Senior Scientist (Method Transfer)

Must Haves:

• BS+8 years of industry experience, preferably in GMP; MS + 6 years of industry experience, preferably in GMP or PhD. + 2 years of industry experience, preferably in GMP.
• Extensive hands-on experience and strong background in either Chemistry, Microbiology or molecular biology assays.
• Experience with troubleshooting assays and improving method performance.
• Strong technical writing and presentation skills.

Pluses:

• Experience with method validation and method transfer skills to manufacturing site.
• Experience with bio-process downstream development.
• Understanding of critical quality attributes of drug substance and drug product.

Job Summary:

A pharmaceutical manufacturing client is seeking a Senior Scientist to provide critical support within their Method Transfer and Development Group by performing analytical method validation activities (draft protocols/reports, execute validation assays, data analysis), and procedural updates. Additionally, the candidate should be reviewing various reports, and data to in accordance with cGMP and data integrity principles. The candidate should guide the newer resources on the documentation and good manufacturing practices.

Responsibilities:

• Independently conceptualize, plan, and execute laboratory experiments.
• Collaborate with colleagues and subject matter experts to determine the most suitable analytical methodologies to support project initiatives, including the use of computational predictive tools, modeling software, and data visualization tools as necessary.
• Lead and manage multiple projects, assisting teams in developing effective strategies for analytical needs and controls.
• Engage with the method development team and participate in both in-process and final product sample analyses.
• Author relevant sections of technical reports to support interdepartmental technology and method validation and transfer processes.
• Prepare technical reports, critically review data, and evaluate new instrumentation and analytical techniques/approaches as required.
• Independently analyze experimental data and provide conclusive insights.
• Mentor junior scientists and offer technical guidance when required.