Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare! What can Adare offer you?

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

We are seeking to hire a Analytical Scientist II to join our Analytical Research and Development team…

If any of the below describes you, we would love to meet you! JOB SUMMARY

The Analytical Scientist II reports to the Manager of Analytical Research and Development and is based at our Philadelphia location. This is a laboratory-based position and the Scientist will be responsible to support formulation development by performing method development, validation, writing protocols and reports, conducting chemical and physical testing activities for both ANDA and NDA projects.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• Develop and evaluate analytical test methods for raw materials and in-process and finished products
• Write protocols and reports

• Conduct and document chemical and physical testing of finished products, raw materials, API, in- process products, stability samples to support new product formulation development for both ANDA and NDA projects
• Conduct and document method verification and method validation as per approved method validation protocols, Company SOPs, FDA Guidance, and ICH Guidelines
• Conduct and document in-process and finished product testing for product release and stability as per the approved test method
• Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
• Attend SOP, Safety and scientific trainings to remain current with cGMP regulations, and safety standards.
• Follow relevant Adare SOP’s and FDA/ICH guidance
• Other duties as assigned

REQUIRED SKILLS AND QUALIFICATIONS

• Master’s Degree with 3+ years of experience, or a Bachelor’s Degree with 6+ years of experience
• Good understanding of chemical and physical analysis principles, experience in method development
• Fundamental understanding of GMP, ICH and FDA compliance
• Excellent written and oral communication skills and interpersonal skills

PHYSICAL REQUIREMENTS

• Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
• Occasionally move items or equipment weighing up to 25 pounds
• Occasionally required to climb ladders and/or steps to reach equipment.
• Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.
• Must have a sense of smell to detect odors of unacceptable compounds and/or mixtures.
• Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment.
• The employee may be required to wear personal protective equipment (PPE) during certain phases of the operation, such as high noise areas from machinery, exposure to a variety of chemicals, or exposure to dust, mists, and fumes.