Lead Process Technician
Essential Job Function: This position carries the responsibility for the direct client interface during the development; scale-up, transfer, and /or commercialization of products. This includes batch record creation, review, generation of DOE and sampling protocols, validation documents, authorship of final reports and technical project guidance to the client.
Expertise in fluid bed processing is highly sought as well as high shear granulation, drying, milling/sizing, compression, encapsulation, coating and packaging operations are fundamental requirements for the position.
This position is also accountable for the training and mentorship for junior personnel within the R&D, Technical Process Operations and Manufacturing Operations.
This position is classified as a “safety sensitive” position especially in light of our formulation and development work with controlled substances and is therefore subject to random drug testing.
General Information: Bachelor’s degree or equivalent Industry Standard Certification and +10 years related pharmaceutical experience. Position requires a demonstrated skill for scientific report writing, excellent verbal communication skills, and a customer oriented behaviors.
Responsibilities include but not limited to:
- Direct client interface during the development, scale-up, transfer, and /or commercialization of products. This position has the obligation to meet or exceed the Client’s expectations set forth in the Statement of Work. This includes both the delivery of “hard” documents (DOE protocols, interim/final Product reports, validation documents, etc.) and driving major activities to meet project milestones and goals as stipulated in the Statement of Work.
- Identification of critical scale-up and process validation parameters for each project, in close association with Technical Process Operations and Commercial manufacturing.
- Liaise with Business Development, Planning, QA, Contract Manufacturing, and Development on behalf of external client projects.
- Provide guidance and mentoring to junior scientists and Technicians. Specific activities would include, 1) review of data summaries, 2) mechanical set-up, maintenance, and running of equipment, 3) cGMP and OSHA operating standards, 4) review of lab notebooks and process reports for completeness and accuracy.
- Technical and process training to CM personnel as part of product transfers or new product introductions.
- Ability to carry out complex work assignments in a high quality work environment.
- Liaise with Project Manager for guidance and coordination of Development and Tech. Process supported activities.
- Serve as a process technology expert for new unit operations installed in laboratory as assigned. Activities include gaining an intimate scientific, mechanical, systems knowledge of these new processing systems.
- Support Product Development/Formulations, Technical Services, and Business Development with client and affiliated process transfers.
- Assimilate R&D and Process Development product data to devise commercial scale processes which are valid table and cost effective.
Resumes forwarded to email@example.com