CMC Development Manager

3 days ago


København N, Denmark Loma Therapeutics ApS Full time

About Loma Therapeutics

">

Loma Therapeutics is a pre-clinical stage biotech startup focused on developing an HPV-targeted immunotherapy. The company aims to initiate clinical trials in the near future, with the current priority being the CMC development of its lead medicinal product.

">

Job Overview

">

This role will be responsible for overseeing the company's CMC-related activities, primarily at a contract manufacturing organization (CDMO). As the main point of contact, you will ensure a smooth and efficient collaboration, prioritizing quality and adherence to timelines.

">

The successful candidate will work closely with the CDMO, ensuring adherence to GMP standards and troubleshooting any production issues that may arise. Additionally, they will be involved in regulatory interactions and responsible for CMC-related aspects.

">

Main Responsibilities

">
  • ">
  • Coordinating and managing CMC development and GMP manufacturing at the CDMO">
  • Ensuring smooth and timely collaboration">
  • Overseeing scale-up">
  • Ensuring quality requirements and production consistency">
  • Validation and documentation of manufacturing processes and analytical methods">
  • Analysing and interpreting data from the CDMO to maximize quality, yield, and stability">
  • Communicating updates and concerns to the Loma team">
  • Preparing, reviewing, and updating regulatory submission documents">
  • Coodinating and collaborating with the R&D team">
">

Requirements

">

The ideal candidate should possess:

">
  • ">
  • A MSc degree and 3 years of experience as a CMC leader">
  • Experience from a CDMO or collaborating with CDMOs">
  • Deep understanding of CMC requirements for clinical trials">
  • Experience with manufacturing of viral vectors is an advantage">
  • Ability to work independently and as part of a small team">
  • Fluent English">
  • Experience from early-stage biotech is an advantage">
">

Benefits

">

We offer a challenging and dynamic environment with opportunities for growth and professional development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.



  • 2200 København N, Denmark Loma Therapeutics ApS Full time

    Location Copenhagen @ BioInnovation Institute (Ole Maaløes Vej 3) About Loma Therapeutics Loma Therapeutics is a pre-clinical stage biotech startup developing an HPV-targeted immunotherapy. Loma Therapeutics is at the pre-clinical stage, with the aim of starting clinical trials in a few years. Loma Therapeutics is currently initiating the CMC...


  • København N, Denmark Loma Therapeutics ApS Full time

    About the Role">Loma Therapeutics is seeking a highly skilled and experienced CMC manager to join our team. As a key member of our operations team, you will be responsible for overseeing the CMC development and GMP manufacturing of our lead medicinal product at a contract manufacturing organization (CDMO).">Key Responsibilities">">Developing and implementing...


  • København N, Denmark Loma Therapeutics ApS Full time

    Our Mission">Loma Therapeutics is committed to developing innovative treatments for patients with HPV cancer and pre-cancer. Our team is dedicated to making a difference in the lives of those affected by these diseases.">About the Role">We are seeking a highly skilled and experienced CMC manager to join our team. As a key member of our operations team, you...


  • København V, Denmark Danske Bank Full time

    Key Responsibilities:Collaborate with delivery teams to develop and implement Data Quality Issue Management processesStructure the overall Data Management Programme, ensuring alignment with business objectivesDevelop and deliver training materials to support employee developmentFacilitate workshops to drive process improvements and enhance collaboration


  • København, Denmark Scandinavian Tobacco Group Tobacco Service B.V. Full time

    HOURS – Full time ABOUT THE ROLE : We have an exciting opportunity for a People Development Manager to join our newly established team. As the People Development Manager, you will play a crucial role in executing our global people development processes & initiatives, fostering employee growth, and driving a performance culture across Scandinavian Tobacco...


  • København, Denmark Nordea Bank Norge ASA Full time

    Senior Business Developer to Financial Solutions in Wealth Management Denmark Job ID:28085 We are now looking for a strong profile to take on a Senior Business Developer role within the financial offerings in Nordea Wealth Management. We see that you are a business-driven profile with a strong sense of responsibility and thereby be a key player in...


  • København, Denmark Nordea Bank Norge ASA Full time

    Senior Business Developer to Financial Solutions in Wealth Management Denmark Job ID:28085 We are now looking for a strong profile to take on a Senior Business Developer role within the financial offerings in Nordea Wealth Management. We see that you are a business-driven profile with a strong sense of responsibility and thereby be a key player in...


  • København, Denmark Skyven Technologies Full time

    Business Development and Technical Sales Manager, Europe 3 days ago Be among the first 25 applicants About The Opportunity At Skyven Technologies, we have developed a revolutionary heat pump technology to decarbonize industrial heat and move the needle on climate change. Our technologies have the potential to completely eliminate on-site CO2 emissions from...

