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Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission to enable our customers to make the world healthier, safer, and cleaner.
Within our Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
As a Planning and Shipping Logistics Specialist supporting Sterile Drug Product Development in our client's Pharmaceutical R&D, you will have the opportunity to utilize logistic skills and expertise to support development of drug product formulations and associated manufacturing processes.
A Day in the Life:
Partner with Formulation & Process Development (FPD) Scientists to plan, coordinate, and execute shipping logistics that support the development and clinical manufacturing of traditional and advanced dosage forms, including nanosuspensions, hydrogels, emulsions, controlled-release implants, sterile solutions, and lyophilized products.
Manage end-to-end shipment activities for drug substances and drug products requiring gamma irradiation, including creation of shipping requests, preparation of technical documentation and travel sample memos, quotation and purchase order request, request for protocol (PFR), coordination with carriers, and oversight of successful delivery and return.
Monitor and manage temperature-controlled shipments, investigate temperature excursion incidents, and coordinate appropriate corrective actions to ensure product integrity and compliance.
Ensure all shipping activities are executed in accordance with established protocols, quality requirements, regulatory expectations, and company procedures.
Coordinate the timely receipt, tracking, and distribution of gamma-irradiated development samples to Analytical Sciences (AD), Pharmaceutical Sciences (PharmSci) and FPD teams.
Maintain shipment schedules and proactively communicate logistics timelines, risks, and status updates to project stakeholders.
Identify, troubleshoot, and communicate issues impacting shipment execution, supply continuity, or project deliverables, escalating concerns as appropriate.
Collaborate cross-functionally with scientists, quality representatives, manufacturing teams, external vendors, and logistics partners to resolve operational challenges and support project milestones.
Anticipate potential transportation, customs, carrier, or vendor-related risks and implement preventive measures to minimize disruptions.
Maintain accurate shipping records, documentation, and tracking information in compliance with Good Documentation Practices (GDP), company policies, and applicable GMP/GLP requirements.
Complete required training and demonstrate proficiency in applicable Standard Operating Procedures (SOPs), work instructions, and shipping processes.
Prepare clear and concise written reports, shipment summaries, and verbal updates for project teams and management.
Maintain an organized, compliant, and inspection-ready work environment, including shipping and sample handling areas.
Participate in safety training programs and consistently adhere to laboratory, transportation, and workplace safety requirements.
Follow safe handling practices for pharmaceutical materials and development samples during preparation, packaging, shipment, and receipt activities.
Maintain accurate safety documentation and promptly report, investigate, and address potential safety concerns.
Support continuous improvement initiatives by identifying opportunities to enhance shipping efficiency, reliability, compliance, and overall logistics performance.
Education and Experience:
Bachelor’s degree in relevant life sciences. Having industrial experience in the pharmaceutical industry is a plus.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Technically competent in planning and shipping logistics management.
Demonstrates competence and experience in proper handling, recording and analyzing scientific data.
Has operational knowledge of scientific laboratories.
Understands the basic principles, concepts and methodology governing the work performed.
Experience working in a GMP environment particularly for sterile products is strongly preferred.
Can learn and apply new planning and shipping tools.
Full understanding of laboratory requirements, ThermoFisher & client SOPs, ICH guidelines, USP requirements and FDA guidance.
Ability to use Microsoft Excel and Word to perform tasks.
Proficiency on technical operating systems.
Proven problem solving and troubleshooting abilities.
Effective oral and written communication skills
Proven ability in technical writing skills.
Time management and project management skills.
Ability to work in a collaborative work environment with a team.
Proven problem solving and troubleshooting abilities.
Ability to train junior staff.
Work Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
