Senior Site Specialist - Scale Up Lab Support

Work Schedule

Environmental Conditions

Job Description

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue exceeding$35 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving complex analytical challenges or improving patient diagnostics and therapies we are here to support them.

When you join the team at Thermo Fisher Scientificyoulldo important work. Things like helping customers in finding cures for cancerand genetic disorders protecting the environment or making sure our food is safe. Your work will have real-world impact andyoullbe supported in achieving your career have the opportunity for continual growth and learning in an environment that will support your development.

We areseekingan energetic and enthusiastic individual withstrong communication leadership technical and operational skills to join our growing Process Development team.

This position is focused on service delivery excellence for Unity Lab Services (ULS). The senior site specialist will perform process manufacturing duties under the direct supervision of research staff and ULS management in a team environment. The candidate will routinely perform moderate to complex processes according to Standard Operating Procedures operating guidelines instructions and departmental policies. Generally this will include all aspects associated with small molecule drug substance research and manufacturing.

Responsibilities:

Assistance with production runs on a multi-kilo scale

Operation and process monitoring of reaction equipment

Equipment and parts assembly disassembly and cleaning

Execution of equipment commissioning and qualification

Equipment maintenance and mechanical support for research equipment including assisting with design and equipment modifications development and execution of preventative maintenance schedules review and upkeep of safe operating guidelines

Maintain good house keeping

Work in a team environment with scientific staff

Partner with Research staff and Environmental Health and Safety to ensure safe operations at all times.

Adhere to all customer cGMP SOPs

Responsible for maintaining cGMP logs daily

Maintain compliance with cGMP training

Archiving GMP documents

Raw material inventory and consumables stocking and control using SAP inventory systems

Position work hours.

Work hours are Monday-Friday 8-430pm. Weekend and holiday work is required on an as needed basis.

How will you get there

Bachelors Degreeinbiology chemistry biochemistry(bio)chemicalengineeringbiomedicalengineering ora related field.

1years experience in aprocess development /manufacturing environment preferred.

Industry experience in aseptic technique cell culture single-use bioreactors (SUBs) wave reactors preferred.

Demonstrated knowledge of cGMPs/GLPor regulatory affairspertaining tothe pharmaceutical and biological industries is preferred.

Excellent problem solving and critical thinking skills including strong attention to detail.

Advisesupervisor of factors that may affect quality accuracy timeliness and usefulness of data.

Excellentorganization planning and time management skills.

Self-motivated willing to learn independent and a proactive driving force of efficient execution.

Strong interpersonal and communications skills (written and oral).

Able to work effectively with a wide range of constituencies in a diverse environment.

Good comprehension of Microsoft Office Suite software.

A flexible work schedulemay berequired includingweekendsandeveningsas neededto completeclient work.

While performing the duties of this job the employee:

Will be expected to function in a dynamic environment and balance multiple priorities simultaneously.

Will be expected to learn new software and tools quickly.

Will use highly specialized equipment and instrumentation in daily manufacturing.

Will proactivelyidentifyareas for opportunity and drive efficiency results.

Will critically review processes andprovideinput to supervisor/manager.

At Thermo Fisher Scientific each one of our100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthiercleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminateon the basis ofrace color religion sex sexual orientation gender identity national origin protected veteran statusdisability or any other legally protected status.