MALLINCKRODT ENTERPRISES, LLC Formulations Scientist in Webster Groves, Missouri
JOB DESCRIPTION SUMMARY Company is seeking a highly motivated and experienced candidate as a Sr. / Staff/ Principal Formulations Scientist in generic dosage product development Research and Development. The successful candidate for the position will lead all formulation development activities including the analysis of innovator s patents, planning and execution of the formulation and process development, tech transfer, scale up, manufacture of registration batches, creation of product development report and CMC documents for submission, and pre- and validation support at a commercial manufacturing site. The candidate will serve as a key driver to identify, analyze, suggest and own improvement actions to build a high performance organization. ESSENTIAL FUNCTIONS * Executes assigned projects and activities; develops detailed planning of the formulation and process, scale-up activities, registration batch manufacturing and pre- and validation support at a commercial manufacturing site. * Conceives and develops novel, innovative drug delivery systems to enrich product the pipeline. * Generates and/or reviews scientific documents including protocols, summary reports, tech transfer reports, and other relevant scientific information packages for internal and external use. * Assists the Regulatory Affairs group in preparation of CMC documents for the submission of ANDAs including the product development report PDR. * Provides troubleshooting at scale-up/commercial level. * STAFF/ PRINCIPAL LEVEL Leads a team over multiple projects; manages team's project timelines and deliverables. * STAFF/ PRINCIPAL LEVEL Serves as a scientific and technical mentor to junior level scientists. * Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS EDUCATION / EXPERIENCE / SKILLS: SR. FORMULATIONS SCIENTIST EDUCATION/EXPERIENCE: * PhD. in pharmaceutical sciences or related science field with minimum of 0-1 year of related experience, or; * MS degree with minimum of 4 years of related experience, or; * BS with minimum of 7 years of related experience. * Strong knowledge in pharmaceutical dosage products e.g., both oral liquid and solid dosage forms and drug delivery concepts for various administration routes. * Working knowledge of evaluating patents and literature prior arts. * General knowledge of pharmaceutical analytical techniques. PREFERRED EXPERIENCE: * Hands-on experience in formulation for oral solid and liquid pharmaceutical dosage forms. * Hands-on experience supervising, leading and training scientist and other laboratory personnel. STAFF/ PRINCIPAL FORMULATIONS SCIENTIST EDUCATION/EXPERIENCE: * PhD. in pharmaceutical sciences or related science field with minimum of 5 to 7 years of related experience, or; * MS degree with minimum of 7 9 years of related experience, or; * BS with minimum of 11 * Typical laboratory environment. * Ability to travel 10 30%. * Must pass a security clearance * Ability to wear PPEs.Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Employer's Job# JR000009220Please visit job URL for more information about this opening and to view EOE statement.