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 methodologies
• Support identification and definition of critical quality attributes (CQAs) and critical process parameters (CPPs) in collaboration with analytical and quality teams
• Conduct process characterization experiments, analyze data, and prepare technical summaries ensure process adequacy for commercial implementation
• Assist in evaluating new technologies, equipment, and analytical tools that improve product robustness and manufacturability
• Support scale‑up activities from lab to pilot and commercial manufacturing environments, ensuring process consistency and operational readiness
• Prepare and maintain process documentation, including batch records, bill of materials, process flow diagrams, and equipment specifications
• Participate in technology transfer to internal manufacturing sites or external CMOs, ensuring alignment on process controls, equipment capability, and documentation requirements
• Provide on‑the‑floor technical support during engineering, process validation, commercial stability and initial GMP batches
• Partner with Manufacturing, MS&T, and Operations teams to troubleshoot process deviations, equipment issues, and performance challenges
• Contribute to root cause investigations and corrective/preventive action (CAPA) development
• Support continuous improvement initiatives aimed at enhancing yield, reducing variability, and strengthening process reliability
• Ensure commercial product implementations comply with GMP, ICH guidelines, and global regulatory expectations
• Participate in regulatory inspections and technical discussions as a subject matter contributor
• Support post‑approval changes, process optimization projects, and cost‑reduction initiatives
• Maintain detailed technical records and ensure knowledge transfer across teams and project phases

Our Most Successful NPD Technical Operations Specialist:

• Strong understanding of GMP, ICH guidelines, QbD principles, and CMC expectations
• Hands‑on experience with formulation, process development, scale‑up, process validation or tech transfer
• Ability to interpret complex data sets and make evidence‑based recommendations
• Effective communication and cross‑functional collaboration skills
• Demonstrated problem‑solving ability in manufacturing or development environments
• Proficiency with MS Office and familiarity with electronic documentation systems

Minimum Requirements for this Role:

• BS, MS, or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related discipline
• 3-7+ years of experience in pharmaceutical product development, technical operations, MS&T, or related functions
• Demonstrated ability to work in fast‑paced environments undergoing growth or scale‑up
• Ability to sit and/or stand 8 hours or more per day if needed
• Ability to manipulate necessary office equipment, computer software, hardware & equipment
• Ability to perform the following physical activities: stooping, reaching, standing, grasping, walking, feeling, talking, and hearing
• Occasionally lift up to 40 lbs.
• 18+ years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Experience supporting scale‑up, tech transfer, or manufacturing investigations
• Exposure to regulatory submissions or CMC documentation

Benefits of Working at Quva:

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities
• The 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 conditions
• Range: $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. Quvas 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."

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