Formulation Scientist

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