Position: Sr. Manufacturing Specialist
Location: Charleston, South Carolina
Shift: 2nd Shift | Monday – Friday | 3:00 PM – 11:30 PM
Compensation: $90,000-$120,000 annually
Benefits: Full Benefits Package | Paid Time Off | 401(k) | Relocation Assistance

Position Summary
The Sr. Manufacturing Specialist – Aseptic plays a key role in supporting cGMP sterile drug product manufacturing. This position is responsible for troubleshooting manufacturing issues, conducting continued process verification (CPV), and providing technical support for both commercial and clinical operations. The role collaborates cross-functionally with Formulation Development, QA, Regulatory, EHS, and Engineering to ensure robust and compliant production. Strong leadership and training capabilities are essential.

Key Responsibilities

• Analyze manufacturing data to identify trends and areas for process improvement.

• Evaluate unit operation durations to optimize scheduling and meet production goals.

• Author and manage Change Controls related to investigations, process changes, and equipment modifications.

• Lead and close investigations in a timely manner.

• Review and approve new and executed batch records.

• Train manufacturing staff on SOPs, batch records, and GMP rationale.

• Provide on-the-floor technical support for commercial, clinical, and validated processes.

• Serve as a subject matter expert for clients and stakeholders.

• Assess product impact from process deviations and excursions.

• Identify opportunities for process optimization within equipment capabilities.

• Troubleshoot unexpected manufacturing events and support CAPA documentation.

• Ensure compliance with FDA, EPA, OSHA, DEA, and internal policies.

• Maintain a safe, clean, and organized work environment.

• Complete all required cGMP and company training on time.

• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or related field (Chemical Engineering preferred).

• Minimum 4 years of experience in sterile injectable manufacturing within a regulated environment.

• At least 2 years of experience in technical writing (e.g., deviations, SOPs, batch records).

• Demonstrated leadership and training experience.

Skills & Competencies

• Strong training and mentoring abilities.

• Proven ability to identify and improve operational inefficiencies.

• Effective communication across all organizational levels.

• Proficient in data analysis, including graph/chart interpretation.

• Strong problem-solving skills in dynamic environments.

• Skilled in writing reports, procedures, and business correspondence.

• Ability to interpret technical documents and regulatory guidelines.

• Confident in presenting information to internal and external stakeholders.

• Proficient in Microsoft Office and other relevant software.

• Familiarity with aseptic manufacturing and documentation review.

Physical Demands & Work Environment

• Regular use of hands, arms, and senses; frequent sitting; occasional standing, walking, kneeling, and crawling.

• Ability to lift/move up to 50 lbs.

• Visual acuity required for close and distance vision, color perception, and depth.

• Moderate to high noise levels; occasional exposure to airborne particles, chemicals, and mechanical vibrations.

• Must be able to wear required PPE.