About the Company
Amgen Inc. is a leading 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 focus on areas of high unmet medical need, Amgen is dedicated to improving health and saving lives. Headquartered in Thousand Oaks, California, Amgen has a significant presence throughout Southern California, including research and development facilities that drive forward groundbreaking scientific advancements.
Job Description
Amgen Inc. is seeking a highly motivated and experienced Chemistry Project Lead to join our dynamic Pharmaceutical Development team. This strategic role is critical for driving the success of our drug development pipeline. As a Chemistry Project Lead, you will be responsible for overseeing the full lifecycle of chemistry-related projects, from early-stage development through commercialization, ensuring alignment with regulatory standards and business objectives. You will lead cross-functional teams, manage resources, and act as the primary scientific and strategic point of contact for complex chemical development initiatives. This is an unparalleled opportunity to make a significant impact on patient lives within a top-tier global biotechnology organization.
Key Responsibilities
- Lead and manage chemistry-focused projects from concept to commercialization, ensuring timely delivery and adherence to quality standards.
- Develop and execute comprehensive project plans, including scope definition, resource allocation, budget management, and risk mitigation strategies.
- Provide expert scientific guidance and strategic direction on complex chemistry challenges within drug development.
- Serve as the primary liaison between R&D, manufacturing, regulatory affairs, and external partners for all chemistry-related activities.
- Oversee the design, execution, and interpretation of experiments for process development, optimization, and scale-up of active pharmaceutical ingredients (APIs).
- Ensure all project activities comply with cGMP, ICH guidelines, and other relevant regulatory requirements.
- Mentor and develop junior scientific staff within project teams.
- Present project updates, strategies, and results to senior leadership and stakeholders.
Required Skills
- Ph.D. in Organic Chemistry, Pharmaceutical Chemistry, or a related field.
- Minimum of 9 years of experience in pharmaceutical R&D, with at least 5 years in a project leadership or management role.
- Demonstrated expertise in synthetic organic chemistry, process chemistry, and analytical techniques relevant to API development.
- Strong understanding of cGMP regulations and ICH guidelines.
- Proven ability to lead and motivate cross-functional scientific teams.
- Excellent communication, interpersonal, and presentation skills.
- Expertise in project management methodologies and tools.
Preferred Qualifications
- PMP certification or equivalent project management qualification.
- Experience with regulatory submissions (IND, NDA, BLA).
- Knowledge of QbD (Quality by Design) principles in pharmaceutical development.
- Track record of successful project delivery in a fast-paced biotechnology or pharmaceutical environment.
- Experience in managing external contract research organizations (CROs) or contract manufacturing organizations (CMOs).
Perks & Benefits
- Highly competitive base salary and performance-based bonuses.
- Comprehensive medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Generous paid time off and holidays.
- Employee stock purchase program.
- Tuition reimbursement and professional development opportunities.
- On-site fitness center and wellness programs.
- Relocation assistance for eligible candidates.
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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