Overview
Are you a PhD chemist ready to translate cutting‑edge research into life‑changing medicines? Join our dynamic chemistry team and play a central role in developing, scaling and launching Phase III and commercial drug substances. You’ll collaborate with leading scientists across our labs and U.S. research & commercialization sites, apply new chemistries and technologies, and provide hands‑on technical support to manufacturing.
Responsibilities
* Lead process R&D for late‑stage clinical and commercial active ingredients, developing robust synthetic routes in the lab and preparing processes for scale‑up and regulatory filing.
* Support Phase III process development and the commercial launch and continuous supply of new products.
* Conduct initial development of new chemistries/technologies for commercial processes and deliver practical, scalable solutions.
* Provide dynamic on‑site and off‑site manufacturing support: process maintenance, troubleshooting, real‑time deviation assessment and documentation.
* Drive and document process improvements via Change Control; support process validation and produce validation documentation.
* Define and document efficient cleaning procedures and produce cleaning technical assessments for new products.
* Support technology transfers to partner sites, supplying technical chemistry expertise and transfer documentation.
* Apply Lean Six Sigma tools (Kaizen, etc.) to resolve process issues and contribute to small improvement/maintenance projects.
* Prepare and author required documentation and milestone reports for plant operations, tech transfers and regulatory submissions.
* Present technical findings internally and collaborate with cross‑functional commercialization partners (CERD/CCTO, Pharm, Process Research, Operations).
Qualifications
* PhD in Chemistry, Chemical Engineering or a closely related discipline.
* Experience in the pharmaceutical industry or advanced research in a relevant chemistry area is a strong advantage.
* Strong hands‑on laboratory skills and experience developing or scaling synthetic routes.
* Practical experience supporting process transfers, validation activities and manufacturing troubleshooting.
* Good knowledge of GMP principles, safety and laboratory waste/risk assessment procedures.
* Ability to interpret analytical and process data and communicate technical conclusions clearly.
* Experience with documentation for regulatory filings (e.g., IND/NDA/MAA) is desirable.
* Comfortable working in cross‑functional teams and presenting technical material to diverse audiences.
Why join us
* Make a tangible impact on product launches that improve patient lives.
* Collaborate with world‑class scientists and commercialization teams in an innovative, supportive environment.
* Opportunities to work on new chemistries and scale cutting‑edge technologies to commercial production.
* Professional development, training on GMP and Lean Six Sigma, and career progression in a growing organization.
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