Opportunities
JOB DESCRIPTION:
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 protocol development, 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 in-process 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, GC-Headspace, 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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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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