Technical Specifications Manager – Raw Materials

Job not on LinkedIn

🔥 1 hour ago

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Develop, implement, maintain, and manage the lifecycle of clinical and commercial raw material specifications and related controlled documents • Author, revise, and maintain raw material specifications and controlled documents • Ensure specifications are scientifically accurate, compliant, and aligned with manufacturing and quality needs • Manage new material introductions, revisions, periodic reviews, supplier changes, obsolescence activities, and implementation of approved changes • Partner with Process Development, Material Sciences, Engineering, Quality Assurance, Quality Control, Supply Chain, Regulatory Affairs, Manufacturing, and external suppliers • Facilitate specification review meetings and resolve technical issues • Support material qualification, technology transfers, investigations, supplier onboarding, and regulatory inspections as a specification SME • Drive continuous improvement, standardization, digital transformation, and data quality initiatives related to specification management

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of related experience OR Bachelor’s degree and 4 years of related experience OR Associate’s degree and 8 years of related experience OR High school diploma / GED and 10 years of related experience • Bachelor's or Master's degree in Chemistry, Biology, or related field preferred • Experience with raw material specifications preferred • Familiarity with PLM software • Quality experience preferred • Knowledge of cGMP requirements and pharmacopeial standards (USP, EP, JP) • Ability to translate technical, manufacturing, and regulatory requirements into raw material specifications • Sponsorship for this role is not guaranteed

🏖️ Benefits

• A comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group 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 models where possible • Career development opportunities • Work/life balance • Financial plans with opportunities to save towards retirement or other goals

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