503B Associate Director Formulation Development
Columbia, SC Columbia, SC Estimated:
$101K - $128K a year Estimated:
$101K - $128K a year The 503B Associate Director Formulation Development is responsible for developing formulations and formulation processes for 503B drug products from small scale through commercial scale.
The position will create appropriate change requests, formulation and filling studies, batch records, forms, procedures, work instructions, risk assessments, cleaning verifications, filter validations, etc.
as needed to achieve the development and production goals of the organization.
Responsibilities:
Create formulation studies to determine material quantities and orders of addition to meet the products quality target product profile.
Product Development Life Cycle, Planning, Initiating and Development.
Ensuring new or revised manufacturing process follow cGMP.
Create or revise new product documentation as required such as formulation cards, development plans, lab batch protocols, process flows, procedures, work instructions, batch records, and bill of materials.
Equipment Cleaning Assurance Cleaning Lifecycle, Concepts of Cleaning, Determination of Cleaning Limits, Cleaning Cycle Studies and Verification, and Cleaning Agent Determination.
Purchase of goods and services.
Work with internal and external experts to assist in the development of product specifications, testing requirements and process descriptions.
Perform process Failure Mode and Effects Analysis, Critical Process Parameter and Critical Quality Attribute assessments.
Review and approval of product filter validation studies and protocols.
Coordinate resources towards completion of tasks assigned in the project management plan.
Execute process development studies related to the batch manufacturing including process sampling, and studies of equipment capability, and when applicable cleaning and sterilization cycles, including summary reports.
Follow Standard Operating Procedures, safety and cGMP Guidelines.
Perform other tasks as directed by Management including but not limited to the above responsibilities.
Degree in Pharmacy or directly related field 10 years manufacturing experience 503B manufacturing / pharmaceutical manufacturing experience Strong interpersonal/group communication skills Proficient with MS Office products, Visio and CAD.
Estimated Salary: $20 to $28 per hour based on qualifications.
$101K - $128K a year Estimated:
$101K - $128K a year The 503B Associate Director Formulation Development is responsible for developing formulations and formulation processes for 503B drug products from small scale through commercial scale.
The position will create appropriate change requests, formulation and filling studies, batch records, forms, procedures, work instructions, risk assessments, cleaning verifications, filter validations, etc.
as needed to achieve the development and production goals of the organization.
Responsibilities:
Create formulation studies to determine material quantities and orders of addition to meet the products quality target product profile.
Product Development Life Cycle, Planning, Initiating and Development.
Ensuring new or revised manufacturing process follow cGMP.
Create or revise new product documentation as required such as formulation cards, development plans, lab batch protocols, process flows, procedures, work instructions, batch records, and bill of materials.
Equipment Cleaning Assurance Cleaning Lifecycle, Concepts of Cleaning, Determination of Cleaning Limits, Cleaning Cycle Studies and Verification, and Cleaning Agent Determination.
Purchase of goods and services.
Work with internal and external experts to assist in the development of product specifications, testing requirements and process descriptions.
Perform process Failure Mode and Effects Analysis, Critical Process Parameter and Critical Quality Attribute assessments.
Review and approval of product filter validation studies and protocols.
Coordinate resources towards completion of tasks assigned in the project management plan.
Execute process development studies related to the batch manufacturing including process sampling, and studies of equipment capability, and when applicable cleaning and sterilization cycles, including summary reports.
Follow Standard Operating Procedures, safety and cGMP Guidelines.
Perform other tasks as directed by Management including but not limited to the above responsibilities.
Degree in Pharmacy or directly related field 10 years manufacturing experience 503B manufacturing / pharmaceutical manufacturing experience Strong interpersonal/group communication skills Proficient with MS Office products, Visio and CAD.
Estimated Salary: $20 to $28 per hour based on qualifications.
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