MSAT Engineer

York, United States | Posted on 08/27/2026

Bio Technique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. Bio Technique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

With operations spanning the globe and featuring a multi-cultural team, Bio Technique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At Bio Technique, it’s about more than just a job—it’s about your career and your future.

Bio Technique is seeking a Mid-Level to Senior MSAT Engineer to support formulation development, compounding process design, technology transfer, scale-up, and commercial manufacturing readiness for sterile injectable products.

The successful candidate will serve as the technical lead for drug product formulation and compounding activities, supporting products ranging from early clinical development through commercial manufacturing. This role will work closely with clients, Manufacturing, Quality, Validation, Process Engineering, and Regulatory teams to ensure formulations are robust, scalable, and suitable for aseptic manufacturing.

This position requires strong expertise in sterile formulation development, compounding operations, biologics handling, process characterization, and GMP manufacturing.

• Lead formulation assessment and process transfer activities from client organizations.
• Review development reports, formulation histories, and manufacturing records.
• Support development and optimization of sterile injectable formulations.
• Evaluate formulation robustness, manufacturability, and scale-up risks.
• Develop formulation and process transfer documentation.
• Collaborate with clients to establish manufacturing strategies for clinical and commercial production

• Develop and optimize compounding processes for sterile drug products.
• Establish mixing strategies, hold times, filtration approaches, and process parameters.
• Support formulation scale-up from laboratory to GMP manufacturing.
• Identify critical process parameters (CPPs) and critical quality attributes (CQAs).
• Author process descriptions and manufacturing instructions.
• Evaluate process performance and support continuous improvement initiatives.

• Solution preparation
• Sterile filtration
• Aseptic filling
• Support engineering runs and manufacturing campaigns.
• Troubleshoot processing deviations and formulation-related challenges.
• Investigate batch failures, yield losses, or process excursions.

• Design and execute process characterization studies.
• Support:
• Hold time studies
• Product recovery studies
• Process robustness evaluations
• Evaluate manufacturing scalability and process capability.
• Generate data supporting process validation and commercialization.
• Serve as technical SME during client onboarding and transfer activities.
• Support preparation of:
• Gap Assessments
• Process Transfer Reports
• Participate in client meetings and technical reviews.
• Provide scientific guidance throughout development and manufacturing campaigns.
• Collaborate with Lyophilization Development teams on:
• Formulation optimization
• Product stability considerations
• Support cycle transfer and scale-up activities.

• Ensure activities comply with:
• FDA cGMP requirements
• EU GMP Annex 1
• ICH Guidelines
• USP…