Role Description The Scientist III in CMC is a senior-level contributor responsible for leading regulatory strategy and execution for pre-approval, post-approval changes and lifecycle management activities across client Rx and non-Rx programs. Operating in a client-facing, consultant capacity, this role provides strategic guidance on complex regulatory submissions, authors and reviews high-impact documentation, and drives alignment across cross-functional teams to ensure successful regulatory outcomes. The individual is expected to work independently, manage competing priorities, and deliver high-quality, submission-ready content aligned with global regulatory requirements, while also supporting the development of junior staff. - Develop regulatory strategy and execution plan for pre-approval, post-approval changes and lifecycle management activities. - Serve as an author strategist, defining document structure, content strategy, and submission approach for complex regulatory dossiers. - Author, review, and approve high-quality regulatory documents (e.g., supplements, variations, responses to health authority queries) ensuring scientific and regulatory rigor. - Provide strategic input on CMC and lifecycle change assessments, including regulatory risk evaluation and submission pathways. - Collaborate with cross-functional stakeholders (CMC, Quality, Clinical, Supply Chain) to drive alignment on regulatory strategy and ensure accurate and complete submission content. - Act as a primary regulatory point of contact for assigned client projects, providing guidance and maintaining strong client relationships in a consultant role. - Lead timeline planning, tracking, and execution of regulatory deliverables to meet critical milestones. - Perform advanced document quality control, formatting, and publishing in compliance with global regulatory standards using tools such as MS Office and Adobe Acrobat. - Mentor and provide day-to-day guidance to junior regulatory staff, supporting their technical development in regulatory strategy, authoring, and submission processes. - Review, edit, and provide feedback on work produced by junior team members, ensuring accuracy, consistency, and compliance with regulatory and client standards. - Promote best practices in document preparation, quality, and regulatory compliance across the team. - Support regulatory inspections, audits, and responses related to lifecycle management activities, as needed. - Ensure an established level of billable hours per fiscal year. Qualifications - Understanding and application of scientific principles and techniques used in pharmaceutical product development. - Knowledge and experience with cGMP regulations and ICH guidance. - Proficiency with Health Authority regulations (FDA, EMA, Health Canada, etc.). - Experience with writing global regulatory applications in eCTD format. - Proven experience in support of pharmaceutical product development, quality assurance and/or CMC regulatory affairs, highly preferred. - MS/BS in Chemistry, Analytical Chemistry or related life sciences is preferred. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). - Proficiency with Adobe Acrobat for document editing, formatting, and publishing. - Team-oriented mindset with the ability to collaborate across functions. - Proactive, self-motivated, and able to work independently in a client-facing role. - Strong attention to detail and organizational skills. - Effective written and verbal communication skills. - Ability to manage multiple tasks and meet deadlines in a dynamic environment. Requirements - Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects. - May contribute to the development of policies and procedures. - Works on complex projects of large scope. - Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives. - Completes work independently with attention to detail. - Receives general guidance on new projects. - Work reviewed for purpose of meeting objectives. - Mentor to less experienced staff. - Support client projects as a consultant. - Ability to work remotely from home office. - Requires adaptability and responsiveness to changing project priorities. Benefits - Medical, dental and vision coverage. - Paid time off plan. - Health savings account (HSA). - 401k savings plan. - Access to wages before pay day with myFlexPay. - Flexible spending accounts (FSAs). - Short- and long-term disability coverage. - Work-Life resources. - Paid parental leave. - Healthy lifestyle programs.

Role Description Labcorp is seeking a US based remote Lead Bioinformatics Scientist to join our team! The Sample‑to‑Answer Center of Excellence (CoE) within the LabCorp Information Technology department manages a wide range of diagnostic tests using advanced technologies such as next‑generation sequencing and microarrays. This position provides a unique opportunity to interact with CoE personnel and gain hands‑on experience solving real‑world problems in data science and bioinformatics. The role also contributes directly to LabCorp’s research and development efforts by addressing complex data science challenges and accelerating critical production development initiatives. - Produce innovative solutions driven by exploratory data analysis from complex and high-dimensional datasets. - Apply knowledge of statistics, data modeling, data sciences and artificial intelligence to recognize patterns, identify opportunities and make valuable discoveries. - Use a flexible, analytical approach to design, develop, and evaluate predictive models for single-gene non-invasive Fetal Screening (NIFS). - Generate and test hypotheses and be involved from ideation through delivery. Key Responsibilities - Collaborates with R&D scientists on the development of new assays, measurement technologies, and tests for evaluating clinical conditions. - Perform sophisticated analysis of genomic, transcriptomic, or proteomic datasets using state-of-the-art bioinformatics tools and NGS pipelines. - Performs statistical and bioinformatics analyses of experimental data produced by clinical testing instruments such as DNA sequencers and other molecular instruments. - Conducts data mining over internally produced and publicly available data sets. - Provides analysis information to management to aid in decision making on the development of new laboratory developed tests. - Develop statistical classifiers and decision trees integrating spanning read support, flanking-read ratios, allele dropout indicators, and confidence intervals. - Apply a wide range of bioinformatics algorithms and develop novel computational approaches. - Investigate assay limitations at the molecular level and define boundaries of clinical reporting. - Develop and optimize complex analysis pipelines based on deep knowledge of bioinformatics algorithms. - Architect production-grade Nextflow pipelines for whole-genome sequencing, including caller selection, annotation strategy (AnnotSV, Nirvana), and QC threshold design. - Lead bioinformatics proof-of-concept for sequencer transitions, including concordance analysis, metric comparison, GIAB benchmarking, and cost-benefit recommendations. - Drive improvements in accuracy, cost of goods sold (COGS), and turnaround time across the pipeline portfolio. - Establish quality control metrics and procedures to ensure data integrity across production pipelines. - Guide result interpretation and reporting standards in collaboration with clinical and commercial stakeholders. - Set QC thresholds for new sample metrics and make production-impacting recommendations. Qualifications - Ph.D. in bioinformatics, computational biology, genetics, or computer science. - 3 or more years of experience in biotechnology. - 5 or more years of experience in programming languages in bioinformatics, such as Python, R, Perl, or Java. Requirements - 5 or more years of experience with high-throughput sequencing data and bioinformatics tools like BLAST, GATK, or Bowtie. - 5 or more years of experience with Linux/Unix environments and high-performance computing (HPC) or cloud platforms. Benefits - Comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. - Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. - Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO.

