MSAT Engineer

PSC Biotech • York, PA

6d • Onsite

About The Position

BioTechnique 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. The Experience With operations spanning the globe and featuring a multi-cultural team, BioTechnique 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 BioTechnique, it’s about more than just a job—it’s about your career and your future.

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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level