Contract - Senior Associate/Scientist – Analytical Development

Job Summary:

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 will be required to sit in our Newark, CA site. This will be onsite 5 days a week.  This role is a contractor-based position with a minimum contract timing of 6 months.

 

Responsibilities/Essential Duties:

• 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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Company Summary:

Revance is a global company developing, producing, and distributing industry-leading, differentiated products across aesthetics, skincare, and therapeutics. Revance drives innovation beyond convention to offer treatment options for individuals across generations. The Company’s vision is to redefine excellence in aesthetics, skincare, and therapeutics through science-powered innovation, with an unwavering commitment to its providers, patients, and consumers. Revance’s award-winning products are the result of robust research and development, a cornerstone for the Company, driven by renowned scientists. For more information about Revance, please visit us at www.revance.com.

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.