Associate Scientist I - Technical Services

Bora Pharmaceuticals•Maple Grove, MN

4d•$60,000 - $80,000•Onsite

About The Position

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Job Summary Completes projects that provide general technical support for production operations and validation testing of production quality systems. This role requires to be onsite.

Requirements

Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or related life science field; 1 year experience in pharmaceutical manufacturing or other regulated industry preferred.
OR an Associate's degree in Chemistry, Engineering, or health-related fields w/at least 2 years' experience in pharmaceutical manufacturing or other regulated industry.
Computer Skills: To perform the essential functions of this position, basic computer skills are required.
Foundational skills that are essential to this position include experience with word processing and spreadsheet software (e.g. Microsoft Word & Excel).

Nice To Haves

Supplemental skills which are beneficial to this position include graphics (e.g. Microsoft PowerPoint) and database software.

Responsibilities

Support the development and execution of process validation (PPQ) protocols and technical reports for commercial manufacturing and product transfers within a CDMO environment.
Assist in technology transfer activities, including risk assessments, development, scale-up, and validation of client processes at the manufacturing site.
Coordinate and execute validation and tech transfer activities with cross-functional groups, ensuring adherence to project timelines and cGMP requirements.
Conduct process development, engineering, and optimization studies to support successful scale-up and technology transfer.
Perform monitoring, sampling, and testing to validate equipment, systems, and processes per validation protocols.
Provide technical support and data analysis for equipment, systems, and processes, including identification and monitoring of critical process parameters (CPPs).
Support and execute cleaning validation test protocols and support documentation.
Participate in change control activities, including documentation and execution of changes related to process and equipment updates.
Support investigations into deviations, atypical results, and customer complaints, including data collection, root cause analysis, and CAPA implementation.
Review and verify GMP documentation and data, ensuring accuracy and compliance with internal procedures.
Perform statistical analysis of study data and present conclusions with clear, logical justifications in technical reports.
Contribute to Annual Product Quality Reviews (APQRs) and ongoing process monitoring efforts.
Maintain familiarity of current FDA and ICH requirements and cGMP regulations and complies with BPI safety requirements.
Conduct departmental training as required.