Job Description

This position is located in San Diego and relocation assistance is available for well qualified candidates.

Sr. Scientist-ANALYTICAL DEVELOPMENT & QUALITY CONTROL

Seeking an experienced analytical chemist to join our QC & Analytical Development group at the Sr. Scientist level. The ideal candidate will be a self-starter, familiar with a broad range of analytical techniques, possess a strong work ethic, have good communication skills, and have experience working in a GMP environment. The successful candidate will be able to perform the following responsibilities with a high degree of independence and attention to detail.

RESPONSIBILITIES:

Coordinate and execute testing of drug substance intermediate, drug substance, and drug product samples
Develop drug substance specifications ensuring efficient integration across Chemistry, Manufacturing, and Controls (CMC) and other relevant disciplines such as Clinical and Toxicology
Author scientific reports and portions of the CMC section of regulatory filings
Manage the analytical activities for therapeutic development projects
May develop and optimize analytical methods
Design and execute method validation and method transfer protocols
Manage outsourced analytical activities at external contract labs
Conduct analytical investigations
Present at internal and cross-functional scientific meetings

REQUIREMENTS:

MS with at least 10 years of industry experience in Analytical Chemistry or related discipline
Ph.D. with at least 5 years of industry experience in Analytical Chemistry or a related discipline
Skilled in operating LC-MS, HPLC, and GC for the analysis of drug substance and drug product samples
Good understanding of the drug development process
Practical knowledge of GMP requirements, with hands-on GMP experience preferred
Good understanding of ICH and FDA method validation guidelines, including phase-appropriate strategies
Ability to problem solve, manage priorities and maintain aggressive timelines for multiple projects
Ability to work productively and independently within a team or matrix environment
Good written and verbal communication skills

Job Tags

Contract work, Relocation package,

Similar Jobs

Gulfstream Aerospace Corporation

RS Structural Mechanic IV Job at Gulfstream Aerospace Corporation

...RS Structural Mechanic IVin GAC Appleton Unique Skills: At Gulfstream, our people are at the heart of everything we do. We believe in inspiring and empowering every individual to reach their fullest potential. From workforce development and meaningful connections...

ProPivotal Staffing

Senior Accountant (CPA needed) Job at ProPivotal Staffing

...Senior Accountant (CPA needed) We are looking for a Senior Accountant to oversee the research, analysis, and documentation of complex accounting matters, including revenue recognition, purchase accounting, lease accounting, and impairment assessments. This role is responsible...

Piedmont Healthcare Inc.

Nutrition Svc Rep, Food Svc, Variable Job at Piedmont Healthcare Inc.

Overview: Join Piedmont to move your career in the right direction. Stay for the diverse teams youll love, a shared purpose, and schedule flexibility that frees you to live for what matters both in and outside of work. Youll feel valued, motivated to be your best, and...

Promise Healthcare

Clinical Assistant Job at Promise Healthcare

...to lead with passion and precision, apply now to become our Clinical Assistant and help us make a lasting impact on the future of... ...concerns promptly to RN supervisor/provider as appropriate Documentation & Workflow Support : Enters clinical data into EHR Tracks...

Spencer Ogden

Construction Coordinator Job at Spencer Ogden

...responsible for overseeing all aspects of construction projects, from planning to completion. This role will involve coordinating with contractors, suppliers, and other stakeholders to ensure projects are completed on time and within budget.Key Responsibilities: Manage...

Senior Scientist Job at BioPhase, Alameda, CA

UEt3SVVVN0w0RUJHMkgvQVc2WmMrcVdOdmc9PQ==