Looking for a new challenge within procurement? Join a trailblazing biotech on the cutting edge of science and technology!
Proclinical is seeking a Formulation and Process Senior Scientist to join a team dedicated to the development of pharmaceutical products, including injectable and oral forms. This role focuses on formulation and process development, ensuring compliance with regulatory standards and contributing to the continuous improvement of drug product development. You will play a key role in advancing innovative medicines and improving patient outcomes.
Responsibilities:
- Develop and implement formulation and process strategies aligned with the Quality Target Product Profile.
- Apply Quality by Design principles throughout the development lifecycle.
- Plan and oversee formulation studies in collaboration with analytical teams.
- Manage the transfer and scale-up of manufacturing processes, including technical and stability campaigns.
- Coordinate internal meetings and ensure alignment across CMC functions for technical and GMP manufacturing campaigns.
- Oversee outsourced activities, including subcontractor management, timelines, and budgets.
- Prepare and ensure timely availability of required documentation, such as protocols, reports, and batch records.
- Analyze results, identify anomalies, and conduct investigations to resolve issues.
- Collaborate with Quality Assurance to manage quality events, including Change Controls and CAPAs.
- Present project updates and results at internal technical meetings.
- Support clinical manufacturing teams and contribute to drug product process validation.
- Assist in writing CMC sections for regulatory submissions (IMPD, IND, NDA, MAA).
- Represent the Formulation and Process function in CMC project meetings and ensure effective communication with stakeholders.
- Manage relationships with CDMOs, including contracts, quality agreements, and performance monitoring.
- Maintain a network of subcontractors and ensure regulatory compliance.
- Contribute to the development of technical expertise within the team.
- Promote continuous improvement and knowledge management within the department.
Key Skills and Requirements:
- Background in pharmacy, engineering, or science; advanced degree preferred.
- Proficiency in Good Manufacturing Practices (GMP) and current GMP (cGMP) standards.
- Strong project management and organizational skills.
- Experience managing CDMO relationships and external contractors.
- Excellent communication skills and ability to work in a collaborative, matrix environment.
- Fluency in English for effective communication and documentation.
- Knowledge of Quality Risk Management and regulatory requirements.
- Ability to analyze data, draw conclusions, and solve problems effectively.
If you are having difficulty in applying or if you have any questions, please contact Ed Little at e.little@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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