Senior CMC Project Manager

Senior CMC Project Manager

Job Description:

Dicot Pharma AB, based in Uppsala, is a progressive pharmaceutical company focused on developing the candidate LIB-01 into a modern potency medication for the global market. We are currently seeking a Senior CMC Project Manager for a key role within the company. As the Senior CMC Project Manager, you will report to the Chief Technology Officer and play an essential role in coordinating the CMC operations. You will serve as the primary CMC contact for manufacturers and suppliers, overseeing the process from Active Pharmaceutical Ingredient (API) to finished product. Your responsibilities include developing and implementing CMC strategies tailored to Dicots projects and ensuring that relevant tasks are executed in alignment with the various phases of project development. This position offers an exciting and challenging opportunity in a dynamic organization with high ambitions. You will collaborate with experienced colleagues in a creative and innovative environment, allowing you to enhance your skills and contribute your expertise.

IT Languages:

• English

As a Senior CMC Project Manager, you will undertake a variety of responsibilities critical to the success of Dicots development projects.:

Ensure that relevant CMC requirements are met in collaboration with Dicots suppliers.;; Draft and coordinate CMC documentation and regulatory submissions.;; Organize and participate in meetings with regulatory authorities.;; Present and discuss CMC strategies and content with potential business partners.;; Provide strategic input on the selection of new suppliers as necessary.;; Lead Dicots manufacturing campaigns and oversee the coordination of the company's material shipments.;; Develop budget proposals for your area of responsibility in collaboration with the CTO.;; Support the Quality Assurance function during investigations related to CMC.

Spoken Languages:

• English;; Swedish

Skillset:

• CMC project management
• Regulatory compliance
• Documentation skills
• Budgeting
• Quality Assurance support

Soft Skills:

• Strong interpersonal skills
• Team player
• Adaptability
• Effective communicator
• Highly organized

Qualifications:

• Several years of experience in CMC projects for pharmaceuticals, preferably including late-stage development.
• Strong understanding of regulatory requirements for pharmaceuticals.
• Proven experience in CMC project management.
• Excellent written and verbal communication skills in English.
• Independent working style with both strategic and operational responsibilities.
• University education in a relevant scientific field.
• Good knowledge of current Good Manufacturing Practices (cGMP).
• Experience working with Contract Development and Manufacturing Organizations (CDMOs), preferably internationally.

Years of Experience:

5

Location:

Uppsala, Uppsala County, Sweden, EU

Job Benefits:

• Opportunity to work in a dynamic and ambitious environment
• Collaborate with a team of experienced professionals
• Professional development and skill enhancement
• Competitive salary and benefits package
• Flexible working conditions

Working Conditions:

Full Time

Employment Type:

Permanent Contract

Company Culture:

• Dicot Pharma fosters an innovative and collaborative atmosphere where creativity is encouraged, and team members are empowered to contribute their ideas. The company values open communication and teamwork, creating an environment that is supportive and conducive to professional growth.

Opportunities For Advancement:

• Potential for career growth within the company, Opportunities to lead future projects, Involvement in strategic decision-making processes

Visa Sponsorship:

Available