Regeneron
Overview
We are currently looking to fill a Director of Combination Product Development role. In this position you will provide technical expertise to support and implement the strategic vision outlined by the senior leadership of Combination Products. This role is responsible for driving device and packaging development, ensuring alignment with Regenerons therapeutic programs, and supporting clinical and commercial combination product manufacturing. The position involves collaboration with internal teams, external partners, and suppliers to advance device industrialization, regulatory compliance, and operational excellence. Responsibilities
Collaborate with Combination Products senior leadership to revamp and execute Regenerons combination product development strategies. Lead technical relationships with alliance partners, device manufacturers, component suppliers, and consultants, ensuring alignment and project success. Provide technical expertise to guide the development of devices, packaging, and accessories for therapeutic programs. Interface with internal teams, alliance partners, and suppliers to ensure effective communication, alignment, and project execution. Oversee the creation and maintenance of thorough documentation, including Design History Files, quality engineering data, human factors and usability study results. Provide expertise and documentation for regulatory filings, ensuring compliance with device design, manufacturing process controls, and quality risk management standards. Support device component manufacturing and clinical/commercial manufacturing of combination products. Provide technical support for qualification activities, assembly guidance, process controls, and risk assessments for Regenerons internal fill-finish manufacturing operations. Qualifications
Role may include directing device development engineers, project leaders, and team managers, fostering professional growth and operational excellence. Ability to represent IOPS in promoting device-related initiatives and integration across the organization. Ability to ensure work activities comply with applicable regulations and industry standards. Ability to represent Regeneron at industry meetings and forums, advocating for device-related advancements and partnerships. Educational requirement: Bachelors degree in Science, Engineering, or related discipline. Experience: Associate Director: 10+ years; Director: 12+ years in the pharmaceutical or medical device industry or equivalent combination of education and experience. Additional Information
Salary Range (annually): $145,600.00 - $282,600.00 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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We are currently looking to fill a Director of Combination Product Development role. In this position you will provide technical expertise to support and implement the strategic vision outlined by the senior leadership of Combination Products. This role is responsible for driving device and packaging development, ensuring alignment with Regenerons therapeutic programs, and supporting clinical and commercial combination product manufacturing. The position involves collaboration with internal teams, external partners, and suppliers to advance device industrialization, regulatory compliance, and operational excellence. Responsibilities
Collaborate with Combination Products senior leadership to revamp and execute Regenerons combination product development strategies. Lead technical relationships with alliance partners, device manufacturers, component suppliers, and consultants, ensuring alignment and project success. Provide technical expertise to guide the development of devices, packaging, and accessories for therapeutic programs. Interface with internal teams, alliance partners, and suppliers to ensure effective communication, alignment, and project execution. Oversee the creation and maintenance of thorough documentation, including Design History Files, quality engineering data, human factors and usability study results. Provide expertise and documentation for regulatory filings, ensuring compliance with device design, manufacturing process controls, and quality risk management standards. Support device component manufacturing and clinical/commercial manufacturing of combination products. Provide technical support for qualification activities, assembly guidance, process controls, and risk assessments for Regenerons internal fill-finish manufacturing operations. Qualifications
Role may include directing device development engineers, project leaders, and team managers, fostering professional growth and operational excellence. Ability to represent IOPS in promoting device-related initiatives and integration across the organization. Ability to ensure work activities comply with applicable regulations and industry standards. Ability to represent Regeneron at industry meetings and forums, advocating for device-related advancements and partnerships. Educational requirement: Bachelors degree in Science, Engineering, or related discipline. Experience: Associate Director: 10+ years; Director: 12+ years in the pharmaceutical or medical device industry or equivalent combination of education and experience. Additional Information
Salary Range (annually): $145,600.00 - $282,600.00 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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