Pharmaceutical Analytical HPLC Chemist II

Chemist II Analytical Development Job Description

Job Summary - a concise overview of the job

An Analytical Chemist II will be part of a team responsible for ensuring the analytical readiness for incoming projects in a CDMO environment by performing method transfer, validation, or verification as appropriate. The position will define and execute analytical requirements in an accurate and timely manner to meet current regulatory requirements and expectations of the customer. Strong leadership, scientific writing, and laboratory skills are required.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

The Analytical Chemist II operates within the Analytical Technical Services and Quality Control Laboratories, under the directions of the Technical Services and Quality Organization.

The Analytical Chemist II has no budget/spend authority, but may act as SME in the selection of materials and equipment.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Floor

Operations

• Maintain a clean, organized, and safe work area.
• Perform daily calibrations and maintenance on analytical equipment, such as analytical balances, pH meters, density meters, etc.
• Prepare test solutions, compounds, or reagents for analysis of raw materials and finished products.
• Accurately and precisely perform analytical testing using a variety of wet chemistry techniques, such as weighing and measuring, density, specific gravity, pH, viscosity, titration, and conductivity.
• Perform assay, impurity/degradant, and solvent determinations by chromatographic analysis via thin-layer, gas (GC), high performance (HPLC), Mass Spectroscopy, and ultra performance chromatography (UPLC).
• Perform minor maintenance and troubleshooting on chromatographic equipment.
• Multitask projects while maintaining high levels of accuracy
• § Other duties as assigned

75%

Non-Conforming Events

• Complete basic laboratory investigations with a thorough understanding of root cause analysis and required CAPAs

15%

Process Improvement

• Work in cross functional teams as necessary to complete projects, method transfers, verifications, validations, and investigations

10%

Compliance

• § Maintain current training compliance on assigned SOPs and company policies
• § Accurately and legibly document and record all work completed so that analyses may be fully traceable and reproducible
• § Identify as an expert on at least one type of laboratory equipment, and acts as a SME for that instrument

continuous

Safety

• Operate under all corporate safety requirements at all times, including use of PPEs and adherence to company policies in handling of hazardous substances

continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Bachelor's degree in Chemistry or Related Field with 3-5 years experience in Analytical Development

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Knowledge of FDA regulations
• Familiarity with Current Good Manufacturing Practices (cGMPs)
• Familiarity with analytical laboratory operations and associated safety requirements
• Possesses an expanded understanding of chromatography with ability to troubleshoot most problems without support
• Conduct method validation activities in support of API, excipient, finished drug product, and stability testing
• Coordinate Technical Services, Operations, QA, QC, and other relevant departments within TriRx
• Author and execute protocols for analytical method validation, verification, and transfer.
• Work as part of a team in conducting method validation/verification/transfer activities
• Write thorough and accurate method validation reports and final test methods in a timely manner
• Reports to the Analytical Technical Services Manager
• Perform other related functions as needed to complete overall company and department objectives.

Skills

Abilities

Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

• Experience with chromatographic equipment and integration software
• Experience with Microsoft Office Suite of Products, including Word, Excel, and Teams
• Analytical laboratory experience

• Skilled in analytical method development, validation, verification, and transfer
• Expertise in chromatography to include HPLC, UPLC, GC, IC, and LCMS as well as spectral (FTIR, UV/VIS, etc) and wet chemistry techniques on API, excipient, in-process, and liquid pharmaceutical formulations
• Commitment to safety, cGMP compliance, and DEA regulations
• Must be able to work in a team environment, communicate, organize, plan, and execute projects

• Strong scientific writing skills required

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Must be capable of wearing all appropriate PPEs correctly during handling of hazardous substances
• Some work may require extended periods of time standing at a lab bench to complete
• Must be visually capable of accurately measuring and reading volumes of solution in volumetric apparatus (i.e., accurately read meniscus)