Thermo Fisher Scientific

Research Analyst

• Monitors investigator sites with a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
• Assess investigational product through physical inventory and records review
• Documents observations in reports and letters in a timely manner using approved business writing standards
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution
• Conducts monitoring tasks in accordance with the approved monitoring plan
• Ensures a shared responsibility with other project team members on issues/findings resolution
• Participates in investigator meetings as necessary
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner

Clinical Research Associate, Level II

Project Manager

• Ensures achievement of project management group objectives through leadership and development to meet the needs of the business
• Acts as Project Manager for key studies and a back-up for the Associate Director PM when required
• Advises on project management issues and identifies areas within Project Management for development and efficiencies in performing tasks
• Liaises with major sponsor's operational personnel and manages all project related activities internally and with external vendors
• Manages and motivates project management staff
• Recruits, trains, develops, and assesses employees' performance
• Writes, evaluates, amends and deploys procedures and SOPs in global alignment
• Monitors SOP and key task compliance
• Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during the conduct of the study
• Controls, manages and delegates day-to-day activities during the course of the clinical trial to resolve any issues and answer queries
• Conducts regular face-to-face client meetings and continuously addresses client concerns and interprets needs in order to increase client satisfaction
• Manages client and/or program level oversight and relationship to pro-actively address needs, expectations and modifications across similar studies
• Establishes and advocates high-level of customer service for clients and programs to support continued service and growth of relationship
• Plans and supports work flow of team members
• Performs as a mentor and trainer, identifies and coaches on areas for development and efficiencies in performing tasks
• Authors, reviews, revises and implements relevant procedural documents
• Serves as a back-up for the Associate Director PM, when needed and advises on action plans

Manager, Labs Project Management

Product Marketing

• Review analytical analysis experiments on pharmaceutical and biopharmaceutical compounds
• Ensure compliance with SOPs and GMP standards
• Communicate with laboratory staff to maintain accurate documentation
• Identify and facilitate process improvements

Data Reviewer – Small Molecule, GMP

Engineer

• Lead automation and data projects across the DSD manufacturing sites, from concept and design through commissioning, validation, and user adoption.
• Own technical delivery of SCADAs(Ignition, Wonderware etc ), DCSs (Emerson DeltaV), MESs ( PharmaSuite, OpCenter, MasterControl etc), and data capture/historization systems (OPC, Aveva PI, Kepware, Litmus etc).
• Design and deploy data collection architectures that enable secure, reliable data flow from shop-floor automation systems to enterprise analytics platforms.
• Champion change management and adoption, ensuring stakeholders and site users fully embrace new digital solutions.
• Define and enforce standards for system design, configuration, and data management consistent with GMP, GAMP 5, Annex 11 and 22, 21 CFR Part 11, and cybersecurity best practices.
• Collaborate cross-functionally with process engineering, IT/OT, validation, and operations to deliver integrated, business-ready solutions.
• Manage vendors and system integrators, ensuring adherence to technical specifications, schedule, and cost.
• Drive the Connected Plant and digital enablement strategy, increasing plant maturity and improving data visibility across the Drug Substance network.
• Travel frequently (>50%) to provide on-site leadership, support project execution, and facilitate system handover and training.

Staff Technical Project Engineer – Automation

QA Automation Engineer

• Lead the integration of IT and OT systems by identifying hardware, software, and network architecture to ensure seamless communication and data sharing across CTD sites
• Assist with scaling automation initiatives across CTD operations, including equipment selection and designing of automation architecture, particularly for packaging equipment and related systems
• Support system data collection, analysis, and visualization to guide process enhancements
• Partner with Business Leads and IT-OT Automation Leads to support project teams in developing and improving process automation with IT-supported applications
• Collaborate with multidisciplinary teams to serve as a technical mentor in automation and support long-term automation strategies, participating in design reviews, project meetings, and technical discussions
• Develop User Requirement Specifications (URS) for new equipment and systems to ensure new equipment compatibility with the established network connectivity framework
• Develop strategy for upgrading existing equipment to achieve network connectivity
• Support all phases of equipment qualification and process validation
• Assist with training and support of staff on new and upgraded equipment, including technical documentation such as design specifications, test plans, and user manuals
• Monitor the performance of newly deployed systems and provide technical support and guidance to site-level engineers and technicians
• Recommend improvements for efficiency and scalability
• Stay updated with emerging automation technologies and propose improvements

Automation Engineer

Director

• Lead a portfolio of strategic, cross-functional programs that accelerate our aspiration to enable patients around the world to get the right diagnosis for their allergic and autoimmune diseases
• Build and oversee a high-performing project management organization, driving consistent execution excellence across complex portfolios spanning R&D, Marketing, MSA, Operations, Quality/Regulatory, and Commercial functions
• Provide enterprise visibility, governance, and leadership to ensure program success in alignment with Thermo Fisher’s strategic priorities and PPI (Practical Process Improvement) culture

Senior Director, PMO, IDD

• Performs and coordinates all aspects of the clinical monitoring and site management process.
• Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
• Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• Travel up to 50-75%.

