Analytical Chemist II

General Description:

Performs all essential job functions of Analytical Chemist II.

• Works independently on execution of procedures and methods.
• Assists scientists and other laboratory personnel in design and interpretation of experiments or project (goal).
• Performs routine as well as more complex assays and preparations.
• Troubleshoots equipment, laboratory protocols and procedures.
• Accurately records and reviews laboratory data generated from established methods and procedures.
• Treats data with a high level of integrity and ethics.
• Maintains laboratory supplies of day to day materials and chemicals.
• Conscientious with safety procedures and knowledgeable of hazardous waste procedures.
• Performs other related duties as assigned by management.

Work Experience Requirements

• 2 years’ experience in a pharmaceutical lab setting

Education Requirements

• BS/BA with a science or chemistry background

Analytical Validation Chemist II

General Description:

Performs all essential job functions of Analytical Chemist II.

• Works independently on execution of procedures and methods.
• Assists scientists and other laboratory personnel in design and interpretation of experiments or project (goal).
• Performs routine as well as more complex assays and preparations.
• Troubleshoots equipment, laboratory protocols and procedures.
• Accurately records and reviews laboratory data generated from established methods and procedures.
• Treats data with a high level of integrity and ethics.
• Maintains laboratory supplies of day to day materials and chemicals.
• Conscientious with safety procedures and knowledgeable of hazardous waste procedures.
• Performs other related duties as assigned by management.

Work Experience Requirements:

• 2 years’ experience in a pharmaceutical lab setting
• GMP Validation
• Method Transfers
• GC/Gas Chromatography
• HPLC
• Finished Product
• Empower Software Preferred

Education Requirements:

• BS/BA with a Science/Chemistry background

Director- Business Development

General Description
In this role, you will serve as the business development representative for the organization, with responsibilities for identifying new CoreRx clients, managing the sales cycle, and securing contracts for our drug product development and manufacturing (CDMO) business.

Responsibilities include:

• Work independently to identify new business opportunities for the organization from industry knowledge, personal research, interactions with marketing and business intelligence tools.
• Actively prospect for potential new business opportunities within a specified account(s)/territory by cold calling new clients and networking at industry related events in the region.
• Develop territory sales plan to grow CoreRx brand and achieve yearly goals.
• Establish or maintain regular face to face meetings with both new and existing contacts.
• Effectively deliver value proposition and key differentiators of CoreRx to customers.
• Manage sales cycle for Request for Proposals (RFPs), identifying key decision makers and buying motivations for client.
• Review, understand and present proposals to clients to close the deal.
• Update information involving activities, opportunities, accounts, and contacts within CRM database.
• Prepare quarterly update reports for business development activities and pipeline growth.
• Represent CoreRx organization at various tradeshows and conferences. Other duties as assigned by Manager.

Work Experience Requirements

• Minimum of 3 years’ experience performing similar B:B sales/business development in the pharmaceutical/biotech industry.
• Proven track record of success in new business development and sales growth.
• Relevant established contacts in pharmaceutical/biotech companies preferred.

Education Requirements

• Bachelor’s degree in a related science field. Additional MBA degree preferred.

Work Environment

Remote, US

Facilities Technician

General Description

Facilities Technicians are responsible for a variety of semi-skilled and skilled day-to-day facility operations, the scheduled, unscheduled and preventative maintenance and repair of a wide variety of facility systems and manufacturing equipment, and require a strong mechanical skill base to include but not limited to: HVAC, compressed air components and systems, generators, building management systems, control logic systems, security systems, water conditioning systems, electrical, lighting, fenestration, plumbing, drywall, and general landscape maintenance.
Areas of responsibility for the Facilities Technician include:

• Perform scheduled, unscheduled and preventative maintenance on, but not limited to: HVAC, generators, water conditioning systems, manufacturing equipment, and compressed air systems.
•  Perform installation and repair projects as scheduled or assigned, involving, but not limited to: plumbing, drywall, lighting fixtures, carpentry, fenestration, furniture, floors, and painting.
• Maintain cleanliness and appearance of the internal and external building and grounds.
• Prepare for company event set-ups, employee moves, and workstation modifications or relocations.
• Perform tasks that may involve the use of ladders, measuring equipment, and hand or powered tools.
• May oversee basic contracted facility services.
• May assist in or provide basic knowledge for the recommendation of purchase, cost saving measures, and development of a project or repair project.
• Maintain logbooks, work orders, and maintenance documents.
• Perform other duties as assigned by manager.
• Works in a neat, orderly, and safe manner, constantly seeking to improve methods and the safety of others.
• Ensure safety procedures are followed. Maintain a safe and clean work environment for employees while performing required duties.
• Work within a work schedule designed to minimize the impact on manufacturing and other critical operations.
• Works under general supervision.

