Kelly Services Job - 39437894 | CareerArc
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Company: Kelly Services
Location: Levittown, PA
Career Level: Entry Level
Industries: Recruitment Agency, Staffing, Job Board

Description

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:

  1. 3-5 years of experience in formulation development of Generic (ANDA) product and FDA related queries (required)
  2. Expertise in QbD development approach (required)
  3. Understanding of packaging material selection in development and preparation of documentations. i.e Specification and testing methods etc. (nice have)
  4. 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.



Why Kelly®

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

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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