Kelly is actively recruiting for a Formulation Scientist as a Direct Hire in the Greater Philadelphia, PA Area.
Customer Job Title: Formulation Scientist
Top skill sets:
- 3-5 years of experience in formulation development of Generic (ANDA) product and FDA related queries (required)
- Expertise in QbD development approach (required)
- Understanding of packaging material selection in development and preparation of documentations. i.e Specification and testing methods etc. (nice have)
- Experience with oral liquid and/or suppository formulations is a plus.
• Minimum 3-5 years' experience in formulation development for regulated market for oral solution, suspension, OTC product in bottle and Unit dose and suppository product.
• Prior experience in ANDA formulation development, preparation of documents such as PDR, MFC, specification etc, scale up and ANDA submission.
• Basic knowledge of packaging component.
• Ability to investigate quantity issue, co-ordinate with multidisciplinary team, documentation for investigation and CAPA.
• Exposure in ANDA submission, query response and commercial launch activity.
Description of Job :
• Conducting literature search and preparation of literature review presentation.
• Participating in the patent evaluation and making non-infringing formulation report.
• Preparing prototype formulations. Conducting API characterization & compatibility studies.
• Procuring raw materials and conducting development trials.
• Conducting dissolution profiling comparison with RLD's and taking stability batches.
• Evaluating trial results scientifically and planning experiments with the help of GL/RL.
• Recording of experimental data in lab note book.
• To plan and execute development trial at lab scale and scale up in oral solution and suspension, OTC product and suppository.
• Exposure to packaging development for OTC, Unit Dose, oral solution and suspension will be preferred.
• Documentation of routine development, scale up, dossier submission, FDA query response.
• Initiation of change control, review and approval of all packaging material specification and MOA at Levittown as per R&D India guidance.
• Participate in route cause investigation, implementing CAPA and commercial support would require as and when required.
• Co-ordination with R &D at India for scale up, documentation related to dossier submission and commercial launch.
• Perform GAP assessment for existing US product to Brazil/Mexico/UK market.
If you feel you have the knowledge and expertise, apply today to connect with a Kelly professional who will work to enrich your life.
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At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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