Pharmaceutical Development Senior Associate Scientist II
About The Position
The Senior Associate Scientist II supports formulation design and development of oral solid drug products. Trains others in clinical trial manufacturing operations using sound pharmaceutical principles. Ensures that all work is carried out is in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). The role: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Draft technical documents such as laboratory notebook writeups, protocols and batch records. Trains others on procedures and laboratory techniques Executes efficiency improvement project with guidance Has applied knowledge of the principles and concepts of a discipline. Applies technical and functional knowledge to job related duties on most projects/ assignments within own group/project team. Performs parallel review of GMP documents and laboratory notebooks and may become qualified to conduct compliance technical reviews. Develop and executes procedures, methods, manufacturing processes with minimal complexity, with high quality. Demonstrated ability to lead small team projects
Requirements
- Bachelor's degree in related life science or physical science field required with 4+ years related work experience
- Master’s degree in related life science or physical science field required with 2+ years related work experience
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
Responsibilities
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
- Draft technical documents such as laboratory notebook writeups, protocols and batch records.
- Trains others on procedures and laboratory techniques
- Executes efficiency improvement project with guidance
- Has applied knowledge of the principles and concepts of a discipline.
- Applies technical and functional knowledge to job related duties on most projects/ assignments within own group/project team.
- Performs parallel review of GMP documents and laboratory notebooks and may become qualified to conduct compliance technical reviews.
- Develop and executes procedures, methods, manufacturing processes with minimal complexity, with high quality.
- Demonstrated ability to lead small team projects
Benefits
- Competitive medical benefits
- 401K
- 152 hours PTO
- 8 Paid Holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