Clinical Research Associate – Part-Time

Account Executive

• Orchestrates RFP strategy calls, develops client proposals, prepares client presentations, and negotiates and closes contracts
• Signs new business authorizations at or above assigned authorization goal
• Makes cold calls and client visits; maintains sales database; maintains cold call and client visit activity reports
• Ensures client satisfaction through periodic client contact; report and develop recommendations to address client dissatisfaction; respond to all client requests
• Sales experience within a CRO selling bioanalytical and biomarker services to biotech clients

Senior Account Director, Business Development – Bioanalytical Labs

Analyst

• Serves as Validation Support for new releases and modifications to applications
• Prepares Master Validation Plans, Test Cases and Validation Summary Reports
• Reviews change controls associated with validated systems
• Ensures test scripts meet functional requirements and demonstrate software accuracy
• Creates, updates, and manages data within the testing environment
• Presents change controls to validation committees

Validation Analyst

Implementation Specialist

• Completes amendment activities within assigned projects
• Ensures amendment deliverables meet customer expectations
• Supports the amendment implementation strategy at country and site levels
• Collaborates with project teams on amendment planning
• Tracks amendment related actions
• Schedules progress check calls with project teams
• Liaises with Regulatory Affairs Leads
• Prepares and distributes the Amendment Progress Report
• Updates forecasting for amendment related units
• Supports risk identification and contingency planning

Amendment Implementation Specialist

Content Writer

• Manage, mentor, and develop Medical Writers to ensure exceptional performance and continuous growth
• Supervise and review the preparation of a wide range of medical writing deliverables
• Ensure projects are completed on time and to the highest scientific and regulatory standards
• Deliver compelling capabilities presentations to prospective clients
• Contribute to the development, evaluation, and improvement of SOPs and work practices

Medical Writing Manager – FSP

• Join a strategic commercial leadership role at Thermo Fisher Scientific, where you'll support growth and customer success across our innovative scientific solutions portfolio
• As Director of Sales, you'll guide teams to deliver exceptional value to customers while contributing to our mission of making the world healthier, cleaner, and safer
• You'll develop and execute comprehensive commercial strategies, build strong customer relationships, and support revenue growth through both direct sales and distribution channels
• This role offers the opportunity to work with advanced technologies while collaborating across divisions in a sophisticated matrix organization
• Working closely with leadership teams, you'll develop go-to-market strategies, enhance sales processes, and ensure consistent delivery of our value proposition
• You'll focus on expanding market share, improving sales effectiveness, and delivering an outstanding customer experience
• This position requires a leader who can build and develop teams, foster commercial excellence, and embody our core values of Integrity, Intensity, Innovation and Involvement

Key Account Director, Americas

Research Scientist

• Independently performs analytical testing, method optimization/validation, and/or other specialist technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems
• Understands and conforms to methods, and protocols applicable to assigned tasks
• Designs and completes experiments independently
• Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents
• Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents
• Communicates data and technical issues to clients on a weekly basis (or as needed)
• Provides technical mentorship and training to staff
• Leads analytical (procedural and instrumental) troubleshooting sessions
• Assists in preparation and implementation of SOPs and quality systems
• Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP)
• Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers

Associate Research Scientist – Technical Lead, Biopharma

Field Engineer

• Installation, commissioning, maintenance, qualification, troubleshooting and repair of assigned products
• Technical and application support for customers
• Thorough documentation of service activities and escalation management
• Support in the sale of service products such as service contracts, qualifications and upgrades
• Close collaboration with support teams and manufacturing sites
• Maintenance of material inventory as well as measuring and testing equipment
• Support for trade shows and exhibitions
• Operational collaboration with technical team leaders
• Frequent travel within Germany and, as required, within the EMEA region and worldwide for training purposes

Field Service Engineer – Service Technician, LC‑MS (m/f/d)

Support Engineer

• Manage complex technical issues for customers via phone, email, chat
• Collaborate with technicians in the field
• Document solutions in service case tickets
• Create service offers for repairs and spare parts
• Participate in quality management processes