This Administrative role will be for the Stroudsburg Manufacturing Facility on Rockdale Lane.

The primary function of the role of the Maintenance Administrative Specialist is to support the Maintenance department in all areas of administration, communication and coordination for any and all issues necessary for the efficient operation of the department. This will include but not be limited to coordination with the Director, Managers and other key members that are involved in the management and operation at this department in order to achieve corporate objectives. This position will support the department operating efficiently and safely. The job function will also manage both internal and external detailed confidential information.

The Associate Process Chemist will drive results by safely and accurately operating process equipment and utilities. The Associate Process Chemist must understand and be able to monitor reaction progress and be able to perform chemical reactions on a gram to multi-kilogram scale. The Associate Process Chemist must document using Good Documentation Practices and prepare final reports for completed projects, including final procedures and compiling all analytical data.

The Laboratory Analyst III performs all testing and solution preparations, performs complex instrumental calibrations and maintenance, communicates between departments when reporting results, and executes all protocols as assigned by management. The analyst is also responsible for writing protocols & reports as well sampling raw material, finished goods, stability samples and additional samples as assigned. The Quality Control Analyst III is responsible for training new employees when necessary. This position is required to be fluent in all testing and laboratory requirements. The Quality Control Analyst III is also responsible for overseeing daily laboratory functions, in the absence of the Quality Manager, and ensuring that all finished good testing is executed by the required dates. Must be able to perform all duties of the QC Analyst Levels up to II.

The Laboratory Supervisor is responsible to supervise and direct the day-to-day activities of the laboratory division.

The Maintenance Mechanic will perform preventative maintenance on all equipment, utilities and outside equipment for all BioSpectra facilities.

Small scale chemical tech transfer from a research environment and carrying out cGMP chemical synthesis on a kilogram scale. The Process Chemist is responsible for conducting reaction optimization, developing robust processes, scaling up and delivering high-quality chemical intermediates. The Process Chemist must be skilled in the art and practice of modern chemistry, and have demonstrated technical proficiency in performing sensitive chemical reactions, isolations, separations, purifications and crystallizations. Demonstrated experience at scale-up and a track record of problem solving are required.

Small scale chemical tech transfer from a research environment and carrying out cGMP chemical synthesis on a kilogram scale. The Process Chemist Manager is responsible for conducting reaction optimization, developing robust processes, scaling up and delivering high-quality chemical intermediates. The Process Chemist must be skilled in the art and practice of modern chemistry, and have demonstrated technical proficiency in performing sensitive chemical reactions, isolations, separations, purifications and crystallizations. Demonstrated experience at scale-up and a track record of problem solving are required. The Process Chemist is expected to provide laboratory-based leadership and be a role model for the scientific/technical community in the company by effectively managing technical details and providing sound scientific opinions. Mentor and lead Process Chemist Technicians.

The Quality Manager is responsible for managing the Quality Program and BioDevelopment GMP activities are performed in compliance with industry standards and the Quality System expectations. This position will author, review and/or approve procedures and records associated with product quality and manufacturing operations. This position is also responsible for the quality disposition of all incoming raw materials and components as well as the release of all finished goods.

The Chemist participates in the development of new products, product processes and test methods. This position is responsible for performing testing during process development and collaborating with various functional areas to facilitate data acquisition for scale up and process development. Bench to Pilot Chemist – Product Lifecycle writes technical research and laboratory reports detailing protocols, calculations, results, observations and conclusions. The position is responsible for writing and reviewing process and method feasibility reports, as required.

The Computer Systems Quality Manager is responsible for ensuring that BioSpectra’s GMP computerized systems are validated and used in accordance with GMP requirements and their intended use. The Computer System Quality Manager is responsible for the quality aspect of any BioSpectra GMP Computer System life cycle. The Computer Systems Quality Manager is the owner of all validation activities associated with a BioSpectra computer system intended to generate, store, or impact GMP activities or records.

The Environmental Chemist is responsible for all Environmental Monitoring, sampling, and testing of Process Rooms, Utilities, and Equipment from Development Studies to cGMP Equipment Release including sanitation assessments (cleaning verification). This role is responsible for assisting with the establishment, execution, and maintenance of a compliant Environmental Monitoring program. The Environmental Chemist is responsible for activities at the Bangor and Stroudsburg facilities.

The HVAC Mechanic will perform installation, qualification and maintenance of heating, ventilation and refrigerant based units for all BioSpectra facilities.

The Laboratory Quality Systems Manager is directly responsible for all areas of the Laboratory Quality System. This position is responsible for enforcing data integrity, compliance with documentation and the quality system within the laboratory. The Laboratory Quality Systems Manager is to oversee the Lab documentation work flow from start to finish. This position is responsible to ensure testing is reviewed in its entirety.

The Maintenance Mechanic is responsible for conducting machine setup, troubleshooting, repairs and preventative machine service to ensure continuous operations.

The Manufacturing Supervisor leads their team to accomplish the safety, quality, delivery and cost objectives of the manufacturing department. A supervisor reviews the daily production schedule, assigns work to their team, coordinates plant activities, ensures their team is trained and inspects chemical operator activity throughout the shift. Responsible for ensuring finished goods meet the production schedule and are in compliance with quality standards set for the facility. Leads by example and holds their team accountable for performance/results.

The Mechanical Electrician’s primary function will be to install conduits and to run and pull wiring, also assisting in maintaining, testing, troubleshooting and repairing electrical controls for all BioSpectra facilities.

This position is responsible for packaging, labelling and preparing finished goods for shipment. This position is also responsible for sifting in-process material, cleaning and house-keeping.

The Process Technology Specialist is responsible to assist execution of projects for the Process Technologies division. These projects include participation in the development/validation of new products, increasing capacity of current products, and improving safety, compliance, cost for current manufacturing operations. These responsibilities will be fulfilled by training, understanding of equipment procedures and capabilities requiring a thorough technical understanding of Biospectra’s processes and products.

The Production Technician will run all chemical manufacturing processes in compliance with all associated quality systems. Packs and ships all products. Maintains processes in their validated or compliant state.