The Senior Scientist, Process Development Analytics, is a proactive, strategic, and "hands-on" technical lead who will drive and execute on team objectives in the client-facing role. They will demonstrate flexibility and adaptability while working in a fast paced, rapidly changing CDMO environment. They are self-motivated, accountable, inquisitive, and have excellent organizational and communication skills. They can multi-task, while delivering excellent customer service.
The Senior Scientist, Process Development Analytics, will support the development of protein biologics through analytical characterization of process development intermediates and establishment of analytical methods.
Duties and Responsibilities- Design, lead, and execute method development in support of internal and external partners for use within quality control departments for clinical and commercial manufacturing
- Lead, execute, review, and present high-throughput testing of in-process sample for process development work packages
- Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives
- Coordinate with management for the day-to-day execution of experiments in lab to ensure proper personnel coverage for timely completion
- Author high-quality documents, including technical reports, SOPs, and experimental protocols
- Identify, evaluate, and implement new and existing technologies to improve testing efficiency, control and understanding
- Provide alignment between development and quality control laboratories for upcoming sample transfer and testing requests
- Coordinate technical transfer of established methods to quality control and clients
- Provide technical support Quality Control and Manufacturing floor activities
- Serve as PD representative and participate in cross functional meetings
- Oversee ordering and tracking of routine and client-billable consumables
- Lead, train, and mentor junior lab staff
- Interpret analytical data and understand relation to manufacturing process steps
- Review data packages and compile slides to present at client project presentations
- Contribute to the overall operations of process science lab and infrastructure improvements
- Ability to work in a team environment and drive the success of the projects
Qualifications - Minimum required experience:
- A university degree and 8 + years of related experience
- A Master's degree and 5+ years
- A PhD and 2+ years of experience
- Hands-on experience with analytical technique such as: HPLC/UPLC, cGE/iCIEF, bioassay, activity assay, ELISA, qPCR, and microbial testing
- Experience with monoclonal antibodies, bispecific, fusion proteins, and enzymes is preferred
- Experience with method development, qualification, and validation
- Knowledge and understanding of protein manufacturing process (upstream/downstream) is is preferred
- Proficient in Microsoft Office (Word, Excel, Power Point, SharePoint)
- Demonstrates ability to work both independently and as a member of local / global teams
- Excellent customer service skills and ability to meet client project deadlines
- Flexibility to switch between projects
- The candidate should be self-motivated, accountable, inquisitive, and have excellent organization and communication skills
Working Conditions - Laboratory environment working with chemical reagents and analytical equipment
- Personal Protective Equipment must be worn as required
- Normal office working conditions: computer, phone, files, fax, copier
- Pace may be fast and job completion demands may be high
Physical Requirements - Frequent lifting up to 10 lbs
- Frequent standing/walking to work in lab environment for extended periods
- Frequent sitting for extended periods to use computer
