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Amgen
Amgen
Sponzor vizuma H1BBiotehnologijaFarmacevtski izdelkiZdravstveno varstvo
Amgen je globalno biotehnološko podjetje, ki razvija in trži zdravila, izdelana iz živih celic. Njegovo delo je osredotočeno na resne bolezni, vključno z boleznimi z omejenimi možnostmi zdravljenja, pri čemer temelji na znanstvenih raziskavah in kliničnih preskušanjih. Podjetje je povezano z napredkom pri zdravljenju raka in obvladovanju debelosti, hkrati pa poudarja etične raziskave, varnost bolnikov in okoljsko trajnost.
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Delovna mesta v podjetju

Product Quality Director, Hybrid Modalities

Lead product quality strategy for Amgen’s hybrid-modality medicines, overseeing GMP activities, stability programs, regulatory submissions, and cross-functional teams.

USZdružene države AmerikeCAKalifornijaMAMassachusetts
176.370 $ – 238.619 $ / leto
HibridnoPolni delovni časVodjaZahtevani Jezik: angleščinaDirektor

Opis

  • Act as Product Quality Leader and advocate for a product team.
  • Set technical direction and lead strategy and projects across Product Quality.
  • Partner with quality, regulatory, development, manufacturing, and executive teams across the organization.
  • Address product quality matters across manufacturing, testing, specifications, stability, investigations, change control, submissions, and inspections.
  • Improve operational processes and align quality practices across international sites.
  • Support development and commercial lifecycle management for large and small molecules.
  • Lead Product Development Team quality work, including comparability, specifications, stability, and annual product reviews.
  • Provide scientific oversight for pivotal and commercial products.
  • Review product data, maintain GMP documents and filing sections, use GMP systems, and support audits and regulatory responses.
  • Lead the Product Quality Team, oversee stability programs, and guide staff indirectly.
  • Manage long-term hybrid-modality program deliverables, including specifications, comparability, stability, transfers, non-conformance impact statements, filing sections, and responses to questions.
  • Assess complex processes and product data using scientific and risk-based methods.
  • Explain complex topics to leaders, colleagues, and regulators.
  • Track emerging scientific and technical developments and their implications.
  • Coach new and current team members.

Zahteve

  • Doctorate plus 4 years of quality, operations, scientific, or manufacturing experience; master’s plus 7 years; or bachelor’s plus 9 years.
  • Advanced degree in chemistry, biochemistry, biology, or a related biotechnology science.
  • Expertise in large- and small-molecule and bioconjugate development, analytical testing, and industry regulations.
  • At least 8 years of pharmaceutical experience with increasing responsibility in quality, analytical or process development, pharmaceutics, regulatory, or manufacturing.
  • At least 6 years working directly in a GMP-regulated environment.
  • At least 4 years managing people or leading teams, projects, or programs, or directing resource allocation.
  • At least 2 years as a technical expert or product champion.
  • At least 1 year authoring or reviewing regulatory filings or similar documentation.
  • At least 1 year supporting non-conformance investigations and authoring, reviewing, and defending critical product-impacting non-conformances.
  • Project management experience supporting product development.
  • Knowledge of quality, compliance, and regulatory requirements for proteins and small molecules.
  • Knowledge of analytical methods used in small-molecule and protein product quality control.
  • Understanding of drug substance and drug product development and manufacturing.
  • Strong leadership and people management skills.
  • General knowledge of cGMP and filing regulations, practices, and trends for pharmaceutical manufacture and testing.
  • Experience working on cross-functional teams in a matrix environment.
  • Excellent written and verbal communication, facilitation, and presentation skills.

Ugodnosti

  • Comprehensive employee benefits package.
  • Retirement and savings plan with company contributions.
  • Medical, dental, and vision coverage.
  • Life and disability insurance.
  • Flexible spending accounts.
  • Discretionary annual bonus program.
  • Stock-based long-term incentives.
  • Award-winning time-off plans.
  • Flexible work arrangements, including remote and hybrid options where available.
  • Career development opportunities.
  • Support for work-life balance.

Sorodna delovna mesta