NPD Technical Operations Specialist

Quva • Bloomsbury, NJ

5d

About The Position

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

Requirements

• 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
• 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

Nice To Haves

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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level