Sr Technician, Bioanalytical

Sr Technician, Bioanalytical 

Kelly Outsourcing Consulting Group (Kelly OCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Sr Technician, Bioanalytical for a long-term engagement at one of our global pharmaceutical clients in Somerset, NJ. 

Schedule:  Monday–Friday, 1st shift 

Location:  Somerset, NJ 

Compensation:  $30.00–$40.00 per hour 

SUMMARY 

The Senior Technician performs all tasks a Technician can perform, with a primary focus on bioanalysis, method development support, and validation studies. Working within established regulated frameworks and under the scientific direction of an (Associate) Scientist, the Senior Technician executes assigned work independently, troubleshoots methods hands-on, and contributes to method development, optimization, and validation. The role also coordinates and coaches technicians, and is recognized as a practical problem solver with extensive knowledge of company processes. 

RESPONSIBILITIES 

Method development & validation (primary focus) 

• Executes and supports bioanalytical method development, transfer, optimization, and validation activities within GLP/GxP and ICH M10 frameworks, under the scientific direction of an (Associate) Scientist. 

• Performs hands-on troubleshooting of bioanalytical methods (e.g., LC-MS/MS), identifying root causes and implementing corrective actions to ensure robustness, accuracy, and reproducibility of study results. 

• Coordinates the execution of a bioanalysis or validation study end-to-end, ensuring runs meet acceptance criteria and documentation standards. 

• Applies a solid working knowledge of validation principles — selectivity, accuracy and precision, calibration range, stability, and carryover — to daily work, and can identify and resolve issues within bioanalytical and validation processes. 

Operations & compliance 

• Performs all tasks and responsibilities of a Technician (STYR 4). 

• Can serve as System Manager for laboratory equipment and support the implementation and qualification of new equipment. 

• Maintains high standards across all deliverables, with strong attention to detail and full regulatory compliance and reliability. 

• Effectively prioritizes tasks and meets deadlines under pressure; adapts quickly to changing priorities, new technologies, and evolving project requirements. 

• Capable of organizing activities to meet project goals. 

People & knowledge 

• Trains new employees and can mentor an MBO intern. 

• Provides guidance and support to colleagues and shares knowledge and complex concepts effectively. 

QUALIFICATIONS 

• Higher professional or master's-level laboratory education (HBO / MSc) — or an equivalent US laboratory-science degree (BS/MS in chemistry, biochemistry, analytical or pharmaceutical sciences, or a related field). 

• 1–3 years of relevant experience in a regulated environment (GLP/GxP preferred), including direct, hands-on involvement in bioanalytical method development and/or validation. 

• Hands-on LC-MS/MS experience for the bioanalysis of small molecules and/or large molecules (experience with both strongly preferred), including method development, optimization, and troubleshooting. 

• Working familiarity with bioanalytical method validation requirements (ICH M10 / FDA / EMA) and the ability to execute validation runs to defined acceptance criteria. 

• Fluent in English (verbal and written). Dutch is a plus. 

• Proficiency in Microsoft Office (Word, Excel, Outlook). 

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