About the Company
Amgen is one of the world’s leading biotechnology companies, dedicated to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. With a presence in approximately 100 countries, Amgen has touched the lives of millions of patients worldwide. We are committed to using advanced science and technology to tackle some of the most challenging diseases of our time, pushing the boundaries of what’s possible in healthcare.
Job Description
We are seeking a highly skilled and experienced Process Development Chemist with a strong background in manufacturing scale-up to join our dynamic team. This role is crucial for optimizing chemical processes from lab-scale to commercial production, ensuring robust, efficient, and cost-effective manufacturing of our innovative therapeutic compounds. The ideal candidate will possess deep expertise in reaction engineering, process analytical technology (PAT), and quality-by-design (QbD) principles. You will be instrumental in bridging the gap between discovery and manufacturing, driving the development of scalable and reproducible synthetic routes for complex molecules. This is a top-pay opportunity for an individual who thrives on technical challenges and wants to make a significant impact on patient lives.
Key Responsibilities
- Lead the development and optimization of synthetic routes and chemical processes for active pharmaceutical ingredients (APIs) and intermediates.
- Design, execute, and interpret experiments for process characterization, robustness studies, and impurity profiling at various scales.
- Collaborate closely with R&D, Analytical Development, Engineering, and Manufacturing teams to ensure seamless technology transfer to pilot and commercial scale.
- Apply QbD principles and PAT tools to enhance process understanding, control, and efficiency.
- Troubleshoot process issues, identify root causes, and implement effective solutions during scale-up and manufacturing.
- Prepare detailed technical reports, process descriptions, and regulatory documentation (e.g., CMC sections for IND/NDA filings).
- Stay current with scientific literature, industry trends, and regulatory requirements related to process chemistry and manufacturing.
- Mentor junior chemists and contribute to a culture of scientific excellence and continuous improvement.
Required Skills
- Ph.D. in Organic Chemistry, Chemical Engineering, or a related field.
- Minimum of 5 years of industrial experience in process development and manufacturing scale-up within the pharmaceutical or biotechnology industry.
- Extensive knowledge of reaction mechanisms, synthetic methodologies, and organic synthesis.
- Proven experience with process optimization techniques (e.g., DoE, statistical analysis).
- Proficiency in analytical techniques commonly used in process chemistry (e.g., HPLC, GC, NMR, MS, IR).
- Strong understanding of cGMP principles and regulatory guidelines relevant to API manufacturing.
- Excellent problem-solving, analytical, and communication skills.
- Ability to work effectively in a cross-functional team environment.
Preferred Qualifications
- Experience with flow chemistry, biocatalysis, or continuous manufacturing processes.
- Familiarity with process modeling and simulation software.
- Track record of successful technology transfers from development to commercial scale.
- Experience in leading projects or small teams.
- Publications or patents in relevant fields.
Perks & Benefits
- Competitive base salary with performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off and holidays.
- 401(k) retirement plan with company match.
- Employee stock purchase program.
- Tuition reimbursement and professional development opportunities.
- On-site fitness centers and wellness programs.
- Subsidized cafeteria and employee discounts.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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