Contract - Senior Associate/Scientist – Analytical Development

Revance•Newark, NJ

3d•Onsite

About The Position

Revance (a Crown Laboratory Company) is seeking a Sr. Associate Scientist to contribute to our Analytical Development team. The Sr. Associate Scientist will participate in a team responsible for all aspects of method development, qualification, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for Revance projects. This is an on-site, technical laboratory-based position that involves development, validation, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support. This role is a contractor-based position with a minimum contract timing of 6 months.

Requirements

Experience performing basic analytical assay techniques such as absorbance and fluorescence plate-based assays, immunoassays (AlphaLISA, ELISA, SPR, and western blot), SoloVPE, and SDS-PAGE/CE-SDS.
Familiarity in interpreting data from common characterization techniques such as HPLC, AUC, SEC-MALS, MFI, DLS, and CD.
Experience developing/authoring protocols, methods, and SOPs.
Ability to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
Strong written and verbal communication skills.
Working knowledge of statistics; R, Python, Graphpad, JMP or other statistical tools preferred.
Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
Self-motivated, proactive and driven individual with an interest in experimental design and development.

Nice To Haves

Master’s degree in biological sciences or related field with 3+ years of progressive experience in the biotechnology or biopharmaceutical industry.
PhD with minimal industry experience may be considered.
Bachelor’s degree in biological sciences or related field with 5+ years of progressive experience in the biotechnology or biopharmaceutical industry.
Outstanding academic achievements may be considered in combination with industry experience.
Strong experience with immunoassays is highly desired, HPLC experience is a plus.
Experience working in a GMP setting is preferred.
Knowledge of SoftmaxPro and/or Empower is a plus.
Experience in drafting protocols, methods, and/or procedures.
Experience or working knowledge of neurotoxin therapeutic development.
Experience in performing change control, deviation, laboratory investigation, and/or other quality records.

Responsibilities

Execute technical analytical methodologies to support development and validation of test methods.
Author and review analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
Operate and maintain (as well as overseeing the installation of) sophisticated analytical instrumentation and associated computer control systems.
Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development area.
Provide support for laboratory operations – inventory tracking, reagent preparation, sample management, and documentation review.
Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.
Interact with contract manufacturers and contract testing laboratories.
Provide support as required for regulatory submissions.
Train other qualified staff to ensure effective execution of roles and responsibilities.