TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Job Description:
Work in a team-based environment and perform antibodies purification for use in research and commercial products for the life sciences industry.
Experiments are performed following controlled protocols and data is recorded on batch records following good documentation practices.
Key Objectives of the role: Responsible for manufacturing of product(s) in a lab setting following standard operating procedures.
Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products.
Will perform purification using AKTA, HPLC, and in process testing through SDS-Page.
Responsible for Batch Data Records, notebooks, customer reports and work order documents.
Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters.
Advise manager of factors that may affect quality of product.
Suggest options/ideas for corrective actions.
Maintain equipment, product inventories and related records as assigned.
Note variances on manufacturing documents; audit and evaluate process documents and propose revisions.
Complete, distribute and file records as required in accordance with Document Control Practices.
Identify potential issues in the qualification process; report findings to team management and members for resolution or participate in troubleshooting.
May lead process improvement projects.
Complete, distribute and file records; prepare ad hoc reports as requested.
May perform other related duties as required and/or assigned.
Advise the team lead/manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and suggest options and ideas for corrective actions and preventive actions (CAPA).
Minimum Qualifications:
Bachelor's degree in biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and 2+ years of experience in a manufacturing or research laboratory.
Masters. Degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and some experience in a manufacturing or research laboratory.
Experience in the use of the laboratory techniques, equipment and materials that includes some of the following techniques: AKTA purification of antibodies, SDS-page testing, HPLC analysis. • Ability to carry out the procedures and make recommendations for improvement.
Excellent documentation and communication skills.
Displays positive attitude toward job and others.
Regularly required to lift up to 20 pounds.
May be required to lift weight of 45 pounds or more, with assistance and/or with equipment on occasion.
Must be flexible to work varying schedules and hours as needed.
Must be able to work safely with chemicals and hazardous materials.
May be required to stand for long periods of time while performing duties.
May intermittently sit at desk/lab bench for a long period of time to perform experiments, write, and use a keyboard to communicate through written means. Preferred
Ability to work independently/in a group setting with direct supervision.
Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
Experience in ISO 90001, ISO 13485 and/or GMP manufacturing environment. Good problem-solving skills.
Antibodies purification experience a big plus.
Lab Setting experience critical.
Experience with Controlled guidelines.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.