Quality Scientist - Biotech Manufacturing (Foodstuff/KSM/API)Manus Bio • Augusta, GA
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Quality Scientist - Biotech Manufacturing (Foodstuff / KSM / API)
Manus Bio • Augusta, GA
30+ days ago
Job type
- Full-time
Job descriptionServe as the quality lead for one or more QMS elements : Change Control, Deviation Investigation, CAPA, and Supplier Quality, Audit Management, Validation Lifecycles Implement and maintain quality oversight for production of biotech-derived materials, including process validation, cleaning validation, and analytical method validation. Lead compliance gap assessments, internal audits, and coordinate responses to regulatory observations (FDA 483s etc.). Ensure compliance with 21 CFR Part 210 / 211, ICH Q7, and EU GMP Part II (APIs). Perform comprehensive batch record reviews and ensure timely QA disposition. Support the generation and review of Master Production Records and Batch Production Records specific to biotech-derived materials. Lead complex root cause investigations using QRM tools (5-Whys, FMEA, Ishikawa). Author and approve deviation reports and associated CAPA plans, ensuring timely implementation and closure. Support risk-based decision-making using tools aligned with ICH Q9 (R1) and site Quality Risk Management processes. Support preparation for regulatory inspections (FDA, EMA, WHO PQ), customer audits, and internal audits. Contributes to the preparation of quality sections for regulatory submissions (DMFs, CMC sections of INDs / NDAs). Create and maintain SOPs, forms, and protocols associated with foodstuff / KSM / API production and testing. Train cross-functional staff on cGMP procedures related to fermentation-derived ingredients and complex biologically sourced APIs. Bachelor’s degree in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Microbiology, or related field. Master’s Degree preferred. 7+ years of experience in pharmaceutical or biotechnology quality assurance, with a focus on API or fermentation-based manufacturing. Strong knowledge of ICH Q7, EU GMP for APIs, FDA Guidance for Biotech APIs, and data integrity. Familiarity with bioprocessing, microbial control strategies, and impurity profiling in biotech manufacturing. Experience with QMS and QbD documentation. Experience supporting Drug Master Files (DMFs), QbD documentation, or CMC sections. Prior involvement in precision fermentation or enzyme-catalyzed bioconversion operations is a strong asset. Auditing experience (internal, external, or supplier). ASQ-CQA, Six Sigma Green Belt, or equivalent GMP certifications preferred. Strong technical writing, cGMP interpretation, and quality decision-making skills. Ability to interpret process analytical data and translate into risk-based QA decisions. Collaborative mindset with cross-functional teams (Manufacturing, Regulatory Affairs, and Supply Chain). Based in Augusta, GA, with potential for hybrid flexibility depending on company policy. May require on-call rotation and occasional after-hours maintenance for critical systems.
Why work at
Manus :
- Opportunity : Manus offers growth opportunities for motivated, results-oriented team members, allowing for personal and professional advancement.
- Accountability : Team members are given the resources they need to succeed and the freedom to make it happen, with a culture of holding each other accountable for high expectations.
- Passion : Manus values working with individuals who love what they do and embrace the challenges and hard work that come with working on the cutting edge.
- Impact : Working at Manus is an opportunity to bring state-of-the-art manufacturing back to Augusta, Georgia. The organization is mission-focused, and the people here believe they can make a positive impact on the community and country for generations to come.
Responsibilities :
Quality Systems & cGMP Oversight
Product Quality & Batch Review
Deviation Management & Investigations
Audit and Regulatory Readiness
Document Control & Training
Required Qualifications :
Preferred Skills :
Key Competencies :
Working Conditions :
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Manufacturing • Augusta, GA
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