Sterile Injectable Manufacturing Manager

COMPANY OVERVIEW

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

Our family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is part of Noramco. We are stronger together!

OVERVIEW

The Sterile Injectable Manufacturing Manager is a senior operational and technical leader responsible for overseeing all aspects of sterile fill/finish manufacturing operations within a cGMP-compliant pharmaceutical contract development and manufacturing organization (CDMO). This includes but is not limited to formulation, filling (vials/syringe/cartridge), visual inspection and secondary packaging. Products will be a mix of branded and Gx and types of sterile injectable dosage forms across many therapeutic areas.

This role ensures continuous improvement, optimal capacity utilization, regulatory compliance, and delivery performance while maintaining a strong focus on safety, quality, cost, and customer satisfaction. The position requires a highly technical and operational leader capable of understanding and assisting with equipment qualification, media fills and process validation, leading complex investigations, implementing continuous improvement initiatives, and managing cross-functional capital and operational projects.

The Sterile Injectable Manufacturing Manager serves as a critical link between front-line aseptic operations and senior leadership, reporting to the Director of Operations.

100% onsite position at 30 N. Jefferson Rd, Whippany, NJ

ESSENTIAL FUNCTIONS

Operational Leadership

• Lead and manage all sterile injectable manufacturing operations to ensure safe, compliant, and efficient aseptic production. Ensure the department meets production schedules, customer delivery commitments, and financial targets for the new fill/finish line.
• Develop and manage capacity models, manufacturing scheduling, and utilization plans to optimize throughput and asset performance. Manage departmental budgets and control operational costs in alignment with site financial targets.
• Collaborate with Supply Chain, Production Planning, and Project Management to align sterile manufacturing capacity with client demand forecasts and technology transfer timelines. Ensure operational readiness including staffing, training, gowning qualification, and equipment availability.
• Maintain Tier boards and drive KPI performance visibility for aseptic manufacturing operations. Establish performance goals aligned with site strategy and conduct performance reviews aligned to strategic direction.
• Lead and execute capital projects, sterile line expansion initiatives, and operational improvement projects. Develop project timelines, budgets, and deliverables. Coordinate cross-functional project teams and participate in client project meetings, providing sterile manufacturing expertise and representing fill/finish capabilities.
• Actively contribute to the development and revision of SOPs, batch records, work instructions, and training materials reflecting aseptic best practices and current regulatory requirements.
• Lead, mentor, and develop a team of manufacturing operators, technicians, and supervisors, fostering a culture of aseptic discipline, accountability, and continuous improvement.
• Support business development efforts by providing technical input for sterile proposals, client tours, capability assessments, and technical feasibility evaluations.

Continuous Improvement

• Drive Continuous Improvement initiatives utilizing Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies specific to aseptic fill/finish operations.
• Lead productivity improvement, waste reduction, fill rate optimization, and OEE improvement programs for the sterile line.
• Promote a culture of aseptic discipline across the sterile manufacturing suite.
• Lead root cause investigations and implement effective CAPAs related to sterile manufacturing deviations, environmental excursions, and product quality events.

Technical Leadership and Validation

• Provide technical leadership for aseptic fill/finish manufacturing processes, including isolator operations, stopper bowl feeding, fill weight control, stoppering, crimping, and visual inspection.
• Lead and/or support execution of Equipment Commissioning, Equipment Qualification (IQ/OQ/PQ), Validation Lifecycle management, and Aseptic Process Validation including Aseptic Process Simulations (Media Fills / APS) per current FDA guidance and EU Annex 1.
• Support technical transfers for injectable products from sending sites to the Halo Whippany facility, including execution of comparative analytical testing, process comparability, and CMC documentation requirements.
• Provide hands-on technical troubleshooting and problem solving for aseptic process issues, equipment malfunctions, and contamination control challenges.
• Maintain expertise in sterile injectable processes including liquid formulation handling, compounding, filtration, bioburden testing, endotoxin testing, fill/finish unit operations and assembly/secondary packaging.
• Support capacity planning and operational analytics for sterile manufacturing scheduling and resource allocation.

Quality and Safety Compliance

• Ensure full compliance with cGMP, FDA, EU Annex 1, and other applicable domestic and international regulatory requirements for sterile drug products. Partner with Quality Assurance to ensure audit readiness and regulatory inspection success, including Pre-Approval Inspections (PAI) associated with ANDA/NDA submissions.
• Lead and approve deviation investigations, root cause analysis (Fishbone/5-Why/FMEA), and CAPA implementation for sterile manufacturing events.
• Review and approve batch records, deviation reports, change controls, CAPAs, and other GMP documentation in a timely and accurate manner.
• Oversee and own the Environmental Monitoring (EM) program for classified areas (ISO 5–8), including viable and non-viable particulate monitoring, personnel monitoring, and trending in compliance with the site contamination control strategy.
• Ensure compliance with all safety policies and procedures applicable to sterile manufacturing environments. Lead safety initiatives and behavioral-based safety programs.

POSITION QUALIFICATIONS

EDUCATION:

• Bachelor’s Degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or related technical field required. Master’s Degree preferred.
• Lean Six Sigma Green Belt or equivalent; Black Belt strongly preferred.
• PMP (Project Management Professional) certification strongly preferred.

EXPERIENCE:

• Minimum 10–15 years of experience in pharmaceutical manufacturing, with the majority of experience in sterile injectable / aseptic fill-finish operations.
• Minimum 7–10 years of leadership experience in sterile injectable manufacturing operations, specifically within aseptic fill/finish or parenteral drug product environments.
• Hands-on experience with isolator-based filling systems is a significant advantage.
• Demonstrated experience with greenfield or new sterile line startups, including equipment commissioning, CQV execution, and the transition from qualification to commercial operations.
• Experience with aseptic process simulations (media fills), contamination control strategy development, and Environmental Monitoring (EM) program management.
• Demonstrated experience with Container Closure Integrity (CCI) testing programs per USP and applicable FDA/ICH guidance.
• Experience in a CDMO environment strongly preferred. Ability to work in a fast-paced, multi-client regulated environment. Proven track record of leading teams through regulatory inspections, FDA Pre-Approval Inspections (PAI), and audits.
• Demonstrated experience with equipment qualification and validation (IQ/OQ/PQ/PV/APS) for sterile manufacturing equipment.
• Experience supporting technical transfers and associated CMC regulatory submissions is highly preferred.
• Experience leading deviation investigations and CAPA for sterile manufacturing events including EM excursions, media fill investigations, and product quality deviations.
• Strong experience in capacity planning and utilization optimization for aseptic fill/finish operations.
• Strong working knowledge of FDA 21 CFR Parts 210/211, cGMP, EU Annex 1, ICH Q7/Q8/Q9/Q10, and applicable regulatory standards for injectable drug products.
• Experience with controlled substance injectable manufacturing (DEA Schedule II–V) is a plus.
• Experience with combination products is a plus.
• Strong analytical thinking. Excellent communication (written and verbal) skills. Strong organizational and project management skills with the ability to manage multiple complex priorities in parallel.

PHYSICAL REQUIREMENTS

• Ability to work in and move throughout sterile manufacturing areas, classified cleanrooms, and isolator environments.
• Ability to wear required PPE.

Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background.

Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.