Senior/Principal ARD Scientist

The Senior/Principal Scientist will be part of the CMC ARD team responsible for drug product related CMC strategy development for clinical stage biosimilar and conjugate biologics programs. The individual will be proficient in multiple analytical techniques as well as with the latest ICH, FDA and EMA regulatory guidance on pharmaceutical development. A successful candidate will act as an intellectual resource in the area of expertise by supporting analytical method development, tech-transfer, and validation.

Key responsibilities include:

1. Provide scientific guidance and leadership on phase appropriate methods development, optimization, qualification, technical transfer, product comparability, extended characterization, and stability programs.
2. Conduct characterization, investigation, and troubleshooting to provide key insights and understanding for drug product CQA assessment.
3. Work on analytical method development, optimization, troubleshooting, qualification, and validation: LC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, MALS, and other large molecules characterization methods.
4. Author experiment summaries, development reports, technical reports, operation and test method procedure documents, and provide review for documents comprising, but not limited to standard operating procedures, standard test methods, validation protocols and reports.
5. Actively participate in project team meetings, and communicate scientific data and concepts effectively through presentations, posters, and reports.
6. Stay well-informed with advancements in separation sciences and large molecule characterization tools, and attend/present at scientific conferences.
7. Communicate effectively with supervisors, colleagues, clients, and vendors.
8. Maintain accurate, detailed, and timely records of method development and analytical data.
9. Perform data review to ensure accuracy, completeness, and validity.

Requirements:

1. Ph.D. or Masters in Analytical Chemistry, Organic Chemistry, Biochemistry, or related areas.
2. More than five years of experience in analytical method development and problem solving in the large molecules pharmaceutical industry is required for this position.
3. GMP experience is required.

Experience and Skills:

1. Must have fundamental understanding of analytical and biophysical characterization of mAbs and conjugate biologics.
2. Must have practical and hands-on experience with analytical instruments and method development using instruments such as HPLC/UPLC (SEC, RP, IEX, HIC etc.), mass spectroscopy, capillary electrophoresis, MALS, and other large molecules characterization methods.
3. Experience with any or all of the following is considered advantageous: potency assay, plate-based assays, spectroscopy (UV-Vis, FT-IR, CD, and fluorescence).
4. Must be able to handle complex data interpretation and perform statistical analyses.
5. Familiarity with ICH guidelines and USP/EP pharmacopeia requirements.
6. Be able to work on multiple projects simultaneously.
7. Ability to be an individual contributor as well as collaborative team member.
8. Demonstrated ability to apply critical thinking and good problem-solving skills.
9. Strong willingness to learn and work proactively.
10. Good communication and technical writing skills.
11. Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is a must.

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

1. Laboratory and controlled cleanroom space.
2. Cleanroom gowning may be required.
3. Standard noise levels expected with laboratory and manufacturing equipment.
4. Extended periods of standing and walking while working in the lab areas.
5. Must be able to lift 15 lbs.
6. High-paced demanding environment to meet manufacturing schedules.
7. Travel as per need basis will be required, as part of method transfers or troubleshooting at manufacturing/QC sites.

Benefits:

1. Medical
2. Dental
3. Vision
4. 401K
5. Commuter/Transit
6. Student Loan Assistance
7. Cell Phone Allowance