Quva · 6 hours ago
NPD Technical Operations Specialist
Bloomsbury, NJ
Full-time
Onsite
Mid, Senior Level
$89K/yr - $117K/yr
3+ years expQuva is a company that provides industry-leading health-system pharmacy services and solutions, and they are seeking an NPD Technical Operations Specialist to support the technical execution of new product development processes. This role involves translating early-stage product concepts into scalable manufacturing processes while collaborating with various teams to ensure compliance and quality in drug production.
Health CareManufacturingMedicalMedical DevicePharmaceutical
No H1B
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
Qualification
Required
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
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
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
Preferred
Experience supporting scale‑up, tech transfer, or manufacturing investigations
Exposure to regulatory submissions or CMC documentation
Benefits
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
Company
Quva
Quva is a national, industry-leading provider of health-system pharmacy services and solutions, including 503B sterile injectable outsourcing and data software solutions that generate insights to help power the business of pharmacy.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$356MKey Investors
Goldman SachsBain Capital Ventures
2021-05-06Debt Financing· $275M
2018-07-26Debt Financing· $41M
2018-01-31Private Equity· $15M
Leadership Team
Brian Coyle
Director of National Accounts
Recent News
PR Newswire UK
2025-10-20
Company data provided by crunchbase