Senior Formulation Scientist
Senior Formulation Scientist
Mallinckrodt Pharmaceuticals
St Louis, MO
See who Mallinckrodt Pharmaceuticals has hired for this role
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
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.
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.
- 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.
- Experience with aseptic filling of viscous formulations
- Experience with Minitab and/or JMP software packages
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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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Pharmaceutical Manufacturing
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