Mallinckrodt Pharmaceuticals Principal Formulations Scientist in St. Louis, Missouri
Principal Formulations Scientist
JR000010939 Principal Formulations Scientist (Open)
Webster Groves (Pharma) - USA038
St. Louis, MO
Mallinckrodt Pharmaceuticals is seeking a highly motivated and experienced Principal Formulations Scientist in generic dosage product development Research & 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.
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.
Leads multiple projects; manages project timelines and deliverables.
Serves as a scientific and technical mentor to junior level scientists.
Other duties as assigned with or without accommodation.
Education / Experience / Skills:
PhD in pharmaceutical sciences or related science field with minimum of 7 to 9 years of related experience, or;
MS degree with minimum of 9 – 11 years of related experience, or;
BS with minimum of 11 – 13 years of related experience required.
In-depth, hands-on experience in formulation for oral solid and liquid pharmaceutical dosage forms required.
Hands-on experience supervising, leading and training scientist and other laboratory personnel required.
In- depth, working knowledge of pharmaceutical dosage products (e.g., both oral liquid and solid dosage forms) and various drug delivery systems required.
Advanced working knowledge of pharmaceutics, pharmaceutical sciences, and clinical pharmacokinetics required.
Demonstrated knowledge, experience, and track record in pharmaceutical manufacturing process in the oral dosage area.
Working knowledge of evaluating patents and literature prior arts.
General knowledge of pharmaceutical analytical techniques.
Sound knowledge of pharmaceutical research and development processes.
Mastery of pharmaceutical concepts, and application of those concepts and techniques to efficiently and effectively resolve technical issues.
Excellent communication and interpersonal skills to collaborate with others including both internal teams and external collaborators.
Technical report writing experience required.
Excellent verbal and written communication skills.
This position reports to the Sr. Director Formulations and has no direct reports.
Partners closely with marketing, regulatory affairs, legal, project managers, and manufacturing.
Typical laboratory environment.
Ability to travel 10 – 30%.
Must pass a security clearance.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.