Scientist

• Conduct wetland delineations and boundary flagging per U.S. Army Corps of Engineers (USACE) and state methodologies
• Prepare permit applications and supporting documentation for NJDEP and NYSDEC environmental programs
• Conduct field investigations including soil sampling, hydrology assessments, and vegetation surveys
• Support threatened and endangered species habitat assessments
• Prepare technical reports, exhibits, and agency correspondence
• Coordinate with regulatory agencies on permit status and inquiries
• Support GIS mapping and data management for wetland and natural resource projects
• Assist senior scientists and project managers with multidisciplinary project delivery

Wetland Scientist supporting environmental permitting and natural-resource projects across New Jersey and New York

Wetland Scientist

Wetland Scientist supporting Matrix New World Engineering's environmental consulting services. Conducting delineations, field investigations, permitting, GIS mapping, and regulatory coordination across New Jersey and New York.

• Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, and regulatory submission documents
• Perform investigations and technical troubleshooting
• Provide documentation and technical input during regulatory and internal inspections and audits
• Apply working knowledge of data integrity
• Train staff on analytical techniques and problem solving as needed
• Influence external sites in the worldwide manufacturing network to identify, implement, and troubleshoot laboratory test methods, workflows, and materials
• Support compliant, robust, and responsive supply
• Drive lead-time reduction and efficiency gains supporting World Class Supplier and Operationalizing Quality goals

Senior Scientist advancing pharmaceutical analytical chemistry for Merck’s global healthcare manufacturing network

Senior Scientist, Chemistry

Senior Scientist advancing analytical chemistry for Merck’s global pharmaceutical manufacturing network.
Developing methods, troubleshooting laboratory workflows, and supporting compliant drug-substance supply.

• Develop and validate statistical analysis and reporting programs using global and therapeutic-area standards, departmental SOPs, and good programming practices
• Develop safety and efficacy analysis datasets, tables, listings, and figures for clinical trials, regulatory submissions, and post-marketing support
• Design and maintain statistical datasets supporting clinical development, outcomes research, and safety evaluation stakeholders
• Serve as statistical programming point of contact and knowledge holder throughout the product lifecycle
• Maintain and manage project plans, including resource forecasting
• Coordinate global programming teams, including outsourced provider staff
• Collaborate with statisticians and other project stakeholders to execute plans efficiently and deliver high-quality outputs on time
• Participate on departmental strategic initiative teams
• Ensure programming process compliance, deliverable quality, and consistency across protocols and projects
• Direct other programmers' program development efforts and provide programming mentorship when applicable

Senior scientist programming clinical-trial analyses for Merck’s medicines and vaccines

Senior Scientist, Statistical Programming, Late-Stage Oncology

Senior scientist programming clinical-trial analyses for Merck’s medicines and vaccines. Leading datasets, regulatory deliverables, and global outsourced programming teams.

• Provide expert support during pre- and post-sales activities, including scientific, technical, and application assistance.
• Deliver hands-on training by scheduling and managing demos, instrument installations, and customer onboarding sessions.
• Simplify complexity by presenting technical material in an engaging and accessible way, while professionally addressing questions or objections.
• Collaborate with the sales team to identify customer needs and demonstrate tailored product solutions.
• Assist customers with assay development, data analysis, and reporting to support their equipment purchase decisions.
• Monitor industry trends by maintaining knowledge of competitive products and emerging technologies.
• Advocate for customers by acting as the voice of the customer to internal teams and sharing valuable feedback about product performance and market needs.
• Build relationships by resolving inquiries, investigating complaints, and ensuring customer satisfaction.
• Contribute to market growth by supporting collaborations, preparing technical materials for seminars, and representing the company at scientific events and trade shows.

Field Application Scientist supporting biotech and pharmaceutical industries with expert instruments.

Field Applications Scientist

Field Application Scientist supporting biotech and pharmaceutical industries with Axion’s live cell analysis instruments. Engaging with customers during pre-sales and post-sales processes and providing expert technical assistance.

• Support the design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards and tools that can be used for drug and/or vaccine projects across all therapeutic areas
• Adhere to standard operating procedures and guidelines established by the department
• Drive data structures which includes analysis and reporting data standards and submission standards and actively contribute to the department's strategic initiatives
• Develop and validate global programming standards for ADaM datasets
• Develop and validate global programming standards for efficacy analysis and reporting
• Develop and validate global programming standards for safety analysis and reporting
• Design and develop complex programming algorithms
• Provide technical consultation and analytical support to statistical programmers and statisticians

Sr. Scientist conducting drug and vaccine analysis and reporting standards development

Senior Scientist – Analysis and Reporting Standards, Innovation

Sr. Scientist in R&D focusing on analysis and reporting standards for drug and vaccine projects. Collaborating with quantitative scientists to drive strategic initiatives in healthcare.

• Designing, implementing, simulating, and analyzing network protocol models.
• Designing cutting-edge medium access, routing, and transport protocols for mesh networking.
• Constructing models and running simulations in Network Simulator 3 (ns-3) or similar discrete-event simulation tool to evaluate, refine, and estimate performance for a variety of scenarios.
• Producing design specifications and experimental analysis reports.
• Understanding the radio hardware and constraints to accurately represent them in models.
• Collaborating with the firmware team to support the implementation in actual radio hardware, including supporting the firmware implementation via simulation results and auxiliary software as appropriate.
• Working with the Product team to determine the feasibility of new features and capabilities.
• Professional activities including publishing at peer-reviewed conferences, journals and performing committee service.
• Driving cutting-edge innovation in wireless networking and related technologies, facilitating new idea generation, and patenting inventions.
• Writing company white papers to allow the team and customers to keep up with state-of-the-art developments.
• Supporting troubleshooting of issues found by the QA team, when needed.
• Providing expert-level protocol know-how training and support to other teams.

