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.
• Collaborate with originating laboratory on the timing of method co-validations, analytical method transfers, and compendial verification; provide technical support for method challenges.
• Troubleshoots equipment, laboratory protocols and procedures.
• Accurately records and reviews laboratory data generated from established methods and procedures.
• Participates in audits for regulatory requirements.
• 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 professional GMP pharmaceutical lab setting.
• Previous experience with protein analysis, a plus.
• HPLC and wet chemistry experience required.
• ELISA a plus.
• Willingness to learn instrumentation.
• Must be fluent in English. (speaking, reading and writing)

Education Requirements

• BS/BA with a science or chemistry and biology 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

Manufacturing Supervisor – 1st Shift

General Description

• Oversee the daily manufacturing operations process
• Create Manufacturing Batch Records for developmental, clinical, registration and commercial products.
• Create and distribute Production schedules. Schedule Overtime when necessary.
• Create/revise existing/new SOP’s for equipment and processes.
• Assist in training Manufacturing personnel.
• Maintain training program in compliance.
• Provide administrative support for all Manufacturing documents.
• Review and approve executed batch records for completeness
• Assist in the creation of Process and Cleaning Validation activities.
• Author manufacturing deviations and CAPA
• Assist in creation of technical risk assessments.
• Other duties as assigned.
• Maintain manufacturing equipment
• Order supplies/materials as needed for the manufacturing department
• Ability to clearly communicate with colleagues and clients in written and verbal form
• Performs other related duties as assigned by management.

Work Experience Requirements

• 6+ years’ experience in a Supervisory/Managerial role in a pharmaceutical manufacturing environment
• Must be able to speak, read and write in English.

Educational Requirements

• BS/BA in Engineering or Sciences or equivalent work experience

Physical Demands

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

Manufacturing Technician

ESSENTIAL RESPONSIBILITIES  

• 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.
• Perform cleaning, equipment assembly/set-up and documents entry activities
• Perform preventative maintenance, calibrations, repairs to equipment, set-up and daily checks to support the manufacturing operation.
• Supports process and facility operations complying with CoreRx Inc. and FDA, GMP requirements
• 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.
• Author/review SOP’s and execute qualification protocols.
• Ability to comprehend and follow written instructions.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• 1-3 years’ experience preferred in a cGMP pharmaceutical manufacturing environment.
• Experience preferred in manufacturing, production, machine operator or technician, batch records, tablets, tablet compression, solid dosage, powder, sachets, pouches, SOPs, GMP and FDA.
• Must be able to understand written and verbal directions in English.

EDUCATION REQUIREMENT

• High School Diploma/GED required.
• Must be able to speak clearly, read, write and understand the English language.

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.

Manufacturing Technician

ESSENTIAL RESPONSIBILITIES  

• 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.
• Perform cleaning, equipment assembly/set-up and documents entry activities
• Perform preventative maintenance, calibrations, repairs to equipment, set-up and daily checks to support the manufacturing operation.
• Supports process and facility operations complying with CoreRx Inc. and FDA, GMP requirements
• 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.
• Author/review SOP’s and execute qualification protocols.
• Ability to comprehend and follow written instructions.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• 1-3 years’ experience preferred in a cGMP pharmaceutical manufacturing environment.
• Experience preferred in manufacturing, production, machine operator or technician, batch records, tablets, tablet compression, solid dosage, powder, sachets, pouches, SOPs, GMP and FDA.
• Must be able to understand written and verbal directions in English.

EDUCATION REQUIREMENT

• High School Diploma/GED required.
• Must be able to speak clearly, read, write and understand the English language.

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.

Preformulation Research Associate

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
• Demonstrate Fluency in one or more of the following
  • 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.

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 of the following
  • • 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

Project Manager

GENERAL DESCRIPTION

Accomplishes project objectives by planning and evaluating project activities. Plan the project:

• Create a detailed work plan which identifies and sequences the activities needed to successfully complete the project
• Determine the resources (time, money, equipment, etc.) required to complete the project
• Develop a schedule for project completion
• Review the project schedule with senior management and all other staff that will be affected by the project activities; revise the schedule as required
• Determine the objectives and measures upon which the project will be evaluated at its completion
• Execute the project according to the project plan:
• Develop forms and records to document project activities
• Set up files to ensure that all project information is appropriately documented and secured
• Monitor the progress of the project and adjust as necessary to ensure the successful completion of the project
• Establish a communication schedule to update stakeholders including appropriate staff in the organization on the progress of the project

The Project Manager should demonstrate competence in some or all of 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.
• Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve problem, and make decisions that enhance organizational effectiveness.
• Lead: Positively influence others to achieve results that are in the best interest of the organization.
• Make Decisions: Assess situations to determine the importance, urgency and risks, and make clear decisions which are timely and in the best interests of the organization.
• Organize: Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
• Plan: Determine strategies to move the organization forward, set goals, create and implement actions plans, and evaluate the process and results.
• Solve Problems: Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem.
• Performs other related duties as assigned by management.

Work Experience 

• Min. 1-3 years’ experience in Project Management role or similar (preferably in the pharmaceutical or technical industry).

Education Requirements

• Min. Bachelor’s Degree (Preferably in a Science or Technical Field)

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 Requirements

• High School Diploma
• BS or BA preferred

Supply Chain Materials Manager

GENERAL DESCRIPTION

The Supply Chain Materials Manager is a customer facing, hands on position that implements planning, forecasting, capacity planning and materials planning for clinical and commercial projects. Responsibilities include but are not limited to:

• Execute Sales & Operation Planning (S&OP) process, facilitate consensus forecast and drive execution while adhering to Safety, Quality, Deliver and Cost (SQDC) priorities and objectives.
• Leads the supply planning and scheduling team to manage operations planning, master production scheduling, material supply management, life cycle product project management, capacity planning, supply & scheduling reporting.
• Responsible for capacity planning in line with changing demand and investigate capacity against mid and long-term forecast to identify key constraints and opportunities.
• Leverage existing and new systems and processes to Improve end to end Supply Chain efficiencies.
• Manages the Procurement of raw materials for production.
• Leads the Management of Supplier issues that may affect the on-time and cost-effective supply of product.
• Actively engage in the process of establishing new ERP system which is critical to Operations planning/scheduling and supply chain management.
• Closely work with counterparts in Operations, Project Management, Quality and other functions to align and develop executable plans.
• Personally creates, promotes and delivers continuous improvement activity surrounding Master Production Scheduling, and Material Supply Management.
• Manages and works toward attaining service level metrics – On Time Delivery and Backorders.
• Responsible for the efficient and accurate management of all supply related systems in the facility, ERP, and scheduling related spreadsheets. 

WORK EXPERIENCE REQUIREMENTS

• A minimum of 4+ years of progressively increasing managerial experience in a supply chain role.
• MRP/MPS.
• Strategic Planning.
• Experience in Manufacturing (Pharmaceutical Manufacturing a plus)
• Experience with ERP systems. (Dynamics AX 365 a plus)

EDUCATION REQUIREMENTS

• Bachelor’s degree in science, engineering, supply chain management, logistics, business administration or related discipline.
• Advanced education preferred.

Job Type: Full-time and Onsite.