A world leader in the field of in vitro diagnostics for over 55 years, bioMerieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. bioMerieux's global headquarters is located in Marcy L'Etoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMerieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMerieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.

Purpose and Overall Objective of the Job:

As part of the Industrialization Analytical department, the Associate Process Scientist (Biochemist) will perform projects to support the manufacturing of BACT/ALERT Culture Media products. Within this role the Associate Process Scientist will be required to interface with Manufacturing, Quality Control, Quality Assurance, R&D, Purchasing, Supply Chain, and other functions as required in order to ensure successful project achievements to facilitate quality production that meets on-time customer demands.

Main Accountabilities:

In this position the Associate Process Scientist's primary focus will include the analysis of both biological and chemical derived raw materials for secondary/alternate sourcing projects in order to achieve site securitization and/or cost saving initiatives. Analysis includes laboratory testing at the bench scale, performance testing on final product, and large scale validation activities. Strong knowledge of cGLP and cGMP, microbial testing (environmental monitoring, bioburden, isolating and monitoring microorganism cultures) and analytical instrumentation proficiencies (HPLC, GC, SEC, pH, FTIR) will be required, along with understanding impact to both upstream and downstream processes when considering raw material changes. Management of multiple projects will be required, whereby assessments are generated to evaluate interim progress and effectiveness. Project leadership is necessary in order to guide timelines, adjust expectations, and collaborate cross-functionally. This position will require a strong knowledge of both chemistry and microbiology in order to provide subject matter expertise in evaluating raw material and process changes in both planned and unplanned circumstances, provide departmental representation on cross-functional teams, as well as, participate and identify improvement opportunities and strategies.

Education and Experience:

• BSor MS in Biochemistry or closely related field, with 0-3years of experience.
• Preferred experience in a FDA regulated cGMP industry.

Skills and Qualifications:

• Robust technical background in analytical chemistry methods, microbiological methods, and aseptic technique.
• Basic SAP knowledge, or a related ERP system.
• Computational aptitude for scaling formulation recipes
• Experience with data analysis and statistical software competence, Minitab preferred.
• Experience with implementing changes/qualifications through change control process.
• Strong project management skills, familiarity with Microsoft Project.
• Direct experience in authoring and review/approval of documentation.
• Agility to re-prioritize workload independently due to business needs.
• Exhibit instrument and method trouble shooting skills (HPLC, GC, SEC, pH, FTIR, BCID, etc).
• Self-directed individual who can work with limited direction.
• Excellent organizational, analytical, and communication skills.
• Demonstrated ability to work in a team environment.

Joining bioMerieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMerieux team members who already identify with these values!

bioMerieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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