Senior Manager, Engineering Innovation at Aprecia Pharmaceuticals in Ohio, IL
Establish and manage the Engineering Innovation team at the Blue Ash facility to further the development of innovative dosage forms, intellectual property, novel equipment, processes and procedures for application of Aprecia's proprietary three-dimensional printing technology to the scale up and manufacturing of Aprecia's products that meets the needs of Aprecia's Manufacturing and Product Development departments. Work in a team environment with other members of the company such as Technical Services, Product Development, Manufacturing, Quality, and Business Development. Primary Duties and Responsibilities (Essential Functions):
1 Develop the Engineering Innovation staff to advance Aprecia's proprietary three-dimensional printing technology 2 Provide technical guidance and leadership to the EI engineering staff relative to the design, management, and coordination of activities regarding the development and design of automated equipment and processes 3 Guide the generation of equipment and design processes, SOPs (standard operating procedures), or validation documents based on subject matter expertise 4 Facilitate and support product development projects through the development and integration of custom machinery to enable the manufacture of innovative dosage forms 5 Coordinate with Technical Services to identify and recommend process improvements to existing equipment and systems to improve the safety, reliability, and operability 6 Maintain the lab space and necessary equipment to ensure a productive work environment for the engineering development function 7 Support Manufacturing and Operations Engineering departments regarding operation, support, and validation of manufacturing equipment 8 Support Regulatory Affairs department in the preparation of submission documentation 9 Comply with internal procedures and cGMPs (current Good Manufacturing Practices) Reporting to this Position:
Members of the Engineering Innovation team based in Blue Ash will report to this position Travel:
Position may require periodic travel to vendor or client sites up to 25% Work Shift:
This position typically works days, but responsibilities for this role may be covered across multiple shifts Knowledge, Skills and Abilities:
o Excellent oral and written communications skills o Knowledge of cGMPs (current GMP) and FDA (Food & Drug Administration) pharmaceutical regulations o Well-developed interpersonal and problem-solving skills o Excellent leadership and organizational skills including experience leading technical projects within multi-functional teams o Ability to effectively interpret and analyze data so that decisions can be made on process and equipment performance and capability Education and
Experience:
o B.S. degree (or higher) in an engineering field, technology field or related discipline (applicable to equipment automation or pharmaceutical sciences) required o 10 years of experience in pharmaceutical development or manufacturing, and/or innovative technology platforms such as three-dimensional printing o Broad engineering background encompassing multiple disciplines including mechanical, electrical and software/controls development o 3 years of experience managing projects within R&D and/or equipment development; PMP a plus o Practical working experience or research with printing technologies a plus Physical Demands and Work Environment:
o Good eyesight to read, interpret, and create technical materials o Good manual dexterity to operate computer and other general office equipment o Sitting at a desk or standing for extended periods of time o Occasional lifting of boxes (up to 25 pounds) containing engineering materials, manuals, tools, etc. o Exposure to odd body positions (i.e. twisted torso, bent over position, etc.) for brief periods of time while completing validation work in the laboratories or manufacturing areas taking samples, documenting batch information, etc. o Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, safety shoes, safety glasses, etc.) Uniforms, gloves, hairnet, and moustache cover and barrier outerwear is required within the manufacturing area GENERAL INFORMATION:
The expectation for all employees is to support the company's mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.
Salary Range:
$150K -- $200K
Minimum Qualification
Engineering ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
1 Develop the Engineering Innovation staff to advance Aprecia's proprietary three-dimensional printing technology 2 Provide technical guidance and leadership to the EI engineering staff relative to the design, management, and coordination of activities regarding the development and design of automated equipment and processes 3 Guide the generation of equipment and design processes, SOPs (standard operating procedures), or validation documents based on subject matter expertise 4 Facilitate and support product development projects through the development and integration of custom machinery to enable the manufacture of innovative dosage forms 5 Coordinate with Technical Services to identify and recommend process improvements to existing equipment and systems to improve the safety, reliability, and operability 6 Maintain the lab space and necessary equipment to ensure a productive work environment for the engineering development function 7 Support Manufacturing and Operations Engineering departments regarding operation, support, and validation of manufacturing equipment 8 Support Regulatory Affairs department in the preparation of submission documentation 9 Comply with internal procedures and cGMPs (current Good Manufacturing Practices) Reporting to this Position:
Members of the Engineering Innovation team based in Blue Ash will report to this position Travel:
Position may require periodic travel to vendor or client sites up to 25% Work Shift:
This position typically works days, but responsibilities for this role may be covered across multiple shifts Knowledge, Skills and Abilities:
o Excellent oral and written communications skills o Knowledge of cGMPs (current GMP) and FDA (Food & Drug Administration) pharmaceutical regulations o Well-developed interpersonal and problem-solving skills o Excellent leadership and organizational skills including experience leading technical projects within multi-functional teams o Ability to effectively interpret and analyze data so that decisions can be made on process and equipment performance and capability Education and
Experience:
o B.S. degree (or higher) in an engineering field, technology field or related discipline (applicable to equipment automation or pharmaceutical sciences) required o 10 years of experience in pharmaceutical development or manufacturing, and/or innovative technology platforms such as three-dimensional printing o Broad engineering background encompassing multiple disciplines including mechanical, electrical and software/controls development o 3 years of experience managing projects within R&D and/or equipment development; PMP a plus o Practical working experience or research with printing technologies a plus Physical Demands and Work Environment:
o Good eyesight to read, interpret, and create technical materials o Good manual dexterity to operate computer and other general office equipment o Sitting at a desk or standing for extended periods of time o Occasional lifting of boxes (up to 25 pounds) containing engineering materials, manuals, tools, etc. o Exposure to odd body positions (i.e. twisted torso, bent over position, etc.) for brief periods of time while completing validation work in the laboratories or manufacturing areas taking samples, documenting batch information, etc. o Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, safety shoes, safety glasses, etc.) Uniforms, gloves, hairnet, and moustache cover and barrier outerwear is required within the manufacturing area GENERAL INFORMATION:
The expectation for all employees is to support the company's mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.
Salary Range:
$150K -- $200K
Minimum Qualification
Engineering ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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