QC Chemistry Scientist II

Overview:

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US:

About the Role

The QC Chemistry Scientist II is a technical subject matter expert (SME) responsible for QC analytical chemistry methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The QC Chemistry Scientist II ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs technical/compliance reviews and approves analytical results. The role also approves laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The QC Chemistry Scientist II authors, reviews, and approves SOPs, protocols, and technical reports. When needed, the QC Chemistry Scientist II trains other QC Bioassay laboratory associates and executes routine analytical methods. The role serves as the subject matter expert (SME) for QC Chemistry in cross-functional projects and meetings.

What You'll Do

• Performs physical and chemical analytical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance.

• Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.

• Performs laboratory work and peer reviews of analytical data in support of tech transfer and routine manufacturing.

• Executes and reviews method qualification and validation activities and maintains lab equipment.

• Monitors assay performance and implements improvements that ensure quality and efficiency within QC Chemistry.

• Troubleshoots and investigates deviations and invalid assays performed in QC Chemistry.

• Authors, reviews, and approves SOPs, protocols, reports, change controls, Trackwise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Chemistry team, as needed.

• Represents QC Chemistry in cross-functional collaborations with other QC Departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives.

• Manages and monitors lab activities as needed.

• Provides training for QC Chemistry associates.

• Provides technical support as the QC Chemistry SME during customer visits, audits, and regulatory inspections.

• Participates in risk and gap assessments during project scoping as needed.

• Authors technically-sound simple to moderately complex reports with limited guidance.

• Collaborates with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements.

• Liaises with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results as needed.

• Performs other duties, as assigned

Minimum Requirements:

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of experience of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)

• 4-6 years experience in a GMP environment

• In-depth technical knowledge of physical and chemical analytical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CESDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance.

• Advanced knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to Chemistry analytical methods.

• Familiarity with LIMS Software.

Preferred Requirements:

• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 7+ years of experience, OR

• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience

• Experience with Customer Relationship Management

• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.

• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Abiltiy to stand for prolonged periods of time up to 120 minutes

Abiltiy to sit for prolonged periods of time up to 120 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race,.