Job DescriptionBioTechnique 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. BioTechnique utilizes our team's expertise to create a process design for our clients' products that best suits their needs.
Your RoleBioTechnique 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.
Formulation Development & Technical Transfer- 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
Compounding Process Development- 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.
Aseptic Manufacturing Support- Provide technical support during:
- Solution preparation
- Compounding operations
- Sterile filtration
- Aseptic filling
- Lyophilized product manufacturing
- Support engineering runs and manufacturing campaigns.
- Troubleshoot processing deviations and formulation-related challenges.
- Investigate batch failures, yield losses, or process excursions.
Process Characterization & Scale-Up- Design and execute process characterization studies.
- Support:
- Mixing studies
- Hold time studies
- Filtration studies
- Product recovery studies
- Process robustness evaluations
- Evaluate manufacturing scalability and process capability.
- Generate data supporting process validation and commercialization.
Technology Transfer & Client Support- Serve as technical SME during client onboarding and transfer activities.
- Support preparation of:
- Technology Transfer Plans
- Gap Assessments
- Risk Assessments
- Process Transfer Reports
- Participate in client meetings and technical reviews.
- Provide scientific guidance throughout development and manufacturing campaigns.
Lyophilization Support- Support formulation development for lyophilized products.
- Collaborate with Lyophilization Development teams on:
- Formulation optimization
- Reconstitution performance
- Product stability considerations
- Support cycle transfer and scale-up activities.
Regulatory & Compliance Support- Ensure activities comply with:
- FDA cGMP requirements
- EU GMP Annex 1
- ICH Guidelines
- USP Standards
- Support investigation activities, CAPAs, and client audits.
- Provide technical documentation for regulatory submissions when required.
Requirements- Bachelor of Science in: Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, Related discipline
- 4-7 years of experience in:
- Sterile formulation development
- Drug product manufacturing
- Pharmaceutical process development
- Senior MSAT Engineer
- 8+ years pharmaceutical industry experience
- Strong experience supporting sterile injectable products
- Must be authorized to work in the U.S.
- No C2C at this time
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
- Financial Perks and Discounts
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