Manufacturing Operations Manager (Tablet manufacturing)

Nivagen Pharmaceuticals•Pittsburg, CA

13h•Onsite

About The Position

Nivagen Pharmaceuticals Inc. is seeking a Manufacturing Operations Manager for their Sacramento, CA location. This role is responsible for performing tasks related to oral solid pharmaceutical manufacturing, with a specific focus on tablet manufacturing. The company develops, acquires, and sells generic prescription drugs and over-the-counter products for the North American market, aiming to deliver high-quality, affordable products by partnering with FDA-approved manufacturing facilities globally. Nivagen focuses on product development, acquisition/in-licensing, and sales/marketing services.

Requirements

Bachelor’s Degree with 5 to 10 years in the pharma/Nutraceutical/Supplement environment
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
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

Responsibilities

Responsible for hands-on operation of production equipment including 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. 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 manuals, qualification documents, protocols, and other controlled documents.
Manage receiving and warehouse personnel, inventory management, and ordering of supplies.
Perform all job duties in compliance with current Good Manufacturing Practices (cGMPs), following Nivagen Pharmaceuticals Quality Manual and Facility Standard Operating Procedures (SOPs).
Record all pertinent operations in packaging records, logbooks, and controlled documents.
Perform assembly, disassembly, operation, and cleaning of production and equipment.
Assist in routine preventive maintenance of all the utilities, production and packaging equipment.
Clean and maintain production environments.
Perform 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.