CMC Specialist

ClinChoice

Poland

Main Job Tasks and Responsibilities:

The CMC (Chemistry, Manufacturing, and Controls) Specialist is responsible for providing expertise in Chemistry, Manufacturing, and Controls to support regulatory submissions, manufacturing processes, and product development. You will collaborate with cross-functional teams to ensure the successful execution of CMC strategies.

Key Responsibilities:

Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, and variations, ensuring compliance with global regulatory requirements;
Collaborate with Regulatory Affairs to support regulatory agency interactions related to CMC topics;
Work closely with manufacturing teams to ensure the quality, consistency, and compliance of manufacturing processes for drug substance and drug product;
Provide CMC support for process development, scale-up, and technology transfer activities;
Ensure compliance with cGMP regulations and company quality standards in all CMC-related activities;
Contribute to the development and maintenance of quality systems related to CMC;
Prepare and review technical documents, including batch records, protocols, reports, and standard operating procedures (SOPs);
Generate and maintain accurate and up-to-date CMC documentation;
Collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance, Research and Development, and Project Management, to align CMC strategies with overall project goals;
Act as a subject matter expert on CMC matters and provide guidance to project teams;
Ensure all regulatory submissions meet quality and compliance standards by performing quality checks, verification of document completeness, and adherence to regulatory guidelines;
Stay informed about regulatory guidelines related to CMC and ensure adherence to relevant regulations (e.g., FDA, EMA, ICH) in all operational activities;
Foster collaboration and effective communication across cross-functional teams, including R&D, quality assurance, supply chain, and regulatory affairs;
Coordinate and liaise with internal and external stakeholders to ensure seamless integration of CMC operations with organizational objectives;
Produce quality work that meets or exceeds client expectations.

Education and Experience:

Bachelor's degree in a scientific or related field;
Minimum of 3-5 years of relevant experience in CMC within the pharmaceutical or biotechnology industry;
General knowledge of regulatory requirements and guidelines related to pharmaceutical manufacturing requirements;
Solid understanding of CMC principles and regulatory requirements;
Strong technical writing and communication skills;
Detail-oriented with excellent organizational and project management abilities;
Ability to work effectively in a fast-paced and dynamic environment;
Ability to liaise with stakeholders;
Problem-solving skills and the ability to make sound decisions under pressure;
Ability to deliver against project timelines;
Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint);
Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.