Scientist II, Manufacturing

Job Description:

• Work in a team-based environment and perform antibodies purification for use in research and commercial scientific 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.
• Plus: 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 scientific 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 scientific 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 Qualifications:

• 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.
• Expected first shift hours are Monday through Friday 8:00 AM - 4:00 PM excluding lunch time.
• 1 teams interview Executing through Workorders.
• Antibodies purification experience a big plus. Lab Setting experience critical.
• Experience with Controlled guidelines.