NPD Technical Operations Specialist

Our New Product Development Technical Operations Specialist plays a critical role in translating early-stage product concepts into robust, scalable, and compliant manufacturing processes. This position supports the technical execution of, process characterization, scale-up, and technology transfer activities to ensure new and existing drug products can be reliably manufactured across Quva's network. Working closely with R&D, Manufacturing, Quality, and Regulatory teams, the Specialist contributes to experimental design, data analysis, process documentation, and readiness activities that enable smooth progression from development to commercial production. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.What the NPD Technical Operations Specialist Does Each Day:Execute formulation and feasibility studies using science-based and risk-based methodologiesSupport identification and definition of critical quality attributes (CQAs) and critical process parameters (CPPs) in collaboration with analytical and quality teamsConduct process characterization experiments, analyze data, and prepare technical summaries ensure process adequacy for commercial implementationAssist in evaluating new technologies, equipment, and analytical tools that improve product robustness and manufacturabilitySupport scale-up activities from lab to pilot and commercial manufacturing environments, ensuring process consistency and operational readinessPrepare and maintain process documentation, including batch records, bill of materials, process flow diagrams, and equipment specificationsParticipate in technology transfer to internal manufacturing sites or external CMOs, ensuring alignment on process controls, equipment capability, and documentation requirementsProvide on-the-floor technical support during engineering, process validation, commercial stability and initial GMP batchesPartner with Manufacturing, MS&T, and Operations teams to troubleshoot process deviations, equipment issues, and performance challengesContribute to root cause investigations and corrective/preventive action (CAPA) developmentSupport continuous improvement initiatives aimed at enhancing yield, reducing variability, and strengthening process reliabilityEnsure commercial product implementations comply with GMP, ICH guidelines, and global regulatory expectationsParticipate in regulatory inspections and technical discussions as a subject matter contributorSupport post-approval changes, process optimization projects, and cost-reduction initiativesMaintain detailed technical records and ensure knowledge transfer across teams and project phasesOur Most Successful NPD Technical Operations Specialist:Strong understanding of GMP, ICH guidelines, QbD principles, and CMC expectationsHands-on experience with formulation, process development, scale-up, process validation or tech transferAbility to interpret complex data sets and make evidence-based recommendationsEffective communication and cross-functional collaboration skillsDemonstrated problem-solving ability in manufacturing or development environmentsProficiency with MS Office and familiarity with electronic documentation systemsMinimum Requirements for this Role:BS, MS, or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related discipline3–7+ years of experience in pharmaceutical product development, technical operations, MS&T, or related functionsDemonstrated ability to work in fast-paced environments undergoing growth or scale-upAbility to sit and/or stand 8 hours or more per day if neededAbility to manipulate necessary office equipment, computer software, hardware & equipmentAbility to perform the following physical activities: stooping, reaching, standing, grasping, walking, feeling, talking, and hearingOccasionally lift up to 40 lbs.18+ years of ageAble to successfully complete a drug and background checkMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visasAny of the Following Will Give You an Edge: Experience supporting scale-up, tech transfer, or manufacturing investigationsExposure to regulatory submissions or CMC documentationBenefits of Working at Quva:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match17 paid days off plus 8 paid holidays per yearOccasional weekend and overtime opportunities with advance noticeNational, industry-leading high growth company with future career advancement opportunitiesThe base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditionsRange: $88,792 - $116,838 Annually About Quva: Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care. Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will." California Consumer Privacy Act (CCPA) Notice for Applicants and Employees Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.