Manufacturing Operations Manager

Company

Nivagen pharmaceuticals Inc. located in Sacramento CA, we are engaged in the development, acquisition and sales of generic prescription drugs and over the counter products for the North American market. Our vision is to deliver high-quality products at affordable prices by leveraging global partnerships with the best FDA approved manufacturing facilities across the world.

​Nivagen is focused in three areas of product development: development/co-development, acquisition/in-licensing, and providing sales and marketing services.

Role Purpose:

Responsible for performing tasks to specifications related to oral solid pharmaceutical manufacturing. The process includes tablet manufacturing.

Key Duties & Responsibilities:

• Responsible for hands-on operation of production equipment including but not limited to: Blenders, Tablet Press, High Shear Granulator, Tray Dryer, Fluid Bed Processing Units, Mixers, Pumps, Vacuum and Loading machines, Labeling machines, Imprinting machines, Sealers, Bottle filling machines, Cappers, Induction sealers as Production Supervisor / Team Lead to manufacture oral dosage forms in a cGMP manufacturing facility.
• Draft and manage daily/weekly production schedule
• Ensure compliance with regulatory requirements such as Good Manufacturing Practices (GMP), Occupational Safety and Health Administration (OSHA) guidelines, and Environmental Health and Safety (EHS) regulations. You will stay updated with industry regulations and implement necessary changes to maintain compliance.
• Manage workload of all the technicians and support staff in various departments such as mixing, granulation, drying, blending, compression, coating, packaging, receiving and warehouse.

• Coordinate with relevant functional groups to ensure adherence to the production protocol and target volume requirements. Collaborate with cross-functional teams, such as R&D, engineering, and quality control, to support product launches, process validations, and technology transfers.

• Troubleshoot and investigate deviations, actively participate in process optimization, support QA and other functional groups during internal and external audits including FDA, and actively support change control process.
• Draft SOPs, training manual, qualification documents, protocols, and other controlled documents.
• Manage receiving and warehouse personnel, inventory management, and ordering of supplies.
• Performs all job duties in compliance with current Good Manufacturing Practices (cGMPs), following Nivagen Pharmaceuticals Quality Manual and Facility Standard Operating Procedures (SOPs).
• Records all pertinent operations in packaging records, logbooks, and controlled documents.
• Performs assembly, disassembly, operation, and cleaning of production and equipment.
• Assists in routine preventive maintenance of all the utilities, production and packaging equipment.
• Cleans and maintains production environments.
• Performs line clearances prior to initiation of production orders to ensure materials and documents pertaining to the previous order have been appropriately removed from the production area.
• Promote a culture of continuous improvement by encouraging suggestions and ideas from the team, implementing best practices, and monitoring key performance indicators (KPIs) to drive operational excellence.

Education

• Requires Bachelor’s Degree with 5 to 10 years in the pharma/Nutraceutical/Supplement environment
• Requires experience with and an in-depth knowledge of cGMP regulatory requirements as they relate to the production of pharmaceutical products
• Must be able to operate pharmaceutical manufacturing machinery
• Solid mechanical aptitude and troubleshooting skills
• Must have excellent communication skills
• Execute procedures for manufacturing processes in accordance with batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements, GMP
• 5 to 10 years in Pharmaceuticals production

Technical competencies

• Excellent written and verbal communication skills
• Excellent math skills
• Ability to read and comprehend SOP’s, Batch Records and training documents.
• Ability to multi-task effectively
• Excellent interpersonal skills and ability to effectively interact with different functional groups