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Amgen
Amgen
H1B vīzas sponsorsBiotehnoloģijaFarmaceitiskie produktiVeselības aprūpe
Amgen ir globāls biotehnoloģiju uzņēmums, kas izstrādā un komercializē no dzīvām šūnām ražotas zāles. Tā darbība ir vērsta uz smagām slimībām, tostarp slimībām ar ierobežotām ārstēšanas iespējām, un to atbalsta zinātniskie pētījumi un klīniskie izmēģinājumi. Uzņēmums ir saistīts ar sasniegumiem vēža ārstēšanā un aptaukošanās kontrolē, vienlaikus uzsverot ētisku pētniecību, pacientu drošību un vides ilgtspēju.
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Vakances uzņēmumā

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.

USAmerikas Savienotās ValstisCAKalifornijaMAMasačūsetsa
176 370 $ – 238 619 $ / gads
HibrīdiPilna slodzeVadošais speciālistsNepieciešamā Valoda: angļuDirektors

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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.

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