Job Information
Mallinckrodt Pharmaceuticals Senior Formulation Scientist in St. Louis, Missouri
Job Title
Senior Formulation Scientist
Requisition
JR000014113 Senior Formulation Scientist (Open)
Location
MKG-Hazelwood, MO (325) - USA137
Additional Locations
St. Louis, MO
Job Description
The Sr Formulation Scientist will assume a key functional role within Global Technical Operations. The Sr Formulation Scientist will be responsible for providing formulation and aseptic fill/finish expertise for late-stage drug product development and commercial manufacturing initiatives. This includes conducting laboratory-scale formulation and fill/finish experiments for process optimization, scale-up and tech transfers. The Sr Formulation Scientist will also be responsible for providing on-site oversight of commercial manufacturing campaigns at external manufacturing partners.
Essential Functions
Conduct laboratory formulation and fill/finish experiments to establish critical process parameters for drug product manufacturing.
Travel to contract manufacturing organizations to provide oversight of drug product development, manufacturing and tech transfer initiatives.
Provide routine technical support to External Operations and Quality to ensure successful manufacturing campaigns.
Interrogate and interpret experimental data and present conclusions at project meetings and technical forums.
Collate data, author, and review reports for drug product CPV programs.
Evaluate and propose opportunities to enhance robustness and efficiencies of drug product manufacturing processes.
Author relevant sections for regulatory dossiers and submissions.
Maintain detailed laboratory notebook records and demonstrate safe work habits within the laboratory.
Represents a Formulation Sciences function as a core team member for Operations and Quality projects.
Maintain awareness of advances in drug product development science and fill/finish technologies.
Proactively apply scientific or engineering expertise to develop solutions to complex technical, operational, and/or business problems.
Minimum Requirements
PhD in Pharmaceutical Science, Chemistry, Chemical Engineering, Physics, or related scientific disciplines, and at least 3 years of pharmaceutical or related work experience in the field.
MS in Pharmaceutical Science, Chemistry, Chemical Engineering, Physics, or related scientific disciplines and at least 5 years of pharmaceutical or related work experience in the field.
BS in Pharmaceutical Science, Chemistry, Chemical Engineering, Physics, or related scientific disciplines and at least 8 years of pharmaceutical or related work experience in the field
Hands-on experience and knowledge of aseptic fill/finish equipment.
Working knowledge of GMP drug product manufacturing, including aseptic and terminal sterilization processing and lyophilization.
Proficient with statistical analysis tools such as Design of Experiments, Regression Analysis, etc.
Familiarity with requirements of various pharmacopeias (USP, EP, JP)
Self-starter with strong work ethic, excellent written and verbal communication skills; the ability to successfully conduct or manage various formulation projects in a timely manner.
Ability to work in a team environment and operate with limited supervision.
Demonstrates strong organizational and planning skills; excellent interpersonal skills with ability to work in a team environment.
Demonstrates capability and comfort in communicating and interfacing with all levels in the organization including management and senior management.
Ability to understand overall project timelines and manage prioritization of individual contributor deliverables with appropriate supervision.
Preferred Qualifications
Experience with aseptic filling of viscous formulations
Experience with Minitab and/or JMP software packages
Working Conditions:
This position requires frequent work in a research laboratory, both standing at a bench and seated. It also requires reaching into flammable cabinets. This position involves frequent work in an office environment, using a computer to analyze data, write reports, and document experiments in notebooks. Occasional travel will be required for engagement with external laboratories and collaborators and oversight of CMO manufacturing campaigns.
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Mallinckrodt is a global specialty p harmaceutical 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.