Sr Scientific Support Specialist - Scale Up Lab

Thermo Fisher Scientific Inc. is the world leader in serving science. Join our colleagues in bringing our Mission to life - enabling 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. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

When you join the team at Thermo Fisher Scientific, you’ll do important work. Things like helping customers in finding cures for cancer and genetic disorders, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. You’ll also have the opportunity for continual growth and learning in an environment that will support your development.

We are seeking an energetic, enthusiastic, and detail-oriented individual with strong 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 Sr Scientific Support 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 cell culture research and manufacturing.

Responsibilities:

• Assistance with production runs on a multi-kilo scale

• Operation and process monitoring of laboratory 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 preventive maintenance schedules, review and upkeep of safe operating guidelines

• Perform laboratory testing on samples, according to established laboratory procedures and verifies/reports test results as requested by production run protocol. Label samples and document results.

• Utilize department protocols to undertake procedures to a consistently high standard.

• Maintain good housekeeping, with focus on maintaining control of laboratory environment and safety specification

• Work cooperatively 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 cGMP documents

Education and Experience:

• High School Diploma or equivalent.

• Bachelor's Degree in Biology, Chemistry, Biochemistry, (Bio)Chemical Engineering, Biomedical Engineering, or a related field.

• 1+ year of experience in in a process development/manufacturing environment preferred.

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

• Experience with SAP or related inventory system preferred.

• Demonstrated knowledge of cGMPs/GLP or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.

• Knowledge of gene therapy product and/or process development preferred.

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

• Alert supervisor to factors that may affect quality, accuracy, timeliness, and usefulness of data.

• Excellent organization, 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.

• Ability to perform under stress.

• Ability to multi-task.

• Good comprehension of Microsoft Office Suite software.

• A flexible work schedule may be required including weekends, evenings, and holidays as needed to complete client 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 proactively identify areas for opportunity and drive efficiency results.

• Will critically review processes and provide input to supervisor/manager.

• Will maintain regular and consistent attendance.

• Will work with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.

• Will perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

Physical Requirements:

• Employee will be regularly on their feet for a large portion of the workday.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Regular mobility required.

• Regular crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.