Opportunities

Position:

JOB TITLE: Chemist II Quality Control

DEPARTMENT: Quality Control

SUPERVISOR: Team Leader Quality Control

Description:

The Quality Control Chemist 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:

• In a team setting and cGMP environment, under routine supervision, performs the physical and chemical testing of raw materials, materials in-process, and finished products to assess conformance to applicable standards.
• Ensures the commercial laboratory testing process is well defined, adheres to current Good manufacturing Practices (cGMP), all equipment are appropriately qualified for analytical testing.
• Prepares and standardizes test/volumetric solutions, standard solutions and samples for various chemical and physical test according to approved methods, perform and lead others in performing complex analyses including, but not limited to HPLC, GC, IC, UV-Visible Spectrophotometry, FTIR, and Karl Fischer
• Responsibilities include peer review, evaluate and investigate results from various analyses and accountable for identifying trends and reoccurring issues. Additionally prepare, organize and final review paperwork and lab results for lot release to ensure accuracy and completeness, represent the team as a leader in problem solving, troubleshooting and documentation related to laboratory investigations.
• Responsible for scientific leadership within the Analytical QC laboratory performing method verification, troubleshooting, and USP method verification. Suggest alternative methods, processes and procedures in solving problems and meeting changing laboratory opportunities. Review technical problems and procedures within the laboratory and recommend solutions to problems or changes in procedures.
• Experience with Method Validation and Qualification activities, including protocoldevelopment, execute protocols and write summary reports.
• Comply with Norac Pharma’s policies, procedures, quality standards as well as safety and environmental regulations. This individual will assure compliance with all US (e.g. FDA Guidelines, USP, cGMP) and compliance requirements.
• Maintain working knowledge of assigned instrumentation, equipment, and operating procedures necessary to perform assigned tasks.
• 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
• Perform day to day general lab activities e.g. sampling raw materials and inprocess testing, cleaning lab glassware, monitoring stability chambers, maintaining cleanliness in the laboratory
• Participate in analytical investigations and CAPA’s
• Must be able to periodically lift and move bulky items of up to 50 pounds

Education / Experience / Personal Requirements:

• Minimum 2-3 years in a Pharmaceutical Analytical Laboratory environment
• Hands-on working experience of Laboratory Instrumentation (HPLC’s, GC’s, GCHeadspace, Ion Chromatography, FTIR, UV-Vis, KF, etc.)
• Prior experience with characterization of raw materials, APIs and chemical impurities using FT-IR, UV-Vis, KF, ICP, NMR, LC-MS, GC-MS, Particle Size Analyzer and XRD is preferred
• Knowledge and understanding of FDA, ICH, and USP requirements
• Excellent interpersonal, communication and organizational skills
• Excellent computer proficiency and technical writing skills
• Degree in Science, preferably in Chemistry or related field

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Position:

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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Position:

JOB TITLE: Chemist, Process Research and Development

DEPARTMENT: Chemist, Process Research and Development

SUPERVISOR: Senior Chemist, Senior Chemist I, Senior Chemist II, Principal Scientist or 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:
  • Method transfer in-house and from clients
  • 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. degree 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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Position

Senior Process Chemist

Salary compensation commensurate with experience.

Norac Pharma is looking to hire an experienced Process Chemist to join our team of dedicated professionals involved in Active Pharmaceutical Ingredient (API) research, development and manufacture at our Azusa California site. The candidate that we recruit will ultimately be responsible for developing safely scalable processes for manufacture of existing API’s, as well as new medicines to benefit patients worldwide. These manufactures will be implemented in our Kilo Lab, Pilot Plant and Commercial Manufacturing facilities. The position requires the individual to provide technical leadership in performing synthetic chemistry experiments for understanding, developing and validating process chemistry for new and/or established products and projects, characterizing reaction products utilizing appropriate methodology and maintaining laboratory records in accordance with cGMP practices and requirements. Norac Pharma is a California-based API contract research, development and manufacturing facility located in Azusa California, just east of Pasadena, at the foothills of the San Gabriel Mountains. The region offers numerous hiking trails, as well as being ideally located for travelling to the beaches in the summer and to the mountains with skiing in the winter, in addition to providing easy access to superb arts, culture and a myriad of other social/leisure facilities and opportunities. We believe that the long-term success of Norac Pharma depends first and foremost on recruiting and retaining the highest quality personnel, as well our cooperative cross-functional working thanks to our relatively small size of around 70 staff at this location, albeit with ongoing investment and growth and with strong supporting financial security. Norac Pharma enjoys world class facilities with state of the art analytical equipment which our scientists use for effective and efficient process design (detailed below). Apart from this breadth of analytical equipment, Norac Pharma has a variety of other process tools to aid in developing safe, scalable, robust processes (detailed below). We encourage diversity along with close and cooperative project team collaboration on each and every project.

