Scientist II
Job Description
Job Summary:
- As a Manufacturing Sciences Scientist II you will play a critical role in optimizing manufacturing operations, implementing innovative technologies, and driving continuous improvement initiatives across production processes.
- You will collaborate with cross-functional teams to ensure the efficient production of high-quality products while maintaining compliance with applicable regulatory requirements.
- This is an excellent opportunity for early-career scientists to build expertise in chemistry while Producing hands-on manufacturing experience while working alongside experienced scientists who will support your professional growth.
Duties and Responsibilities:
- Lead chemical synthesis projects for bead and resin manufacturing.
- Develop, validate, and implement robust manufacturing processes and analytical methods.
- Utilize analytical techniques such as liquid chromatography, NMR, GC, Mass Spectrometry, particle sizing/characterization, and IR.
- Perform vendor evaluations and raw material qualifications.
- Apply statistical methods and software to experimental design and data analysis.
- Effectively communicate validation efforts for both technical and non-technical audiences.
- Write product documentation (incoming specifications, batch records, and bills of materials).
- Ensure compliance with GMP, ISO, and applicable regulatory requirements.
- Collaborate with operations, engineering, and cross-functional teams to troubleshoot manufacturing and analytical issues.
Education:
- Bachelor’s degree in chemistry, biochemistry, or related field with 4+ years experience, OR
- Advanced degree, OR
- Equivalent combination of education and manufacturing sciences experience in a regulated industry.
- Lean Six Sigma certification preferred.
Experience:
- Experience with chemical synthesis, resin/bead synthesis, polymer chemistries, or chromatography methods.
- Experience planning and performing laboratory experiments independently.
- Expertise in process validation and change control management.
- Experience with risk assessment methodologies and root cause analysis.
- Experience with statistical applications in experimental planning and results analysis.
- Experience diagnostic reagents, bioprocessing, or analytical method validation.