CMC Project Manager - Usona Institute - Promega

Job Description:

JOB OBJECTIVE: We are seeking a highly motivated and experienced CMC Project Manager to join our team. This pivotal role will coordinate and oversee all Chemistry, Manufacturing, and Controls (CMC) activities, ensuring seamless integration across the process and analytical development, manufacturing, and regulatory functions. The ideal candidate will have a strong technical background in chemistry, exceptional project management skills, and the ability to navigate complex regulatory landscapes.

CORE DUTIES:

1. CMC Project Management Expertise:

Lead and manage all CMC-related projects, ensuring alignment with overall company goals and regulatory milestones.
Utilize project management tools and methodologies to track progress, identify risks, and implement mitigation strategies.

1. Technical Background in Chemistry:

Provide technical oversight and support for process and analytical chemistry activities.
Troubleshoot and resolve technical issues that arise during development and manufacturing.

1. Cross-functional Collaboration:

Foster effective communication and collaboration with adjacent teams in quality, regulatory, supply chain, and clinical development.
Translate technical requirements into actionable plans for non-technical team members.

1. Strategic Planning:

Develop and implement long-term strategic plans for CMC, ensuring scalability and quality of manufacturing processes.
Align CMC activities with the companys overall strategic objectives and regulatory milestones.

1. Embrace and Utilize AI Tools:

Demonstrate a genuine curiosity and enthusiasm for leveraging AI technologies to enhance efficiency, improve processes, and drive innovation within your role. Willingness to learn and adapt to new AI tools is essential.

1. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
2. Embracing and being open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.
3. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Advanced degree (PhD, MS, or equivalent) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
2. 7+ years of experience in the pharmaceutical industry, with a focus on CMC activities.
3. Proven project management experience, including the use of project management tools and methodologies.
4. In-depth knowledge of regulatory requirements and guidelines for CMC, including experience with regulatory submissions.
5. Strong technical background in both process and analytical chemistry.
6. Excellent interpersonal and communication skills, with a proven ability to collaborate across functions and translate technical concepts for diverse audiences.
7. Strategic thinker with the ability to develop and implement long-term plans.
8. Experience managing relationships with CMOs and external vendors is a plus.
9. Highly organized and detail-oriented with a proactive approach to problem-solving.
10. Strong leadership skills with the ability to motivate a team.
11. Adaptable and flexible, able to thrive in a fast-paced start-up environment.
12. Passionate about advancing medical science and improving patient health.

PHYSICAL DEMANDS:

1. Ability to use a computer/Microsoft Office applications.

At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.