Celcuity jobs

Senior Quality Assurance Auditor Remote Title: Senior Auditor Location: Remote Position Summary: We are seeking a Senior Auditor who will report into the Director, Quality Assurance. The Senior Auditor is a technical expert responsible for independently planning, leading, and executing complex internal and external GxP audits across Celcuity. This role focuses on assessing and mitigating high-risk compliance issues and leading continuous improvement initiatives. The Senior Auditor plays a critical role in maintaining the highest standards of product quality, safety, and regulatory compliance. Responsibilities: Conduct vendor, investigator site, and internal audits according to applicable GxP requirements. Prepare detailed, high-quality audit reports and facilitate responses to audit observations. Support the vendor management program by performing initial audits of vendors. Manage the audit process through the quality management system. Lead or participate in strategic initiatives to continuously improve the Quality Management System (QMS), audit processes, and overall compliance to global standards. Provide guidance and training on GxP requirements to functional area personnel. Provide guidance and support during inspections and assist in developing responses to agency observations. Provide audit metrics to Executive Management. Working knowledge of regulatory requirements (FDA, EU) and related standards (GxP, CAP, CLIA). Other duties as assigned. Qualifications: Bachelor's degree in in health or life sciences; or relevant experience. 10 plus (10+) years of experience in auditing and quality management systems in pharmaceutical, biotechnology, or medical device industry in a GxP regulated environment. Relevant professional certifications such as ASQ Certified Quality Auditor (CQA) or a Lead Auditor certification are highly preferred.

Associate Director, Process Engineering Minneapolis, MN POSITION SUMMARY: Reporting to the Chief Science Officer, the Associate Director, Process Engineering works within a high-complexity, cellular, and molecular testing laboratory to develop processes, procedures, and products from conception to production for clinical test products. PRIMARY RESPONSIBILITIES AND DUTIES: Process Development: • Lead a team of scientists and engineers to develop and optimize processes for complex biochemistry and cell biology laboratory testing Cross-Functional Collaboration: • Work closely with Engineering and R&D teams to implement and maintain quality control of test processes Assay Development: • Develop molecular assays and define mechanisms of action in complex cell-based systems • Establish test performance criteria and data quality standards Statistical Design & Analysis: • Design and execute statistical studies (Design of Experiments, screening designs) to identify key factors in complex assay systems Process Lifecycle Management: • Develop and maintain process plans from concept through validation and scale-up • Support feasibility and development phase reporting Documentation & Regulatory Support: • Create pre-clinical documentation and support regulatory readiness Equipment & Maintenance: • Establish and implement maintenance and calibration programs for laboratory equipment in partnership with Facilities Quality & Compliance: • Support QA/QC programs • Ensure adherence to safety standards, quality systems, and HIPAA requirements Scientific Collaboration: • Participate in cross-functional meetings and support translational and clinical study initiatives QUALIFICATIONS AND SKILLS: Education & Experience: • PhD or MS in bioengineering or related field • Extensive experience leading scientific/engineering teams in complex laboratory environments • Strong experience in process development

Senior Medical Director Remote Position Summary: We are seeking a Senior Medical Director who will report into the Vice President, Clinical Development. You will be responsible for working within Celcuity's medical team providing medical oversight of service suppliers driving on-going clinical studies and plans and executes the study design protocol development, implementation and monitoring of the company's new Phase I-III Oncology clinical trials. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures. Responsibilities: Assist in design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents. Act as a medical monitor for assigned study. Discuss study design with investigators and key opinion leaders. Provide clinical input for clinical protocol monitoring guidelines and analysis plans. Drive clinical database design, data collection and cleaning and oversees clinical interpretation of study data. Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur. Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator's Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling). Lead or assist in the development of publications - abstracts, manuscripts, slides, etc. In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring

