Job Title
Manufacturing Section Head
Job Details
Manufacturing Section Head – Direct Hire
Salary Range: $83,200 – $104,000
Job Location
Fall River, MA
Work Hours
General hours: 8:30 AM – 5:00 PM (may vary based on business needs)
Reports To
Manufacturing Department Head
Position Purpose
The Manufacturing Section Head is responsible for overseeing manufacturing activities within the assigned section to ensure compliance with cGMP, safety standards, quality requirements, and production timelines. This role drives operational efficiency while meeting quality, cost, and delivery targets.
Duties and Responsibilities: include the following. Other duties may be assigned.
Production Planning & Execution
Review planned vs. actual production daily and control production activities according to schedules
Prepare and manage production schedules; ensure adherence to targets and quality standards
Ensure availability of raw materials, reagents, and solvents across all shifts
Execute new product introductions and technology transfers through gap analysis
Review in-process testing data daily to improve final product quality
Monitor unit operations to prevent process failures
Ensure effective shift-to-shift communication through performance dialogue meetings
Maintenance & Asset Utilization
Coordinate with Engineering to resolve maintenance issues impacting production
Optimize utilization of manufacturing consumables within budget constraints
Conduct daily cross-functional AET meetings to improve yield, solvent recovery, and reduce OOS/OOT and complaints
Ensure availability of critical spare parts and consumables to minimize downtime
GMP Compliance & Documentation
Maintain audit readiness through proper facility management and documentation
Lead investigations including deviations, OOS/OOT, change controls, and CAPAs
Perform surprise documentation checks to ensure GMP compliance
Prepare and review qualification, validation, and GMP documentation
Participate in internal and external audits
Review batch records, SOPs, and APQRs for accuracy and completeness
Workforce Management & Training
Ensure adequate and effective manpower allocation across shifts
Plan and conduct training on SOPs, policies, and regulatory updates
Drive zero non-conformance through continuous employee development
Safety & Environmental Compliance
Ensure all operations comply with safety standards and procedures
Coordinate with EHS to maintain PPE availability and compliance
Conduct safety training and promote a culture of safe working practices
Manufacturing Excellence & Continuous Improvement
Maximize equipment utilization through performance monitoring
Review OOE data and drive PDCA initiatives to reduce losses
Track machine performance trends to sustain baseline performance
Develop plans to optimize bottleneck equipment
Monitor yields of key products to exceed baseline targets
Major Challenges
Managing competing equipment demands in a multiproduct facility
Maintaining production schedules during renovations and equipment upgrades
Adjusting capacity plans due to fluctuating demand
Delays in regulatory document approvals
Limited spare parts availability due to budget constraints
Extended cycle times for batch record changes and approvals
Raw material quality issues requiring supplier CAPAs
Key Interactions
Internal
Quality Assurance / Quality Control (daily)
Engineering & Utilities (daily)
Technical Support & Technology Transfer (as needed)
Stores & Warehouse (daily)
EHS (daily)
R&D, RA, Capacity Planning, IT, Central SCADA Team
External
Key Decision Areas
Production batch scheduling
Manpower allocation and shift planning
Consumable utilization
Deviation handling and CAPA implementation
Equipment and facility modifications
Batch size optimization and capacity enhancement
Vendor development for cost-effective sourcing
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Education & Experience
Bachelor’s degree in Pharmaceutical Manufacturing, Industrial Management, or related field preferred
5–9 years of experience in pharmaceutical formulation manufacturing
Strong knowledge of cGMP, manufacturing processes, and documentation systems
Technical & Systems Skills
Knowledge of pharmaceutical manufacturing equipment
Strong troubleshooting and root-cause analysis skills
Experience supporting regulatory inspections and audits
Proficiency in Microsoft Office
SAP experience preferred
Inhalation / MDI product experience is a plus
Professional & Behavioral Competencies
Strong communication and interpersonal skills
Self-starter with high initiative
Detail-oriented with strong organizational skills
Ability to work in a fast-paced, regulated environment
Willingness to work flexible schedules and multiple shifts
Company Overview
Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology and professional services.
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume, salary expectations, and any references in your application.
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