Avalo Therapeutics
Director/Senior Director, Device Development
Avalo Therapeutics, Wayne, Pennsylvania, United States, 19087
Director/Senior Director, Device Development
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At Avalo (ahh-vah'-low), we’re 100% focused on developing treatments for immune‑mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL‑1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.
Position Summary We are seeking a highly experienced and skilled Device engineer to join our CMC organization and serve as a senior technical subject matter expert and advisor for Avalo’s combination products programs with a focus on prefilled syringes and autoinjectors to support biologics. This role’s scope and accountability will encompass the entire lifecycle from early development through lifecycle management, providing critical technical strategic oversight and guidance in the implementation and commercialization of combination products. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, development, manufacturing, testing, commercialization, and regulatory aspects supporting the validation and commercialization of combination products.
Main Responsibility Areas
Provide deep subject matter expertise in the design, development, assembly, and manufacturing of combination products (prefilled syringes and autoinjectors), ensuring compliance with industry standards and regulatory requirements (e.g., ISO 13485, FDA regulations). Actively seek out, anticipate, and solve significant scientific and technical challenges.
Lead investigations at third party manufacturers through technical challenges related to design, manufacturing, and scale‑up processes, to resolve device and assembly issues timely and effectively.
Act as the primary technical advisor for Avalo working on combination products (prefilled syringes and autoinjectors), fostering collaboration among Avalo and third‑party manufacturers in the engineering, quality assurance, regulatory, and manufacturing teams across the CMC roles. Key collaborative and influential partnerships span across multiple stakeholders and organizations.
Oversee and manage CDMO relationships related to design and development activities for device combination products. This includes working with CDMO to develop the DHF and all required documents (i.e. PRD, DIR, V&V matrix, Risk Management, Design Reviews and Design Transfer) and support of technology transfer efforts for the final drug product assembly.
Interface with external suppliers and partners to ensure the quality and compliance of components used in combination products (prefilled syringes and autoinjectors), driving performance, accountability, and innovation.
Oversee lifecycle support for combination products, including performance monitoring, design optimization, and process validation.
Manage a broad scope of technical transfer activities related to the introduction of new combination products from development to manufacturing, ensuring robust introduction, qualification, and performance monitoring.
Collaborate closely regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing technical documentation for regulatory submissions and audits.
Ensure that all engineering activities adhere to relevant regulatory standards and industry best practices.
Analyze and interpret results and methods, troubleshoot processes, generate solutions to problems and meet related regulatory requirements.
Stay abreast of industry trends, emerging technologies, and best practices in combination product technology, providing and championing recommendations for continuous improvement and innovation.
Champion initiatives for design enhancements and supply chain expansions, ensuring that components meet their intended use and performance qualifications against industry standards.
Encourage the exploration of problem solving in innovative ways to achieve technical and business results. Personally drive and model technical rigor in expectations and actions.
Promote knowledge sharing, technical excellence, and best practices within Avalo, ensuring that technical expertise is disseminated effectively. Inspire a learning culture and drive deep technical understanding.
Other duties as assigned.
Education & Experience
Degree in Biomedical Engineering, Materials Science, or related discipline. BA/BS with 12 years experience / MA/MS with 10 years of hands‑on experience / PhD with 8 years of experience in medical device engineering at a biotech or pharma company, with a focus on prefilled syringes, autoinjectors and combination products.
Significant relevant biopharmaceutical industry experience working in development of drug/device combination products required, with experience working on large molecule programs (monoclonal antibodies preferred) for subcutaneous administration highly valued.
Additional Skills, Knowledge, and/or Abilities
In‑depth understanding of prefilled syringes, autoinjector design, manufacturing processes, and regulatory requirements.
Familiarity with materials science, particularly as it relates to drug delivery systems, including knowledge of damage mechanisms, common defects, and performance testing.
Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global regulatory standards pertaining to medical devices and combination products.
Proven track record of successful technical leadership and problem‑solving in a regulated environment.
Excellent communication, interpersonal, and collaboration skills to effectively engage with cross‑functional teams, external suppliers, and industry partners.
Ability to influence and drive consensus among diverse stakeholders.
Entrepreneurial spirit with a hands‑on, roll‑up‑your‑sleeves approach and high sense of urgency and dedication to drive for results.
Collaborative, self‑motivated team player capable of critical and strategic thinking and able to manage multiple tasks effectively in a dynamic organization.
Travel Requirement Travel, both domestically and internationally, up to 10‑15% may be required.
Job Type Full‑time
Location Hybrid; This role offers a flexible work arrangement but requires travel to corporate headquarters and attendance at customer‑facing meetings as needed.
About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL‑1β‑based treatments for immune‑mediated inflammatory diseases. Our lead asset, AVTX‑009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com.
ATTENTION: External Agencies and Placement Firms A member of the Avalo Human Resources Department will contact an agency directly if an open position is eligible to be sourced from an outside recruiting service. Avalo does not accept unsolicited resumes from employment agencies for any employment opportunity. All agencies/recruiters must have a written agreement/SOW in place with Avalo and prior to submitting any resume or CV.
All resumes must be submitted through the appropriate process. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e‑mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.
Seniority level
Director
Employment type
Full‑time
Job function
Product Management and Engineering
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Avalo Therapeutics by 2x
Inferred benefits Medical insurance
Vision insurance
Disability insurance
401(k)
Get notified about new Device Engineer jobs in
Wayne, PA .
#J-18808-Ljbffr
At Avalo (ahh-vah'-low), we’re 100% focused on developing treatments for immune‑mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL‑1β pathway, which is a central driver of the inflammatory process. We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.
