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Quality Scientist - Biotech Manufacturing (Foodstuff/KSM/API)
Quality Scientist - Biotech Manufacturing (Foodstuff/KSM/API)Manus Bio • Augusta, GA
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Quality Scientist - Biotech Manufacturing (Foodstuff / KSM / API)

Quality Scientist - Biotech Manufacturing (Foodstuff / KSM / API)

Manus Bio • Augusta, GA
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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

  • Serve 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).

    • Product Quality & Batch Review

  • 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.

    • Deviation Management & Investigations

  • 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.

    • Audit and Regulatory Readiness

  • 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).

    • Document Control & Training

  • 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.

    • Required Qualifications :

  • 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.

    • Preferred Skills :

  • 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.

    • Key Competencies :

  • 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).

    • Working Conditions :

  • 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.
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    Manufacturing Quality • Augusta, GA

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