22 jobs found in Portsmouth, NH

Company Description   Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at  www.axsome.com  and follow us on  LinkedIn  and  X ....

We are seeking to hire a Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for Regeneron Cell Medicines involving novel cell therapies and combinations with bispecific antibodies across multiple disease areas. In this highly matrixed role, they will design, develop, communicate across levels and operationally implement clinical biomarker strategies to support select programs in early and late stage drug development. Clinical biomarker assays include pharmacokinetic assays, patient stratification assays as well as immunology based pharmacodynamic assays. As a Director, a typical day may include the following: Program-level Precision Medicine lead for implementation of strategic vision for Pharmacokinetic and exploratory biomarkers in the clinic to enable indication and/or patient selection, early indication of biological activity and potential novel combinations. Collaborate with Biomarker and clinical operation teams...

We are seeking an enthusiastic Senior Associate Scientist to join our Analytical Innovation team as a part of our broader Regeneron Cell Medicines (RCM) group. You will join our Biomolecular Innovation group, which explores new molecular biology approaches to characterizing CAR-T cells and lentiviral vectors (LVVs) to further process and translational knowledge of our therapies. We hope you are excited to work collaboratively across functions to meet project milestones, with the goal to deliver therapies that transform the lives of patients. As a Senior Associate Scientist, a typical day might include: Assisting in the development of novel multiomic NGS workflows for CAR-T cell products and ddPCR assays for characterizing virus-like particles Preparing NGS libraries and ddPCR experiments Performing general laboratory tasks, including sequencer operation and maintenance of equipment Maintaining accurate and reliable records including electronic notebooks and all...

We are seeking a highly skilled and passionate Senior Scientist to support Regeneron Cell Medicine (RCM) mission to bring innovative cell therapy products to patients. This role will be critical to advance TCR- and CAR-based programs, as well as bring new ideas to improve our platforms and future programs. As a Senior Scientist, a typical day might include: Leveraging molecular biology techniques to design constructs, clone, and generate lentiviral vectors using proprietary platform technology Designing and carrying out experimental plans to functionally characterize TCR- and CAR-based T cell products through cell based assays and other relevant procedures to explore and validate novel cell therapy approaches. Maintaining detailed and timely records of experimental protocols, results, and observations. Identifying experimental challenges and collaborating with the team to troubleshoot technical issues and propose creative solutions to overcome obstacles....

To be eligible for this position, you must reside in the same country/sales region where the job is located. Sales Executive – Northeast Region (Boston Area) Location: Must be commutable to Boston, MA or willing to travel frequently within the Northeast region Job Profile Summary:  This role is highly focused on driving sales and cultivating new business opportunities in the Northeast region, requiring expertise in hunting for new clients, identifying growth areas, and building long-term, profitable partnerships. The Sales Executive will work directly with BioTech and Pharma clients to provide value-added input on strategic issues, identify business development opportunities, cultivate executive-level relationships, and deliver tailored, technology-enabled clinical solutions. This position combines strategic sales leadership, deep industry expertise, and cross-functional collaboration to expand IQVIA’s footprint in the clinical technology solutions space. Essential...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Job Description The Position The Women’s Health Clinical Account Specialist (WHCAS) supports customers by providing clinical information on our Company's products, as well as education, and supporting clinical training programs.  They do this to support customer needs, to help the provider or system meet the goals of their patients.  The Clinical Account Specialist is a key member of our customer-facing team and is responsible for partnering with customers to address identified needs, educating stakeholders, and driving results that are consistent with the Company's mission and goals. The Women’s Health Clinical Account Specialist is the primary point of contact for a variety of customers within their assigned geography. These customers may include Health Care Providers such as Physicians across multiple specialties, Nurse Practitioners, Physician Assistants, Midwives, Nurses and Pharmacist in addition to quality Directors, Service Line Leaders, Family Planning...

At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Senior Pharmaceutical Sales Specialist for the Specialty Care Team, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Accountabilities - Develop and demonstrate strong knowledge of clinical disease states and treatment...

Career Category Sales Job Description Territory covers: FARMINGTON, MIDDLETOWN. WATERBURY, WETHERSFIELD. DANBURY, BRISTOL Relocation is not offered for this role. 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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,...

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...

Regeneron is currently looking for a Quality Control (QC) Analyst for our QC Raw Material Utility laboratory with a 1st shift, Monday-Friday, 6am-2:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. The QC raw material utility laboratory performs testing of the raw materials used in the manufacturing process. Various raw materials are tested in the laboratory using manual or instrumentation testing procedures.     As a QC Analyst, a typical day might include the following: • Train other employees on laboratory activities • Utility (water/gas) testing • Data review • Perform laboratory investigations • Write / revise laboratory related documentation (e.g. SOPs, SPECs) • Maintain laboratory supplies • Ensure continuous laboratory compliance to cGMP requirements (e.g. Laboratory cleanliness, equipment within calibration, proper...

Regeneron is currently looking for an Analytical Specialist position with a 1st shift, Monday-Friday, 8am-4:30pm schedule. This position is part of the Analytical Sciences Chemistry Method Development Team. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product through Process Validation. This position will be responsible for development and troubleshooting of chromatography and spectrometric-based assays utilized in Quality Control testing. In this fast pace environment with a strong pipeline, Analytical Specialists have the opportunity to develop scientifically but also gain insight into other areas of the business. As an Analytical Specialist, a typical day might include the following: Work cross-functionally to bring new assays into the group from our research groups. Design and execute assay development experiments to...

We are looking to add an Executive Director Quality Control to our team in Rensselaer, NY! This role leads activities in Quality Control, including but not limited to: release and in-process testing, stability testing, lab investigations, manufacturing failure investigations, environmental monitoring and microbiological testing. Providing comprehensive testing support to clinical and commercial manufacturing, regulatory inspections, filing and facility operations. Leading operational and technological collaboration between the QC group and its business partners. In this role, a typical day might include the following: Leading a full scale of QC operation to support production, facility and cGMP compliance. Providing broad experience and guidance for biopharmaceutical quality control and analytical testing. Interpreting scientific data and draw reasonable conclusions. Advising manufacturing, QA, RA, facilities and material management of quality control requirements and...

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...

The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. A typical day might include the following: Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supply Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes Support the regulatory submission forms to support regulatory release and QP certification. Foster strong communication and working relationships between IOPS and Global Development Keeps management and all stakeholders informed of assessments, overall strategy, and project status Works within the procedures and systems for enhanced tracking of global regulatory submission packages and approval status....

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

Regeneron is currently looking for a Quality Control (QC) Microbiology Analyst with a 3rd shift, Wednesday-Sunday, 10pm-8:30am schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Microbiology Analysts perform microbiological assays, related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. This position will be primarily responsible for performing routine environmental monitoring for aseptic fill/finish manufacturing areas, utilities sampling and testing, , gowning and aseptic qualifications, and raw materials, in process and finished product testing related to drug manufacturing. As a QC Micro Analyst, a typical day might include the following: Environmental monitoring of controlled environments, personnel and...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...

The MSL/Senior MSL is a field based scientific expert that strategically supports the research and business objectives of a designated therapeutic area across the product life cycle for a specific geography/territory    The MSL/Senior MSL is the primary communicator of AbbVie science within a specific geography with healthcare professionals.   The MSL/Senior MSL develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to AbbVie initiatives in assigned therapeutic areas.      The MSL/Senior MSL is viewed as a peer scientific expert in a designated therapeutic area/product.    Combined with strong strategic vision, market therapeutic area awareness, as well as clinical expertise, the MSL/Senior MSL serve as a conduit of information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized...