Sr. Associate, Project Management - Biopharmaceuticals

ABOUT MEITHEAL PHARMACEUTICALS

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.

The Biopharmaceutical Project Management position drives the scientifically advanced development, high-quality manufacturing processes, and complex clinical studies required to obtain FDA approvals to supply biosimilars and biologics across Meitheal’s Specialty pharmaceutical portfolio. This role provides program direction and manages timelines and project controls across global functional teams, manufacturing/development sites and external service providers. The ideal candidate possesses strong and effective global Project Management, problem solving, and interpersonal skills and has a proven track record working cross-functionally across a wide variety of technical, business, and operational areas. Experience in biologicals and biosimilar drug development, clinical trials and/or regulatory areas is required.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Leads and manages cross-functional teams to develop project plans, budgets and manage/report project meetings/notes. Cross functional teams include technical, regulatory, and clinical trials and ensure timely completion of new biosimilars projects in alignment with corporate goals.

• In cooperation with the global project team, defines project objectives, requirements, and assumptions necessary to structure a project or task related to biosimilars product development, clinical trials, manufacturing and FDA submission/approval.

• Closely monitors/controls project progression to ensure project is completed on schedule and within budget.

• Reports project progress to all key stakeholders.

• Supports the project team to evaluate project challenges with necessary risk assessment, evaluates budget and timeline impact and implements corrective and/or mitigation.

• Prepares and manages project budget and milestones.

• Cultivates effective communication, cooperation, and trust within the global cross-functional and external teams

• Facilitates and leads effective project meetings.

• Other duties may be assigned.

Competencies

• Understanding of biosimilar CMC development, manufacturing, clinical trials and/or regulatory areas is required.

• Experience in planning and managing the global cross functional aspects of biosimilar product development.

• Demonstrated knowledge and application of Project Management tools, such as Risk Management.

• A high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Demonstrated experience in biosimilar Project Management or related field.

• Detail focused with exceptional organizational skills.

• Proven ability to show initiative and sense of urgency.

Education and/or Experience Required

• Minimum of 5 years of relevant pharmaceutical or biotech industry experience in biosimilar development and/or biosimilar Project Management.

• BS Degree or equivalent experience in a related field.

Travel

Up to 15% domestic and/or international travel.

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint)

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.

Work Environment

The noise level in the work environment is usually moderate.

EEO

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.