Scientist – Analytical Chemistry > Mountain View CA

JOB Description

Turn Biotechnologies is seeking a full-time Senior Scientist/Scientist - Analytical Chemistry at PhD/MS level in our Chemistry & Formulations Group.

COMPANY

Based in Mountain View, California, Turn Biotechnologies, Inc. is a development-stage company focused on restoring cells’ youthful vigor to repair damage caused by the aging process. Using a proprietary ERA™ Platform, we develop mRNA medicines that are specially formulated to instruct specific cells in the body to fight disease or repair damaged tissue. We do this by reprogramming the epigenome to restore cell function that people often lose as they age. This approach can be used to revitalize different cells throughout the body. We are researching its applicability across multiple therapeutic areas, including dermatologic conditions, pulmonary disease, osteoarthritis and ophthalmology.

Responsibilities:

Essential duties of the position include:

  • Accountable for selecting, developing, and executing a great variety of chemical and physical analytical methods including HPLC, Mass, UV, Particle Analyzer, DLS, etc., to support product characterization, stability study in an R&D setting as well as other research projects for process, formulation and manufacturing development.

  • Perform analytical tests to support method development, DS/DP characterization, PD studies, and stability testing of drug substances and drug products.

  • Helping to set up and manage an analytical chemistry lab and maintaining the lab instruments.

  • Maintaining all appropriate corporate standards for lab safety and hazardous material management.

  • Executing daily chemistry operations with an approach designed to minimize risks and hazard waste streams.

  • Maintaining a lab notebook, instrument, and inventory records in accordance with department guidance and regulatory requirements.

  • Generating, reviewing, and approving necessary reports to provide scientifically sound and data-based support for product development, knowledge management, and data traceability. Evaluate new technologies and innovate analytical methods to expand the analytical capabilities of the group.

  • Author method SOPs, development reports, and qualification/validation reports to support method transfer.

  • Participate in analytical method development, qualification, validation, and transfer at CRO/CMO sites.

  • Serve on analytical teams supporting the clinical development of drug candidates.

  • Propose specifications for drug substance and drug product manufacturing.

  • Contribute to regulatory submissions.

  • Training, leading and directly managing staff as the company grows.

Qualifications

Education/Experience

  • Degree in chemistry or related discipline with relevant industrial experience.

  • Ph.D. with minimum of 5 years of experience.

  • BS/MS with minimum of 10 years of experience.

  • Familiar with current analytical techniques used for pharmaceutical analysis, and hands-on experience in analytical techniques, such as Liquid Chromatography (HPLC, UPLC), NMR, MS, GC etc.

  • Prior experience with ribonucleic acid, and lipids analysis are preferred.

  • Some prior experience in impurity characterization by mass spectrometry is desirable.

  • Hands-on GMP experience would be an asset.

  • Sound understanding and adequate skills in statistics.

  • Experience with outsourcing work to CMOs or CROs, tech transfer, and the ability to supervise projects.

  • Knowledge of GLP/GMP and knowledge of compliance requirements for analytical methods development and validation as in guidelines published by FDA, ICH, EMA, USP, etc.

  • 3-5+ years of supervisory experience desirable

REQUIRED Characteristics

  • Detail-oriented while understanding the CMC overall business needs.

  • Ability to prioritize responsibilities and multi-task in a fast-paced environment.

  • Strong desire to work in a collaborative and multidisciplinary environment, learning new skills, and proactively solving problems.

  • Strong and independent problem-solving and troubleshooting abilities.

  • Proficient in presenting data and results in group setting.

  • Flexible and can prioritize/accommodate demanding work schedules as required.

  • Experienced writing scientific reports.

  • Excellent oral and written communication skills.

  • Ability to work independently and in a team environment.

  • Emotionally intelligent; a “whatever it takes” attitude.

Turn Biotechnologies is an equal-opportunity employer and values diversity. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status or disability status.