Rentschler Biopharma
Senior Scientist, Process Development Analytics
Rentschler Biopharma, Milford, Massachusetts, us, 01757
Senior Scientist, Process Development Analytics
Join Rentschler Biopharma to apply for the
Senior Scientist, Process Development Analytics
role.
Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects.
Advancing medicine to save lives. Together.
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 samples 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 to 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 techniques 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 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
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Science, Quality Assurance, and Manufacturing
Industries Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr
Senior Scientist, Process Development Analytics
role.
Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects.
Advancing medicine to save lives. Together.
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 samples 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 to 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 techniques 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 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
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Science, Quality Assurance, and Manufacturing
Industries Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr