Technical Manufacturing Services Specialist
Proclinical is currently recruiting for a Technical Manufacturing Services Specialist, with a background in small molecule manufacturing, for an exciting and rapidly growing biopharmaceutical company based in Cambridge, MA. As the Technical Manufacturing Services Specialist, you will be a key contributor towards maintaining compliance at the company's manufacturing site whilst also facilitating improvements to their documentation, procedures, and wider processes, ensuring best practices are being implemented.
- Lead root cause investigations, develop CAPAs and other relevant documents to resolve deviations.
- Author and submit revisions to documents to support GMP Operations. These include: SOPs, Work Instructions and MBRs
- Support the development and validation of data reporting as it relates to continuous manufacturing
- Troubleshoot analytical instruments and methods.
- Apply GMP concepts to ensure consistent and compliant practices across manufacturing operations.
Skills and Requirements:
- Bachelor's Degree in a pharmaceutical science or engineering discipline
- Proven experience in a GMP manufacturing facility
- Thorough understanding of cGMP concepts and practices
- Previous experience in Small Molecule and Solid Oral Dosage manufacturing
- Knowledge of troubleshooting lab equipment and analytical methods
- In-depth knowledge of learning theories and instructional design models
- Lesson and curriculum planning skills
- Basic HTML and Flash programming knowledge
- Visual design skills (Dreamweaver, Photoshop, Illustrator)
- Ability to write effective copy, instructional text, audio and video scripts
If you are having difficulty in applying or if you have any questions, please contact Alex Tooulas at (+1) 917-284-9670 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.