Director, Product Development
2.
3 Bristol, TN Bristol, TN Estimated:
$110K - $140K a year Estimated:
$110K - $140K a year Qualified candidates must be legally authorized to be employed in the United States.
UPM does not anticipate providing sponsorship for employment visa status (e.
g.
, H-1B or TN status) for this employment position.
Essential Duties and Responsibilities Responsible for technology transfer of solid dose products into Bristol site commercial manufacturing, site transfer of existing commercial products, and scale-up and process development for new formulations.
Provides technical leadership for product development and tech transfer projects.
Routine interface and communications with clients.
Serves as a technical resource within UPM, assisting Manufacturing, Quality Assurance, and Business Development.
Provide technical support to Manufacturing for the resolution of deviations, investigations, and process issues.
Formulation of immediate and modified release tablet and capsule products by QBD principles to meet clinical and regulatory requirements for submissions to FDA.
Plan and conduct required pre-formulation and formulation stability studies, hold time studies, excipient compatibility studies, process development and optimization studies.
Write experimental reports and product development reports to support technical portions of client CTD filings and Response Letters.
Manufacturing experimental, clinical, registration, and validation batches of tablets and capsules.
Operating high shear mixers, mills, fluid bed dryers, V-blenders, bin blenders, roller compactors, tablet presses, encapsulators, Wurster particle coaters, tablet pan coaters.
Work with QA, Validation, Engineering, Purchasing, Regulatory, R & D, and Manufacturing on project teams.
Write, review, and execute process validation protocols.
Perform process monitoring using statistical analysis.
Evaluate and develop process improvements for manufacturing processes.
Write Master Batch Records, process development reports, investigation reports.
Training and mentoring of new scientists and technical staff in product development, formulation, principles of experimental design.
Other duties as assigned.
Education/
Experience:
Minimally 5 to 8 years of relevant pharmaceutical product development experience.
Minimally an applicable Bachelors of Science or Engineering degree.
Provides expert project direction.
To apply, send resume and salary requirements to:
email protected .
Estimated Salary: $20 to $28 per hour based on qualifications.
3 Bristol, TN Bristol, TN Estimated:
$110K - $140K a year Estimated:
$110K - $140K a year Qualified candidates must be legally authorized to be employed in the United States.
UPM does not anticipate providing sponsorship for employment visa status (e.
g.
, H-1B or TN status) for this employment position.
Essential Duties and Responsibilities Responsible for technology transfer of solid dose products into Bristol site commercial manufacturing, site transfer of existing commercial products, and scale-up and process development for new formulations.
Provides technical leadership for product development and tech transfer projects.
Routine interface and communications with clients.
Serves as a technical resource within UPM, assisting Manufacturing, Quality Assurance, and Business Development.
Provide technical support to Manufacturing for the resolution of deviations, investigations, and process issues.
Formulation of immediate and modified release tablet and capsule products by QBD principles to meet clinical and regulatory requirements for submissions to FDA.
Plan and conduct required pre-formulation and formulation stability studies, hold time studies, excipient compatibility studies, process development and optimization studies.
Write experimental reports and product development reports to support technical portions of client CTD filings and Response Letters.
Manufacturing experimental, clinical, registration, and validation batches of tablets and capsules.
Operating high shear mixers, mills, fluid bed dryers, V-blenders, bin blenders, roller compactors, tablet presses, encapsulators, Wurster particle coaters, tablet pan coaters.
Work with QA, Validation, Engineering, Purchasing, Regulatory, R & D, and Manufacturing on project teams.
Write, review, and execute process validation protocols.
Perform process monitoring using statistical analysis.
Evaluate and develop process improvements for manufacturing processes.
Write Master Batch Records, process development reports, investigation reports.
Training and mentoring of new scientists and technical staff in product development, formulation, principles of experimental design.
Other duties as assigned.
Education/
Experience:
Minimally 5 to 8 years of relevant pharmaceutical product development experience.
Minimally an applicable Bachelors of Science or Engineering degree.
Provides expert project direction.
To apply, send resume and salary requirements to:
email protected .
Estimated Salary: $20 to $28 per hour based on qualifications.
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