Line Manager -Manufacturing

Position Line Manager -Manufacturing

Location Sacramento, California

Previous Experience Must be in Pharmaceutical Sterile Manufacturing and Operations

Company

Nivagen pharmaceuticals Inc. located in Sacramento CA is in the process of setting up a Greenfield project for multiple sterile dosage forms such as vials, PFS, Cartridges, and IV Bags. Currently, all our products are being manufactured by a Contract Manufacturing company (CMO). Eventually, these products will be manufactured at the proposed facility. The Proposed facility is spread over 60,000 to 85000 Sq. Ft footprint which has manufacturing and packing functions along with Quality control Labs, R&D, and administration offices.

Overview

The incumbent in this position has overall responsibility for fill finish of General Injectables from compounding till packing. Can also able to handle timely preparation, labelling, packaging, and shipping of all compounded sterile products as an add on responsibility. The primary function is to oversee all operations of one filling line in terms of manufacturing, quality, and regulatory aspects during manufacturing operations. The incumbent is responsible for working schedules of Manufacturing Operations. Production planning, Material Planning, that lead the preparation, compounding, filling, inspection, labelling and packaging of variety of drug products. Reports shift Key Performance Indicators reflecting adherence to department quality, safety, delivery, and productivity objectives. Ensures people and processes comply with safety requirements, current Good Manufacturing Practices, company policies and procedures. Modifies department standard operating procedures, investigates variances, and executes change controls to support safety, quality and productivity objectives. Establishes & maintains cooperative cross-functional relationships with peers in Quality, Technical Operations, and Supply Chain to meet plant objectives.

Roles and Responsibilities

• Expertise in sterile operations including manufacturing, filling, and Quality Management System for various dosage forms like vials, IV bags, PFS, cartridges, lyophilized products, Aseptic as well as Terminally sterilized products.
• Operational and functional Knowledge of vial washing, depyrogenation, sterilization and aseptic filling of vials (aseptic, lyophilized & terminally sterilized products, and dry powders) and Prefilled syringes including cartridges manufacturing operations.
• Significant exposure for handling of GMP audits of various regulatory inspections like USFDA and EU.
• Expertise in Quality Management System including deviations, investigations, market complaints, Troubleshooting, CAPAs, change controls and SOP revisions.
• Involved in technology transfer from R&D /other location to manufacturing site.
• To monitor and handling of ANDA batches, Clinical batches, and commercial batches of injectable “vials, pre-filled syringes, aseptic, terminally sterilized products, lyophilized products and dry powder” dosage forms in regulated markets like USA, EU.
• Responsible for process improvement activity in view of cost saving, productivity enhancement and maximum utilization of filling line.
• Expertise in managing various operations as per the set parameters & standards as well as experience of developing procedures for operational excellence.
• An effective communicator with excellent skills in building relationships. Possess strong analytical, problem solving, troubleshooting and organizational abilities.
• Preparation of area for all time audit readiness and handling of Audits.
• Experienced in facing audits viz. FDA-US and Global Customer Audits.

Education

• Bachelor degree in pharmaceuticals technology, Pharmacy or related science, as MS preferred or Pharmaceutical degree or a combination.

Experience and Necessary Skills of Senior Manager, Technical Services

• Minimum 10 years of experience in a pharmaceutical development management position.
• Hands-on in Sterile manaucfturing and Supervisory experience is a must.
• Pharmaceutical manufacturing, and/or laboratory (GLP), 503B experience also preferred.
• Experience leading new products/projects through implementation in the Pharma industry.
• Deep knowledge of Product and Process Development and process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GxP), Risk Management concepts, statistical process control, and statistical problem solving.
• Must have good organizational skills; able to perform work with little supervision. Requires mathematical aptitude with a good background in algebraic skills and statistical analysis skills.
• Knowledge of analytical laboratory methodologies is a plus.
• Strong attention to detail and accuracy of manufacturing facility.
• Ability to multi-task, with strong organization, time-management and prioritizing skills.
• Good verbal and written communication skills to make oral presentations and write technical reports.

Competencies

Functional

• Knowledge of Sterile formulation engineering
• Knowledge of USFDA, cGMP, GLP, ISPE, ISO
• Troubleshooting expertise on manufacturing equipment
• Project Management- added advantages
• Manufacturing Planning & Execution

Behavioural

• Result oriented
• Innovative thinking
• Time Management
• Problem-solving ability
• Strong interpersonal relationship skills
• Strong written & verbal communication

Suitable candidate will have opportunity to work in USA California

Candidate should have valid passport

for more details please visit our website https://www.nivagen.com/