Work Experience Requirements

• Basic knowledge of hand and power tools, and measuring equipment.
• Ability to read and understand compressed air, electrical wiring and control diagrams.
• Knowledge of safety and environmental rules and regulations concerning procedures, tools, mechanical and electrified equipment, commonly used chemicals and basic safe work practices is required.
• Must possess a welcoming manner and positive attitude; demonstrate effective communication skills; ability to professionally interact with guests and other employees; and assist in handling customer work orders, involving management as necessary.
• Must be able to communicate clearly and effectively in English both verbally and in writing.

Education/Additional Requirements

• High school diploma or GED and one or more (1+) years of building maintenance experience, or any equivalent combination of training and experience.
• Basic use of a laptop/personal computer and computer skills.
• Must possess basic math and reading skills

Physical Demands

• Standing, walking, kneeling, crawling, crouching and bending approximately 75% of the day.
• Ability to lift and carry up to 50 pounds

Work Environment 

• Will work in a controlled environment with limited exposure to outdoor conditions.

Preformulation Research Assistant

 General Description:

The preformulation researcher will be expected to support the development of small molecule and peptide drug products through characterization, analytical development, and stability. The focus will be providing support for the formulators in the following areas: physiochemical properties, characterization, analytical method development, and summary reports. This job will allow you to experience a wide range of scientific disciplines and multiple analytical and characterization instruments.

 ESSENTIAL JOB FUNCTIONS

• Conduct laboratory experiments to evaluate pharmaceutical properties such as solubility, pKa, LogP/LogD, stability, polymorph, particle size, and crystallinity of small molecule drug candidates
• Flux/Permeation studies
• Verify/validate phase appropriate analytical methods
• Assist with development and implementation of solubilizing preclinical formulations to support preclinical and clinical studies
• Collaborate with other teams to advance compounds through the various phases of drug product development while meeting timelines.
• Collect and analyze data, and maintain both R&D and GMP laboratory notebooks

DEMONSTRATED FLUENCY IN ONE or MORE OF THE FOLLOWING AREAS

• UVVIS, IR, K-F, pH
• HPLC (Reverse Phase, Normal Phase, SEC, GPC) (Empower Software)
• HPLC Detectors (RI, Fluorescence, CAD, ELSD, PDA, UV)
• GC (Direct Inject/Head space)
• USP dissolution (Vankel/Distek)
• X-ray Powder Diffraction (Rigaku Mini Flex 600 PDXL Software)
• Differential Scanning Calorimetry
• Particle Size Analysis

 EDUCATION REQUIREMENTS

BS/BA with 2 years experience or MS/MA with 0 years experience

Manufacturing Technician I

General Description

Specific tasks carried out by a warehouse manufacturing technician can include:

• Supports process and facility operations, complying with CoreRx, Inc. and FDA cGMP requirements.  Perform cleaning, equipment assembly/set-up and document all activities.
• Supports process and facility operations, complying with CoreRx, Inc. and FDA cGMP requirements.  Perform cleaning, equipment assembly/set-up and document all activities.
• Perform batch instruction to include dispensing of materials, operation of mill or process and blending equipment, physical testing, product inspection, packaging, and general support of the manufacturing operation.• Room cleaning, equipment cleaning and storage of related parts.
• Training on SOP’s to remain current for job requirements, lob book entries and cGMP documentation.  Ability to comprehend and follow written instructions.
• Perform preventative maintenance, minor repairs to equipment, equipment set up, and daily checks to support the manufacturing operation.

Work Experience Requirements

• Pharmaceutical experience preferred

Education/Additional Requirements

Physical Demands

Work Environment 

• Work in climate-controlled environment

Manufacturing Technician III

General Description

• Meets all Manufacturing Technician I & II requirements.
• Supports process and facility operations complying with CoreRx Inc. and FDA, GMP requirements.
• Perform cleaning, equipment assembly/set-up and documents entry activities.
• Conducts and Leads batch processes.
• Works cross functionally within the organization to facilitate the successful completion of all development projects and meets the objectives and goals of CoreRx Inc.
• Leads manufacturing projects applicable to the individual’s qualifications.
• Performs batch instructions to include dispensing of materials, operation of all minor and some major process/blending equipment.
• Perform physical testing, product inspection, packaging, and general support of the manufacturing operation.
• Room cleaning, equipment cleaning and storage of related parts and equipment cleaning verification.
• Training on SOP’s to remain current for job requirements, logbook entries and GMP documentation.
• Assist in writing Master Batch Records and Qualification Protocols, batch record review and approval.
• Sourcing and purchasing of equipment and supplies to support the manufacturing operation.
• Perform preventative maintenance, calibrations, repairs to equipment, set-up and daily checks to support the manufacturing operation.
• Computer and math skills required with advanced mechanical aptitude and knowledge of metric system required.
• Ability to comprehend and follow written instructions.
• May perform as back-up for Manufacturing Group Leader when assigned.
• Performs other related duties as assigned by management.

Work Experience Requirements

• 4 or more years’ experience in a cGMP pharmaceutical manufacturing environment.

