Chemist

Location: Elizabeth, NJ

Duration: 6 months

·        Previous Pharma experience (0-1 yr) - Entry level

·        HPLC, Assay, Dissolution, Uniformity, Karl Fischer, Particle Size, Empower, Chemstation

·        BS/BA in Chemistry, or BS in a Related Science

·        cGMP

·        This position performs analyses, inspection, and testing of products, raw materials, in-process materials, release test samples, stability samples, or packaging materials.

·        Performs qualitative and quantitative assays on samples, to ensure quality standards and compliance with company standards, customer and governmental regulatory requirements, and product specifications for the chemical or physical properties.

·        Uses approved Test Methods, Protocols, Procedures (SOP’s) and Corporate Policies while maintaining adherence to current industry standards.

·        Employs variety of analytical techniques that vary from standard analytical equipment to highly modern and automated instrumentation, aides in maintenance and certification of test instruments and apparatus to ensure compliance.

·        May be involved or responsible for performing Laboratory Investigations, Change Controls, audit/review of laboratory data, implementing CAPA, Planning and scheduling laboratory activities, and coordinating process improvements.

·        Follow established laboratory safety procedures.

·        Analyze samples using appropriate instrumentation (depending on training, some or all of the following would apply – HPLC, GC, UV, IR, KF, pH, etc.) while following current Methods & Procedures (SOP’s).

·        Process and report HPLC instrumental analysis using Empower data processing software.

·        Process and report other instrumental analysis using the instrument specific data processing software.

·        Document all activities in a legible manner following established formats and procedures.

·        Identify and troubleshoot problems with instrumentation and analytical preparations.

·        Initiate and conduct laboratory investigations

·        Review and approve analytical data

·        Participate in process improvement projects

·        Train new and current employees.

·        BS/BA in Chemistry, or BS in a Related Science

·        Minimum 0 - 1 year in a pharmaceutical laboratory environment.

·        Specialized or Technical Knowledge, Licenses, Certifications required - Must possess knowledge regarding various tests and wet chemistry techniques that pertain to Raw Material and/or Finished Product analyses (depending on assigned product line, some or all of the following would apply – Viscosity, Thin

·        Layer Chromatography, various forms of “Limit Tests”, etc.)

·        Knowledge of cGMP’s.

·        Knowledge of compendia procedures where applicable (i.e., USP, NF, BP, etc.).

·        Possess good written and oral communication skills.

·        Proficiency with Empower software and Microsoft Office– Word and Excel.

·        Possess strong mathematical skills – fractions, percentages, ratios and algebraic expressions.

·        Possess good problem-solving skills

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Approximately 60% standing or walking.