Opportunities
Are you a Process Research and Development Chemist with:
- with a BS/MS degree in chemistry (required)
- and basic chemistry laboratory experience
Do you enjoy practical chemistry problem solving and working on a variety of projects in a collaborative team environment
Are you interested in Working with a long established, world leading active pharmaceutical ingredient
contract development and manufacturing organization noted for solving tough
chemical process challenges and providing unbeatable customer service, located
in the beautiful surroundings of Azusa, California, within short access to
spectacular hiking and beaches and benefiting from year-round warm California
climate.
If so, Norac Pharma is looking for an additional synthetic organic chemist to support our expanding API process R&D team.
When applying please specifically list:
1. Your degree (with need for Masters or Doctorate qualifications in synthetic organic chemistry)
2. Details of experience
3. Your available start date
Please visit the career section of our website at www.noracpharma.com for a detailed job description.
Qualified candidates meeting the 3 criteria listed above are invited to submit their resume and supporting letter by email to:
resumes@noracpharma.com
If you need assistance in applying for this or any other position with Norac Pharma, please contact our Human Resources Department at 626-334-2908 and direct assistance will be provided.
Norac Pharma is an Equal Opportunity Employer: Minorities/Female/Disabled/Veteran
--------------------------------------------------------------------------------------------------------
JOB DESCRIPTION:
JOB TITLE: Chemist II 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 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:
- Assist and contribute to developing and validating new process
chemistry and exploiting and validating established process chemistry
for synthetic organic chemical reactions.
- Generate unforeseen insights into chemical reactions and procedures
under development.
- Some mentoring of junior staff.
- Assist and contribute with the scale-up of new products from gram
quantities to production quantities.
- Reasonable ability to interpret data via modern spectroscopic tools (IR,
NMR (H,C,1-D,2-D), UV-Vis, MS)
- 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.
- Obtain scale-up kinetic and thermodynamic experimental data
involving controlled variables by performing periodic removal,
quenching (if required) and analysis of aliquots.
- Perform routine characterization of reaction products and
intermediates by both wet and instrumental methods.
- Ability to distinguish between expected and unexpected experimental
results.
- Maintain laboratory records in accordance with accepted cGMP/GLP
laboratory practices, SOPs, and regulatory requirements.
- Assist with the preparation / review of GMP-related (i.e., controlled)
documentation.
- Adheres to current Good Manufacturing Practices (cGMP’s).
- Ability to write detailed reports and present results to upper
management and clients when required.
- 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) with 5+ years of experience
- M.Sc. in Chemistry
- Experience with basic chemistry laboratory technology and practical
hands-on knowledge of general chemistry.
- Detailed experience in scale-up of a variety of synthetic organic
transformations.
- Knowledge of broad based cGMP/GLP principles and the ability to apply
said principles is helpful.
- Ability to perform a range of chemical calculations.
- 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.
- Able to manage multiple tasks and prioritize work.
- Self-motivated with strong time management skills.
--------------------------------------------------------------------------------------------------------
JOB DESCRIPTION:
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 broad based cGMP/GLP principles and the ability to apply
said principles is helpful.
- Ability to perform a range of chemical calculations.
- Practical experience in the techniques and procedures of modern organic
chemistry including spectroscopy, chromatography, handling air-sensitive
agents, etc.
- Knowledge of current Good Manufacturing Practices for pharmaceutical chemical
manufacture.
--------------------------------------------------------------------------------------------------------
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.