Scientist performs process development studies and process validation activities. This position also prepares technical documentation to support development and validation program. This position provides technical support to Manufacturing and Quality department.
Responsibilities
Design and execution of DOE's, process optimization studies, and process qualification batches, Process data compilation and analysis using statistical tools.
Develop a strong documentation package, involving from conceptual study to various phases of product development like process study, characterization, process qualification and cleaning validation.
Responsibility for preparation of Master batch records, Exhibit Batch protocols, pre-validation and process validation documentation and reports.
Provide troubleshooting support to manufacturing operations.
Champion compliance investigations, commitments (CAPA), and change controls.
Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
Travel Estimate - 10%
Job Qualifications
Minimum B.S. in relevant science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines. M.S. preferred.
Minimum four (4) years of experience. Experience in solid oral dosage development is desirable.
Proficient in MS office applications (Word, Excel, Projects, PowerPoint).
Good interpersonal, oral communication and technical report writing skills.
Analytical thinking and problem solving skills
A self-starter with a hands-on approach and a can-do attitude.
The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.