Industrialization Scientist, Molecular Biology

bioMérieux; Philadelphia (Philadelphia County); On-site; USD 78,000 - 135,000; Full time

Job summary

bioMérieux is seeking an Industrialization Scientist in Molecular Biology to oversee PCR process management and product development. The role involves collaboration with R&D, Quality, and Manufacturing teams to ensure efficient transitions from development to production, focusing on regulatory compliance and quality assurance. Ideal candidates will hold an MS or PhD in relevant fields and have extensive experience in molecular diagnostics.

Qualifications

• 7+ years of experience in manufacturing or product development of molecular diagnostics.
• Laboratory experience required, preferably in molecular biology.
• Management experience in related fields preferred.

Responsibilities

• Lead industrialization of PCR-based assays from development to production.
• Implement and optimize manufacturing processes for regulatory compliance.
• Collaborate with R&D and suppliers to support production readiness.

Skills

Data analysis

Project management

Communication

Team collaboration

Education

MS in Molecular Biology

PhD (preferred)

Job description

Industrialization Scientist, Molecular Biology

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Industrialization Scientist, Molecular Biology

Join to apply for the Industrialization Scientist, Molecular Biology role at bioMérieux

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Description

Industrialization Scientist, Molecular Biology is responsible for planning, implementation and management of PCR processes and products. This individual will be expected to provide scientific guidance and molecular expertise in transferring development projects from R&D into Operations as well as improving the robustness and profitability of existing PCR products and processes. They will ensure Operations and Suppliers have accurate and detailed specifications, SOPs, BOMs, and Product Master Data as well as lead troubleshooting efforts that arise within Supply Chain, QC, and Manufacturing. The ideal candidate will work closely with cross-functional teams including R&D, Quality, Manufacturing, and suppliers to support product lifecycle development and production readiness.

Description

Industrialization Scientist, Molecular Biology is responsible for planning, implementation and management of PCR processes and products. This individual will be expected to provide scientific guidance and molecular expertise in transferring development projects from R&D into Operations as well as improving the robustness and profitability of existing PCR products and processes. They will ensure Operations and Suppliers have accurate and detailed specifications, SOPs, BOMs, and Product Master Data as well as lead troubleshooting efforts that arise within Supply Chain, QC, and Manufacturing. The ideal candidate will work closely with cross-functional teams including R&D, Quality, Manufacturing, and suppliers to support product lifecycle development and production readiness.

Job Responsibilities

• Maintain a safe work environment and perform work in compliance with company quality procedures and standards.
• Lead the industrialization of PCR-based molecular diagnostic assays from development through scale-up to full production.
• Design, implement, and optimize manufacturing processes, ensuring reproducibility, scalability, and regulatory compliance (ISO 9001, ISO 13485, IVDR, etc.).
• Collaborate with R&D to define product requirements and transfer technical knowledge to production teams.
• Collaborate with suppliers to define raw material specifications. Support supplier validation efforts and transfer specifications, technical knowledge, and test methods to QC team.
• Develop and execute technology transfer plans, validation protocols (IQ/OQ/PQ), and risk assessments (e.g., FMEA).
• Support process validation, troubleshooting, and continuous improvement of manufacturing workflows.
• Partner with Supply Chain, Purchasing, and suppliers to evaluate potential external or internal suppliers of critical reagents (e.g., enzymes, primers, probes).
• Implement and monitor quality control (QC) testing strategies for intermediate and final product release.
• Manage stability studies when applicable following product or process changes and for continuous improvement.
• Lead troubleshooting and root cause investigation for issues arising from multiple sources, including customer complaints, QC failures, manufacturing challenges, and supplier notifications.
• Assist with design, implementation, and maintenance of PCR automation.
• Lead and participate in root cause analysis, CAPAs, and non-conformance investigations.
• Work with Quality Assurance and Scientific Affairs to ensure compliance with applicable standards and regulations.
• Mentor engineers, scientists, and technicians throughout Operations.
  
  

Minimum Requirements

• MS in Molecular Biology, Biotechnology, Biochemistry, Chemical Engineering, or related field is required. PhD is preferred.
• 7 or more years of relevant experience including at least 3 years in manufacturing, industrialization, or product development of molecular diagnostics required.
• Laboratory experience is required; experience during school is accepted. Laboratory experience in chemistry, microbiology, or molecular biology is preferred.
• Management experience, including in areas/roles not directly related to MFG, is preferred.
• Lean MFG or other continuous improvement experience is preferred.
  
  

Knowledge, Skills, Abilities

• Familiarity with manufacturing processes for molecular assays, including raw material synthesis, reagent formulation, lyophilization, and cleanroom environments.
• Proficient in data analysis tools and statistical methods for process validation.
• Strong project management and communication skills.
• Experience with automation and liquid handling platforms is a plus (e.g., Integra, Tecan).
• Fluency in English (written and spoken); additional languages are an asset.
• Ability to work with a team, identify and implement feasible solutions to challenges, and independently manage improvement projects and raw materials suppliers required.
  
  

10% Domestic Travel per year

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at [phone], by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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