- Lilly (Indianapolis, IN)
- …goes from design, to start-up, and to steady-state operations. The Analytical GMP Strategy & Compliance Director role, a technical-track position, seeks ... for establishing and maintaining a comprehensive GMP framework for analytical operations, ensuring compliance with relevant regulations and guidelines. The… more
- BeOne Medicines (Emeryville, CA)
- …complex systems. Highly effective in analytical and strategic assessment of GMP and GDP compliance risks; able to articulate potential business impact. ... addition, develops partnerships with key enterprise business partners and stakeholders to advance GMP and GDP and GDP compliance solutions, embed preventive … more
- Lilly (Lebanon, IN)
- …goes from design, to start-up, and to steady-state operations. The Process Analytical Technology Strategy Leader role, a technical-track position, seeks a ... product development and commercialization. Proven skills developing, validating, and transferring analytical methods. + Fundamental knowledge of cGMP compliance … more
- Takeda Pharmaceuticals (Lexington, MA)
- …cGMP's + Demonstrates effective project management skills + GMP and compliance experience required + Analytical method development experience required + ... and scientists and their teams in the field of analytical controls and compliance + Global CMC...clinical trial material efforts across four main areas: a) GMP review and control for analytical documents;… more
- Cambrex High Point (Charles City, IA)
- …document analytical methods + Maintain laboratory notebooks documenting work + Maintain compliance with GMP SOPs and DEA regulations + Transfer documented ... across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years...methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most… more
- Catalent Pharma Solutions (San Diego, CA)
- …compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good ... in compliance with company standard operating procedures (SOPs) and GMP (Good Manufacturing Practices) regulations, as appropriate. **This is a full-time… more
- Lilly (Indianapolis, IN)
- …seeks a collaborative, inclusive, and energetic leader who will define and lead the strategy to be employed for the analytical workflows and testing strategies ... are aligned with all relevant development quality, regulatory, HSE, GLP and GMP requirements. **Basic Requirements:** + Ph.D. in analytical , biophysical,… more
- Merck (Rahway, NJ)
- …teams, overall approximately 40-50 scientists. Strategic partnering with Biologics Analytical Research and Development method development GMP laboratories, ... Analytical Development, Biologics, Biologics License Application (BLA), Control Strategy , People Management **Preferred Skills:** **Job Posting End Date:**… more
- Merck (Durham, NC)
- …and external GMP and Financial audits, QSAT actions, to ensure compliance . This is a fast-paced and multi-faceted role that provides leadership and input ... Manufacturing facility in Durham NC, the Supply Chain Logistics Strategy Leader will be responsible for the development, management,...success. + SME support during routine internal and external GMP and Financial audits, input to QSAT actions, to… more
- Lilly (Lebanon, IN)
- …to build the processes and facility to enable a successful startup into GMP manufacturing operations. **Position Description** The purpose of this position is to ... alignment. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Develop, monitor, and… more
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