Senior CMC Specialist
1 week ago
Senior CMC Specialist – Small Molecules Drug Development
Our client is advancing impactful therapies for neuromuscular diseases following recent fundraising success. They are seeking an experienced Senior CMC Specialist to lead small-molecule drug substance projects from candidate selection to commercialization.
This flexible role allows remote work, with occasional visits to Denmark and CDMO in France.
Key Responsibilities:
- Lead drug substance development for small molecule drug projects from candidate selection to late stage and commercialization
- Lead cross-functional CMC and R&D initiatives, innovation and excellence in drug substance development
- Ensure regulatory compliance by preparing and reviewing regulatory documentation (IBs, INDs, CTAs, NDAs)
- Manage CDMO relationships for high-quality outcomes
Qualifications:
- M.Sc. or PhD in Chemistry, Pharmacy, or related fields
- 10-15 years of experience with small molecules late-stage drug development
- Proven experience as a Drug Substance Lead with expertise in ICH guidelines and GMP
- Strong communication and collaboration skills
Ready to make a difference in patients’ lives? Apply today to be part of a mission-driven team
ContactIf you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon. Alternatively apply on LinkedIn here
#J-18808-Ljbffr-
(Senior) CMC Technical Integration Manager
3 months ago
København, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at (Senior) CMC Technical Integration Manager Locations: Copenhagen Time Type: Full time Posted on: Posted 2 Days Ago Job Requisition ID: R11639 At Genmab, we’re committed to building extraordinary...
-
Senior CMC Project Manager
3 months ago
København, Denmark Genmab Full timeAt Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science,...
-
Global Regulatory Affairs Manager – CMC
3 months ago
København, Denmark Ferring Pharmaceuticals AS Full timeWould you like to join an international company with excellent development opportunities and an open work environment where your contributions will make a difference, as you take on CMC responsibility for one of our products and a development project? You will be part of our Small Molecule team, which is responsible for all global regulatory CMC activities...
-
Senior Associate CMC for the Stability Team
3 months ago
København, Denmark Genmab Full timeAt Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...
-
København, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Director/Associate Director, Global Regulatory Affairs - CMC At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that...
-
København, Denmark Genmab Full timeAt Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe that being proudly...
-
Senior QC Scientist
3 months ago
København, Denmark H. Lundbeck AS Full timeSenior Quality Control Scientist, QC CMC Biologics Do you want to join our international CMC Biologics Quality Control team? And are you eager to work in an international setting where empowerment and cross functional collaboration skills are key? Then you might be our new Senior Quality Control Scientist! Your new role – why is this a great opportunity? ...
-
Preformulation Scientist/Specialist
3 months ago
København, Denmark H. Lundbeck AS Full timePreformulation scientist/specialist, Pharmaceutical Development small molecules Lundbeck’s passion is tied to our goal of restoring healthy mental well-being, so that every person can be their best. We strive to make a real difference for patients by developing innovative treatments that improve the lives of people living with brain diseases. We are...
-
København, Denmark Genmab AS Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Senior Digital Product Owner, CMC, R&D Digital Products At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change...
-
Senior Operations Specialist
3 months ago
København, Denmark IT Minds Full timeHar du erfaring med drift af forskellige IT-miljøer og infrastruktur og interessere du dig for at optimere og automatisere processer? Så er du muligvis den Senior Operations Specialist vi søger til vores Infrastructure Management team. Fellowmind Vi er en cloud orienteret konsulentvirksomhed, der først og fremmest stræber efter at skabe meningsfulde...
-
Senior Paid Search Specialist
7 days ago
København, Denmark Dentsu Aegis Network Ltd. Full timeSenior Paid Search Specialist Apply locations København K time type Full time posted on Posted Yesterday job requisition id R1078528 Job Description: Har du en stærk passion for betalt søgeordsannoncering og erfaring med at drive komplekse strategier inden for betalt search? I iProspect har vi vokseværk, så vi er på udkig efter endnu en Senior Paid...
-
Senior Programmatic Specialist
3 months ago
København, Denmark Dept Digital Marketing ApS Full timeDepartment Digital Marketing Employment type Employee Senior Programmatic Specialist Apply This position sits in our Creative Marketing service based in Copenhagen. We combine data, technology, creative content, and paid media to crack brands’ business problems & drive revenue through a variety of digital marketing solutions like ad campaigns, augmented...
-
Senior Paid Search Specialist
7 days ago
København, Denmark Dentsu Aegis Network Ltd. Full timeHar du en stærk passion for betalt søgeordsannoncering og erfaring med at drive komplekse strategier inden for betalt search? I iProspect har vi vokseværk, så vi er på udkig efter endnu en Senior Paid Search Specialist til vores ambitiøse kontor i København. Vi søger en Senior Paid Search Specialist, der har lyst til at være en del af vores...
-
Senior Test Specialist
3 months ago
København, Denmark Dalux Full timeDo you have a passion for quality of software development, and do you get excited when you hear someone talks about test planning? Then this might be just the right opportunity for you! Quality and Test Management at Dalux We are looking for a Senior Test Specialist to join our software development organization. This role will be one of the first hires in...
-
Programmatic Integration Senior Specialist
3 months ago
København, Denmark Better Collective Full timeJob description Better Collective is a leading sports betting media group that provides users with educational content, bookmaker information, and betting tips. Our mission is to make sports betting and gambling entertaining, transparent, and fair. As part of our continued growth, we are expanding our esports vertical and looking for a talented Programmatic...
-
Tech Transfer Lead – Biopharma
2 months ago
København, Denmark Blackswansexist Full timeWe are supporting a biopharma CDMO that has multiple incoming projects and is expanding their Tech Transfer team. They have invested heavily into expanding their manufacturing capabilities over the last few years, which also means several challenges around scaling their existing tech transfer processes. This is a priority area within their company, and the...
-
Senior Specialist SRA Nordics
2 months ago
København, Denmark Mars, Incorporated and its Affiliates Full timeJob Description: As an associate of Scientific & Regulatory Affairs, the Senior Regulatory Specialist performs a variety of regulatory activities related to raw materials, finished products, product registration, labelling, claims, packaging, and regulatory database management to ensure compliance with applicable food and other product-related laws and...
-
Senior CRM Specialist
2 weeks ago
København, Denmark Miinto Group Full timeWould you like to be the new Senior CRM Specialist in Miinto Marketing? We are looking for a CRM professional who has the hunger to own Miinto’s technical CRM solutions, manage the quality assessment of sendouts (both manual and automated), and share ownership of the reporting of the Customer Marketing performance. You get excited by the nitty-gritty, the...
-
København, Denmark PL & Partners AS Full timeSenior Paid Social Specialist eller Paid Social Director Vil du være en del af et Paid Social-team i vækst, løfte vores niveau og håndtere nogle af vores mest spændende kundecases? Vi rådgiver vores kunder om digital markedsføring. Og sammen med kunderne skaber vi synlige resultater for kundernes forretning. Vi er bredt anerkendt som nogle af...
-
Senior DCO specialist
3 months ago
København, Denmark IT Minds Full timeDescription Position at GroupM Vi søger en erfaren teknisk profil med baggrund i Javascript, CSS og HTML Har du en solid udviklerbaggrund og et ønske om at prøve kræfter af i et teknologiorienteret mediebureau? Så er GroupM måske en mulighed for dig. Hvad skal du lave? Som Senior DCO Specialist i afdelingen Addressable Content hos bureaugruppen...