Network Scientist developing goTenna’s mesh networking protocols for advanced connectivity

Network Scientist

Network Scientist developing goTenna’s Aspen Grove mesh networking protocols. Working with teams to implement innovative networking solutions in hybrid locations across the US.

• The Sterility Assurance Scientist is responsible for supporting activities that maintain compliance to the applicable regulations (FDA, Canadian Medical Device Regulations (CMDR), European Medical Device Regulation (EU MDR), ISO 13485, and ISO 9001) as they apply to sterilization
• Maintains and revises procedures and methodologies to cover sterilization programs across sites
• Obtains and maintains knowledge of FDA, ISO, and EN sterilization and related microbiology standards and guidelines
• Supports EU MDR compliance by performing gap analysis and formulating gap resolution plans
• Monitors and ensures adequacy of contamination control measures at external suppliers
• Provides training to procedural changes
• Provides guidance and input on the resolution of sterility related non-conformances
• Creates and finalizes validation protocols and report ensuring they are clear, concise and compliant to work instructions and standards

Sterility Assurance Scientist ensuring compliance with sterilization regulations in healthcare

Senior Sterility Scientist

Sterility Assurance Scientist ensuring compliance across sterilization processes and methodologies in healthcare. Collaborating closely with various departments to maintain quality and regulatory standards.

• Programmatically develop, validate and maintain datasets, tables, listings, and figures
• Assure deliverable quality and compliance with departmental SOPs and good programming practices
• Collaborate effectively with project team members including outsource provider staff

Senior Statistical Programmer in Biostatistics & Research Decision Sciences

Scientist, Statistical Programming

Senior Statistical Programmer providing statistical programming deliverables in Early Development Statistics for drug and vaccine development at a global health care company.

• support statistical programming activities for late stage drug/vaccine clinical development projects
• leadership of one or more projects
• development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures)
• design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
• key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables
• serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle

Sr. Scientist supporting statistical programming for late stage drug development

Senior Scientist, Statistical Programming – Late-Stage, Non-Oncology

Sr. Scientist supporting statistical programming activities for late stage drug/vaccine clinical development projects. Leading project initiatives, ensuring high-quality statistical deliverables.

• Supports Commercial Production at the Cherry Hill pharmaceutical manufacturing facility through the Administration of User Account Creation and Maintenance, Software Archival to support (Backup, Restoration, Disaster Recovery), and System Administration and Troubleshooting for Production based systems
• Assists in investigations of manufacturing challenges, data integrity issues to support Commercial production equipment usage and product release
• Responsible for Stand alone User Administration of Computer Controlled Systems in the Cherry Hill Production environment to ensure compliance to 21 CFR Part 11 and cGMP practices
• Responsible for Software Archival as determined by Site management and cGMP practices
• Archival of Software Backup of Production based system for Disaster Recovery, and Periodic Data backup, etc
• Works with Information Technology to automate backup systems for secure, timely data capture and continued business continuity
• Maintain database for Software Records and User maintenance
• Handles routine tasks timely, accurately

Scientist supporting Commercial Production at Hikma Pharmaceuticals in Cherry Hill, NJ

Scientist, Production Systems

Scientist supporting Commercial Production at Hikma Pharmaceuticals in Cherry Hill, NJ. Responsibilities include Software Archival and System Administration for production-based systems.

• Support the Global Medical Office team in defining medical narrative and strategic imperatives, and outlining a roadmap for successful delivery of the imperatives across the Ascendis Pharma portfolio of products
• Leverage medical expertise and hands-on clinical experience to ensure relevance and rigor of the medical strategy
• Contribute to the development of an integrated plan for generating evidence e.g. real-world evidence, observational studies, phase IV studies, etc.) to address unmet medical needs, evidence gaps, and anticipated competitive advantages
• Filter and communicate key insights on disease areas, competitive landscape, and unmet medical needs
• Maintain up-to-date knowledge of relevant science, applicable literature, disease state information, and landscape trends within aligned therapeutic areas.
• Support the medical education strategy to amplify key medical messaging and enhance country readiness
• Support congress activities, including symposia
• Cultivate relationships with thought leaders in medicine, rising stars, and reference centers in rare endocrinology
• Share scientific and medical insights with healthcare professionals through 1:1 meetings and conferences
• Contribute to the planning and execution of advisory boards and other key KOL meetings (speaker bureau, preceptorship)
• Provide expert medical input to support reimbursement and policy-related activities
• Ensure full compliance with internal SOPs and global regulatory requirements
• Work closely with & support the country medical teams, ensuring alignment with & execution in line with global medical strategy

Medical Scientist overseeing global medical strategy in biopharmaceutical company

Global Medical Scientist

Medical Scientist developing global medical strategy for Ascendis Pharma's endocrinology and oncology programs. Collaborating with clinical and commercial teams to address unmet medical needs.

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