13 scientific business analyst jobs found

Career Category Manufacturing Job Description Specialist Contract Development & Manufacturing The Specialist, Contract Development & Manufacturing at Amgen provides technical support to the External Supply manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. Working within a diverse Commercialisation & Performance Execution (CPE) team, this role works in partnership with different departments & stakeholders to ensure a smooth manufacturing process and compliance with quality standards. The role helps provide information insights and data analysis; identify problems and troubleshoot to evaluate options and solutions; drive precision through the execution of transactional/tactical tasks to ensure Amgen Contract & Development Manufacturing (ACDM) work cell (hub) success. The role also requires applying process, operational, and scientific expertise, as well as basic compliance knowledge...

Career Category Medical Services Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....

As Regeneron continues to push the boundaries of science to create life-changing medicines for people with serious diseases worldwide, we're evolving our capabilities to cultivate a culture of safety, environmental stewardship, and compliance. In this newly formed role as Director of Occupational Toxicology, you will provide robust, scientifically-sound hazard analysis, risk profiles, and risk mitigation strategies for novel therapeutics handled in our laboratory, scale-up, and manufacturing settings. Success in this role will require partnering with our EHS teams and key stakeholders across Regeneron to support the evolution of our occupational toxicology programs and business strategies. This role is based at our Corporate Research HQ in Tarrytown, NY and is not open to remote assignments As Director EHS, Occupational Toxicology, a typical day may include: Responsible for development and life cycle management of ADEs, OELs, and SDS documentation, including risk...

Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Sciences support the following areas; Upstream Sciences, Downstream Sciences, Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support, Process Validation and Process Solutions. As a Sr Process Scientist in Manufacturing Support a typical day might include, but is not limited to, the following: Supporting delivery of process solutions to IOPS and contributing to best-in-class laboratory and process validation report packages Assisting in root cause analysis of process related deviations using scientific data–driven rationale Participating in cross functional teams to understand process issues in technical and laboratory investigations Contributing to knowledge-based reports summarizing conclusion of studies, investigations and process improvements...

We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles. In this role, a typical day might include the following: Reviewing design and development paperwork and records for compliance to internal procedures and regulations Ensuring accurate justification of statistical analysis and hypothesis testing Reviewing technical reports as well as documents for Design History Files Participating in device risk management activities including UFMEA, DFMEA, PFMEA Aiding in establishing statistical controls in development and transfer to manufacturing processes Verifying data integrity, electronic data storage and data sheet validations Reviewing and coordinating with QA Validation for all test method and design validations Reviewing activities related to Design Verification and Design Transfer of Medical...

Regeneron is currently seeking an Associate Director to join our Downstream Sciences and Investigations (DSIG) team. The Associate Director- Process Sciences leads a lab based team responsible for the assessment of changes to raw materials and their impact to Manufacturing operations and product quality. The role also maintains awareness of industry and regulatory trends to manufacturing technologies and material sciences to assess and support implementation within IOPS to remain in the forefront of industry.   As an Associate Director- Process Sciences a typical day may include: Leads cross-functional teams in generating and analyzing data to assess raw material attributes for impact to new and existing manufacturing processes which include change notifications, secondary sourcing, raw material investigations, and impurity/byproduct/extractable risk assessments. Perform risk assessments for changes to raw materials to determine potential impact to the processes. Leads...

We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Associate Director reports to the Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As an Associate Director a typical day may include the following: May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist Contributes to program team meetings, scientific advisory boards, study...

Within this role you will be part of the QC Technical Resources Material Identification Team and will be responsible for identifying unknown material observed at IOPS.  As a Senior QC Scientist a typical day might include, but is not limited to, the following:   Executing investigation testing (FT-IR, SEM, ICP-MS, SEM, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support Evaluating/interpreting data, author and review technical documents for investigational testing Establishing, developing and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices Participating in routine maintenance and troubleshooting of laboratory instrumentation Liaising with contract laboratories as required to support investigational analysis Tabulating results and writing summary reports of assay development and validation studies Presenting findings at group...

As a QC Staff Scientist in Biochemistry you would participate in assay development, transfer, and validation for QC. You would provide technical support, guidance and supervision for release, stability, and in-process testing and assay development/validation and/or transfer. In this role a typical day might include, but is not limited to, the following: Participating in assay development/validation for QC Reviewing and approving new test procedures and assays Evaluating new methodologies, techniques and equipment when new procedures are warranted Participating in transfer of methodology from R&D Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as needed Evaluating assay performance through yearly method performance reports Facilitating assay transfer from R&D and to business partners Providing technical input into additional studies supporting regulatory filing e.g.. Bridging/comparability...

The Protein Expression Sciences - AAV team at Regeneron, located in Tarrytown, NY, is seeking an independent and highly motivated Sr Scientist to support the stable cell line development of viral vector technology. In this exciting role, yowill be conducting research activities around the design, characterization, and validation of engineered adeno-associated viruses  ​(AAV) components stable integration, to build a novel platform to Regeneron’s gene therapy technology. As a Sr Scientist, a Typical Day Might Include: Designing gene expression vectors. Performing molecular biology techniques (Cloning, Western blotting, DNA/RNA extractions, PCR, RT-PCR, quantitative PCR, etc.). Creating and validating stable integration cell lines.  Developing cell-based assays to analyze AAV vectors efficacy. Working collaboratively with team members, and with collaborators in various therapeutic focus areas and core facilities across research and discovery. Participating in team...

Regeneron Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a Process Development Engineer III for Plasmid Purification Process Development . In this role, you will work as part of a multi-functional team to develop Fermentation manufacturing processes, fermentation derived-starting materials, and products with the aim of providing treatment to unmet medical needs. A Typical Day in the Role Might Look Like: Leading the design, execution/optimization, scale-up and characterization of robust processes for purifying fermentation products (e.g., plasmid DNA and recombinant proteins) and starting materials from microbial expression platforms. Independently utilizing multivariate design of experiment approaches such as DOE with influences from experimental data and scientific literature to solve molecule specific-problems and optimize parameters for purification of fermentation starting materials and products. Designing and...

Process Sciences is a technical services department that deals with a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. Within this department, the Upstream Process Sciences team perform laboratory scale mammalian cell culture studies in support of manufacturing operations. As a Process Scientist in the Upstream group a typical day might include, but is not limited to, the following:   Performing scientific investigations related to upstream unit operations of biologics manufacturing processes at laboratory scale Using Design of Experiments (DOE) or other experimental principles to develop experimental protocols Assisting in root cause analysis of process related deviations using scientific data–driven rationale Contributing to knowledge-based reports summarizing conclusion of studies, investigations and process improvements Presenting findings at group meetings Producing and...

Regeneron's Preclinical Manufacturing and Process Development (PMPD) group is looking for an energetic Staff Engineer  responsible for analytical development, supporting manufacturing process development functions. In this role you will work as part of a multi-functional team to develop Adeno-Associated Virus (AAV) manufacturing processes, assays, and products. This is a growth opportunity that combines the excitement and opportunity of a start-up with the security and institution knowledge gained from working for a larger firm. A Typical Day in the Role of Staff Engineer Might Look Like: Perform physicochemical characterization for all stages of viral vector products Support process development by designing, developing, and automating fast and robust assays for the characterization of AAV. Support sample testing for characterizing AAV safety, integrity, strength, purity and quality, generate results, and onboard new technologies. Cross-train on and provide support for...