Wafer Process Development Manager jobs in New Haven, CT

This is what you will do:  

The Scientist I is responsible for leading and executing efforts for downstream process development for diverse biotherapeutics to support pre-clinical, early, and late-stage clinical studies. This position is expected to require minimum 70% of the time conducting in-laboratory studies. The ideal candidate will have in-depth of knowledge of filtration, column/membrane chromatography, tangential flow filtration, other protein purification methods, and scale-up.Experience with process characterization using DOE and associated data analysis is also desired. The candidates will perform detailed scientific research, execute experiments, analyze experimental data, and provide recommendations to improve efficiency of process workflows, and enhance robustness while ensuring regulatory compliance. 

The Scientist I will work closely with other functions within the drug substance process development group and will also work routinely with other groups within Process Development and Clinical Supply (PDCS), Research, Global Operations, Quality (QA), Regulatory (RA) and external vendors. They will have opportunities to innovate, collaborate and present scientific progress, both internally and externally. The successful candidate must also have mature team-working behaviors and organizational awareness and insight. 

You will be responsible for:  

• Leading biologics downstream process development to design and conduct studies to deliver high process yield, robust, and scalable processes to support GMP manufacturing of biotherapeutics. 

• Serving as a technical expert in protein purification, process characterization, and process scale-up with cross-functional teams and during technical transfer activities. 

• Advancing downstream platform process with innovations, and championing creative process improvement initiatives. 

• Assessing and proof-of-concept demonstration of new technologies and ideas and their implementations to support technology advancement to improve process efficiency, reduce material costs, and process yield while maintaining high product quality. 

• Leading technical projects and routinely managing the work of others to facilitate technical milestone deliverables. 

• Authoring regulatory documents, technical protocols, reports and peer-reviewed external journal articles; presenting scientific findings at scientific conferences. 

You will need to have: 

• A PhD in Biochemistry/Chemistry/Chemical Engineering or related fields, MS with at least 8 years of experience, or BS with at least 10 years of experience in biotechnology/pharmaceutical industry. 

• Scientific understanding of the principles of the purification of proteins or viral vectors from mammalian and/or microbial cell lines.  

• Demonstrated technical proficiency, scientific creativity, strong leadership, and advanced problem-solving skills. 

• Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors. 

• Strong interpersonal, verbal, and written communication skills. 

• Record of scientific achievement (presentations, publications, patents, etc.) 

• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. 

We would prefer for you to have: 

• Technical proficiency with laboratory automation and high throughput technologies: such as AKTA Avant, AKTA Crossflow, TECAN, etc. 

• Knowledge and the use of statistical analysis, multivariate data analysis and DOE. 

• Demonstration of expertise in column chromatography for protein purification and filtration technologies. 

• Experience with purification of proteins from mammalian and/or microbial cell lines.