CMC Project Manager in CRISPR Microbiome company
Do you have a passion for CMC and want to contribute to a biotech company dedicated to developing new medicines within infectious and metabolic diseases?
If yes, you have the opportunity to be part of a dynamic international team at SNIPR situated in the Innovation District Copenhagen, Denmark (www.sniprbiome.com).
The role can be at a manager or director level, depending on experience. You will report to the VP, Drug Development.
Company Description
SNIPR Biome is a Danish clinical-stage biotech company pioneering CRISPR-based medicines to treat and prevent human diseases. We leverage CRISPR-Cas technology for precision killing of harmful bacteria and targeted gene modification.
Our team of 40+ employees are from top academic institutions and biotech companies worldwide and is highly diverse in gender, nationality, age, and education. Together, we drive a robust AMR pipeline of several CRISPR-based experimental medicines from early preclinical to Phase 2, supported by strong IP and advanced AI- and robotics-assisted R&D labs.
The responsibilities within this role are as follows:
- Manage CDMOs and other contractors to ensure project CMC progress according to timelines and budget.
- Participate in SNIPR project teams, and ensure CMC deliverables match project plans
- Plan and coordinate writing and updates of module 3 (IND/IMPD).
- Identify vendors for CMC activities as required
- CMC input to authority interactions
- Maintain an overview and manage regulatory CMC commitments
- Sponsor review and sign-off of relevant CDMO documents
Requirements and qualifications
You have at least 5 years’ experience as a CMC project manager in a pharmaceutical or biotech company or in a pharmaceutical CDMO. The position is also open to a Regulatory CMC project manager who is looking for a new challenge and to broaden their experience.
You understand the process of outsourcing manufacturing and how it should be managed. Direct experience in managing CDMOs is an advantage, but not a requirement. You are organized, responsible and can work independently. You are fluent in written and spoken English. You know your way around CTD module 3 and are familiar with relevant ICH Quality guidelines.
We encourage you to apply even though you may not fulfil all above points as we above all expect you to be self-driven with a can-do personality.
Benefits
In addition to competitive salaries, we offer a comprehensive benefits package, including health insurance, pension programme, bonus and warrants programme, etc.
We offer a fun, social and diverse work environment with colleagues from many different nationalities and backgrounds.
Application
We seek to fill the position as soon as possible and we aim to conduct interviews on a running basis (possibility for online interview). Application deadline: 9 February 2026
All applications must be in English and include (Please include in 1 document):
- Curriculum vitae incl. a short paragraph motivating the application