CMC Expert
Gdańsk, PL
Boost your career with us
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities include, but are not limited to:
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Participation as a member of CMC team in interdisciplinary project teams; partner with Quality, Research & Development, Manufacturing, Clinical and Regulatory teams;
- Providing regulatory guidance to analytical project teams on all aspects of technical development and production;
- Active participation in defining CMC regulatory strategy. Materials preparation for regulatory decision making, balancing risks and benefits;
- Authoring and/or reviewing of high-quality CMC documentation for Health Authority submissions (i.e., CMC content of Module 3 sections for IMPDs/INDs, MAAs/BLAs, briefing books);
- Preparation of and/or supervision over responses to CMC-related questions from Health Authorities to ensure regulatory approvals. Participation and preparation of materials for meetings with Health Authorities (e.g. EMA, FDA and local ones) depending on the scope of a meeting;
- Coordination over the format of the quality documentation from third parties (external stakeholders) and assurance of documentation consistency;
- Filing and archiving regulatory documentation, including correct formatting according to global requirements.
- Preparation and verification of NCBiR grants;
- Assistance and participation in unit inspections (CMC scope of topics);
- Participant and/or coordinator of cross-functional matrix teams for preparation of regulatory submissions;
- Co-responsible for successful implementation of strategic CMC plans. Ability to achieve timely submissions and to adhere to regulatory requirements;
- Interact with external contacts from license partners, service providers and CMOs.
If you have:
- Over 8 years of industry experience with focus on biologics/monoclonal antibodies (ideally biosimilars), including both development and commercial pharmaceutical products;
- MSc or PhD in biotechnology, biochemistry, biology or equivalent;
- Expertise in CMC topics, including aspects such as cell line development, process development, analytical methods, comparability studies and/or similarity assessments as well as in biological medical products registration process US/EU/MHRA;
- Expertise in guidelines with focus on EU and US;
- Practical experience in registration processes and handling post-approval changes (e.g.: preparation of CMC content of Module 3 sections for IMPDs/INDs, MAAs/BLAs, briefing books, post-approval changes; and related interactions with Health Authorities);
- Excellent planning, communication, documentation and organizational skills with hands-on mentality;
- Ability to work successfully in a matrix organization in cross-functional teams;
- Ability to coordinate task oriented groups;
- Orientation towards collaboration and aligned decision-making;
- Technical writing skills (pharmacy/biotechnology);
- Professional proficiency in both written and spoken English, Polish language is an advantage.
What we offer:
- Competitive salary;
- Private healthcare;
- Life insurance;
- Pension plan above national standards;
- Additional free day;
- and more..
Why you should work with us
Contact us
career@polpharmabiologics.com