Job Description

Job Description

Job Description

MR Lowcountry, LLC .

Nebo, NC 28761 Telephone: 843-628-5021 tom@mrlowcountry.com

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

Aiken, SC area On-site

The company is a next-generation industrial biotechnology company headquartered in Massachusetts that produces plant-based ingredients. They use a variety of patented and proprietary technologies to engineer microbes to produce specialty chemicals such as food ingredients, flavor materials, agricultural chemicals, and pharmaceuticals. The company works across industries and value chains to accelerate the transition to Bio Alternatives – better performing and more sustainable versions of complex molecules traditionally sourced from plants, animals, or fossil fuels. Our platform is proven to work across scales, bridging the Valley of Death between lab and manufacturing more efficiently and more reliably to deliver the benefits of synthetic biology today. We are seeking a self-motivated and highly organized individual to join our Quality Department.

The Quality Scientist supports cGMP compliance across biotech manufacturing operations for foodstuff, key starting materials (KSM) and active pharmaceutical ingredients (API). This role is essential in ensuring the integrity, safety, and quality of regulated foodstuff, intermediate and drug substances produced using fermentation, enzymatic bioconversion, or precision fermentation technologies. The role involves deep interaction with manufacturing, analytical, regulatory, and supply chain teams to maintain compliance with FDA, ICH, EU GMP, and PIC/S expectations.

Why work for the company:

Opportunity – For motivated, results-oriented team members, our growth creates opportunities for personal and professional advancement.

Accountability – You are given the resources you need to succeed and the freedom to make it happen; in return, we hold each other accountable for our high expectations.

Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that come with working on the cutting edge.

Key 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 Aiken, SC area , with potential for hybrid flexibility depending on company policy.
• May require on-call rotation and occasional after-hours maintenance for critical systems.

Other Duties: Please note this job description does not fully describe or provide a comprehensive list of all duties and responsibilities of the position. Duties and responsibilities, including essential functions, may vary amongst locations and/or individuals holding this position and may be added or changed without notice. All qualified applicants will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, national origin, age, disability, or protected veteran status. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. We are an Equal Opportunity Employer M/F/Vets/Disability.

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