Senior Formulations Scientist
sciAre 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 Senior Formulation Scientist to join our Pharmaceutical Development Team …
If any of the below describes you, we would love to meet you!
JOB SUMMARY
The Senior Formulations Scientist will report to the Associate Director of Formulations, and will be expected to develop pharmaceutical dosage forms with an emphasis on immediate and modified-release solid oral dosage forms. This is a client-facing role providing a career path to advancement within Pharmaceutical Development.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Design and perform formulation development studies on immediate and modified release oral solid dosage forms defined by management/customer and assume the responsibility needed to meet the product specific objectives.
- Develop new products utilizing existing and new technologies available within the industry from pre-formulation to manufacturing stage.
- At times, interact directly with Adare’s clients in project update meetings; provide technical expertise, presentation of data
- Write development and cGMP batch records, stability study protocols, in-process and finished product specifications and product development reports
- Assist both Manufacturing and Quality Assurance departments in scale-up and production trouble-shooting
- Perform technology transfer to customer production sites and train/assist customer personnel in scale-up and production.
- Develop and/or locate new technologies that will be of interest to the Company’s product development objectives.
- Supervise/train formulation scientists and ensure their activities comply with CGMP regulations.
- Conducts and manage development projects with manager’s guidance and ensure the successful scale-up of a new product and/or process.
- Comply with all regulations as specified by OSHA, EPA, FDA, DEA, etc., and as defined in the Corporate Hygiene plan.
- Assist in writing and preparation of Drug Master File reports and any other FDA required documentation.
- Maintain excellent oral and written communication with and ensure customers’ requirements are promptly met.
- Follow other job-related instructions and perform other job-related tasks as required.
REQUIRED SKILLS AND QUALIFICATIONS
- Ph.D. in Pharmacy (preferred), Chemical Engineering or related physical sciences with 4+ years’ experience or M.S. degree with 6+ years of experience in industrial pharmaceutical formulations.
- Knowledge of pharmaceutical operations, including granulation, tableting, particle coating for controlled or targeted release applications, encapsulation, fluid bed operation, and microencapsulation.
- Knowledge of CGMP’s, FDA, DEA, and OSHA regulations.
- Knowledge of PK-PD relationships and IV/IV correlation’s desirable.
- Good oral communication and technical report writing skills.
- Interface with Manufacturing, R&D, Quality Control, management personnel, customers, outside vendors, and suppliers.
- Work with minimal supervision and reviews controversial issues or questions with manager.
- Confidentiality of projects, test results, personnel matters and both customer and Company information/data is a definite requirement.
PHYSICAL REQUIREMENTS
- Stand, walk, push, pull, twist, reach overhead, and bend to the floor.
- Occasionally move items or equipment weighing up to 50 pounds – potential to handle heavier materials with mechanical assistance.
- Occasionally required to climb ladders and/or steps to reach equipment.
- Reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.
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
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