Manufacturing Supervisor - MDI

Invagen Pharmaceuticals is searching for an experienced Manufacturing Supervisor to manage production staff and oversee production processes at our Fall River, MA facility. This role ensures compliance with cGMPs, company policies, SOPs, and FDA requirements.

Responsibilities

• Schedule the production process, including setting specific targets for phases of production.
• Delegate responsibilities for production to team members and create team leadership positions to oversee groups of employees.
• Manage performance and train assigned employees using company systems, procedures, policies, practices, and tools to meet established performance standards, productivity targets, and business requirements.
• Conduct performance assessments and compile reports on the production process to identify areas where efficiency can be increased.
• Perform raw material and component review to ensure correct quantities, labeling, and visual appearance.
• Perform weight checks for incoming and dispensed materials ensuring compliance with established procedures.
• Operate scales including set-up, verification, leveling, and challenging.
• Follow Master Batch Records for the packaging of MDIs dosage forms when required.
• Identify defects and report quality issues.
• Set up, operate, and clean packaging equipment in compliance with batch records and SOPs.
• Clean and sanitize packaging equipment per SOPs.
• Complete accurate and timely documentation following good documentation practices in accordance with cGMP.
• Perform in-process testing and inspections as required by Master Batch Record (e.g., weighing, visual inspection).
• Provide technical expertise and direction to colleagues, applying knowledge in accordance with approved SOPs, company policies, and regulatory requirements.
• Actively participate in Production team and Site communication meetings.
• Support GMP investigations and events.
• Contribute to Standard Operating Procedure (SOP) writing in technical areas.
• Operate all necessary equipment and instrumentation to perform activities.
• Maintain documentation in accordance with internal procedures and regulatory requirements (e.g., GMP, SOPs).
• Interface with Warehousing, Planning, Operations, and Quality management to implement procedural requirements.
• Perform activities for manufacturing (e.g., batch record review, packaging line clearances, manufacturing room clearances, deviations).
• Comprehend and adhere to all pertinent EHS regulations, policies, and procedures, including the use of Personal Protective Equipment.
• Ensure compliance with documentation and accountability procedures, maintaining high alert to diversions.
• Demonstrate a level of consciousness to safety and health-related activities; recognize and report safety issues to management.
• Independently search, gather, and present information to support compliance with regulations and internal systems.
• Ensure compliance with safety, quality, productivity, and performance expectations in manufacturing and packaging operations.
• Follow strict internal protocols, SOPs, cGMP, legal regulations, and monitor the environment.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in pharmaceutical engineering, Pharmaceutical Sciences, or a related field from an accredited college/university required.
• Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or a related field preferred.
• One (1) to three (3) years of direct work experience in pharmaceutical manufacturing.
• Understanding of machines used in pharmaceutical manufacturing.
• Capable of conducting troubleshooting, investigations, and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• 3+ years’ experience in a pharmaceutical setting preferred.
• General ability to perform basic to complex mathematical computations (addition, subtraction, multiplication, division).
• Understanding of the Metric System of Measurement.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.
• Packaging with serialization experience preferred.

Skills

• Proficient in speaking English as a first or second language.
• Ability to read, write, and communicate effectively.
• Ability to understand and analyze complex data sets.
• Knowledge of good manufacturing practices (GMP) and good documentation practices preferred.
• Strong understanding of work discipline, chain of command, and teamwork.
• Able to apply knowledge and experience to complex problems and offer recommendations.
• High standards in safety, environmental, and leadership.
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Basic computer skills (Word and Excel) – Intermediate level.
• Good basic math knowledge and excellent attention to detail.

Pay

$76,000 - $103,000

Schedule

• General work hours: 8:30 AM – 5:00 PM (may vary based on business needs).
• Must be willing and able to work any assigned shift (first, second, or third shift).
• Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• No remote work available.

Relocation is negotiable. This position is local to Fall River, MA, and is not available for global assignments or employees working outside of Cipla's U.S. subsidiaries or affiliates.