The Associate Director, CMC reports directly to Head of CMC and CMC Global Regulatory Affairs and is responsible for managing external CMC development projects and acts as a SME within relevant areas.

Essential Duties and Responsibilities

· Provide broad CMC support for internal programs from GLP tox through IND/CTA clinical programs up to NDA/BLA post-approval

· Ensure timely Drug Substance/Drug Product supply for non-clinical and clinical studies

· Coordinate with internal and external analytical/quality control, quality assurance, and regulatory team members to resolve technical issues or deviations during cGMP production

· Create and manage contracts, requests for pricing, supply agreements, etc., related to drug substance and drug product manufacturing

· Ensure activities are executed in alignment with established Quality Agreements.

· Support and review relevant CMC sections for regulatory filings.

· Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs.

· Develop and maintain collaborative relationships with internal stakeholders (e.g., Discovery, Non-Clinical, CMC, Clinical Operations, Regulatory, Quality, Finance, etc.) to deliver on internal goals and objectives.

· Performs other related duties as assigned by the direct manager.

What you need to succeed (Requirements)
To succeed in the role, we believe that you have;

· Bachelor’s degree in bio-engineering, biotechnology, biological, pharmaceutical or chemical sciences. Advanced (PhD) degree preferred.

· A minimum of 5 years of industry experience in CMC Development. Biologics experience is preferred.

· Strong understanding of, biologics manufacturing strategies, phase appropriate analytical development and characterization.

· Experience in cross-functional management, able to lead diverse and complex projects and timelines with demonstrated success.

· Willing to work in a fast-moving, international environment where processes are continuously evolving. This may involve short timelines and collaboration across different time zones depending on business needs, and the possibility to influence internal processes.

· Strong knowledge of US and EU CMC phase appropriate regulatory requirements for biologics.

· Experience from technical transfers, and complex development & manufacturing activities.

· Collaborative and open-minded.

· Strong communication skills.

You will also benefit from (Preferred requirements):

· Previous experience managing CDMOs for outsourced manufacturing.

· Previous experience in biologics manufacturing.

· Good knowledge in biologics process development, analytical development and characterization of biologics.

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.

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.

Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.

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 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!

Disclosures Sweden:

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