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JOB DESCRIPTION:

JOB TITLE: Senior Chemist II Process Research and Development

DEPARTMENT: Process Research and Development

SUPERVISOR:Projects Leader, Projects Leader I, Projects Leader II, Principal Scientist, Senior Principal Scientist, Group Leader, Senior Group Leader, Associate R&D Director or Director, Process Research and Development

Description:

The Process Research and Development Senior Chemist II provides technical leadership to perform synthetic chemistry experiments 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:
    • Assist in evaluating the feasibility of synthesizing compounds that may be brought to Norac Pharma.
    • Develop and validate synthetic lab and pilot plant processes to produce a variety of organic and organometallic compounds.
      • Conduct relevant literature searches.
      • Develop lab scale procedures for the syntheses of organic compounds.
      • Optimize the procedure to improve yields in the syntheses of organic compounds.
      • Scale up the lab process to produce pilot plant and production quantities of the compounds in accordance with cGMP requirements.
      • Write Development Reports on synthesis and scale up projects per cGMPs.
      • Maintain complete laboratory records in accordance with accepted laboratory practices, SOPs, and regulatory requirements.
      • Develop analytical methodologies
    • Monitor yield and efficiencies of processes after commercial startup at the plant.
    • Help establish necessary practices to ensure GLP/cGMP compliance.
    • Take on Project Leader responsibilities and manage the work load vs. project timelines to complete projects on time, within budget and achieving the desired quality.
    • May provide direct supervision to junior staff as well as work in a mentoring role. Acts as peer review for work of others, consistent with training.
    • Assist with the preparation / review of controlled and regulatory documents.
    • Work with contract organizations as necessary.
    • Adheres to current Good Manufacturing Practices (cGMP’s).
    • Verbal interaction with clients to discuss scientific results.
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security
    • Perform a critical review of the processes to determine potential risk and make recommendations to mitigate the risks.
    • Work with management, technical personnel, and EHS director to ensure any new process or changes to existing processes follow OSHA PSM guidelines.
    • Ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined work space, etc.).

Education / Experience / Personal Requirements:

  • M.Sc. in Chemistry (or equivalent) with 15+ years of work experience in the synthesis and manufacture of active pharmaceutical ingredients
  • Ph.D. in Chemistry (or equivalent) with 5+ years of work experience in the synthesis and manufacture of active pharmaceutical ingredients
  • Hands on experience with a variety of analytical equipment such as HPLCs, GCs, and usual organic spectroscopic instrumentation.
  • Displays excellent working knowledge of cGMP/GLP principles and able to apply the principles.
  • Excellent 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.
  • Demonstration of previous managerial experience and/or team leading experience is preferred.
  • Ability to work as part of a multi-disciplinary team and coordinate activities with cross-functional departments.

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JOB TITLE: Chemist I Quality Control

DEPARTMENT: Quality Control

SUPERVISOR: Team Leader Quality Control

Description:

The Quality Control Chemist I will perform release testing at all stages of chemical manufacture including raw material, in-process and finished product as well as perform analytical method validation, cleaning verification and stability testing according to newly developed and established protocols as well as assisting Analytical R & D Chemists to develop analytical methods suitable for validation on an as-needed basis

Responsibilities:

  • Testing of raw material, in-process, and finished product in support of commercial manufacturing and contract projects using analytical instrumentation and wet chemical tests.
  • Determination of assay, organic impurities, residual solvents, water content and inorganic impurities of molecule of interest using wet chemical analytical methods and LC, GC, IC, etc analytical instruments
  • Characterization of chemical impurities and reference standards
  • Generation of method validation protocols and perform validation experiments
  • Documentation of developed analytical methods, including, but not limited to documentation within the laboratory notebook and method creation within EDMS
  • Document and maintain data from testing of chemical raw materials, in-process material and products as per Good Documentation Practices procedure
  • Prepare and execute stability protocol, initiate stability study and prepare interim and final reports detailing results of protocol execution.
  • Perform cleaning method validation and write cleaning validation reports.
  • Perform the following as needed:
    • Method transfer in-house and from clients
    • Method verification
    • Evaluate and validate client methods
    • In house methods validation, including contract and commercial products
    • Material and standard qualification
    • Routine lab instrument calibration
  • Peer review of lab notebooks, validation and stability reports for calculations and accuracy of results.
  • Perform day to day general lab activities e.g. sampling of solvents for monitoring purposes, cleaning lab glassware, monitoring stability chambers, maintaining cleanliness in the laboratory
  • Write validation and stability reports and memos
  • Perform biennial document review and revise documents as deemed necessary
  • Create new methods and SOPs as necessary
  • Train junior staff on equipments and software usage
  • Compliance with company, legal and regulatory procedures and standards

Education / Experience / Personal Requirements:

  • Degree in chemistry and/or chemistry analytical science with 0 to 2 years of quality control, pharmaceutical process analytical chemistry experience
  • Hands-on working experience of Laboratory Instrumentation (HPLC’s, GC’s, GCHeadspace, Ion Chromatography, NMR, FTIR, UV-Vis, KF, etc.) is preferred
  • Good team working skills and experience
  • Ability to work as part of a multi-functional project team involving quality control staff, process analytical chemist(s), process development chemist(s), and chemical production staff
  • Knowledge of current Good Manufacturing Practices for pharmaceutical chemical manufacture.

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