The Role
Leads sterile injectable formulation development, compounding process design, technology transfer, scale-up, process characterization, and commercial manufacturing readiness. Provides technical support for aseptic filling, sterile filtration, lyophilization, engineering runs, deviations, batch investigations, and validation. Collaborates with clients, Manufacturing, Quality, Validation, Engineering, and Regulatory teams. Develops transfer plans, risk assessments, process documentation, and manufacturing instructions while ensuring compliance with FDA cGMP, EU GMP Annex 1, ICH, and USP standards.
Summary Generated by Built In
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
- 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
Benefits
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.
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Skills Required
- Bachelor of Science in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or a related discipline
- 4-7 years of experience in sterile formulation development, drug product manufacturing, or pharmaceutical process development
- Experience as a Senior MSAT Engineer
- 8+ years of pharmaceutical industry experience
- Strong experience supporting sterile injectable products
- Must be authorized to work in the United States
- No C2C arrangements
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
