CMC Project Coordinator
We are looking for new team members to join our CMC team. If you have the required background and find the role interesting, please apply for this position.
Job Summary / Objective
The CMC Project Coordinator reports directly to the Head of CMC and supports CMC tasks such as change control and deviations, and oversees the CMC document structure and handling. The CMC Project Coordinator also supports in development projects and coordinates activities within the project.
Essential Duties and Responsibilities
- Support project management of CDMOs for process development and manufacturing of Drug Substances and Drug Products for tox/clinical material.
- Work closely with cross functional teams.
- Coordinating activities with internal and external functions as R&D, quality assurance, and regulatory team member.
- Coordinate internal CMC change control and deviations activates and CMC SOP preparations and updates.
- Create and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturing
What you need to succeed (Requirements)
To succeed in the role, we believe that you have;
- Bachelor’s degree in biological, pharmaceutical or chemical sciences.
- A minimum of 3 years of industry experience.
- Experience in management of internal CMC development and production or external CDMOs for DS/DP production
- Experience in change control and deviations, and updating SOP:s
- Collaborative and open-minded
You will also benefit from (Preferred requirements):
- Previous experience managing CDMOs for outsourced manufacturing
- Extensive understanding of GMP regulations
- Experience in biologics manufacturing.
As a person, you are/have (Competencies):
Ethics - Treats people with respect; Shows respect and sensitivity for cultural differences; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values; Promotes a harassment-free environment.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
What we offer (Benefits)
Competitive pay and benefits such as
- Excellent healthcare and retirement plans and insurances with ability to exchange gross salary for pension
- Maximum annual wellness contribution
- Parental salary supplements
- Private health insurance and check-ups
- Inspiring facilities & environment working in our new combined lab & office space in “Forskaren”, Stockholm’s new life science centre
Hiring Process
If you have the right background and skills required for the position, the hiring manager will reach out to you for a an initial interview. Should you move you forward in the interview process, you will meet with other key individuals as well. In the final stages of the process, you will be asked to provide references and give your consent for background checks, which are part of our recruitment procedures.
Applications will be processed as they come, so don’t hesitate to submit your application today. We are looking forward to your application!
Disclosure
Please be aware that there are certain individuals and entities that fraudulently misrepresent to job seekers that ITB-MED has open employment positions when in fact those positions are not available.
We do not recruit or offer positions via text messages, Signal, Facebook, WhatsApp, or any other messaging platforms.
ITB-MED does not ask you to send money and/or personal details such as banking information, passport and/or visa information. Should you think you have been a victim, please report the incident to legal(at)itb-med.com
- Department
- CMC
- Role
- CMC Project Coordinator
- Locations
- Stockholm
- Remote status
- Hybrid Remote
About ITB-MED
ITB-MED, founded in 2016, has grown to over 40 employees across offices in Stockholm and New York. Clinical trials are being conducted globally, with a particular focus on the United States (US) and the European Union (EU), aiming to submit applications for the market authorization of siplizumab. We have expanded rapidly, and in 2024, our Swedish office relocated to a combined lab and office space in “Forskaren,” Stockholm’s new life science center.
CMC Project Coordinator
We are looking for new team members to join our CMC team. If you have the required background and find the role interesting, please apply for this position.
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