Proclinical is seeking a dedicated individual with a strong background in parenteral pharmaceutical development and manufacturing.
The successful candidate will provide scientific, technical, and hands-on support for late-stage drug product development.
This includes contributing to process validation, drug product manufacturing, and global regulatory documentation.
Responsibilities :
- Provide technical support for late-stage drug product development.
- Contribute to process validation and drug product manufacturing.
- Assist in the preparation of technical documentation for GMP activities and process validation.
- Write and review drug product technical sections for global regulatory submissions.
- Provide technical and quality support for GMP operations.
- Work with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or procedural deviations.
- Present results of work, interpret data, and draw conclusions for sterile drug product manufacturing process development, characterization, and validation.
Key Skills and Requirements :
- Experience in late-stage process and formulation development of sterile, parenteral dosage forms.
- Proficiency in writing and reviewing technical documentation for GMP activities and process validation.
- Experience in writing and reviewing drug product technical sections for global regulatory submissions.
- Excellent communication and interpersonal skills.
- Ability to think critically and creatively, work independently, and pay attention to detail.
- Knowledge of regulatory and quality requirements for aseptic processes.
- Experience in parenteral formulation development and manufacturing, late-stage development.
- Experience with small molecule or biologics.
- Advanced degree in Pharmaceutical Sciences or related field.
Interested or know someone who might be? Reach out to Alexander Bero using the following :
020 3831 7644
Apply Now :
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV.
Alternatively, for further details or to talk directly to a life sciences recruitment specialist, 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.
is acting as an Employment Agency in relation to this vacancy.