Formulation Scientist - Lee, United States - BERKSHIRE STERILE MANUFACTURING LLC

Description

Job Description

Position Summary

The Associate Scientist is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position covers a broad range of parenteral dosage formats and categories ranging from identifying gaps and strengthening existing formulations, optimizing the process, and supporting the transfer of products. Develop formulations manufacturing processes and/or characterization and evaluation of material and products at all stages of the development process, taking into account scientific and timing objectives. This position may also serve as an R&D representative on cross-functional technology transfer team.

Duties and Responsibilities

• Identify the Quality Target Product Profile, Critical Quality Attributes, Critical Material Attributes and Critical Process Parameters to arrive at robust formulation design and manufacturing process
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing plant
• With guidance, evaluate the impact of proposed changes in raw materials, packaging, processing equipment and manufacturing methods on the quality of finished product
• Develop understanding of the impact of physiochemical properties of drug substance on the quality attributes of drug product
• Perform due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Develop conceptual process design to support existing production capabilities, including sizing, scale and selection of equipment
• Partner with Client resources and Vendors to ensure industrial implementation of process design
• With guidance, develop lyophilization cycles for various types of samples i.e. small molecules, recombinant protein, peptides and others
• Routinely perform formulation and process development studies/ experimentation
• May conduct small-scale lyophilization experiments and/or direct production-scale
• Fundamentally understand and comply with GMP guidelines
• Generate, analyze and report both GMP and non-GMP data
• Author and review project updates, reports, protocols, SOPs and master batch records
• Perform general laboratory assignments as needed to maintain a safe, clean and organized laboratory
• Support Quality and Operations with investigation of deviations
• Participate in root cause analysis and quality event investigation for OOS and deviations
• Carry out all job responsibilities in a safe manner
• Develop equipment and processes that meet safety codes, policies and guidelines
• Provide for the safety and well-being of operators, maintenance and other personnel
• Take on other responsibilities that may be assigned to meet changes due to business change or growth

Regulatory Responsibilities

• Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines

Supervisory Responsibilities

• N/A

Experience

• Laboratory experience with handling chemicals and reagents
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques is a plus

Education

• Bachelors or above degree in Pharmaceutical Sciences, Chemistry, Biology, or related discipline

Knowledge, Skills & Abilities

• Exceptional computer skills including Microsoft Office, Visio or other related software
• Excellent writing skills
• Attention to details

Physical Requirements

• Ability to sit for prolonged periods of time
• Ability to stand for prolonged periods of time
• Able to lift up to 50lbs