Job Summary

Charles River Labs & our Biologics Testing team located in Wayne, PA/Erkarth, Germany are seeking a Scientist II, Mass Spectrometry. 

Our Scientist II role will be responsible for the development and execution of moderately complex testing and characterization of biotherapeutics using analytical instrumentation and methodologies. This role will be responsible for methodologies under both R&D and cGMP environments which will include managing projects and client interactions. 

Duties and Responsibilities

•    Implement and qualify mass spectrometry equipment at Charles River sites in Germany and US. 
•    Develop, perform, and troubleshoot laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of mass spectrometry instrumentation and methodologies using associated software.  
•    Generate high quality method and study protocols for sponsor and internal characterization and sample testing programs. 
•    Function as contact for the planning and execution of Sponsor interaction related to proposal management, research and method development, and for the design, scheduling, conduct and reporting of studies.
•    Assist in oversight of laboratory and mentor technical staff in the development and execution of studies to generate high quality scientific data within accepted regulatory compliance.
•    Implement techniques to improve productivity, increase efficiencies and maintain laboratory state-of-the-art practices. 
•    Use of Agilent and Thermo MS Platforms/evaluating Mass Spectrometry software.
•    Review, interpret, analyze, evaluate, and present data on assigned studies, with minimal assistance from senior scientific staff.  
•    Prepare high quality final reports appropriate for assigned study, including integration of supporting subcontractor(s)’s reports into final reports as required, with minimal assistance
•    Interact with clients regarding project design, scheduling and conduct as requested.
•    Collaborate with appropriate departments to coordinate performance of projects, discuss issues and prepare reports.
•    Provide scientific and technical guidance within Biologics to resolve analytical challenges in a timely fashion, including research and development of new methodologies in study conduct.
•    Manage or assist with improvement projects (e.g. redesign of SOP’s, research procedures or report formats).
•    Independently compose quality documentation including deviation reports and change control documentation with no/minimal guidance. 
•    Create, review and edit SOPs, protocols and other data Forms and testing documentation. 
•    Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
•    Perform other related duties as required.  

Job Qualifications

•    Education:  Bachelor’s degree (B.A. /B.S.) or equivalent in Chemistry/ Biochemistry or related scientific discipline. M.S. or Ph.D. preferred.
•    Experience:  Minimum 5 year’s relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics. cGMP experience is highly preferred. 
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Other : Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.

• Ability to work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors.  

• Exercises judgment within defined procedures and practices to determine appropriate action.

•  Demonstrated ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required.  

• Ability to handle multiple projects, prioritize work and meet deadlines within a cGMP environment.  

• Capable of data interpretation of basic characterization and analysis of biotherapeutics (glycoproteins and peptides) using analytical laboratory tools and methodologies.

• Demonstrated experience with sponsor interaction and business development.  

• Must possess excellent interpersonal skills to maintain communication across functional groups.

• Ability to collaborate effectively within a group environment both effectively in a small group or one on one setting.  

• Computer proficiency in MS Word, excel, Outlook, HPLC, Mass spec instrumentation and analysis software.

• Ability to understand and use internal software programs such as LIMS required.

Compensation Data

The pay range for this position is  $101,200 - $117,000 . Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.