Senior Scientist, Analytical Development
Concentric Analgesics, Inc. is a private, biotechnology company focused on discovering and developing novel, non-opioid therapeutics for the management of acute and chronic pain.
The selected candidate will be a key member of the Pharmaceutical Operations team. They will provide technical oversight to the analytical development activities for novel small molecule drug substances and products.
Key Roles & Responsibilities:
Apply a science-driven, phase-appropriate and risk-based analytical development strategy to guide the analytical development from pre-clinical through commercialization.
Successfully work in a virtual environment with partner CMOs and CTLs to ensure specifications, test methods, stability protocols and validations are appropriate for monitoring and control of critical attributes.
Review analytical data, COAs, and stability trends for quality and scientific understanding
Author and/or review shelf life statements, compiled analytical reports and stability reports and trend analysis.
Support QA as appropriate in vendor oversight and batch release
Proactively identify analytical risks and issues; lead, support and/or monitor GMP-related incidents and investigations that include laboratory findings.
Write, review and/or approve relevant CTD sections of regulatory filings
Be familiar with current industry best practices for instrumentation, procedures and strategies to efficiently and effectively progress programs through NDA.
Interface with other internal functional groups as needed to mutually support development goals
Travel up to about 20%
Knowledge and Skill Requirements:
Ph.D. degree in Analytical Chemistry or related field with a minimum of 10 years of progressive experience in the biopharmaceutical/biotech industry and a GMP environment. Lesser degrees will be considered with appropriate experience.
Thorough understanding of product development and analytical development for small molecule drug substances and products from discovery through clinical and commercialization
Deep knowledge of modern analytical chemistry techniques and GMP release testing of pharmaceutical products; direct practical experience with core analytical methods
Experience with a contract manufacturing and testing environment
Direct GMP and NDA validation experience with chromatographic methods, spectral, and wet chemistry method development and testing
Ability to interpret and apply regulatory requirements and industry best practices; experience with regulatory submissions (previous Pre-Approval Inspection experience is desirable)
Excellent interpersonal skills and abilities;
Highly motivated, organized, and detail-oriented
Strong written and verbal communication skills
Hands-on individual with a collaborative personal style and the ability to work well in a fast-moving team environment
Concentric Analgesics is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
The Human Resources team manages the recruitment and employment process for Concentric Analgesics. Unsolicited resumes sent to Concentric Analgesics from recruiters do not constitute any type of relationship between the recruiter and Concentric Analgesics and do not obligate Concentric Analgesics to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.
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