Job description

"#INDEED_A"

Duration: 6 months
****Manager is looking for a recent masters degree or PhD graduate for this position****

POSITION SUMMARY

• This position is responsible for performing activities related to critical aspects of products and processes, including process development, pre-validation and optimization of solid oral dosage forms after Abbreviated New Drug Application (ANDA) filing throughout product launch and commercial lifecycle.
• Executes studies with Research and Development (R & D), Laboratory Technical Services (LTS), manufacturing and planning.
• Maintains of expertise related to formulation, raw material properties and manufacturing processes. Identifies, analyzes and suggests corrective actions to optimize procedures, processes, materials, technology and regulatory compliance issues.
• Provides direction and training to other staff, technicians and manufacturing operators.

ESSENTIAL AREAS OF RESPONSIBILITY

• All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, improve safety of the existing commercial products. Coordinate manufacturing of additional batches if required and prepare technical reports.
• Performing process validation activities including process design, process qualification, continuous process verification reviews (CPV), statistical assessments and trend analysis and cleaning validation for the commercial and new products.
• Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs)
• Provide Technical assessments/ product impact assessment summaries on time
• Evaluate the material changes such as changes to the manufacturing process of Active Pharmaceutical Ingredient (API) or site manufacturing changes for raw materials (API, excipients) and packaging components. Coordinate the manufacturing activities and prepare technical reports.
• Execute the experimental and process confirmation studies
• Supports pre-validation commercial scale report that includes detailed summary of the equipment and qualified equipment parameters (QEPs) assessment, CPPs and CQAs identified during pre-validation work.
• Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.
• Leading multiple new product introductions and site transfer projects.
• Responsible for performing additional related duties as assigned.

POSITION REQUIREMENTS
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Requires a Master’s degree in chemistry OR chemical engineering OR Pharmaceutical Science with a 1-3 years relevant experience in the field of Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation OR related field.

Skills/Knowledge/Abilities:

• Ability to handle multiple projects, duties, and assignments.
• Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
• Ability to contribute in a team environment.
• Communicating clearly and concisely, both orally and in writing; good presentation skills.
• Some knowledge of CGMP, FDA, Occupational Safety and Health Administration (OSHA), Environmental Protection Agency (EPA), DEA and other regulatory requirements.
• Intermediate statistical computations (Cpp, Cpk, Regression analysis, etc.) and use of statistical software (JMP, Minitab, Statease etc.).

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to direct method and procedure for problem resolution.

Job Types: Full-time, Contract

Salary: $30.00 - $36.00 per hour

Experience level:

• No experience needed

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Education:

• Master's (Required)

Work Location: One location

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