Opportunities
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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