Process Development Scientist Job Opportunity
We are seeking an experienced Process Scientist in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping to join our team within a leading Biopharmaceutical company.
The successful candidate will be responsible for providing process and product support to drug product formulation and fill-finish operations as drug product process SMEs. The role is part of the Process Development Commercial Support team which is responsible for ensuring efficient and effective processes.
About the Role
* Act as a drug product process development technical expert to provide swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization and vial capping.
* Key contributor to product and process investigations, responsible for assessing product and process impact.
* Leads continuous improvement projects to improve process performance and productivity.
* Affects product impact associated with proposed changes to commercial processes under the change control process.
* Generates product impact assessments associated with process excursions and deviations, with reference to product technical documentation.
* Support new product introduction team, as a process subject matter expert; This would include but is not limited to, recipe development and protocol execution, as well as troubleshooting and investigation support.
* Reviews and approves changes to operating procedures, electronic batch records, and product documentation.
* Identifies and implements operational opportunities for current and new sterile operations
* Risk assessments and mitigation projects relating to line performance
* Perform process gap analysis and developing strategies to close gaps.
* Data trend analysis for all performance aspects of the area.
* Troubleshooting performance trends.
Qualifications and Experience
* Bachelor's or Masters degree in Science, Engineering or related discipline with 3 - 6 years experience in a similar role OR PhD and 3 years of directly related experience.
* Typically 4-6 years drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling or lyophilisation
* Qualification in Lean and 6-sigma methodologies would be an advantage.
* New product introduction (NPI), process development, MSAT experience in a GMP environment would be advantageous.
* Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.