$80K — $100K *
Provides method development, validation or routine analyses in an Analytical Development and Chemistry/Bioanalytical Laboratory environment by following standard or industry best practices.
Performs analytical methods as assigned for testing on samples, stability, environmental and production intermediates. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.
• Small and large (biological) drug molecule formulation and process development experiencerequired.
• Understanding of sterile injectable drug product manufacturing processes is essential.
• Understanding of biological drug substance and drug product manufacture is important. Any experience with manufacture of peptides, proteins (emphasis on MAbs, and fusion proteins), nucleic acids (plasmid DNA, RNA, etc), lipids, and carbohydrates, and/or drug products created using such actives is a plus.
• Experience with leading technical transfer activities between facilities is a plus.
• Understands design and scale up of manufacturing and filling processes used to create sterile injectable drug products.
• Experienced and comfortable working within cross functional teams.
• Strong written and oral technical communication skills.
• Comfortable working independently, with minimal supervision.
• Must be comfortable with presenting technical concepts to technical audience.
• Experience working within a cGMP environment; understanding of ICH, USP, EP guidance.
• Understands drug product development pathway (pre-clinical formulation development, through clinical to commercial manufacturing).
• Must be a self-starter, driven, curious, and goal-oriented
How will you get there?
Good knowledge and understanding of basic and advanced instrumental technologies. Knowledge of qualitative and quantitativechemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.
BS(8+ years), MS(6+ years), or PhD(5+ years) in Biochemistry, Biopharmaceutical Chemistry or Engineering, Chemistry, Pharmaceutical Sciences, Chemical Engineering, or similar degree.
Seeking an individual with strong technical skills and 5-8+ years (see breakdown by education level) of experience in the pharmaceutical or biopharmaceutical industry. Experience working in a CDMO is a plus.
Valid through: 4/1/2021