CMC Project Manager, New Drug Application - Usona Institute

Company: Promega Corporation
Location: Madison
Posted on: January 23, 2025

Job Description:

Job Description JOB OBJECTIVE: The CMC Project Manager is tasked with gathering and synthesizing all available data generated over the of development of the Active Pharmaceutical Ingredient (API) and Drug Product (DP). The primary goal is to leverage AI systems to combine primary data from experiments and synthesize this information into critical documentation required for the CMC portions of the New Drug Application (NDA), reinforcing the company's commitment to AI-driven innovation. As an AI-mediated, non-profit drug company, this role will extensively leverage AI tools across partnerships to achieve these deliverables. Success in this position requires strong Emotional and Social Intelligence (ESI) to build collaborative relationships with internal stakeholders, external expert consultants, and advanced AI models. The role also demands exceptional organizational skills, open-minded workflow innovation, alignment with Usona's mission strategies, and precise execution of deliverables in a dynamic, mission-driven environment aimed at creating the perfect NDA in collaboration with CMC and regulatory teams at Usona.

CORE DUTIES:

1. Partner synergistically with advanced generative AI models to support all aspects of the job objective.

2. Schedule and coordinate meetings with stakeholders to ensure effective gathering and synthesis of data necessary for the CMC documentation of the NDA.

3. Develop project timelines, milestones, and budgets collaboratively with external and internal partners, ensuring alignment with critical deliverables for the CMC portions of the NDA.

4. Establish transparent communication mechanisms that effectively leverage collective intelligence at Usona (e.g., through presentations, CustomGPTs, or other innovative tools), highlighting the role of AI-based tools in facilitating communication, synthesizing data, and enhancing decision-making processes.

5. Actively participate as a member of the Project Management collective.

6. Track project milestones, deliverables, risks, and day-to-day operational aspects using AI tools to ensure consistent progress toward compiling and synthesizing critical CMC data for the NDA, highlighting the role of AI in optimizing these workflows.

7. Develop plans, priorities, and systems to efficiently utilize all resources in functional areas. Ensure manufacturing capability meets current and future needs.

8. Balance opposing drivers to position Usona as an innovative, high-quality, and reliable discovery organization.

9. Participate in strategic planning, budgeting, and operational planning within the area of responsibility.

10. Apply project management concepts to manage product transfer, process improvements, and production projects, utilizing AI-driven insights and automation as integral components to enhance efficiency and accuracy in these processes.

11. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

12. Embracing and being open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.

13. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Highly efficient and effective organizational and communication skills.

2. B.S. in Molecular Chemistry, Biology, Biotechnology, Microbiology, or a related discipline.

3. Familiarity with production and process/systems optimization in a pharmaceutical manufacturing environment.

4. A minimum of 5 years of project management experience supporting cross-functional teams in a scientific environment, including clinical operations, regulatory, CMC (Chemistry Manufacturing and Controls), device, diagnostics, vaccines, or Phase I-IV clinical trials.

5. Working knowledge of small molecule chemistry and QC systems.

6. Proven leadership through positive influence rather than authority.

7. Superior oral and written communication skills.

8. Demonstrated success in implementing ideas and influencing teams in collaborative environments.

9. A track record of improving manufacturing processes in multiproduct environments.

PREFERRED QUALIFICATIONS:

1. Certifications in project management.

2. M.S. in a chemistry field.

3. Strong business management understanding.

4. Familiarity with ICH Q7, DEA, ISO 9000, 13485, and/or cGMPs.

PHYSICAL DEMANDS:

1. Ability to effectively integrate advanced AI tools into workflows.

2. Ability to use computer equipment.

3. Ability to lift 50 pounds.

4. Ability to wear personal protective equipment.
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.

Keywords: Promega Corporation, Dubuque , CMC Project Manager, New Drug Application - Usona Institute, Executive , Madison, Iowa