Madrigal Pharmaceuticals

Senior Manager, Analytical Manufacturing Science and Technology (MSAT)

PA - Conshohocken - Office, USA · Senior · Full-time

Sponsorship not specified$154k-$188kDetected 27 days ago

Supply ChainProcess ImprovementCompensationGMPFDA RegulatoryMass SpectrometryCollaborationProblem Solving

About the role

This role ensures analytical method robustness, compliance, and timely product release while leading technical investigations and supporting method transfers in a fully outsourced environment.

External Partner Analytical Oversight
Act as the day-to-day analytical operations lead for assigned small molecule and oral solid commercial products at CMOs and CTLs.
Support analytical method transfer, bridging, and revalidation activities between third-party sites.
Coordinate and review transfer protocols, reports, and gap assessments with external partners.
lead troubleshooting efforts as needed.
Lead or support the resolution of analytical deviations, OOS, OOT, and lab errors at CMOs/CTLs.
Drive CAPA development and implementation
Monitor method performance across sites and batches; lead troubleshooting efforts as needed.
Drive CAPA development and implementation; ensure timely closure in collaboration with Quality.
Maintain and review GMP documentation including method validation reports, stability protocols, technical memos, and deviations.

Minimum of 8+ years (BS), 6+ years (MS) of experience in analytical development, QC, or MSAT in a GMP-regulated small molecule environment.
Technical expertise in chromatographic methods (HPLC/GC), dissolution testing, stability programs, and compendial testing.
BS/MS/PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field.
Strong background in managing analytical activities at CMOs/CTLs for commercial products.
Location & Travel Requirements:
US Remote
Up to 50% travel to manufacturing sites across the supply network.
Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $154,000 - $188,000 per year. We comply with all applicable minimum wage laws.

Six Sigma training or certification (Green Belt preferred).
Hands-on experience with method transfers and managing external lab performance.
Familiarity with fully outsourced manufacturing models and virtual pharma structures.
Experience supporting regulatory submissions (e.g., NDA supplements, variations) and inspection readiness.
Preferred Experience:

Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity.

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality.
We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration.

This listing is sourced directly from Madrigal Pharmaceuticals's careers page and normalized into a canonical job model.