Formulation Scientist I

Position Summary:

Work in a team based environment and formulate molecular biology reagents for use in research and commercial scientific products for the life sciences industry. The formulations range in scale from 1 mL to 1,500 L, they are manufactured using controlled protocols, and data is recorded on batch records following good documentation practices.

Key Objectives of the role:

• Executes on formulation of reagents and solutions in a fast-paced manufacturing environment following a controlled documents and procedures.
• Utilize specialized technical knowledge and skills to make detailed observations and analyze data within operating parameters. Actively participate in troubleshooting for specific processes or activities as assigned.

• Maintain equipment, product inventories and related records as assigned. Note variances on manufacturing documents; audit and evaluate process documents and propose revisions.

• Identify manufacturing procedures intended to optimize existing processes and ensure compliance with regulatory requirements.

• 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 0-2 years of experience in a manufacturing or research laboratory or combination of experience and education in Biotech relevant to a role in large scale formulation or solutions manufacturing area.
• Proficiency in the use of scientific laboratory techniques, equipment and materials:
  • Aseptic techniques
  • Scales and balances
  • pH/Conductivity meters
  • Mixers and stir plates
  • Pipetting
  • Spectrophotometer operation (Nanodrop)
  • Large scale solution formulation in fixed and mobile tanks with built in scales
  • Walk in fume hood
  • Snorkel dust collectors
  • Good documentation practices
• Safety awareness and identification of potential safety issues.
• Bench work in a lab environment and manufacturing facility with specialized equipment.
• Ability to carry out scientific procedures and make recommendations for improvement.
• Excellent documentation and communication skills.
• Lifting up to 25 lbs will be required on a frequent basis.
• Must be flexible to work varying schedules and hours as needed.
• Must be able to work safely with chemicals and hazardous materials.
• The noise level in the work environment is usually moderate.
• 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.
• Displays positive attitude toward job and others.
• Good problem solving skills.
• Good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation and Microsoft application is preferred.