Formulations Scientist / Senior Formulations Scientist

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 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 Formulations Scientist / Senior Formulations Scientist to join our Formulations Team… If any of the below describes you, we would love to meet you!  JOB SUMMARY Adare is seeking an experienced Scientist to join our Formulation team. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development activities for both ANDA and NDA projects. RESPONSIBILITIES AND LEARNING OPPORTUNITIES
• Design and develop formulations and processes for new drug products with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
• Utilize experimental design to rapidly optimize formulation composition, manufacturing process and product in-process specifications
• Evaluate product testing results, provide next steps for continued development until product formulation and process is finalized
• Present product development progress to upper management and project teams as well as customers
• Write development and cGMP manufacturing batch records, stability study protocols for development and clinical batches, and product development reports
• Manufacture of development, optimization and scale-up batches and submission batches
• Troubleshoot formulation and processing issues that occur during R&D development, scale-ups and / or in production
• Effectively communicate with cross functional teams like Analytical Development, Quality, Project Management, Procurement, Commercial Operations, Regulatory Affairs and Legal teams
• Attend SOP, Safety and scientific trainings to remain current with cGMP regulations, safety standards, and development technologies
• Follow relevant Adare SOP's and FDA / DEA / ICH guidance
• Other duties as assigned REQUIRED SKILLS AND QUALIFICATIONS Level will be dependent on the candidate’s education, years’ of relevant experience, and demonstrated knowledge and skills.
• PhD or Masters’ degree in Chemistry, Pharmaceutical Sciences or Chemical Engineering with 2+ years of experience as a formulator
• Experience with generic drug development is desirable
• Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Proficiency in relevant software (i.e., MS Office or similar systems, Adobe)
• Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
• Willing to participate in our group identity characterized by commitment, trust, and care for each other.
• Willing to invest time and energy in continuous improvement efforts PHYSICAL REQUIREMENTS : The employee is required to :
• stand, walk, push, pull, twist, reach overhead, and bend to the floor
• occasionally move items or equipment weighing up to 50 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 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. Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital & veteran status. PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES