16 business development associate jobs found

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. As an Associate Director , a typical day might include the following: Support filling operations for any technical support. QC method validation and transfer processes. Maintain open communications with scientist including internal, partner and contract manufacturing organizations. Provide direction to Managers and scientist that support the method development, validation and...

We are seeking an Associate Scientist to join our Non-viral Delivery Technology group and support screening potent and tolerable gene delivery modalities. As a part of Regeneron Genetics Medicine, this work would involve lipid nanoparticle (LNP)-nucleic acid formulation, characterization, and optimization, as well as assisting in development of novel LNP characterization assays. Your nanoparticle expertise combined with Regeneron’s technology platforms, including viral and non-viral gene therapy, CRISPR-mediated gene editing, VelociGene transgenic mouse models, and the extensive catalog of fully human therapeutic antibodies, will be applied to make immediate contributions to the field of next-generation genetic medicine. As an Associate Scientist, a typical day may include the following: Performing, analyzing, and troubleshooting LNP characterization assays such as nucleic acid encapsulation efficiency (Ribogreen), sizing (DLS), surface properties (zeta potential), and...

The Associate Director/Director of Technical Operations is responsible for leading the Biopharmaceutical Process Equipment Engineering & Maintenance teams with management responsibilities of direct employees, contractors and specialist vendors involved in supporting GMP manufacturing operations and maintenance. This individual will provide technical leadership, drive operational excellence, and foster a culture of safety, collaboration, and continuous improvement. A strong emphasis will be placed on quality and compliance, people management, team development, leadership, and succession planning. Essential Duties and Responsibilities include, but are not limited to, the following: Leading and the management of the process equipment engineering, maintenance, and calibration teams.  Providing engineering and technical support to manufacturing operations with specific focus on system and equipment continuous improvement. Owning the introduction of new process...

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...

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 an Associate Manager within Process Sciences Manufacturing Support a typical day might include, but is not limited to, the following: Understanding and communicating the big and small picture in order to drive strategic plans. Co-ordinating the provision of technical support to the manufacturing process. Coaching, mentoring and develop staff, including overseeing new employee onboarding and providing career development planning and opportunities. Communicating business and organizational information/priorities and ensure appropriate allocation of resources. Developing strong...

We are seeking a highly motivated Senior Associate Scientist to advance our pipeline of targeted oligonucleotide therapeutics as a part of Regeneron Genetics Medicine (RGM). You will be a key contributor toward the design, generation & physicochemical characterization of bioconjugates for delivery of oligonucleotides. As a Senior Associate Scientist, a typical day might include the following: Planning and running experiments for synthesis, purification, and characterization of oligos and oligo-conjugates Generating oligo conjugates by applying both well-established and novel conjugation chemistries. Optimizing and developing robust processes to increase synthesis and conjugation throughput Accurately documenting results in electronic notebook and present results in team meetings Working successfully in a cross-functional team both independently and as a teammate The job might be for you if you: Enjoy working in a laboratory-based role with strong...

We are seeking an Associate Director within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical and commercial formulation and drug product development activities for peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products. Specialized focus on obesity and metabolic disease. A typical day in this role might look like: Leads clinical and commercial formulation and drug product development activities for peptides, monoclonal antibodies (mAb), antibody-drug conjugates (ADC), fixed dose combinations, and combination products. Specialized focus on obesity and metabolic disease. Applies demonstrated knowledge of risk management and application of QbD principles to formulation and drug product development. Integrates analytical and process development. Interacts broadly and collaboratively with other Regeneron functions and stakeholders including...

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....

The Senior Process Scientist supports Process Sciences, Manufacturing, CMC Regulatory and QA Departments through activities and documentation related to implementation and maintenance of in-process control programs for the manufacture of biologics drug substance and formulated drug substance. A typical day might include, but is not limited to, the following: Carrying out lifecycle activities of established IPC programs for manufacturing bioprocesses including impact assessment both on a site specific and global level, change control, and document generation or revision Supporting CMC Regulatory Sciences in development and writing of responses for technical sections of regulatory documents Facilitating and coordinating interdepartmental discussions in support of Process Sciences validation and IPC activities Presenting findings, limit setting and re-evaluation strategies at group, departmental, and interdepartmental meetings as required. Collating and analysing data...

Regeneron is currently looking for a Drug Product (DP) MSAT (Manufacturing Sciences and Technology) Engineer for our Device Assembly and Packaging team. This role will serve as combination device and secondary packaging design and development lead for biologic product packaging (clinical and commercial). Serve as a technical representative for CMO selection strategy, equipment qualification activities, and be hands on solving issues during technology transfer and cGMP start up. The MSAT team will strive to establish standard methodologies for technical support of cGMP manufacturing operations. As a DP MSAT Engineer, a typical day might include the following: Drives innovation in the area of device assembly, labelling and packaging by identifying the latest technological advancements and ensuring a creative environment and implementation aligning to business needs. Ensuring site to site consistency after the processes are optimally transferred, provide floor support during...

Within this role you will be responsible for providing support, direction and subject matter expertise on equipment reliability issues to Facilities Production, Utilities and HVAC teams. You will be evaluating current plant equipment for reliability and assesses alternative options available. The role involves maintaining data of current equipment performance to identify and prevent potential reliability issues & implement reliability monitoring programs to provide maximum uptime of equipment. As a Senior Reliability Engineer a typical day might include, but is not limited to, the following:   Leading reliability improvements to identify opportunities in advance to support planned and predictive replacement versus reactive replacement using existing and developing technologies Providing support, direction and subject matter expertise on mechanical reliability issues Producing and implementing the site reliability policies for all equipment and...

Regeneron Pharmaceutical’s Analytical Chemistry Group is seeking a highly motivated Sr. Scientist to join our group. Sr. Scientists work with LC-MS technologies to guide and support development and characterization of therapeutic protein candidates and other modalities. We apply and solid understanding of various LC-MS platforms and applications to solve analytical problems. A Typical Day in the Role of Sr Scientist Might Look Like: Design, complete, and optimally communicate analytical characterization of biotherapeutics, including monoclonal and bispecific antibodies, Fc-fusion proteins, and other modalities (adeno-associated virus, mRNA, siRNA, etc.) to support drug discovery and development. Lead and deliver on characterization activities to elucidate product quality attributes like post-translational modifications, sequence variants, charge variants, size variants, and host cell proteins. Form and maintain inter-departmental collaborations to solve any potential drug...

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...

Within this role you will be responsible for the administration, configuration, implementation, maintenance and ongoing support of various manufacturing equipment specific applications and systems in a cGMP environment. As an Automation Engineer a typical day might include, but is not limited to, the following: Providing end-user support for small manufacturing equipment applications including troubleshooting issues and appropriately communicating items to management, business process owners and users Working on equipment ranging from standalone equipment such as UV Specs, pH meters, particle samplers to networked equipment such as wave rockers, chromatography skids and cell analysers Overseeing and execution of automation preventative maintenance activities Being responsible for generating automation documentation such as SOPs, work instructions and configuration specification documents Performing daily business administrative tasks related to functional...

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...