Mallinckrodt Pharmaceuticals Principal Formulations Scientist in St. Louis, Missouri
Principal Formulations Scientist
JR000011177 Principal Formulations Scientist (Open)
Webster Groves (Pharma) - USA038
St. Louis, MO
The Principal Formulations Scientist will perform and/or oversee research and development activities related to new generic drug products and support existing drug products for parenteral, ophthalmic, and transdermal dosage forms. The individual will perform and/or oversee all aspects of product development including pre-formulation, formulation, scale-up, and technology transfer activities utilizing internal resources and contract manufacturing organizations. The individual will design studies, perform testing, analyze and interpret data of varying complexities, and make recommendations.
Design and conduct pre-formulation, formulation, process, stability, and container closure development studies for new and existing molecular entities.
Apply scientific fundamentals to solve complex formulation, stability, and manufacturing issues
Represent the function in cross-functional project teams.
Develop working relationships with internal colleagues and external contract organizations.
Prepare high quality technical reports, presentations, and CMC documents for ANDAs and other regulatory dossiers.
Identify functional activities for projects and provide estimates for timelines/resource requirements; coordinate activities in functional area; keep functional activities on schedule.
Identify and manage contract manufacturing organizations.
Identify new project opportunities.
Draft, review, and revise department SOPs and other technical documents.
Other duties as assigned with or without reasonable accommodation.
PhD in Pharmaceutical Science, Chemical Engineering, Chemistry, or related science with minimum of 5 years of industry experience; or
MS degree in Pharmaceutical Science, Chemical Engineering, Chemistry, or related science with a minimum of 10 years of pharmaceutical industry experience.
Must have at least 3 years of experience in generics product development, preferably in complex generics.
Demonstrated track record in advancing generic drug development from concept to ANDA filing.
In-depth knowledge in manufacturing, quality, and regulatory requirements.
Familiar with industry best practices.
In-depth, hands-on experience in parenteral drug product development, including ophthalmics.
Demonstrated track record in parenteral pharmaceutical manufacturing process development.
In- depth, working knowledge of advanced drug delivery systems (transdermal patches, combination products, extended release suspensions).
Demonstrated ability to collaborate and lead cross-functional project teams.
Familiar with Design of Experiment and other statistical tools.
Knowledge of cGMPs and various other regulatory guidance, and pharmacopeia requirements (USP, EP, JP).
Demonstrate leadership ability and excellent oral and written communication skills.
Familiar with Microsoft Office. (i.e., Excel, PowerPoint, Word)
This position will interact with other cross-functional members of the R&D team and external vendors.
The laboratory facility is air conditioned and environmentally controlled.
Employees are required to wear eye protection and lab coats while in the lab area.
The employee occasionally lifts and/or moves up to 25 lbs. and may work with toxic or caustic chemicals.
Ability to travel 10 – 30% of the time.
Must pass a security clearance.
- This position is eligible for relocation.
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.