Lab Systems Manager Minneapolis, MN POSITION SUMMARY: Reporting to the Manager R&D Laboratory, the Lab Systems Manager ensures that highly regulated laboratory, research, and manufacturing environments operate safely and efficiently. This role encompasses activities related to the maintenance and continuous improvement of R&D laboratory physical operations including instrumentation, process equipment, facilities, CO2/N2 gas supplies, cryo storage, hazardous waste disposal while maintaining strict compliance with FDA, GMP, and OSHA standards. PRIMARY RESPONSIBILITIES AND DUTIES: Laboratory Instrumentation and Process Equipment : Coordinate calibration and preventive maintenance (PM) and sensitive laboratory and process equipment, maximizing work quality and minimizing downtime. Manage instrument alarm systems and LIMBLE CMMS. Coordinate and facilitate new equipment selection. Must understand the purpose and architecture of typical laboratory instrumentation and processing equipment. Demonstrate resourcefulness and troubleshooting capability with respect to laboratory equipment. Lab-Specific Infrastructure : Manage specialized utilities such as DI/RO water systems, lab vacuums, process chilled water, compressed gases, and liquid nitrogen storage units. Building Systems : Monitor operation of and resolve building systems issues, including HVAC, electrical, plumbing, and building automation systems (BAS). Work with the Property Manager as necessary. Regulatory Compliance : Ensure facilities meet cGMP, ISO, and safety requirements. Lead safety audits and maintain detailed documentation for inspections. Environmental Health & Safety (EHS) : Oversee the proper storage, labeling, and disposal of hazardous chemicals and biological materials. Project Management : Lead facility upgrades, lab expansions, and equipment or lab operations improvement projects, coordinating between internal research teams and external contractors. Vendor & Budget Management :

Associate Scientist, Cell Signaling and Assay Development Minneapolis, MN POSITION SUMMARY: Reporting to the Director, Tissue or Assay / Laboratory Manager, the Associate Scientist will play a key role in the development, validation, and execution of live-cell assays supporting translational oncology research. This individual will contribute to advancing precision medicine by characterizing cell signaling pathways and ensuring the generation of high-quality, reproducible data in a high-complexity, CLIA-certified laboratory environment. PRIMARY RESPONSIBILITIES AND DUTIES: Assay Development & Validation: Design, develop, validate, and transfer cell signaling and pathway-based assays across multiple cancer tissue types. Cell Culture & Maintenance: Culture, maintain, and ensure consistency of human cell lines and primary samples under varied laboratory conditions. Cellular Characterization: Perform phenotypic and pathway characterization using cell-based assays and integrate informatics data to identify and classify cell types. Regulatory Compliance: Adhere to CAP/CLIA standards and HIPAA regulations, maintaining compliance within a high-complexity clinical testing environment. Cross-Functional Collaboration: Partner with Scientific Directors and laboratory leadership to troubleshoot assays, optimize protocols, and improve laboratory efficiency. Quality & Data Integrity: Monitor and maintain quality control processes, including QC metrics, preventive maintenance (PM), and standard operating procedures (SOPs), ensuring data accuracy and reliability. QUALIFICATIONS AND SKILLS: Education & Experience: Ph.D. in a relevant scientific discipline with experience in activity-based live-cell assay development for small molecules; OR Master's degree with 5+ years of relevant industry experience; OR Bachelor's degree in a scientific field with 6-8+ years of relevant industry experience. Required Technical Skills: Hands-on experience with human cell culture techniques Experience

Senior or Principal Scientist, Formulation and Process Development Remote Position Summary: We are seeking a Senior or Principal Scientist, Formulation and Process Development, who will report to the Director, Pharmaceutical Development. You will focus on leading formulation and process development work supporting Celcuity's drug product development and product lifecycle management. The Sr./Principal Scientist role will join a collaborative Pharmaceutical Development group focused on advancing Celcuity's lead drug candidates. The Sr./Principal Scientist will lead formulation and process development projects for novel formulations targeted toward existing and new indications, as well as projects supporting Celcuity's existing oncology drug product. Responsibilities: Lead projects to support development of novel and existing formulations, spanning the product lifecycle including pre-formulation, dosage form selection, formulation development, process development, and manufacturing scale-up. Design, execute, and interpret formulation and process development experiments in an outsourced environment at contract laboratories and CDMOs. Identify and vet new contract organizations to support formulation and process development. Help define & execute the project plans for formulation lifecycle management. Support writing technical sections for intellectual property and regulatory filings. Develop and maintain an in-depth knowledge of formulation development trends, techniques, and technologies. Serve as a subject matter expert for formulation development within the Pharmaceutical Development group and the broader Celcuity team. Summarize, document, and present information to subgroup, group, and cross-functional audiences. Other duties as assigned. Qualifications: Ph.D/M.S./B.S. in Pharmaceutical Science, Chemical Engineering, Chemistry, Biochemistry, Biochemical Engineering, or related fields. 7+ years of experience in pharmaceutical development (preferred 4+ years industry experience for Ph.D;

