Location(s): United States; Massachusetts; Marlborough
About Us: GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: The scientist will be responsible for supporting Bioprocess R&D with the design, development, qualification, validation, and implementation of analytical methods. They will support new product development and product care initiatives with analytical characterization strategies. In addition, they will provide technical expertise to support manufacturing process development initiatives and problem-solve for existing products and processes.
Essential Responsibilities: • Develop analytical procedures for characterizing technologies in the bioprocess portfolio (single-use systems, hollow fiber filters etc.). • Prepare qualification and validation protocols and reports for analytical procedures and instrumentation. • Perform method qualification, validation, and sample analysis. • Prepare standard operating procedures for analytical procedures and instrumentation. • Transfer analytical procedures to support manufacturing. • Troubleshoot analytical instrumentation. • Act as a technical consultant on analytical analysis for other parts of the organization (e.g. quality control, manufacturing engineering etc.). • Participate in cross-functional teams on new product development and product care problem-solving efforts. • Prepare application notes, reports, publications, and presentations. • Design and oversee shelf-life studies. • Contribute to the technical growth of the department and serve as a subject matter expert to support the organization. • Actively participate in site EHS program.
Qualifications/Requirements: 1. BS degree in Analytical Chemistry or related field. 2. Minimum of 3 years of experience working in a pharmaceutical, medical device or other life science field. 3. Experience with characterization of polymers and proteins. 4. Experience performing method qualification, validation, and sample analysis.
Desired Characteristics: 1. MS or Ph.D. in Analytical Chemistry or related field. 2. Experienced working in a cross-functional, global team environment. 3. Expertise with HPLC, GPC, GC, FTIR, Raman, particle analysis, SEM, AFM, surface tension, and zeta potential. 4. Identify and report any quality or compliance concerns and take immediate corrective action as required 5. Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables 6. Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible
Locations: United States; Massachusetts; Marlborough
We are in the process of transitioning to an improved job application system and in the interim we are operating with two systems. Have your Job ID ready (from the email you received when you applied) to log in and check your application status.
Click the appropriate button. If you don't know your job ID, you can still check your status: use both buttons.