Senior Technical Leader - Contamination Control Strategy
The Senior Technical Leader - Contamination Control Strategy will play a critical role in supporting the development and implementation of contamination control strategies across multiple new API/Dry Products sites. This position will be responsible for leading cross-functional teams to design, implement, and maintain routine and batch-specific environmental monitoring programs.
Key Responsibilities:
* Design and implement contamination control strategies to ensure compliance with regulatory requirements and industry best practices.
* Lead cross-functional teams to develop and implement process improvements, including equipment qualification, cleaning validation, and product controls.
* Develop and maintain technical documentation, including procedures, protocols, and training materials.
* Collaborate with operations, process engineering, and quality teams to ensure seamless execution of contamination control strategies.
Required Skills and Qualifications:
* Master's degree in Microbiology, Biochemistry, or related science field.
* 8-10 years' experience in pharmaceutical manufacturing, with a focus on contamination control and microbiological testing.
* Strong leadership and communication skills, with the ability to influence and motivate cross-functional teams.
* Excellent analytical and problem-solving skills, with the ability to interpret data and make informed decisions.
Benefits:
* Opportunity to work in a dynamic and rapidly expanding team.
* Competitive salary and benefits package.
* Professional development opportunities, including training and mentorship programs.
Others:
* Significant travel may be required to support site start-ups and project milestones.
* Candidates must be mobile and flexible, with the ability to adapt to changing priorities and deadlines.
**Contamination Control Strategy:** The Contamination Control Strategy is a critical component of our quality management system, ensuring the integrity of our products and processes. As a Senior Technical Leader - Contamination Control Strategy, you will be responsible for developing and implementing strategies to minimize contamination risks and ensure compliance with regulatory requirements.
**Microbiological Testing:** Our team uses advanced microbiological testing techniques to identify and characterize microorganisms in our products and processes. You will be responsible for designing and implementing testing protocols, interpreting results, and making informed decisions to ensure the quality and safety of our products.