Director or Senior Director, API Development Remote Position Summary: We are seeking a Director or Senior Director, API Development, who will report to the Executive Director of Pharmaceutical Development. You will be the technical expert for current API synthesis production and will lead creation, optimization, and management of additional API entities as part of new compound/formulation development activities. Responsibilities: Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities. Lead current drug substance manufacturing process and optimize for continuous improvement of material. Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities. Determine and resolve gaps for regulatory compliance with drug substance manufacturing and development. Support formulation development with drug substance optimization, impurity identification, and pre-clinical study coverage involvement. Author and review drug substance IND-enabling protocols, reports, and regulatory submissions. Engage and support formulation development with new entity optimization and synthetic route creation/advancement. Produce intellectual patent assessments and complete development projects intended for furthering IP generation. Other duties as assigned. Qualifications: PhD, Master's, or Bachelor's degree in a physical science field, ideally chemistry, chemical engineering, or biomanufacturing. ≥ 8 years in small molecule medicinal chemistry, API development, and/or manufacturing. Experienced with early development activities including IND-enabling development and authoring. Managed CDMOs for initial development, manufacturing, process validation, and transfer activities. Knowledge of analytical technologies including LC, GC, NMR, MS, XRPD, and other relevant methodologies used for elucidation and purity determination. Well-informed of FDA, EU, and ICH guidelines for drug substance manufacturing and quality assurance. Excellent

Associate Director, R&D Laboratory Minneapolis, MN POSITION SUMMARY: Reporting to the Chief Science Officer/Technical Supervisor, the Associate Director, R&D Laboratory is responsible for the overall operation and administration of a CLIA-certified, CAP-accredited, GLP high-complexity clinical laboratory. This role will lead laboratory operations, ensure regulatory compliance, and drive high-quality test development and execution within the R&D environment. PRIMARY RESPONSIBILITIES AND DUTIES: Laboratory Operations: • Lead and direct the development, communication, and implementation of effective laboratory-related work processes across the R&D laboratory Test Development & Execution: • Lead the implementation of high quality, effective test processes • Ensure acceptable levels of analytic performance throughout the testing lifecycle Resource & Infrastructure Management: • Ensure personnel, reagent, and equipment resources are in place to support laboratory operations • Partner with Facilities to maintain appropriate research environments Regulatory & Quality Compliance: • Maintain compliance with Celcuity's Quality Management System (QMS), including documentation, QA/QC processes, and regulatory standards (CLIA, CAP, GLP) Continuous Improvement: • Define test specifications and QC criteria • Address Non-Conforming Events (NCEs) and implement continuous laboratory improvements Workflow Management: • Oversee laboratory workflows from sample receipt through analysis, reporting, inventory, and equipment management Leadership & Team Development: • Lead, coach, and mentor laboratory staff • Ensure training and competency requirements are met Technical Oversight: • Resolve technical problems and implement corrective actions • Ensure test systems operate within established performance specifications Operational Planning: • Participate in budgeting, resource planning, and overall laboratory operations strategy QUALIFICATIONS AND SKILLS: Education & Experience: • BS, MS,

