Manager, Project Management

About Us:

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs.

Ranked among the top 100 Crain's Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for - Meitheal (Mee*hall): working together toward a common goal, for the greater good.

Position Summary:

Manager, Project Management (PM), will be responsible for managing injectable pharmaceutical development projects of higher complexity and/or strategic importance to corporate strategy, including complex generics, combination products, biosimilars, and branded products. The successful candidate will drive cross-functional teams within the Company and across business partners to manage project milestones and goals. Experience/knowledge in peptide, biosimilars, and/or combination product development is highly preferred.

The PM will play a key role in the development and execution of the product development plans, ensuring that cross-functional teams are aligned on goals, technical strategy, timelines. This role will also require effective communication across all functional areas, at various levels, including Executive Management.

Why Work with Us?

• Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
• Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
• Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
• Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities

• Planning and tracking of projects in support of Research and Development (R&D) and business objectives.
• Supports drug development for U.S. market in a highly cross-functional internal environment, as well as with international drug development and manufacturing partners.
• Facilitates cross-functional communication and decision making, ensuring alignment with internal functional groups and leadership.
• Independently manages all development projects to meet exhibit batch and submission goals.
• Executes frequent international project team calls, issue agendas, notes and conduct all follow ups.
• Manages all project team activities to resolve technical issues and to ensure all project goals and timelines are achieved by interacting with key stakeholders across divisions and influencing others internally and externally to complete their assigned tasks on schedule.
• Acts as liaison between R&D and CROs/CMOs for contracted projects.
• Assesses project risk and supports mitigation planning and follow up.
• Generates and publishes project status reports and other reports as needed.

Supervisory Responsibilities

None.

Competencies

• Self-starter
• Strong problem-solving abilities
• Establish and Nurture Personal Relationships
• Oral and Written Communication
• Change Management
• Strategic Thinker
• Cost Conscious
• Judgement

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Past experience/knowledge in peptide, Biologic, and/or combination product development preferred.
• Demonstrated experience in managing multiple pharmaceutical projects within the product development process.
• Detail focused with exceptional organizational skills.
• Proven ability to show initiative and sense of urgency.

Education and/or Experience Required

• Bachelor of Science in Pharmacology, chemistry or related discipline preferred; or, equivalent skills and experience required.
• 5 years of pharmaceutical experience.
• 5 or more years of experience in product development and/or project management in pharmaceutical drug development.
• Skilled at troubleshooting and mitigating risks for multiple projects at a time to meet corporate goals.

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint).

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.