Requirements:

• M.Sc. degree in chemistry with at least 7 years of relevant work experience in the synthesis and manufacture of active pharmaceutical ingredients and/or Ph.D. degree in chemistry with at least 3 years of relevant work experience in the synthesis and manufacture of active pharmaceutical ingredients
• Hands-on experience in the development and scale-up of a variety of synthetic organic transformations at multi-kilogram scale
• Practical experience in the techniques and procedures of synthetic organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc
• Excellent interpersonal skills with an ability to work as part of a multi-disciplinary team, with the ability to manage, prioritize and coordinate activities with cross-functional departments
• Self-motivated with strong organizational and time management skills
• Hands-on experience with a variety of analytical spectroscopic equipment such as HPLCs, GCs, for organic reaction analysis
• Clear writing and communication skills
• Demonstration of previous project managerial experience and team leading experience
• Ideally has a working knowledge of cGMP principles and the ability to apply them Experience with a range of chemical calculations
• Computer literacy including practical experience with Excel, Word, Powerpoint, Outlook, Chemdraw or equivalent software
• A careful observer dedicated to maintaining comprehensive experimental records including diligent lab notebook recording of work
• Demonstration of understanding the mechanisms of reactions and reaction kinetics as a predictor of control and scale up
• A working knowledge in the use of factorial experimental design software to aid process optimization is preferred

• Develop and validate new process chemistry or evaluate and validate established process chemistry for synthetic organic chemical manufactures
• Scale-up of new products from gram quantities to multi-kilo to tonnage scale manufacture in our Kilo Lab, Pilot Plant and Commercial Products Facilities
• Take on Project Leader responsibilities and management of workload vs. project timelines to complete projects on time, within budget and achieving the desired quality
• Generate insights into chemical reactions and procedures under development
• Obtain scale-up kinetic and thermodynamic experimental data defining controlling variables by performing periodic removal, quenching (if required) and analysis of aliquots
• Conduct thorough literature reviews to identify and assess feasibility of proposed route(s) of synthesis
• Write and present development reports to upper management and clients
• Verbal interaction with clients to discuss scientific results
• Prepare novel compounds and characterize them using modern spectroscopic tools (IR, NMR (1H, 13C,1-D,2-D), UV-Vis, MS)
• Generate gram quantities of high-purity samples of key intermediates, most often by chromatography, recrystallization, sublimation, and/or fractional distillation
• Maintain laboratory records in accordance with accepted good laboratory practices, SOPs, and regulatory requirements
• Teach and mentor junior staff with possibility of supervisory management role
• Assist with the preparation/review of regulatory and controlled documentation
• Adhere to current Good Manufacturing Practices (cGMP)
• Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee, plant and community safety and security
• 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.
• Ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined work space, etc.).

• Waters and Agilent HPLC’s with a variety of detectors (UV-Vis, PDA, Refractive Index, Charged Aerosol)
• UPLC with Q-TOF Mass Spectrum
• Bruker 400MHz NMR
• Inductive Coupled Plasma Mass Spectrometry (ICP-MS)
• Gas Chromatography (Direct Injection, Head-Space GC, Mass Spectrum)
• Malvern Mastersizer for particle size analysis
• Air Jet Sieve methodology for particle size analysis
• X-Ray Powder Diffraction
• Polarimeter
• Total Organic Carbon analyzer for fast turnaround for cGMP equipment cleaning verification
• Dynamic Vapor Sorption for determining solvent uptake
• Thermal Gravimetric Analysis
• Differential Scanning Calorimetry for thermal analysis of samples
• Morphologi for particle size and shape analysis and visualization
• Ion Chromatography
• UV determination
• Karl Fischer for water determination
• Infrared analysis
• Autotitrators

• ReactIR for real time in-situ reaction monitoring
• Teledyne ISCO for chromatographic separations
• Focused Beam Reflectance Measurement for real time in-situ crystallization monitoring
• RC-1 calorimetry
• Advanced Reactive System Screening Tool for process safety assessment
• EasyMax for automated reaction execution and monitoring
• Fisher-Porter bottles
• Asynt multi-tube autoclave for pressure reaction screening
• Multi-well reaction blocks for quick screening of reactions
• Autoclaves for scale up of pressure reactions
• Optical microscope
• Standard laboratory equipment for reaction monitoring (e.g. J-Kem thermocouples and vacuum controllers, overhead stirrers, jacketed reactors, heater/chiller units, rotary evaporators etc.)

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