Sr. Scientist, Downstream Process Development

Organization
Catalent Pharma Solutions
Job Location
Madison, NJ
Job Description

The Downstream Process Development team is responsible for the development and implementation of downstream processing methodologies and analytical procedures that can be easily transferred to the cGMP Manufacturing Team. Additionally, the Downstream Process Development team supports other groups including Cell Line Development and Upstream Process Development. 
This position will perform a variety of laboratory procedures in Downstream Process Development. The position will perform daily work assignments accurately and in a timely and safe manner. The position will serve as a lead for technical advice and perform multiple complex projects at a time. This position is capable of working independently and without direction on assigned tasks/projects. This position plans and conducts work requiring independent judgment in the evaluation, selection, and substantial adaptation/modification of standard techniques, procedures and criteria. This position designs new approaches to problems encountered and uses a wide application of complex principles, theories and concepts in the specific field. This position works on complex problems of diverse scope where analysis of data requires in-depth evaluation of identifiable factors. 
II. Specific Duties, Activities, and Responsibilities: 
Initiates, directs and executes scientific research for innovation and process improvements 
Acts as the technical lead for client development projects (including DOE), communicates project status internally and externally, and effectively provides technical explanation/rationalization 
Researches and develops existing and new technologies/process improvements 
Critically analyzes complex data, interprets and integrates experimental results with project objectives 
Writes complex procedural SOPs, batch production records, and reports 
Accurately reviews batch records and other data, ensuring consistency 
Accurately ships purified samples to clients and fills out appropriate paperwork 
Executes purification experiments including automated chromatography (AKTA platform), filtration, clarification, column packing, and tangential flow filtration independently 
Expert knowledge of protein purification and analysis with an in depth understanding of all modes of chromatography 
Maintains documentation of experiments and/or batch records according to good documentation practices 
Demonstrates expertise knowledge of scale up principles with respect to purification and filtration 
Demonstrates experience with viral clearance validation and scale down models for biopharmaceutical processes, including review and interpretation of results 
Leads technology transfer of processes to a cGMP facility 
Participates in quality control and quality control tracking systems including change control and deviations 
Manages daily lab operations including oversight of 5S audits, stocking consumables, lab organization and cleanliness, and safety 
Manages interaction with CRO facilities and vendors that support process development and manufacturing projects 
Contributes to maintenance of visual control board including tracking metrics, safety updates, and leading daily meetings in absence of director 
Updates group members on background and status of client projects by giving oral updates or internal presentations 
Aligns best practices and new technologies with needs of process development and manufacturing departments 
Maintains project timelines 
Troubleshoots and problem solves in order to initiate and execute/monitor corrective actions 
Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering and stocking supplies, etc. 
Accurately completes routine and preventative maintenance on laboratory equipment 
Actively participates in team meetings 
Prepares buffers as necessary 
Mentors others, as assigned 
Performs lab overview for client tours and internal clients (shadowing) 
Other duties as assigned

Requirements: 

Ph.D. in Biotechnology, or related field with at least 7 years of laboratory experience, preferably in an industrial setting 
MS in Biotechnology or related field with at least 10 years of industry laboratory experience 
B.S/B.A. in Biotechnology, or related field with at least 12 years of industry laboratory experience 
Experience: 
Aseptic technique experience 
Process scale chromatography and filtration (viral, chromatography, tangential flow, normal flow) experience 
Viral clearance validation, scale up, and technology transfer 
Operating, maintaining, and troubleshooting chromatography work stations and process skids preferably in an industrial setting 
Knowledge and experience working in a cGMP environment 
Good documentation practices (GDP) 
Experience writing standard operating procedures, batch records, and reports 
Experience mentoring junior staff regarding laboratory procedures and scientific projects

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