Senior Scientist I - Analytical Chemistry

5w1 month ago

Kindeva Drug Delivery

Lexington, US · Full-time · $110,000 – $145,000

About this role

At Kindeva Drug Delivery, we make products that save lives, ensuring better health and well-being for patients around the world. As a Senior Scientist I in Analytical Chemistry, you will serve as a technical leader within the R&D Analytical Chemistry group, leading analytical strategies that support pharmaceutical product development from early-stage through commercialization.

In this role, you will lead the development, optimization, and validation of robust analytical methods for drug substances and drug products in accordance with ICH, USP, and regulatory guidelines. You will design and execute complex analytical studies to support formulation development, process development, stability programs, and customer projects, while also supporting technology transfer of analytical methods to internal and external QC laboratories and CMOs.

You will collaborate cross-functionally with Formulation Development, Process Development, Quality Assurance, and Regulatory Affairs teams to advance customer programs and internal development initiatives. This role offers the opportunity to mentor and provide technical oversight to junior scientists and analysts, ensuring scientific rigor and compliance with quality standards.

Our Lexington site continues to experience significant growth across development and manufacturing programs, offering the chance to lead complex analytical projects and influence technical strategy. You will stay current with advancements in analytical technologies, industry best practices, and regulatory expectations while expanding Kindeva's analytical capabilities.

Requirements

Proven expertise in analytical method development, optimization, and validation for pharmaceutical drug substances and drug products.
Strong knowledge of ICH, USP, and regulatory guidelines governing analytical methods and documentation.
Experience authoring and reviewing technical documents for regulatory submissions (IND, NDA, ANDA, BLA).
Demonstrated ability to lead complex analytical studies and troubleshoot method-related issues.
Experience mentoring and providing technical oversight to junior scientists and analysts.
Familiarity with GMP requirements and regulatory inspection readiness.
Ability to collaborate effectively across cross-functional teams including Formulation Development, Process Development, Quality Assurance, and Regulatory Affairs.

Responsibilities

Lead the development, optimization, and validation of robust analytical methods for drug substances and drug products in accordance with ICH, USP, and regulatory guidelines.
Design and execute complex analytical studies to support formulation development, process development, stability programs, and customer projects.
Lead or support technology transfer of analytical methods to internal and external QC laboratories and CMOs.
Support qualification of new analytical laboratory equipment and implement new analytical techniques and instrumentation to expand internal capabilities.
Act as a subject matter expert (SME) for analytical technologies, method troubleshooting, and regulatory inspections.
Author and review technical documents, including method validation protocols and reports, specifications, analytical development reports, and regulatory submissions (IND, NDA, ANDA, BLA).
Mentor and provide technical oversight to junior scientists and analysts, ensuring scientific rigor and compliance with quality standards.
Collaborate cross-functionally with Formulation Development, Process Development, Quality Assurance, and Regulatory Affairs teams.

Benefits

Purpose-driven work environment with direct impact on patient care
Significant growth potential within a growing pharmaceutical CDMO
Collaborative team culture with industry-leading innovation
Opportunity to lead complex analytical projects and influence technical strategy