/formulation/process development, process transfers/scale-up, process/equipment validation/ qualification, and drug substance/drug product contractor evaluation.

- Demonstrated experience working with documentation suitable for regulatory submissions.





About us:



We are a fast growing, global organization with a small company feel, comprised of high performing, multi-disciplinary, collaborative teams. We value independent thinking, learning and development (both personally and professionally), and provide the needed resources for you to reach your potential and goals. We have proudly earned our reputation for insight-driven and creatively bold solutions to help companies navigate complex, customized regulatory pathways, including the 505(b)(2) regulatory pathway, and have established ourselves as a full-service partner of choice for pharmaceutical product development companies in 25 countries around the globe. We have only scratched the surface with our ability to penetrate innovative markets and are actively looking to capture more market share. We are headquartered in Cincinnati, OH, with offices in Durham, NC, and Montreal, Quebec.



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The original job offer can be found in Kit Job:
https://www.kitjob.ca/job/17205882/cmc-scientist-emr-40-montreal/?utm_source=html

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