Director, Medical Science Liaison, North Central Remote Location: North Central (Minnesota, Iowa, Nebraska, South Dakota, North Dakota, Kansas, Missouri) This region does not include Illinois, but the prospective new hire can reside in the Chicagoland area. Position Summary: We are seeking a Director, MSL who will report to the Senior Director, Western US Field Medical. The Director, MSL will be responsible for scientific exchange with Health Care Providers (HCPs) and key decision makers (managed care, payers, formulary committees, etc.) on Celcuity's products, relevant disease states, and in support of clinical trials. MSL's combine a strong business acumen, disease state knowledge, clinical knowledge/experience, market awareness, and serve as a conduit for Celcuity's scientific data to external customers while providing external market and clinical insights internally to cross-functional teams. Travel within the territory and the US for medical conferences will be expected. Responsibilities: Identify and cultivate professional relationships KOLs in designated tumor types. Maintain cross-functional field partnerships allowing for appropriate collaboration with field commercial teams (sales, market access, etc.), and Clinical Development associates. Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities. Assist the Clinical Development Team in the identification and education of potential clinical trial sites, assist, upon request, in troubleshooting issues during clinical trial conduct. Develop scientific expertise on all Celcuity's products, related disease states, and the clinical practice for a given therapeutic area. Communicate scientific content, written and verbal, related to Celcuity's products and related disease states. Be knowledgeable of and follow all

Director, Medical Science Liaison, Carolinas Remote Location: Carolinas (North Carolina, South Carolina, Virginia, West Virginia, Tennessee, and Kentucky) Position Summary: We are seeking a Director, MSL who will report to the Senior Director, Eastern US Field Medical. The Director, MSL will be responsible for scientific exchange with Health Care Providers (HCPs) and key decision makers (managed care, payers, formulary committees, etc.) on Celcuity's products, relevant disease states, and in support of clinical trials. MSL's combine a strong business acumen, disease state knowledge, clinical knowledge/experience, market awareness, and serve as a conduit for Celcuity's scientific data to external customers while providing external market and clinical insights internally to cross-functional teams. Travel within the territory and the US for medical conferences will be expected. Responsibilities: Identify and cultivate professional relationships KOLs in designated tumor types. Maintain cross-functional field partnerships allowing for appropriate collaboration with field commercial teams (sales, market access, etc.), and Clinical Development associates. Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities. Assist the Clinical Development Team in the identification and education of potential clinical trial sites, assist, upon request, in troubleshooting issues during clinical trial conduct. Develop scientific expertise on all Celcuity's products, related disease states, and the clinical practice for a given therapeutic area. Communicate scientific content, written and verbal, related to Celcuity's products and related disease states. Be knowledgeable of and follow all applicable laws, SOPs and guidance documents ensuring compliance Provide scientific training to internal colleagues. Participate in the Medical,

STAGE CESURE - Ingénieur développement d’un outil de veille d’obsolescence des moyens industriels - H/F Châtellerault, Vienne, France Nous recherchons un stagiaire pour développer un outil de veille d'obsolescence des moyens industriels. Vous travaillerez sur l'automatisation de la gestion des composants, en utilisant des technologies comme Python, IA et API. Rejoignez-nous pour contribuer à un projet innovant au sein de Thales.

STAGE CESURE - Ingénieur développement d'algorithmes d'optimisation et d'ordonnancement - F/H Châtellerault, Vienne, France Nous recherchons un stagiaire pour développer un outil logiciel d'optimisation et d'ordonnancement. Vous travaillerez sur la modélisation de contraintes et le développement d'un prototype en utilisant Python et des outils comme MiniZinc et OR-Tools. Rejoignez-nous pour contribuer à l'avenir de l'aéronautique !

