Scientist 1, QC Analytical Development - Chemistry

About the role

Supports the transfer of analytical Chemistry methods for Technology Transfer (TT) of drug substance (DS) and drug product (DP) into the Quality Control laboratories of FUJIFILM Biotechnologies, Holly Springs. This role ensures Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines.

The Scientist 1, QC Analytical Development Chemistry authors transfer documents and executes testing as part of transfer for the following analytical methods:

• HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map)
• UVA280 and slope spectroscopy
• Capillary electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF))
• General pharmaceutical properties methods

Responsibilities

• Supports analytical chemistry method tech transfer and execution through method verification, transfer, and validation.
• Interfaces with customers and program management to identify analytical needs and method gaps during project scoping.
• Participates in meetings for TT programs with cross-functional teams and key stakeholders.
• Authors technical documents including transfer and validation protocols/reports.
• Communicates with QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines.
• Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements.
• Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.).
• Supports regulatory requests and inspections.
• Supports the QCAD team to investigate any project challenges with necessary risk assessment tools and techniques.
• Supports best practices for TT and PPQ strategies globally, as required.
• Performs other duties, as assigned.

Requirements

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO); OR,
• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience; OR,
• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience.
• Experience with analytical method transfers.
• Experience with project management and demonstrated ability for providing regular updates and escalations.
• Proficient in physical and chemical testing methods for biological products, including:
  • HPLC/UPLC chromatography (Protein A/G titer, SEC, PS80, glycans, peptide map)
  • UVA280 and slope spectroscopy
  • Capillary electrophoresis (CE-SDS, imaged capillary isoelectric focusing (icIEF))
  • General pharmaceutical properties methods
• 3+ years of experience working in a regulated GMP environment.
• Relevant experience in analytical method development, transfer, and validation.

Skills

• In-depth technical knowledge of Analytical Chemistry and ability to analyze raw data, assess assay and system suitability criteria.
• Demonstrated application and knowledge of ICH guidelines on analytical method validation.
• Strong communication skills, technical proficiency, scientific creativity, collaboration with others, and independent thought.
• Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary, and display strong problem-solving capabilities.
• Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, PowerPoint, Word, etc.
• Advanced knowledge of GMP requirements for laboratory operations.
• Broad knowledge of quality control operations, systems, and directives.
• Flexibility to support a 24/7 manufacturing facility.

Preferred Qualifications

• Experience with Customer Relationship Management.
• Prior drug substance experience, including analytical method validation, transfer, commercialization, and manufacturing support and troubleshooting.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.