We are seeking a highly motivated
Process Development Scientist
to join our team that provides scientific expertise and technical support to the commercial Drug Product manufacturing facility while supporting new product introductions, complaint investigations, and deviation investigations.
Key Responsibilities
-
Monitor scientific and technological developments within the field of expertise and communicate relevant findings and observations.
-
Understand and interpret primary component specifications, analytical methods, and related technical documentation.
-
Demonstrate knowledge of metal, glass, and polymer formation processes, including primary container component defects and classification systems.
-
Perform Primary Packaging Evaluations and Glass/Polymer Forensic Analysis.
-
Introduce and implement advanced scientific methodologies and technologies.
-
Develop and execute innovative protocols to address technical and operational challenges.
-
Represent the department on cross-functional project teams under appropriate supervision.
-
Foster productive collaborations within the Process Development organization and across internal and external networks.
-
Provide technical guidance in experimental design, data interpretation, root cause analysis, and implementation of corrective actions.
-
Independently author scientific reports, technical summaries, complex regulatory documents, invention disclosures, and patent-related submissions.
-
Participate and engage with the external scientific and technical community.
-
Assume leadership roles in department-wide initiatives including safety, operational excellence, and committee participation.
-
Develop, manage, and follow project timelines to ensure successful completion of team objectives.
Requirements
-
Educational Background in Material Sciences/Engineering/Physics/Sciences
-
Doctorate,
Masters + 2 years experience or
Bachelors + 4 years
experience in related field.
-
Excellent technical writing and communication abilities.
-
Ability to work independently and collaboratively within cross-functional teams.
-
Knowledge of packaging components,forensic analysis, and regulatory compliance is highly desirable.
-
Bilingual Communication (English & Spanish)
