About the Company:
Join a leading pharmaceutical organization at the forefront of cutting-edge drug development and manufacturing.
With significant recent investment in site expansion and a commitment to excellence, innovation, and continuous improvement, this company provides a dynamic and collaborative environment for professionals looking to make an impact in the field of drug product manufacturing.
About the Role:
We are seeking an experienced Senior Scientist to lead and execute process optimization projects aimed at improving manufacturing performance and efficiency.
The successful candidate will apply scientific expertise to develop strategies for capacity and yield maximization while ensuring successful technology transfer and new product introduction from development to commercial manufacturing.
This is a fantastic opportunity for an individual passionate about advancing drug product manufacturing processes, working on innovative studies, and collaborating with cross-functional teams on impactful projects.
Key Responsibilities:
* Lead and execute process optimization projects to enhance manufacturing process performance.
* Utilize scientific principles to develop strategies for capacity and yield maximization in production areas.
* Oversee technology transfer and new product introduction of drug product processes into commercial manufacturing.
* Design and execute process optimization, scalability, and investigation studies to improve efficiency in formulation, filling, lyophilization, sterile filtration, and isolator technology.
* Apply knowledge of CMC activities and risk management to manufacturing science and technology.
* Present ideas and project plans to stakeholders, including site leadership and global teams.
* Perform technical and critical review of data related to sterile manufacturing processes, including lyophilization and formulation.
* Lead Extractables & Leachables (E&L) studies, filter adsorption studies, single-use compatibility assessments, and container closure integrity studies.
* Conduct process monitoring, data gathering, and analysis, proactively identifying areas for improvement.
* Train, coach, and mentor production staff and junior scientists.
* Develop expertise in drug product manufacturing processes, aseptic techniques, sterilization methods, and process improvement activities.
* Supervise and mentor industrial placements, interns, and students.
* Stay informed on emerging techniques in formulation through internal and external collaboration.
Compliance & Safety:
* Adhere to GxP requirements, ensuring all compliance concerns are reported appropriately.
* Lead safety initiatives and work in accordance with Health & Safety regulations.
* Maintain up-to-date training and documentation as per company policies.
Essential Requirements:
* Degree-qualified in scientific, pharmaceutical, or engineering discipline.
* Proven industry experience in pharmaceutical or sterile manufacturing environments.
* Strong knowledge of sterile manufacturing of medicinal drug products.
* Experience in data analysis, visualization, and statistical tools (e.g., JMP, Minitab).
* Expertise in lyophilization, aseptic filling, isolator technology, and sterilization techniques.
* Understanding of biologics process development, stability studies, filtration studies, and scale-up processes.
* Experience in technology transfer, new product introduction, facility fit, and gap analysis.
* Ability to lead technical projects, manage stakeholders, and resolve conflicts.
Preferred Qualifications:
* MSc or PhD in Scientific, Pharmaceutical, or Engineering discipline.
* In-depth knowledge of biologics process development (toxin manufacturing knowledge is a plus).
* Experience in risk assessments, impact assessments, FMEA, and supplier management.
Equal Opportunities Statement:
This company is committed to providing equal opportunities for all applicants.
We encourage individuals from diverse backgrounds to apply, regardless of age, disability, gender identity, sexual orientation, race, religion, or any other protected characteristic.
If you are a highly motivated professional looking to drive innovation in drug product manufacturing, apply now to join this exciting and forward-thinking team!