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


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.


  • 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.


JOB TITLE: Chemist I Quality Control

DEPARTMENT: Quality Control

SUPERVISOR: Team Leader Quality Control


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


  • 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.