Technical Operations Lead - Sterile Drug Products

Overview

We are seeking a highly experienced and detail-oriented Technical Operations Lead to join our Sterile Drug Product Engineering team. The Technical Service Lead will lead and oversee technical operations for a sterile injectable manufacturing facility. This role is responsible for supporting facility start-up activities, CQV execution, technical transfer, process implementation, and commercial product launch readiness. The position will serve as a key technical interface across Engineering, Manufacturing, Quality, Validation, and external vendors, clients, with future responsibility for building and leading a technical services team.

The ideal candidate will have strong hands-on experience with sterile injectable manufacturing processes, including aseptic filling, isolator technology, lyophilization, visual inspection, labeling, and packaging systems for vial, syringe, and cartridge presentations.

Responsibilities

Technical Oversight

• Provide technical leadership for sterile injectable manufacturing processes including vial, syringe, and cartridge filling operations.
• Oversee equipment and process support for formulation, aseptic filling lines, isolators/RABS, lyophilizers, automatic visual inspection, labeling and packaging equipment.
• Support process design, technology transfer, scale-up activities, and process optimization for new product introductions.
• Collaborate between engineering, quality department, vendors and manufacturing teams during equipment commissioning, qualification, and start-up activities.
• Lead technical investigations, troubleshooting efforts, and implementation of corrective/preventive actions related to manufacturing and process performance.
• As member of global engineering team, strongly connecting and involving in DP global engineering projects planning and implementation.

Regulatory Compliance

• Ensure manufacturing processes and technical operations comply with cGMP requirements, FDA, EU GMP Annex 1, and internal quality standards.
• Review and approve technical documentation including protocols, reports, SOPs, batch records, change controls, and deviation investigations.
• Support regulatory inspections, customer audits, and internal audits by serving as a technical subject matter expert.
• Partner with Quality Assurance to maintain validated state and continuous compliance of sterile manufacturing systems.
• Drive contamination control strategy implementation and support aseptic process simulation/media fill activities.

Project Management

• Lead cross-functional technical transfer and product launch activities from development through commercial manufacturing.
• Manage technical deliverables, planning, risk management, and vendor coordination for new equipment and manufacturing initiatives.
• Support continuous improvement, and operational readiness initiatives within the sterile manufacturing facility.
• Work closely with external equipment suppliers, consultants, and contract partners to ensure successful project execution.

Team Leadership

• Build, mentor, and lead a high-performing technical services team as the organization grows.
• Provide technical guidance and coaching to engineers, production technicians, and manufacturing support staff.
• Foster strong cross-functional collaboration with Manufacturing, Quality, Engineering, Supply Chain, and Program Management teams.
• Establish a culture of accountability, continuous improvement, technical excellence, and proactive problem solving.
• Support resource planning, workload prioritization, and talent development to meet business and project objectives.

Qualifications

Required Qualifications:

• Excellent written and verbal communication skills, with attention to detail and clarity.
• Bachelor’s or Master’s degree in engineering, Life Sciences, or related technical discipline.
• Minimum of 8–10 years of experience in the pharmaceutical or biotechnology industry.
• Preferably at least 3 years in a supervisory or managerial role.
• Deep understanding of cGMP requirements, risk-based approach, and global regulatory expectations.
• Proven experience in startup or expansion of manufacturing facilities is highly preferred.

Preferred Qualifications:

• Strong knowledge of current Good Manufacturing Practices (cGMP), regulatory guidelines (FDA, EMA, ICH), and industry standards.
• Experience with sterile filling, lyophilization, automatic visual inspection is a plus.
• Prior experience supporting regulatory inspections and audits.

The anticipated base salary for this opening is $99,000 to $150,000An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityThis job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.