  • Product Developer

    5 days ago


    København, Denmark SAYSKY Full time

    SAYSKY Copenhagen, Capital Region of Denmark, Denmark Product Developer Are you passionate about creating innovative performance apparel that pushes boundaries? Do you thrive on transforming creative visions into functional, high-quality products? If so, this could be the perfect role for you. At SAYSKY, we’re on a mission to craft apparel that empowers a...


  • København, Denmark Pandora AS Full time

    Application Deadline: 7th of February 2025 Are you a visionary leader with a passion for transforming retail environments? Pandora is looking for a Concept Development Director to shape and advance our store concepts. In this pivotal role, you will drive the development and enhancement of both our current and future store designs, ensuring they align with...

  • Fullstack Developer

    5 days ago


    København, Denmark The HubDanske Bank Full time

    At Neurons, we're not just innovating; we're revolutionizing marketing by predicting consumer responses in seconds. Working with groundbreaking profound neuroscience insights, we enable brands to understand and engage with their audiences like never before. If you're eager to be at the vanguard of this transformation and are passionate about harnessing these...


  • København, Denmark E Conomic Full time

    Do you thrive on empowering teams to build scalable, beautifully designed and impactful systems? As an Engineering Manager at e-conomic, you will guide the Design System and Frontend teams to deliver user experiences that matter. Through your team’s talent and collaboration, you’ll shape tools used by hundreds of thousands of businesses across Denmark,...

  • Senior IT Engineer

    3 days ago


    København, Denmark LEGO Gruppe Full time

    Job Description #LI-KO1 Are you an all-around SAP development expert and want to explore the intersection of SAP and cloud technologies? We are seeking an experienced and self-motivated Senior SAP Software Engineer to be the go-to person in our SAP Governance and Enablement team regarding development standards and custom code life-cycle management by...


  • København, Denmark GameAnalytics Full time

    About Game Analytics GameAnalytics is a leading analytics tool for anyone building a mobile game. Our platform helps everyone in the industry, from indie developers to growing games studios to global publishers. Our network includes more than 100k games, which are played by north of 2 billion people each month. That's more than ⅓ of the world's mobile...


  • 2200 København N, Denmark KU - SUND - PANUM KBH N Full time

    Department of Neuroscience Faculty of Health and Medical Sciences University of Copenhagen Are you passionate about advancing neuroscience through innovative open science tools? Join our team at the University of Copenhagen as a Postdoctoral Fellow, where you'll contribute to the development of BrainSTEM.org, an innovative platform for neurophysiological...


  • Esbjerg N, Denmark Happy Minds Full time

    Er du interesseret i at blive en del af vores Reservedels-salgsgruppe som Parts Account Manager? Så søger vi dig!Vores Reservationssalgsgruppens opgaver:Salg af reservedele til Cat motorerIdentifikation af Scope of Supply sammen med kunde, eftersalg- og serviceOpfølgning på tilbudDisponering i samarbejde med Supply ChainAktiv og fysisk kundekontakt i...

  • Software Developer

    7 days ago


    København/Frb., Denmark Randstad Full time

    **About the Role**As a Software Developer at PSQR, you will become a key member of a highly skilled team. Our flat organisational structure promotes open communication, empowering employees to contribute directly and focus on collaboration and results over titles.We are seeking a candidate with an innovative and solution-oriented approach who can think...


  • København, Denmark Copenhagen Infrastructure Partners Full time

    Fundraising Specialist, Investor Relations & Business Development Fundraising Specialist, Investor Relations & Business Development Apply locations Copenhagen time type Full time posted on Posted 3 Days Ago time left to apply End Date: February 9, 2025 (13 days left to apply) job requisition id JR101977 Do you want to join a global leader in renewable energy...

  • Store Manager

    20 minutes ago


    København, Denmark PARETO SECURITIES AS Full time

    Do you dream about managing your own high-performance team and taking responsibility for one of our amazing stores? Are you driven by sales, and do you have experience in retail? Then this position might be for you! THE POSITION As a Store Manager, you get the opportunity to start your leadership journey in Samsøe Samsøe by overseeing the daily management...

  • Sales Manager

    5 days ago


    København, Denmark COSENTINO Full time

    Would you like to be part of a world's leading producer of building materials that inspire architectural and decorative solutions? Are you passionate about distribution of products that inspire the life of many people? At Cosentino ( we are looking for an Architect & Designer Sales Manager who will have the opportunity to work in a multinational...