A global pharmaceutical company is looking for an experienced Associate Director specializing in the development of generic dosage products. You will be responsible for leading and supervising the planning and execution of formulation development and technology transfer activities for scale-up, registration, and validation. You will also provide technical mentorship to junior scientists, ensuring the successful development of generic dosage products. Additionally, the candidate will play a key role in identifying improvement opportunities and driving initiatives to enhance organizational performance. Some travel may be required to support tech transfer and manufacturing activities across various GMP manufacturing sites.
- Oversee and lead the formulation development and tech transfer of generic oral dosage products.
- Manage activities related to formulation and tech transfer, including detailed planning of formulation and process development, scale-up activities, registration batch manufacturing, and pre- and validation support at commercial manufacturing sites.
- Collaborate closely with other functional teams, such as Analytical, Project Management, Clinical, Quality, Regulatory, Legal, and Commercials.
- Communicate actively, collaborate, and contribute to other functional areas to address problems and achieve goals.
- Author and review formulation-related sections for regulatory filings, development reports, and other relevant documents.
- Provide troubleshooting support at the scale-up/commercial level.
- Manage multiple projects, including timelines and deliverables.
- Mentor, coach, and advise other formulation scientists to ensure project goals and timelines are met.
- Ensure compliance with safety requirements, both corporate and departmental, and participate in safety training.
- PhD in pharmaceutical sciences or a related scientific field, with a minimum of 8 years of experience in pharmaceutical formulation development for generic immediate and extended release oral dosage products OR MS degree with a minimum of 10 years of related experience, or a BS degree with a minimum of 14 years of related experience.
- Have at least 3 years of experience managing a formulations development team.
- Demonstrate in-depth, hands-on experience in formulating oral solid and liquid pharmaceutical dosage forms, including various delivery systems.
- Have experience in supervising, leading, and training scientists and
- Demonstrate knowledge, experience, and a track record in pharmaceutical manufacturing processes in the oral dosage area.
- Familiarity with evaluating patents and literature prior to arts.
- Familiarity with FDA and ICH guidelines to effectively lead multiple projects from concept through validation and launch.
This position is eligible for an annual bonus as well as other benefits.