STAGE Césure - Ingénieur Machine Learning - H/F Crolles, France

Automatic Optical Inspection Engineer Hal Kirkop, Malta

Health Tech(Ophthalmolgy) Garner, North Carolina Summary This position is located at the VA Clinic in Garner, NC. Ophthalmology Technicians in the Veterans Health Administration (VHA) support Ophthalmologists in diagnosis, treatment, prevention, follow-up care and patient counseling. The Full Performance Health Technician (Ophthalmology) performs a range of standard, but complex, diagnostic procedures, assists during clinic-based surgical procedures, educates patients and legal representatives. Duties Duties Include but are not limited to: Checks and performs calibration of technical ophthalmology screening instruments. Obtains patient physical history, to include chief complaint; reason for visit; pertinent signs and symptoms; current medication allergies; past ocular and general medical history both ocular and general; family history both ocular and general; social history; and review of medications and allergies, including current ocular prescription and non prescription medications. Accurately tests visual acuity at distance and near, with and without correction or with and without a pinhole. Measures eyeglass prescription using manual or automated lensometer, recording sphere, cylinder, axis, and prism in both plus and minus cylinder. Performs pupil evaluation recording pupil size, shape, symmetry, reaction to light and accommodation. Performs swinging flashlight test to detect a relative afferent pupillary defect. Performs basic refractometry utilizing an auto refraction or habitual glass prescription in the phoropter. Instills eye medications (drops or ointments, including anesthetic, dye, dilating drops, cycloplegic drops , or antibiotics). Measures intraocular pressure with standard techniques, including Goldmann applanation tonometry. Performs pachymetry to determine corneal thickness and manual keratometry or automated topography to determine corneal curvature. Performs intra-ocular lens calculations

Quality Control Analyst, Data Review Bedford, MA Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. Position Summary The Quality Control Analyst, Data Review, is responsible for thorough review of analytical chemistry and microbiology data supporting small‑molecule and combination products. This role ensures all electronic and paper QC records are complete, accurate, and compliant with cGMP, GLP, and ALCOA+ data‑integrity expectations. The position is critical for assuring reliable data used for batch release, stability programs, environmental monitoring, method validation, device testing, and regulatory submissions. Key Responsibilities Quality Control Data Review - Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing). - Verify calculations, instrument suitability, standards, sequences, and chromatographic integration. - Ensure testing complies with compendial methods, validated procedures, and specifications. - Review microbiology data (bioburden, endotoxin, sterility, ID, EM, growth promotion, device-specific assays). - Assess EM trending data, alert/action limit excursions, and

Optometrist (Clinical) Fort Bragg, North Carolina Summary About the Position: This position serves as a primary eye care provider, with emphasis on therapeutic pharmaceutical agents, medical contact lens specialist, operative refractive surgery management, and is located with Womack Army Medical Center's, at Fort Liberty NC. This is a Direct Hire Solicitation. Salary negotiation may be available for those candidates who are new to Federal service. A recruitment or relocation incentive may be authorized. Student Loan repayment may be authorized. Duties Serve as a primary eye care provider on therapeutic pharmaceutical agents, medical contact lens specialist, pre and post operative refractive surgery management, and consultations of Occupational Health through examinations of personnel. Identify systemic problems in addition to visual/ocular problems. Follow quiescent and slowly progressive ocular conditions as long as no medical or surgical intervention is indicated. Treat a full range of eye and visual problems and ocular diseases, to include the application of advanced instrumentation, optometric procedures and techniques. Monitor the maintenance of ophthalmic equipment and instruments. Perform comprehensive/limited visual and ocular examinations on all types of patients; including, but not limited to refractive surgery, pediatrics, adults, geriatric, learning disability, low vision, contact lens, and eye hazardous occupations. Diagnose and treat any visual anomaly and specified pathologic conditions of the ocular adnexa and the eye. Provide supervision, teaching, and guidance to senior optometric interns/Scholarship Program Students, eye specialist students, and/or eye technicians. Perform full range of professional optometric duties with major emphasis in the pre-operative evaluation of refractive surgery patients

Quality Control Analyst I, Raw Materials Bedford, MA Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space. Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity. Position Summary: The Quality Control (QC) Analyst I, Raw Materials is responsible for performing routine and non-routine testing of raw materials to ensure compliance with internal specifications, regulatory requirements, and industry standards. This role involves analytical testing, documentation, and collaboration with cross-functional teams to support manufacturing and supply chain operations. Key Responsibilities: - The primary responsibilities of this role will be performing qualitative and quantitative testing of raw materials using techniques such as HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry. - Support the review and interpretation of analytical data, ensuring accuracy and compliance with cGMP, USP, EP, JP, and other applicable standards. - Support aliquoting, shipment and coordinating the external outsourced testing of raw materials at contract laboratories. - Assist in managing QC incoming inspections and AQL activities related to

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KERING EYEWEAR Sales Support Specialist Brno, Czechia

Dolby Vision Support Engineer Burbank, California,United States

KERING EYEWEAR Product & Process Quality Engineer Limena, Padova, Italy