About the Company
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. With a strong presence in the United States, particularly in the innovative biotech hub of Cambridge, Massachusetts, Novartis focuses on discovering new ways to improve and extend people’s lives. We are committed to groundbreaking research and development in pharmaceuticals and advanced therapies, driving scientific innovation to create a healthier future.
Job Description
We are seeking a highly motivated and experienced Process Development Chemist with a strong background in manufacturing scale-up to join our dynamic team in Cambridge, Massachusetts. This critical role involves leading the development and optimization of chemical processes for the manufacture of active pharmaceutical ingredients (APIs), ensuring efficient and robust scale-up from laboratory to pilot plant and commercial production. The successful candidate will play a pivotal role in translating lab-scale chemistry into commercially viable processes, with a keen focus on safety, quality, and cost-effectiveness. This is an exceptional opportunity for a talented chemist looking to make a significant impact on our pipeline.
Key Responsibilities
- Design, develop, and optimize synthetic routes and chemical processes for APIs at various scales (lab, kilo-lab, pilot plant).
- Lead the investigation and resolution of process chemistry issues during scale-up and manufacturing.
- Conduct process characterization studies to understand critical process parameters and critical quality attributes.
- Collaborate closely with analytical development, engineering, quality assurance, and manufacturing teams.
- Prepare detailed technical reports, process descriptions, and manufacturing instructions.
- Drive continuous improvement initiatives for existing manufacturing processes.
- Ensure compliance with cGMP, EHS, and all relevant regulatory guidelines.
- Mentor junior chemists and contribute to a culture of innovation and scientific excellence.
Required Skills
- Ph.D. in Organic Chemistry, Process Chemistry, or a related field with 5+ years of relevant industry experience OR Master's degree with 8+ years of experience OR Bachelor's degree with 10+ years of experience.
- Demonstrated expertise in synthetic organic chemistry and process development.
- Proven experience with successful scale-up of chemical processes from lab to manufacturing.
- Strong understanding of reaction kinetics, thermodynamics, and process safety principles.
- Familiarity with various analytical techniques (HPLC, GC, NMR, MS, FTIR) for in-process control and characterization.
- Excellent problem-solving, analytical, and communication skills.
- Ability to work effectively in a fast-paced, multidisciplinary team environment.
Preferred Qualifications
- Experience with QbD (Quality by Design) principles and statistical experimental design (DoE).
- Knowledge of cGMP regulations and ICH guidelines.
- Proficiency in process modeling and simulation software.
- Experience with contract manufacturing organizations (CMOs) is a plus.
- Track record of publications or presentations in process chemistry.
Perks & Benefits
- Competitive base salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off and holidays.
- 401(k) retirement plan with company match.
- Life insurance and disability coverage.
- On-site fitness center and wellness programs.
- Employee assistance program.
- Professional development and continuing education opportunities.
- Tuition reimbursement.
- Subsidized public transportation or parking.
- Collaborative and innovative work environment.
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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