Manager Oral Solid Dosage (Mfg & Packaging)

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 Oral Solid Dosage (OSD) Manager is a key operational leader responsible for overseeing all aspects of oral solid dose manufacturing and packaging operations and providing strategic and operational (tactical) leadership within a cGMP-compliant pharmaceutical contract development and manufacturing organization (CDMO). This includes dispensing, granulation, compression, encapsulation, coating, and primary and secondary packaging. Products are a mix of branded and Gx and types of OSD/liquid dosage forms across many therapeutic areas.

This role ensures operational excellence, 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 and process validation , leading complex investigations, implementing continuous improvement initiatives, and managing cross-functional capital and operational projects.

The OSD Manager serves as a critical link between front-line operations and senior leadership, reporting to the Director of Operations. They will have up to 6 direct reports. This position is 100% on site at 30 North Jefferson Road, Whippany, NJ.

RESPONSIBILITIES

Lead and manage all OSD manufacturing and packaging operations to ensure safe, compliant, and efficient production. Ensure departments meet production schedules, customer delivery commitments, and financial targets.

• Develop and manage capacity models and utilization plans to optimize throughput, efficiency, and asset performance. Manage departmental budgets and control operational costs. Support strategic capacity expansion and capital investment planning.
• Collaborate with Supply Chain and Production Planning to align capacity with demand forecasts. Ensure operational readiness including staffing, training, and equipment availability.
• Maintain Tier boards and drive KPI performance visibility. Establish performance goals and conduct performance reviews aligned to strategic direction.
• Lead and execute capital projects, process improvement projects, and operational initiatives. Develop project timelines, budgets, and deliverables. Coordinate cross-functional project teams and participate in client project meetings, providing operational expertise and representing manufacturing and packaging capabilities.
• Actively contributes to the development and revision of SOPs, work instructions, and training materials to reflect best practices and regulatory updates.
• Lead, mentor, and develop a team of Manufacturing and Packaging Supervisors, engineers and production personnel, fostering a culture of accountability, continuous improvement, and operational excellence.
• Support business development efforts by providing technical input for proposals, client tours, and capability assessments

Operational Excellence and Continuous Improvement

• Drive Operational Excellence initiatives utilizing Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies.
• Lead productivity improvement, waste reduction, cycle time reduction, and OEE improvement programs.
• Serve as a change agent promoting a culture of operational excellence and continuous improvement.
• Lead root cause investigations and implement effective CAPAs.

Technical Leadership and Validation

• Provide technical leadership for manufacturing and packaging processes.
• Lead and/or support execution of Equipment commissioning, Equipment Qualification (IQ/OQ/PQ, Validation lifecycle, Process Validation (PV):
• Support technical transfers, scale-up, and process optimization.
• Provide hands-on technical troubleshooting and problem solving.
• Extensive knowledge of Oral Solid Dosage processes (ie. Granulation, compression, encapsulation, coating and primary/secondary packaging)
• Capacity planning and operational analytics

Quality and Safety Compliance

• Ensure full compliance with cGMP, FDA, and other applicable international regulatory requirements. Partner with Quality Assurance to ensure audit readiness and regulatory inspection success.
• Lead and approve deviation investigations, root cause analysis (Fishbone/5-why/FMEA), and CAPA implementation.
• Review and approve batch records, deviation reports, change controls, CAPAs, and other GMP documentation in a timely and accurate manner.
• Ensure compliance with safety policies and procedures. Lead safety initiatives and behavioral-based safety programs.

EDUCATION, EXPERIENCE AND LICENSING REQUIREMENTS:

• Bachelor’s degree in engineering, Pharmaceutical Sciences, 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’ experience in pharmaceutical manufacturing.
• Minimum 7–10 years leadership experience in Oral Solid Dosage manufacturing and packaging.
• Experience in CDMO environment strongly preferred. Ability to work in fast-paced regulated environment. Proven track record of leading teams through regulatory inspections and audits.
• Demonstrated experience with equipment qualification and validation (IQ/OQ/PQ/PV).
• Experience leading deviation investigations and CAPA.
• Strong experience in capacity planning and utilization optimization.
• Strong working knowledge of FDA 21 CFR Parts 210/211, ICH guidelines, and applicable regulatory standards.
• Experience with controlled substance manufacturing (DEA Schedule I–V) is a plus.
• Strong analytical thinking. Excellent communication (written and verbal) skills. Strong organizational skills.

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.