Education Requirements

• High School diploma required
• AAS preferred

Physical Demands

• Able to stand for long periods of time
• Able to lift 55 lbs.
• Able to see/hear and communicate effectively

Work Environment

• Will work in a climate-controlled environment
• Will wear the proper protective equipment for a manufacturing environment

Project Coordinator

GENERAL DESCRIPTION:

• Work closely with project management and clients in support of clinical product development projects
• Understand project scope and associated project quotes and change orders
• Work closely with the Quality Unit to ensure results for material testing are completed and submitted for approval for use in manufacturing
• Provide support to the Logistics department as it relates to project material needs and timing
• Support Project Management in the daily tasks required to maintain customer expected timelines and ensuring all departments are aware of promised delivery dates
• Ensure requirements for operations and the partners / clients are met
• Partner with stakeholders to ensure clear required documentation
• Assess, manage and mitigate risks
• Provide Project Management and Senior Management with project financial status and support monthly invoicing execution
• Maintain financial tools for each project and overall project financial status budget versus billed on a monthly and annual basis
• Develop improved and efficient financial tracking tools as needed to support the financial visibility amongst the various departments
• Track project status for budget burn rate versus project estimates of milestone completions
• Provide project backup during instances of Project Manager absences
• Other duties as assigned by Manager.

Work experience requirements:

• Min. 1-2 years’ experience in customer service / technical support (preferably in the pharmaceutical industry)
• Well-versed in Microsoft Office

The Project Coordinator should demonstrate competence in all the following:

• Behave Ethically: Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
• Communicate Effectively: Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques.
• Creativity/Innovation: Develop new and unique ways to improve operations of the organization and to create new opportunities.
• Proficient in Microsoft Office

Education Requirements:

• Min. Bachelor’s Degree in Business
  
  

Work Environment:

• General office setting

Quality Assurance Inspector

GENERAL DESCRIPTION:

• Adherence to all company procedures/SOP’s (Standard Operating Procedures)
• Perform sampling of in-process and raw materials
• Release of materials
• Participating in the environmental monitoring and water systems
• Perform cleaning verifications
• Inspections on Labels / Components (Printing and Filling out TM-0210 pages for all inspections or Lab Notebook)
• Perform and review In-Process Checks
• Tagging Released Materials in Warehouse (Green Release Tag and Component Inventory Cards)
• Release Staged Batches to GMP from Warehouse
• QA Retain Storage and update location in Database
• Deliver samples to Analytical / Formulations / Project Management
• Major/Minor Clean Room Releases for Manufacturing
• Adhoc Inspections as they arise (i.e. Complaints or special requests)
• Working on Sampling Statistical Form to use for visual capsule defects
• Equipment Cleaning Verification and Validation Sampling
• Preparing and Shipping samples directly to contract laboratory when required
• Review & Approve In House Release Testing performed by QA Inspectors
• Fill out Green Release Tags for any approved In-House Release testing performed by QAI
• Performs other related duties as assigned by management.

Work Experience Requirements

• Proficiency in MS Office Applications; Word, Excel
• Strong organizational skills
• Proofreading skills
• Ability to communicate clearly with colleagues and clients in written and verbal form.

Education/Additional Requirements

• High School Diploma
• BS or BA preferred

Senior Formulation Research Associate in Preformulation

General Description:

The preformulations researcher will be expected to support the development of small molecule and peptide drug products through characterization, analytical development, and stability. The focus will be providing support for the formulators in the following areas: physiochemical properties, characterization, analytical method development, summary reports. This job will allow you to experience a wide range of scientific disciplines and multiple analytical and characterization instruments.

ESSENTIAL JOB FUNCTIONS

• Design and conduct laboratory experiments to evaluate pharmaceutical properties such as solubility, pKa, LogP/LogD, stability, polymorph, particle size, and crystallinity of small molecule drug candidates
• Flux/Permeation studies
• Develop and validate phase appropriate analytical methods
• Assist with development and implementation of solubilizing preclinical formulations to support preclinical and clinical studies
• Collaborate with other teams to advance compounds through the various phases of drug product development while meeting timelines.
• Collect and analyze data, and maintain both R&D and GMP laboratory notebooks
• Write preformulation reports and designated sections of submissions to regulatory authorities.
• Support CRO/CMO activities as lead representative in communications.

DEMONSTRATED FLUENCY IN ONE or MORE OF THE FOLLOWING AREAS

• UVVIS, IR, K-F, pH
• HPLC (Reverse Phase, Normal Phase, SEC, GPC) (Empower Software)
• HPLC Detectors (RI, Fluorescence, CAD, ELSD, PDA, UV)
• GC (Direct Inject/Head space)
• USP dissolution (Vankel/Distek)
• X-ray Powder Diffraction (Rigaku Mini Flex 600 PDXL Software)
• Flux/Permeation (Vertical Diffusions Cell “Franz Cell”) (Side by Side Flux Studies)
• PION Rainbow Fiber Optic Dissolution Monitoring System
• Differential Scanning Calorimetry
• Particle Size Analysis

EDUCATION REQUIREMENTS

• BS/BA with 6 years experience or MS/MA with 4 years experience.