Role Description Labcorp is seeking a US based remote Bioinformatics Scientist I to join our team! We are seeking an initiative-taking and skilled Bioinformatician. This position offers an excellent opportunity for a recent graduate with a Master’s or PhD to apply for advanced training in bioinformatics, computational biology, and data analysis in a collaborative research environment. As a Bioinformatics Scientist, you will collaborate closely with our research scientists and data analysts, contributing to high-impact projects that involve complex data interpretation and algorithm development. Key Responsibilities - Advanced Data Analysis: Perform sophisticated analysis of genomic datasets using state-of-the-art bioinformatics tools and pipelines. - Algorithm Development and Optimization: Develop, refine, and implement algorithms for data processing, including sequence alignment, variant calling, gene expression analysis, and network biology. - Software Development: Contribute to the development and enhancement of bioinformatics software tools and pipelines, ensuring they meet the research needs of the team. - Collaborative Research: Work collaboratively with cross-functional teams, providing bioinformatics expertise to support ongoing research projects and studies. - Data Interpretation and Reporting: Analyze and interpret complex biological data, preparing detailed reports and presentations to communicate findings to both technical and non-technical stakeholders. - Literature Review and Research: Stay abreast of the latest bioinformatics methodologies and advancements, integrating new approaches into ongoing projects. Qualifications - Master’s degree in bioinformatics, computational biology, genetics, or computer science. - 2 or more years of experience in programming languages Python, R, Perl, or Java. - 2 or more years of experience in bioinformatics, or computational biology. Requirements - Ph.D. in bioinformatics, computational biology, genetics, or computer science (preferred). - 2 or more years of experience with machine learning or AI applications in biology (preferred). - 2 or more years of experience with high-throughput sequencing data and bioinformatics tools like BLAST, GATK, or Bowtie (preferred). Benefits - Comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan for employees regularly scheduled to work 20 or more hours per week. - Eligibility for 401(k) Plan for employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees. - Employees on a 7 on/7 off schedule are eligible for all benefits except PTO or FTO.

Role Description Computational Physics, Inc. (CPI) is looking for a Part-Time Scientist-Research to support our customers remotely at NRL. We seek an early-to-mid career scientist to join a team at CPI and NRL developing whole-atmosphere versions of Navy weather prediction models extending from the surface to 500 km altitude. The candidate will: - Run emerging new models on Navy high-performance computing centers (HPCs). - Analyze model output and use insights to target changes or additions to the collective code base. - Collaborate across the broader team in continuous integration of new code into the repository via an enterprise GitHub server. - Identify bugs in the code, devise, test, and submit appropriate bug fixes. - Write and test new code that delivers new or improved model capabilities. - Achieve timely quarterly and annual research deliverables for NRL and downstream sponsors. Qualifications - A Bachelors or higher degree in atmospheric science, computational fluid dynamics, physics, applied mathematics, meteorology, aeronomy, or a related discipline. - Demonstrated skill with high-level programming languages (e.g., MPI Fortran, C++, Java) and visualization/analysis software such as Python, IDL or MATLAB. - Skills and experience with codes written in Fortran 2003 and higher. - Knowledge of or interest in code development and scientific application of state-of-the-art physics-based atmospheric models. - Scientific knowledge of the dynamics, physics, and chemical processes occurring in the uppermost layers of the neutral atmosphere, particularly above 80 km altitude. - An ability and willingness to work within a geographically dispersed multidisciplinary team environment. - Good writing and oral communication skills in conveying research progress clearly. - Experience or interest in running multiprocessor code on massively parallel HPCs. - Experience working with large atmospheric data sets generated by models (e.g., HDF5). - U.S. citizenship is required for DoD contracts. Benefits - Competitive salary and comprehensive benefits. - Positive, upbeat, and transparent company culture with opportunities for self-development and career advancement. - Employee-owned small business that allows team members to learn from each other and take ownership. - Professional development support including conference attendance and certification training. Company Description CPI is an employee-owned company that has served various U.S. Government agencies, universities, international science organizations, prime contractors, as well as commercial customers for 40 years. - We love science! We study the physical properties of the Earth and our atmosphere, neighboring planets, and the sun. - We make the study of science practical by translating our findings into products, both hardware and software, that make our customer's lives easier and better. - Employee ownership motivates and empowers increased productivity, contribution to the longevity of the business, improved retention, and enhanced employee engagement.