The opportunity

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 including validation.

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.

• Work with limited guidance from supervisor or seniors to drive projects to completion.
• Providing process-engineering expertise for technology transfer, from pre-validation through commercial lifecycle for modified release solid oral dosage form manufacturing including scale up, validation and lifecycle changes.
• Perform technical analysis to understand and reduce technology transfer risk, estimate cycle time, improve equipment fit, and implement required technologies.
• Design, develop and optimize process simulation techniques for process optimization and scale up.
• Partner with internal and external groups to ensure technical success of technology transfer and continued cost effective manufacturing;

provide continued technical leadership to commercial operations for various unit operations including blending, sizing, compression, coating, fluid bed processing, and novel technologies.

• Contributing to business teams through innovation, strategic input, and industry knowledge to trouble shoot and achieve cost leadership.
• Perform engineering analysis of process execution, recommends opportunities for improvement with plant efficiency and risk mitigation as goals, and captures analysis in campaign summary documents.
• Provide process expertise, create and update MBR and support batch record review and analysis.
• Act as a quality events investigator for assigned projects.
• Lead documentation for equipment, lead FMEAs, recommend equipment modifications as needed for validation optimization, analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
• Perform studies to support necessary equipment and system PQ's and PPQs to assure compliance in all manufacturing and support areas, analyze data using appropriate statistical tools.
• Maintain product during lifecycle (stage 3 CPV) using appropriate statistical tools.
• Implement and use of new pharmaceutical manufacturing technologies including melt extrusion, spray drying, extrusion spheronization, spray congealing, laser drills, nano particulates, continuous manufacturing, NIR, PAT, etcetera.
• Execute material changes, process changes, cost reduction projects.
• Provide technical training and assistance to others.

Your experience and qualifications

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 bachelor’s degree pharmacy, engineering or science with a minimum of 4 years’ relevant experience in the field of Pharmaceutical manufacturing and / or pharmaceutical formulation and / or pharmaceutical process development and pre-validation OR related field.

Advanced degree is preferred. A combination of education and experience will be considered.

Skills / Knowledge / Abilities :

• Understanding of various unit operations used in conventional and novel oral solid dosage manufacturing.
• Comply with FDA regulations at all times.
• Business, scientific and personal computer hardware and software applications.
• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.

PHYSICAL REQUIREMENTS :

Visual Acuity :

• Visual acuity to perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach.

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day.

We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

Last updated : 2024-08-19