Responsible for the development, implementation and establishing ongoing monitoring of the Contamination Control Strategy (CCS) for new site facilities
Design, implement, support validation of and maintenance of routine and Batch Specific environmental monitoring (EM) programs
Liaise with engineering on the New Facility design requirements to support CCS
Provide microbiological control strategy support for Raw Materials
Liaise with Quality Assurance to ensure microbiological controls are considered
Provide Microbiological support to C&Q and cleaning validation
Ensure implementation of the microbiological requirements for the integrated product control strategy
Provide direction on handling of non-conforming results
Stay current with Industry trends and updates to applicable guidelines
Requirements
BSc Microbiology, Biochemistry or related science field with 8-10 years’ experience in pharmaceutical manufacturing
MSc Microbiology, Biochemistry or science-related field with minimum 5 years appropriate industry experience
Deep technical interest and understanding of Contamination Control Strategy
Excellent verbal and written communications skills
Strong analytical and problem-solving skills
Collaborative skills with operations, process engineering, QCL and other process team members
Technical knowledge of microbial and viral product control
Ability to coach others
Ability to influence without authority
Ability to clarify and simplify complex issues
Strong trust building with peers and leaders
Willing to work off-shift hours as needed to support project milestones and training of new employees.
Benefits
Health insurance
401(k) matching
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Job title
Principal Scientist, Contamination Control Strategy – ADN RAMP Team
Senior Research Scientist focused on quantum computing performance and pioneering research. Working with AI and control theory to optimize quantum systems in a high - performance culture.
Senior Researcher focusing on statistical impact evaluation at NatCen. Designing and analyzing trials to inform national policies across various sectors.
Principal Scientist I or II at Parexel providing operational support for chemistry sourcing projects and ensuring high - quality delivery of products and services.
Leading device development strategies for drug - device combination products. Collaborating with cross - functional teams from concept to launch while ensuring regulatory compliance.
Principal Scientist leading device development strategies for innovative drug - device combination products. Collaborating with cross - functional teams to ensure high quality and robust manufacturing processes.
Lead device development strategies for biologic/drug/vaccine - device combination products with a focus on product and process development. Collaborate with cross - functional teams from concept through launch.
Lead strategic activities in translational medicine studies for AstraZeneca, ensuring compliance with China - specific requirements and collaboration with global teams.
Research Assistant assisting with clinical studies and data analysis at Evolution Research Group. Ensuring compliance and accuracy in research activities with detailed recordkeeping.
Postdoctoral Research Fellow in General Medicine at Beth Israel Lahey Health. Focusing on research linking delirium and Alzheimer's disease under mentorship in a biomedical field.
Statistical lead developing biostatistical support for drug and vaccine projects in R&D. Interacting with multiple disciplines to ensure effective clinical trial design and analysis.