MR Lowcountry, LLC.                                          

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

Plant Manager – South East  - Full Time Onsite

The company works across industries and value chains to accelerate the transition to BioAlternatives – 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 highly motivated Plant Manager to be responsible for the overall leadership, safety, and performance of a cGMP manufacturing facility, including production, quality, maintenance, and site compliance functions. This role ensures the site consistently meets production targets, quality standards, and regulatory requirements (cGMP, FDA, OSHA) while driving continuous improvement in safety, efficiency, and cost performance. This hands-on position requires a desire and ability to work as an integral part of a multidisciplinary team, as well as the demonstration of a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of the position.

Why work for the Company:

• Opportunity – To be part in building a company focused on a future increasingly reliant on bio-manufacturing and making a sustainable and positive impact in the world.
• Accountability – You will build, manage and work in a hands-on environment to develop and articulate the company’s product value propositions.
• Passion – We love what we do and enjoy working with others who feel the same way. We embrace the challenge and hard work that comes with working on bringing cutting edge technologies to market.

Responsibilities:

Operations and Production:

Direct day-to-day manufacturing operations to meet production schedules, yield targets, and cost budgets.

Oversee capacity planning, batch scheduling, and resource allocation across production teams.

Drive Overall Equipment Effectiveness (OEE), right-first-time rate, and cycle time improvements.

Ensure adequate staffing, shift coverage, and cross-training across production areas.

Quality & Compliance:

Maintain full compliance with current Good Manufacturing Practices (cGMP), SOPs, and batch record requirements.

Partner with Quality Assurance on deviation investigations, CAPAs, change controls, and audit readiness.

Serve as a site leader during FDA, customer, and internal audits/inspections.

Ensure timely, accurate documentation practices (data integrity, ALCOA+ principles).

Environmental, Health and Safety (EHS):

Champion a strong safety culture; own site safety metrics (TRIR, near-miss reporting, corrective actions).

Ensure compliance with OSHA, EPA, and other applicable environmental and safety regulations.

Lead incident investigations and implement preventive/corrective measures.

Leadership and People Management:

Lead, coach, and develop production supervisors, shift leads, and manufacturing staff.

Set performance goals, conduct evaluations, and manage disciplinary actions in partnership with HR.

Foster cross-functional collaboration with Quality, Supply Chain, Engineering, and R&D.

Build succession plans and talent pipelines for key production roles.

Continuous Improvement Strategy:

Identify and lead Lean/Six Sigma or similar continuous improvement initiatives.

Manage capital projects, equipment upgrades, and facility expansions in coordination with Engineering.

Develop and manage the site’s annual operating budget and capital expenditure plans.

Report site KPIs (throughput, yield, quality, safety, cost) to executive leadership.

Qualifications

Required:

Bachelor's degree in Engineering, Biology, Chemistry, or related technical field (or equivalent experience)

8+ years of progressive manufacturing leadership experience, including 3+ years in a plant/site manager or senior operations leadership role. Direct experience operating within a cGMP-regulated environment (biotech, pharma, or related life sciences manufacturing).

• Must have prior experience in a specialty ingredient manufacturing, chemical, or bio-processing plant
• Strong working knowledge of FDA regulations, batch record systems, and quality management systems
• Demonstrated success managing P&L, budgets, and capital projects
• Proven people-leadership skills with experience managing multi-shift teams
• Excellent communication skills; both oral and written are required.
• Strong analytical and problem-solving skills are required.
• Computer skills and an in-depth knowledge of Microsoft Windows based programs are required.
• Ability to work flexible hours.
• Requires effective time management skills, personal conduct, and change management abilities.
• Ability to effectively interact with co-workers, vendors, contractors and other business contacts.
• Must comply with the company’s core values for the safe and efficient operation of the business and maintain sound relationships among and with employees.

Food Manufacturing Requirements:

• Working knowledge of food safety management systems (HACCP, SQF, BRC, or FSSC 22000) and GFSI-aligned quality frameworks, in addition to cGMP PCQI (Preventive Controls Qualified Individual) certification and working knowledge of FSMA preventive controls; FSVP knowledge a plus for imported ingredients.
• Demonstrated ownership of yield, giveaway, and cost-of-goods performance in a margin-sensitive production environment.
• Experience with allergen control programs, sanitation/CIP validation, and environmental pathogen monitoring. Comfort managing variable-cost, productivity-driven labor models typical of food manufacturing operations

Preferred:

Master's degree in a relevant scientific or engineering discipline, or MBA

Experience with fermentation-based or bioprocessing manufacturing

Lean Manufacturing / Six Sigma certification (Green Belt or Black Belt)

Experience with ERP/MES systems and electronic batch records

Prior experience leading facility expansions or tech transfers

Company Approach:

First Principles Operations

The company applies first principles thinking to manufacturing and operations – building improvement plans from the underlying physics, chemistry, and mass balance of our processes rather than from industry benchmarks alone.

The Plant Manager is expected to lead in this mindset:

Theoretical yield as the anchor – derive yield targets from feedstock stoichiometry and conversion efficiency and treat the gap to actual performance as the improvement backlog, rather than benchmarking against industry-typical yields.

Bottleneck-first prioritization

• Identify the true rate-limiting step in the production train and size investment and improvement efforts to it, rather than optimizing stations that don't move overall output.
• Cleaning and sanitation parameters derived from first principles – validated Time-Action-Concentration-Temperature (TACT) parameters built from soil-removal kinetics for our specific product matrix, not generic vendor defaults.
• Bottom-up cost modeling – cost-to-produce built from utilities, labor-hours, and consumables per batch, so capital and efficiency cases trace to physical drivers rather than allocated overhead.
• Decomposed OEE analysis – break performance into availability, performance, and quality losses individually so improvement efforts target the actual loss driver rather than a blended metric.

Physical Requirements

Ability to walk/stand for extended periods on the production floor.

Ability to wear required PPE (gowning, safety glasses, hearing protection) in manufacturing and cleanroom areas.

Occasional lifting up to 25 lbs.

Availability for occasional off-shift or weekend coverage as operational needs require.

Work Environment:

Manufacturing plant environment with exposure to controlled/classified spaces, chemicals, and process equipment

May require entry into cleanroom or containment areas per site gowning protocols

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 job 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 accommodations may be made to enable individuals with disabilities to perform the essential functions. We are an Equal Opportunity Employer M/F/Vets/Disability.