MSAT Engineer

PSC Biotech; South Carolina; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical premiums

401(k) matching

Paid holidays

Education assistance

Pet insurance

Fitness benefits

Job summary

PSC Biotech in York, United States is seeking a Mid-Level to Senior MSAT Engineer to support sterile injectable formulation development, compounding process design, and tech transfer for clinical and commercial products.

The role involves leading formulation activities, collaborating with Manufacturing, Quality, Validation and Regulatory teams to ensure robust, scalable processes and successful scale-up for GMP manufacturing.

Qualifications

• Bachelor of Science in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology or related discipline.
• 4-7 years of experience in drug product manufacturing and pharmaceutical process development.
• 8+ years of pharmaceutical industry experience and US work authorization.
• No C2C arrangements at this time.

Responsibilities

• Lead formulation assessment and technology transfer activities from clients.
• Review development reports, formulation histories, and manufacturing records.
• Support sterile formulation development and scale-up for clinical to commercial products.
• Identify CPPs/CQAs and ensure robust, scalable processes.
• Author process descriptions and manufacturing instructions.
• Collaborate with clients, quality, validation, and regulatory teams.

Skills

Sterile formulation development

Process transfer

GMP manufacturing

Regulatory knowledge

Education

Bachelor of Science in Chemical Engineering / Pharmaceutical Sciences / Biochemistry / Biotechnology

Job description

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

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.

Your Role

BioTechnique 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

• 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.
  

Process Characterization & Scale-Up

• 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.

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:
• Drug product manufacturing
• Pharmaceutical process development
• 8+ years pharmaceutical industry experience
  
• Must be authorized to work in the U.S.
• No C2C at this time
  

Offering 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

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.