About the Company
Amgen is a global biotechnology company committed 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 over 100 countries and regions worldwide, Amgen is dedicated to addressing some of the world’s most challenging diseases. Our focus on scientific excellence and groundbreaking research has made us a leader in the biopharmaceutical industry, transforming the lives of millions.
Job Description
We are seeking a highly motivated and experienced Chemistry Project Lead to join our innovative Pharmaceutical Development team. This strategic role is critical for driving the advancement of our robust pipeline of small molecule therapeutics from early-stage development through commercialization. The successful candidate will lead cross-functional chemistry projects, managing complex technical challenges, ensuring regulatory compliance, and fostering a culture of scientific excellence and collaboration. This position demands a visionary leader with deep expertise in synthetic organic chemistry, process development, and a proven track record of successful project leadership within the pharmaceutical industry.
Key Responsibilities
- Lead and manage chemistry-related projects from discovery to commercialization, ensuring successful execution within timelines and budget.
- Develop and implement strategic plans for API process development, scale-up, and manufacturing.
- Oversee the design, execution, and interpretation of experiments for route scouting, process optimization, and impurity control.
- Collaborate closely with discovery, analytical, formulation, quality, regulatory, and manufacturing teams to ensure seamless project progression.
- Provide scientific and technical leadership, mentoring junior chemists and fostering a strong scientific culture.
- Author and review technical reports, regulatory submissions (e.g., CMC sections), and patent applications.
- Manage external collaborations with CROs and CMOs, ensuring high-quality deliverables and compliance with project goals.
- Identify and mitigate technical risks, developing innovative solutions to complex chemistry challenges.
- Stay abreast of new technologies, scientific literature, and regulatory guidelines relevant to pharmaceutical development.
Required Skills
- Ph.D. in Organic Chemistry or a related field.
- Minimum 8 years of experience in synthetic organic chemistry and process development within the pharmaceutical industry.
- Demonstrated project leadership experience with a proven track record of bringing small molecule candidates from preclinical to commercial stages.
- Expertise in reaction mechanism, retrosynthesis, and modern synthetic methodologies.
- Strong understanding of cGMP principles, ICH guidelines, and regulatory expectations for pharmaceutical development.
- Excellent problem-solving skills and ability to work independently and in a team environment.
- Superior written and verbal communication skills, with the ability to present complex technical information clearly and concisely.
- Experience with analytical techniques used in process chemistry (e.g., NMR, LC-MS, GC, HPLC).
Preferred Qualifications
- Post-doctoral experience in synthetic organic chemistry.
- Experience with QbD (Quality by Design) principles in process development.
- Proficiency in statistical experimental design (DOE).
- Experience managing global projects and collaborations.
- Familiarity with intellectual property strategies and patent landscape analysis.
Perks & Benefits
- Competitive top-tier salary and annual performance bonuses.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off, including holidays and vacation.
- 401(k) retirement plan with company match.
- Stock options and employee stock purchase program.
- Life and disability insurance.
- On-site fitness centers and wellness programs.
- Tuition reimbursement and professional development opportunities.
- Relocation assistance for eligible candidates.
- Collaborative and innovative work environment.
- Access to cutting-edge research and technology.
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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