Program Manager I - Biopharmaceutical

NEPSE Trading; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific seeks a Project Manager I - Labs to support GMP laboratory operations remotely in the US. This role coordinates study setup, maintenance, and closure with PMs, ensuring timely deliverables and clear sponsor communication.

You will serve as backup for central PM staff, advise on procedural and budget items, and assist with initial study supply orders while monitoring shipments and deadlines.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 0–2 years of experience or equivalent combination of education, training, & experience.

Responsibilities

• Serve as local study coverage for global studies and point of contact for Clinical teams. Ensure timely completion of study activities and deliverables.
• Manage existing Batch, Supply Only, and “In Conduct” studies. Develop new study set-ups as appropriate in collaboration with the Tech Ops group.
• Serve as designated backup for PM staff (Centralized) and point of contact for PMs when out of office. Review and prepare with PMs in advance of coverage.
• Advise PMs on procedural and budgetary items and on changes due to study modifications or protocol amendments.
• Monitor monthly Budget-to-Burn reviews and contract modifications.
• Support development and implementation of initial study supply orders, including creation of templates and shipment requests.
• Monitor completion of shipment requests.
• Schedule meetings, prepare agendas, and record minutes.
• Adjust priorities to meet deadlines and deliver high-quality deliverables.
• Complete additional tasks in support of project, client, and departmental objectives.

Skills

Project management

Organizational skills

Communication skills

Problem solving

Attention to detail

Confidentiality

Presentations

Team collaboration

Education

Bachelor's degree or equivalent

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

The Project Manager I - Labs liaises with PPD's operational departments, affiliates and sponsors. Coordinates (in collaboration with Project Managers) the study setup, maintenance and closure activities for identified protocols and/or study programs. Consults on project management issues and supports overall function of the Project Management group. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You'll Do:

• Serve as local study coverage for global studies and point of contact for Clinical teams. Ensure timely completion of study activities and deliverables. Document communication and actions with sponsors or investigator sites.
• Manage existing Batch, Supply Only, and “In Conduct” studies. Develop new study set-ups as appropriate in collaboration with the Tech Ops group.
• Serve as designated backup for PM staff (Centralized) and point of contact coverage for Project Managers when out of office. Review and prepare with Project Managers in advance of coverage.
• Advise Project Managers on procedural and budgetary items and on the necessity for changes due to any subsequent study modifications and/or protocol amendments. Monitor monthly Budget-to-Burn reviews and contract modifications.
• Support the Project Management group with development and implementation of initial study supply orders, including creation of initial supply templates and submission of initial shipment requests to the Supply Chain Management group.
• Monitor completion of shipment requests.
• Schedule group meetings and teleconferences (internal and external), prepare and distribute agendas, record and distribute minutes as required.
• Monitor assignments and adjust priorities and work schedules to meet deadlines and provide high-quality deliverables.
• Complete additional tasks needed in support of project, client, and departmental objectives.

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job.

Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:

• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
• Effective project management and organizational skills
• Good computer skills
• General knowledge of clinical trial processes and programs
• Strong attention to detail and problem solving skills
• Good written and verbal communication skills
• Ability to effectively conduct oral presentations
• Demonstrated experience in identification and resolution of technical problems in a professional environment
• Ability to maintain a high degree of confidentiality with clinical teams
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others

Working Environment:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Why join us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.