Manufacturing Scientist
Location: Greater Indianapolis, IN Area
Contact: Janene Cleary, jd@bandishgroup.com
THE ROLE:
Manufacturing Scientist | Leading Global Pharmaceutical Company
DESCRIPTION:
This Manufacturing Scientist search is being conducted on behalf of our global pharmaceutical client who unites caring with discovery to make life better for people around the world.
This role will be part of the Manufacturing Process Team for its respective area, providing daily oversight to ensure safe and reliable supply of medicines. The Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity.
In addition, the manufacturing scientist should be capable and of setting up and executing a variety of experiments at laboratory scale and conducting research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
One will help to build the processes and systems to enable a successful startup into GMP manufacturing operations
This individual should have the creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides the technical support required to achieve reliable and compliant manufacturing of API molecules.
HIGHLIGHTS OF RESPONSIBILITIES:
Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation. investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, etc.
Develop and monitor established metrics in real-time to assess process variability and capability.
Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
Ensure that experiments are well designed with clear objectives.
Ability to analyze data and ensure appropriate documentation.
Write technical reports and documents.
DESIRED SKILLS AND QUALIFICATIONS:
Bachelor’s in STEM Discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or master's degree and 1 year experience in cGMP manufacturing.
Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing.
Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), Quality Control, Quality Assurance, or Development.
Familiarity with cGMP manufacturing environment and terminology.
Excellent analytical, interpersonal, written and oral communication skills.
Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.
CONTACT:
Janene Cleary, Director Life Sciences Recruiting
Phone: 267-483-5233 ext. 103
Email: jd@bandishgroup.com
The Bandish Group, LLC
Life Sciences Executive Search
Greater Philadelphia Region