Sr. Process Development Scientist - Semisolids
The Senior Process Development Scientist will provide technical expertise across the entire portfolio of Sterile products/Semisolid Process Development Activities. This position is responsible for developing process of multiple projects simultaneously, involving all aspects process development, optimization, Technology Transfer at multiple stages. The successful candidate would be expected to identify and assess new processing technologies in order to expand the organizations manufacturing capabilities, as well as assist in the process validation activities. Responsibilities include cGMP manufacture of finished products at pilot scale and transfer of new products to commercial scale.
Key Responsibilities Include But Are Not Limited To
- Process development/ improvement/optimization initiatives and creative solutions for Liquid and Lyo Injectables and Semisolid dosage forms;
- Coordination between R&D and manufacturing/ contract manufacturing organizations (CMO).
- Prepare process flow diagrams;
- Prepare Protocols and execute Engineering batches and process verification batches;
- Conduct Small to pilot scale batch trials with “Quality by Design” approach;
- Scale up formulations processes from bench scale to clinical or exhibit batch scale, which can successfully be further scaled up to commercial batch scale;
- Execute and oversee technical transfers, scale up and clinical manufacture at internal and external drug-product
- GMP facilities;
- Support with Launch batches and Validation Batches.Prepare Product Development report based on “QbD” guidelines and otherrequired documents;
- Prepare ppt presentation before and after execution of trials.Any other task as assigned.Qualifications
- BS in pharmacy/pharmaceutical science, chemicalengineering, chemistry, health sciences, or related field with 5+ years of process development/validation experience or MS/PhD with a minimum of 3+ years of experience.
- Strong technical professional in the development/optimization of manufacturing process including compounding and filling operation of sterile formulation and topical formulations
- Familiar with different container closure systems for Injectables and Semisolids
- Have sound knowledge of regulatory expectations, cGMP, ICH and Supac guidelines.
- Must have strong experience in aseptic technique, lyophilization and Semisolid.
- Knowledge with common analytical equipments (e.g. ph meters, osmometer, viscometer etc.). Strong communication skill
- Strong presentation skill
- Must be able to use microsoft word, excel, power point and visio. Familiar with JMP or Minitab software
- Desired to have experience with PLC controlled equipment’s
- Proven ability to handle and prioritize multiple tasks and projects simultaneously
2+ to 5 years experience
Seniority Level - Mid-Senior
Management ExperienceRequired - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
ALL CANDIDATES MUST HAVE KNOWLEDGE/EXPERIENCE IN THE FOLLOWING TO MOVE FORWARD!
- Do you have at hands-on pharmaceutical semi-solids and liquid suspensions process development experience?
- Do you have QbD experience?
- Do you have experiences in scale-up and technical transfer of semi-solid, liquid suspension including nasal, and sterile manufacturing and filling operations?