Analytical Chemist

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Scientist I, Manufacturing Sciences
Location: Fremont, CA - 94538
Duration: 6 Months - May extend or convert after 6 months, based on performance and business needs.
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday from 09:00 AM to 05:00 PM

Summary

We are seeking a Scientist I, Manufacturing Sciences / Analytical Chemist to support the production of reagents, calibrators, buffers, controls, intermediates, and other laboratory products in a regulated manufacturing environment. This role is responsible for manufacturing operations, batch record documentation, in-process testing, laboratory activities, quality investigations, equipment maintenance, and continuous process improvement while ensuring compliance with cGMP, GDP, Quality System Regulations (QSR), ISO 13485, and IVD standards. The ideal candidate will have laboratory experience, strong documentation skills, and the ability to work safely with hazardous chemicals and controlled substances in a fast-paced manufacturing environment.

Responsibilities

• Manufacture reagents, calibrators, buffers, controls, intermediates, and other laboratory products.
• Complete and maintain accurate batch records in compliance with cGMP and Good Documentation Practices (GDP).
• Perform in-process testing using clinical analyzers.
• Analyze testing data and make in-process adjustments to support product quality and release.
• Review manufacturing batch records completed by other operators and scientists.
• Maintain and analyze lot history records to identify trends and discrepancies.
• Perform laboratory activities including weighing, transferring, mixing chemicals, and product filtration.
• Support process improvement initiatives, 5S activities, and laboratory organization projects.
• Assist with updating Standard Operating Procedures (SOPs), work instructions, and reports.
• Initiate and support investigations involving non-conformances, CAPAs, and variances.
• Maintain, troubleshoot, and support laboratory testing and formulation equipment.
• Communicate production issues and project updates to supervisors and management.
• Perform additional duties as assigned.

Required Skills

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific discipline; equivalent education and experience may be considered.
• Minimum 1 year of laboratory or manufacturing experience preferred.
• Experience working in a cGMP-regulated manufacturing or laboratory environment.
• Knowledge of Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Experience performing laboratory techniques including pipetting, weighing, mixing, filtration, and chemical handling.
• Experience with in-process testing and clinical analyzers preferred.
• Familiarity with hazardous chemical handling and laboratory safety procedures.
• Experience working with human source materials preferred.
• Knowledge of Quality System Regulations (QSR), ISO 13485, and IVD regulations preferred.
• Experience supporting quality investigations, including CAPAs, non-conformances, and variances.
• Ability to review batch records and maintain accurate documentation.
• Experience maintaining and troubleshooting laboratory equipment.
• Strong analytical and problem-solving skills.
• Excellent attention to detail and organizational skills.
• Ability to prioritize multiple tasks in a fast-paced environment.
• Self-motivated with the ability to work independently and as part of a team.
• Strong verbal and written communication skills.
• Ability to comply with controlled substance handling requirements and laboratory safety protocols.
• Ability to successfully complete required background screenings.
• Ability to routinely lift up to 25 lbs. and occasionally lift up to 50 lbs.

TekWissen Group is an equal opportunity employer supporting workforce diversity.