Scientist Iii, Manufacturing Sciences

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

As a Manufacturing Scientist, you will complete activities for the development of new and established manufacturing processes for oral solid dosage products in a traditional batch manufacturing and well as a continuous manufacturing environment.

QUALIFICATIONS:

• Bachelor’s degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required.
• Minimum of five (5) years of experience in a manufacturing environment. Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred. Advanced degree with less experience would be considered techniques, working knowledge of EMPOWER is a plus.
• Understanding of Good Manufacturing Practices (GMP) and regulatory compliance.
• Manage projects of moderate to high complexity in scope and compliance-related challenges to implementing processes to meet changing regulations.
• Skilled in MATLAB or Python programming and data analysis.
• Proficiency using Microsoft (MS) Office applications.
• Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
• Self-starter, mature, independent, and dependable.
• Ability to work in a fast-paced, results oriented environment.
• Experience managing projects related to process development including scale-up and technology transfer.
• Effective time management, multi-tasking and prioritization skills to effectively manage multiple projects.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

• Complete technical activities with cross functional teams including validation, operations, quality, analytical development and process development.
• Provide support and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas.
• Participate in client calls as primary technical representative and provide scientific justification for the project decisions and recommendations.
• Lead the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements.
• Integrate risk-based approach during the scale up and commercialization of processes and develop appropriate mitigation strategies.
• Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches.
• Support routine manufacturing operations in order to assure timely release of products with appropriate quality attributes and providing stewardship for commercial products of responsibility.
• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.