Company Overview:
Novex Innovations is a privately held contract development and manufacturing organization (CDMO) headquartered in Winston-Salem, North Carolina. We specialize in helping our clients navigate the journey from pre-clinical development through commercialization across biologics, pharmaceuticals, and medical devices.
At Novex, we offer the chance to be part of an organization that is scaling quickly, investing in its future, and focused on creating a collaborative, high-performance culture. We value initiative, accountability, and a solutions-driven mindset while keeping client needs at the center of our work. This is an exciting opportunity to join a company where the Scientist will make a direct and meaningful impact on Novex's client relationships, hands-on aseptic operations, and continued growth.
Job Summary:
The Scientist at Novex Innovations is a hands-on role performing many duties in Novex's laboratories, clean rooms, and controlled work areas. This position is expected to participate directly in technology transfer, manufacturing readiness, aseptic processing, documentation, troubleshooting, and program delivery.
The ideal candidate will have direct hands-on experience in GMP-regulated manufacturing and aseptic processing environments, including ISO 5 clean-room operations. This person must be comfortable working directly in the operating environment ensuring quality across a spectrum of scientific manufacturing processes.
Key Responsibilities:
Hands-On Clean-Room and Aseptic Operations:
- Work directly in laboratories, clean rooms, and controlled work areas, including ISO 5 environments, as required to support client programs, technology transfer, manufacturing readiness, batch execution, troubleshooting, and documentation.
- Apply hands-on knowledge of aseptic technique, gowning practices, clean-room behavior, contamination control, GMP operations, SOPs, work instructions, batch records, and Good Documentation Practices.
- Perform aseptic processing activities in accordance with applicable procedures, product specifications, safety requirements, and quality system expectations.
- Assist with process transfer, equipment and material readiness, documentation review, operator training coordination, and execution of manufacturing activities.
- Work closely with Manufacturing, Science & Technology, and Quality to identify execution risks, process gaps, training needs, documentation issues, and facility or equipment constraints.
- Help ensure that processes are appropriately executed within Novex's laboratory, clean-room, quality, and manufacturing capabilities.
Project and Program Management:
- Meet timelines, manage materials, equipment and other resources, and ensure on-time milestones/deliverables across multiple programs.
- Proactively identify project risks, bottlenecks, scope changes, technical issues, resource constraints, and other concerns; escalate appropriately and drive timely resolution.
- Ensure that project documentation remains accurate, current, and useful for decision-making.
Scientific, Technical, and Manufacturing Coordination:
- Apply practical knowledge of biopharmaceutical manufacturing, aseptic processing, GMP operations, and controlled work environments to ensure execution.
- Support technology transfer activities by helping align client processes, internal capabilities, documentation, training, materials, equipment, and manufacturing readiness.
- Work closely with scientific, manufacturing, and quality teams to ensure that client-specific processes are executed according to SOPs, work instructions, product specifications, and Good Documentation Practices.
- Identify technical, manufacturing, and quality issues for internal decision-makers.
Quality, Compliance, and Documentation Support:
- Coordinate activities with Quality to support compliance with applicable laws, regulations, SOPs, and quality system requirements.
- Support processes that are consistent with FDA-regulated, GMP, tissue banking, and/or other applicable quality system expectations.
- Ensure disciplined documentation, clear handoffs, and strong internal communication to reduce execution risk in a multi-client CDMO environment.Commercial and Strategic Support:
- Identify opportunities to improve satisfaction, internal workflows, service offerings, and the scalability of Novex's client’s programs.
- Provide practical input on client needs, project economics, resource requirements, and operational priorities as Novex continues to grow.
- Represent Novex with maturity and credibility in client-facing discussions.Team Leadership:
- Works in cross-functional internal teams without losing sight expectations, operational realities, quality requirements, hands-on execution needs, and business priorities.
Qualifications:
- Bachelor's degree in life sciences, biotechnology, engineering, pharmaceutical sciences, or a related technical field required; advanced degree preferred but not required.
- Minimum of 2-5 years of relevant experience in biopharmaceutical, biologics, cell therapy, sterile/aseptic manufacturing, tissue processing, or another regulated life sciences manufacturing environment.
- Direct hands-on experience working in clean rooms, controlled work areas, biological safety cabinets, laminar flow hoods, isolators, or other ISO 5 aseptic processing environments required.
- Working knowledge of aseptic technique, contamination control, gowning practices, GMP operations, SOPs, work instructions, batch records, Good Documentation Practices, and regulated manufacturing expectations.
- Experience supporting technology transfer, manufacturing readiness, batch execution, deviation investigation, process troubleshooting, or client-specific production activities.
- Excellent written and verbal communication skills, including the ability to communicate clearly with clients, scientists, manufacturing teams, quality personnel, and executive leadership.Additional Preferences:
- Prior experience in a CDMO, contract manufacturing, contract testing, or other multi-client service environment is strongly preferred and will be a significant advantage.
- Experience with sterile fill/finish, biologics, cell therapy, HCT/Ps, tissue banking, or complex biologically derived products is highly desirable.
- Experience supporting process scale-up, manufacturing readiness, batch execution, deviation investigation, and client-specific production activities.
- Familiarity with FDA regulatory requirements, CMC expectations, and the practical operating realities of GMP-regulated manufacturing.
Working Environment:
The work is performed in a combination office, laboratory, clean-room, and manufacturing environment. The position requires direct hands-on work in controlled work areas, including ISO 5 environments, and requires strict adherence to applicable safety, quality, gowning, aseptic behavior, documentation, and facility procedures. The position will require interaction with internal teams, clients, and visitors. Occasional travel may be required for client meetings, audits, conferences, or business development activities.
Pay: $26.50 - $30.50 per hour
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person
