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Opportunities

JOB DESCRIPTION:

JOB TITLE: Chemist, Process Research and Development

DEPARTMENT: Process Research and Development

SUPERVISOR:Senior Chemist, Senior Chemist I, Senior Chemist II, Projects Leader, Projects Leader I, Projects Leader II, Principal Scientist, Senior Principal Scientist, Process Research and Development

Description:

The Process Research and Development Chemist under supervision will perform synthetic chemistry experiments to assist in developing and validating process chemistry for new and/or established products and projects, characterizing reaction products and intermediates with appropriate methods and maintaining laboratory records in accordance with cGMP/GLP practices and requirements.

Responsibilities:

  • Primary Responsibilities:
    • Under supervision assist in developing and validating new process chemistry and exploiting and validating established process chemistry for synthetic organic chemical reactions.
    • Under supervision assist with the scale-up of new products from gram quantities to production quantities.
    • Prepare novel compounds with optimized chemical and/or physical properties.
    • Generate gram quantities of high-purity samples of key intermediates, most often by chromatography, recrystallization, and/or ambient/reduced pressure distillation.
    • Perform routine characterization of reaction products and intermediates by both wet and instrumental methods.
    • Maintain laboratory records in accordance with accepted cGMP/GLP laboratory practices, SOPs, and regulatory requirements.
    • Assist with review of GMP-related (i.e., controlled) documentation.
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security.

Education / Experience / Personal Requirements:

  • B.Sc. in Chemistry (or equivalent)
  • Preferably, experience with basic chemistry laboratory technology and practical hands-on knowledge of general chemistry.
  • Basic experience in a variety of synthetic organic transformations is helpful.
  • Knowledge of broad based cGMP/GLP principles and the ability to apply said principles is helpful.
  • Ability to perform a range of chemical calculations.
  • Some practical experience in the techniques and procedures of modern organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc.
  • Basic computer literacy (knowledge of Excel or other spreadsheet programs recommended).
  • A high degree of patience.
  • A strong commitment to mastering advanced laboratory techniques.
  • Good interpersonal skills in a decentralized environment.
  • A careful observer dedicated to maintaining professionally valid records including lab notebooks.
  • Intellectually inquisitive.
  • Self-motivated.
  • Good at following instructions and asking pertinent questions.

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JOB TITLE: Chemical Operator I TH

DEPARTMENT: TH Manufacturing

SUPERVISOR: Commercial Products Asset Manager

Description:

The TH Chemical Operator I will handle and operate various equipments to process a Pharmaceutical Product following cGMP Batch Records and SOPs. The operator will operate and monitor the chromatography process to ensure the purification process runs efficiently.

Responsibilities:

  • Will observe and perform production-related activities under the supervision of a qualified Production Employee (TH Chemical Operator II or higher) in the manufacturing of Dronabinol.
  • Training will include, but is not limited to, the general cleaning of the facility and manufacturing equipment.
  • Achieve a competency level with the duties associated with the operation and the processing of Phase II, IV and V.
  • Develop a working understanding of cGMP’s and SOPs.
  • Will perform other duties as assigned.
  • Operate chemical process equipment utilizing hazardous chemicals.
  • Properly use Personal Protective Equipment.
  • Read and follow SOPs and document tasks performed clearly.

Education / Experience / Personal Requirements:

  • Ability to lift 50 pounds.
  • Ability to pass a DEA background check.
  • Ability to work off shifts and overtime.
  • Knowledge of basic Chemistry, Math, and Computer skills.
  • Ability to work with Acids, Bases, and Hazardous Chemicals
  • Requires High School Diploma or equivalent.
  • HPLC & GC experience a plus.
  • Must have mechanical aptitude.
  • Have good written and verbal communication skills.

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JOB TITLE: Associate Director of Analytical R&D and Quality Control

DEPARTMENT: Analytical R&D and Quality Control

SUPERVISOR: Director of Quality Assurance and Regulatory Affairs

Description:

The Associate Director of Analytical R&D and Quality Control will oversee and manage the operations, facilities, and systems of the Norac Pharma ARD/Quality Control Department in support of the development, manufacture, testing, and release of Active Pharmaceutical Ingredients, Intermediates, and API Starting Materials.

Responsibilities:

  • Primary Responsibilities:
    • Develop and validate new analytical methodologies or exploit and validate established analytical methodologies to determine the structure of unknown organic materials, to separate complex mixtures, to characterize novel compounds (including primary and secondary standards), and / or to quantitate any desired analytes.
    • Maintain a high level of working knowledge in the major areas of spectroscopy (especially multi-dimensional NMR, mass spec, X-ray diffraction, IR, and UV/Visible) and chromatography (IC, GC, LC, and HPLC). Remain current in electronic and mechanical troubleshooting for commercial analytical instrumentation. Keep abreast of analytical software developments. Conduct relevant literature searches.
    • Manage a cGMP analytical group that can provide consistently superior analytical measurements. Provide direct supervision to analytical staff members for day-to-day tasks and responsibilities.
    • Oversee and mentor the Norac Pharma Quality Control Department.
    • Establish necessary quality systems to ensure cGMP compliance.
    • Maintain complete laboratory records of the analytical group in accordance with accepted laboratory practices, SOPs, and regulatory requirements.
    • Evaluate inquiries and Tech Packages from potential clients. Interface with process R&D and API Operations on feasibility at pre-proposal stage of inquiries.
    • Generate proposals, progress reports, project summaries, Development Reports, Tech Packages, SOPs, and PowerPoint-presentations as needed.
    • Assist with the preparation / review of regulatory documents.
    • Work with contract organizations as necessary.
    • Key accountability to track, manage and improve the cost of analytical services.
    • Guide cost-effective enhancement of Norac Pharma analytical services (through new technologies, in house or subcontracted).
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac to ensure employee and plant safety and security.
    • Work with management, technical personnel, and EHS Director to ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined workspace, etc.).

Education / Experience / Personal Requirements:

  • Minimum BS in Chemistry (or equivalent scientific discipline).
  • 10+ years work experience in the analytical chemistry of organic compounds is required, with significant focus on structure elucidation of complex compounds using multiple techniques.
  • High-level working knowledge in NMR, IR, Mass Spectroscopy, X-ray crystallography, UV/Visible, IC, GC, and HPLC.
  • Working knowledge of wet chemical and electrochemical analytical techniques.
  • Possesses advanced knowledge of cGMP/GLP/FDA principles and is able to apply these principles in the analytical development and quality control environment.
  • Working knowledge and implementation of USP/EP/ICH guidelines and practices.
  • Candidates must have a proven track record of management experience (managing at least 6 staff).
  • Ability to motivate others and show past effectiveness.
  • Good interpersonal and leadership skills.
  • Ability to operate in a decentralized environment.
  • Ability to manage multiple tasks and prioritize work.
  • Self-motivated with strong organizational and time management skills.
Thank you for your interest in Norac Pharma however we regret that we are unable to acknowledge all submissions and only those candidates who we invite for interview will be considered to be confirmed applicants.