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
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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
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Supervisory Responsibilities | |
Experience | - Laboratory experience with handling chemicals and reagents
- Experience in sterile manufacturing is preferred
- Experience in lyophilization and terminal sterilization techniques is a plus
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Education | - Bachelors or above degree in Pharmaceutical Sciences, Chemistry, Biology, or related discipline
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Knowledge, Skills & Abilities | - Exceptional computer skills including Microsoft Office, Visio or other related software
- Excellent writing skills
- Attention to details
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Physical Requirements | - Ability to sit for prolonged periods of time
- Ability to stand for prolonged periods of time
- Able to lift up to 50lbs
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