Position Summary We are seeking a highly experienced and skilled Device engineer to join our CMC organization and serve as a senior technical subject matter expert and advisor for Avalo’s combination products programs with a focus on prefilled syringes and autoinjectors to support biologics. This role’s scope and accountability will encompass the entire lifecycle from early development through lifecycle management, providing critical technical strategic oversight and guidance in the implementation and commercialization of combination products. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, development, manufacturing, testing, commercialization, and regulatory aspects supporting the validation and commercialization of combination products.
Main Responsibility Areas
Provide deep subject matter expertise in the design, development, assembly, and manufacturing of combination products (prefilled syringes and autoinjectors), ensuring compliance with industry standards and regulatory requirements (e.g., ISO 13485, FDA regulations). Actively seek out, anticipate, and solve significant scientific and technical challenges.
Lead investigations at third party manufacturers through technical challenges related to design, manufacturing, and scale‑up processes, to resolve device and assembly issues timely and effectively.
Act as the primary technical advisor for Avalo working on combination products (prefilled syringes and autoinjectors), fostering collaboration among Avalo and third‑party manufacturers in the engineering, quality assurance, regulatory, and manufacturing teams across the CMC roles. Key collaborative and influential partnerships span across multiple stakeholders and organizations.
Oversee and manage CDMO relationships related to design and development activities for device combination products. This includes working with CDMO to develop the DHF and all required documents (i.e. PRD, DIR, V&V matrix, Risk Management, Design Reviews and Design Transfer) and support of technology transfer efforts for the final drug product assembly.
Interface with external suppliers and partners to ensure the quality and compliance of components used in combination products (prefilled syringes and autoinjectors), driving performance, accountability, and innovation.
Oversee lifecycle support for combination products, including performance monitoring, design optimization, and process validation.
Manage a broad scope of technical transfer activities related to the introduction of new combination products from development to manufacturing, ensuring robust introduction, qualification, and performance monitoring.
Collaborate closely regulatory teams to ensure compliance with applicable regulations and standards, preparing and reviewing technical documentation for regulatory submissions and audits.
Ensure that all engineering activities adhere to relevant regulatory standards and industry best practices.
Analyze and interpret results and methods, troubleshoot processes, generate solutions to problems and meet related regulatory requirements.
Stay abreast of industry trends, emerging technologies, and best practices in combination product technology, providing and championing recommendations for continuous improvement and innovation.
Champion initiatives for design enhancements and supply chain expansions, ensuring that components meet their intended use and performance qualifications against industry standards.
Encourage the exploration of problem solving in innovative ways to achieve technical and business results. Personally drive and model technical rigor in expectations and actions.
Promote knowledge sharing, technical excellence, and best practices within Avalo, ensuring that technical expertise is disseminated effectively. Inspire a learning culture and drive deep technical understanding.
Other duties as assigned.
Education & Experience
Degree in Biomedical Engineering, Materials Science, or related discipline. BA/BS with 12 years experience / MA/MS with 10 years of hands‑on experience / PhD with 8 years of experience in medical device engineering at a biotech or pharma company, with a focus on prefilled syringes, autoinjectors and combination products.
Significant relevant biopharmaceutical industry experience working in development of drug/device combination products required, with experience working on large molecule programs (monoclonal antibodies preferred) for subcutaneous administration highly valued.
Additional Skills, Knowledge, and/or Abilities
In‑depth understanding of prefilled syringes, autoinjector design, manufacturing processes, and regulatory requirements.
Familiarity with materials science, particularly as it relates to drug delivery systems, including knowledge of damage mechanisms, common defects, and performance testing.
Strong knowledge of relevant regulatory requirements such as ISO, USP, FDA guidelines, and other global regulatory standards pertaining to medical devices and combination products.
Proven track record of successful technical leadership and problem‑solving in a regulated environment.
Excellent communication, interpersonal, and collaboration skills to effectively engage with cross‑functional teams, external suppliers, and industry partners.
Ability to influence and drive consensus among diverse stakeholders.
Entrepreneurial spirit with a hands‑on, roll‑up‑your‑sleeves approach and high sense of urgency and dedication to drive for results.
Collaborative, self‑motivated team player capable of critical and strategic thinking and able to manage multiple tasks effectively in a dynamic organization.
Travel Requirement Travel, both domestically and internationally, up to 10‑15% may be required.
Job Type Full‑time
Location Hybrid; This role offers a flexible work arrangement but requires travel to corporate headquarters and attendance at customer‑facing meetings as needed.
About Avalo Therapeutics Avalo Therapeutics is a clinical stage biotechnology company fully dedicated to developing IL‑1β‑based treatments for immune‑mediated inflammatory diseases. Our lead asset, AVTX‑009, is in a Phase 2 clinical trial for hidradenitis suppurativa (HS). We’re also exploring additional opportunities to make an impact in prevalent indications that have significant remaining unmet needs. For more information about Avalo, please visit www.avalotx.com.
ATTENTION: External Agencies and Placement Firms A member of the Avalo Human Resources Department will contact an agency directly if an open position is eligible to be sourced from an outside recruiting service. Avalo does not accept unsolicited resumes from employment agencies for any employment opportunity. All agencies/recruiters must have a written agreement/SOW in place with Avalo and prior to submitting any resume or CV.
All resumes must be submitted through the appropriate process. Any resumes submitted without an agreement and/or any resumes sent unsolicited through e‑mail accounts of Avalo employees will be considered outside of the appropriate process, do not imply or create any obligation on our part, do not impart any restrictions on Avalo with respect to the hiring of any persons whose resumes are so submitted and are not eligible for placement fees.
Seniority level
Director
Employment type
Full‑time
Job function
Product Management and Engineering
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Avalo Therapeutics by 2x
Inferred benefits Medical insurance
Vision insurance
Disability insurance
401(k)
Get notified about new Device Engineer jobs in
Wayne, PA .
#J-18808-Ljbffr