Director, CMC Development, Technical Operations | USA

Job Description

Job Title: Director, CMC Development, Technical Operations

Location: Cambridge, MA, Full-time, On-Site

Department: Technical Operations

Reports To: VP, Head of Technical Operations

Who We Are

At Skylark, we are developing AAV gene therapies to improve outcomes for people with genetic disorders. We are committed to scientific excellence across research, development, and manufacturing, with a strong focus on quality and patient safety. Team members join a collaborative, mission-driven environment grounded in scientific rigor and a shared commitment to meaningful patient impact. Our lead program is in a first-in-human study for pediatric hearing loss, with additional programs in hearing and CNS disorders advancing behind it.

Position Description

We are seeking a highly skilled and experienced individual to provide end-to-end CMC development oversight and execution for our AAV gene therapy programs. The successful candidate will be a key member of the Technical Operations team, providing scientific and technical leadership across process development, analytical development, technology transfer, manufacturing, and regulatory CMC. This role oversees internal activities and external work at CDMOs and contract laboratories to ensure phase-appropriate, scalable, and compliant development. The ideal candidate will bring strong experience in AAV and/or biologics CMC development, regulatory CMC experience, and cross-functional technical leadership.

Responsibilities

·        Lead assigned gene therapy programs from early development through clinical development and, as applicable, commercialization readiness, with end-to-end CMC oversight and execution aligned to Technical Operations priorities.

·        Oversee AAV process development across upstream, downstream, and drug product activities to ensure scalable, robust processes.

·        Oversee analytical activities in conjunction with analytical scientists at Skylark to support characterization, release, comparability, stability, and lifecycle management.

·        Develop and maintain integrated CMC plans that connect process, analytical, manufacturing, and regulatory activities to program milestones and clinical supply needs.

·        Lead technology transfer, manufacturing readiness, and campaign oversight at CDMOs to support compliant, high-quality AAV production.

·        Manage CDMOs and contract analytical laboratories, including scope, governance, performance monitoring, and issue resolution.

·        Partner cross-functionally with Regulatory, Quality, and Program Management to drive timelines, align deliverables, and achieve milestones.

·        Author and review CMC sections of regulatory submissions and support responses to health authority questions.

·        Provide technical leadership and mentorship to team members to foster accountability, collaboration, and continuous improvement.

·        Stay current on industry trends and advancements in AAV development, manufacturing, and regulatory expectations.

Qualifications

·        Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field with 8+ years of relevant industry experience OR Master’s degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field with 10+ years of relevant industry experience.

·        Extensive experience in CMC development for AAV gene therapies and/or biologics, with a strong understanding of drug substance, drug product, analytical development, and manufacturing.

·        Demonstrated technical depth in process development and analytical development, with the ability to provide end-to-end oversight, exercise strong technical judgment, and lead cross-functional execution across internal teams and external partners.

·        Proven experience leading technology transfers, external manufacturing, and CDMO oversight, including management of timelines, deliverables, technical issues, and partner performance.

·        Experience authoring and reviewing CMC sections of regulatory filings and supporting interactions with health authorities.

·        Strong knowledge of regulatory requirements, quality standards, and phase-appropriate CMC expectations for gene therapy products.

·        Ability to solve complex technical problems, assess and mitigate CMC risk, and operate effectively in a fast-paced, dynamic environment.

Job Title: Director, CMC Development, Technical Operations

Location: Cambridge, MA, Full-time, On-Site

Department: Technical Operations

Reports To: VP, Head of Technical Operations

Who We Are

At Skylark, we are developing AAV gene therapies to improve outcomes for people with genetic disorders. We are committed to scientific excellence across research, development, and manufacturing, with a strong focus on quality and patient safety. Team members join a collaborative, mission-driven environment grounded in scientific rigor and a shared commitment to meaningful patient impact. Our lead program is in a first-in-human study for pediatric hearing loss, with additional programs in hearing and CNS disorders advancing behind it.

Position Description

We are seeking a highly skilled and experienced individual to provide end-to-end CMC development oversight and execution for our AAV gene therapy programs. The successful candidate will be a key member of the Technical Operations team, providing scientific and technical leadership across process development, analytical development, technology transfer, manufacturing, and regulatory CMC. This role oversees internal activities and external work at CDMOs and contract laboratories to ensure phase-appropriate, scalable, and compliant development. The ideal candidate will bring strong experience in AAV and/or biologics CMC development, regulatory CMC experience, and cross-functional technical leadership.

Responsibilities

·        Lead assigned gene therapy programs from early development through clinical development and, as applicable, commercialization readiness, with end-to-end CMC oversight and execution aligned to Technical Operations priorities.

·        Oversee AAV process development across upstream, downstream, and drug product activities to ensure scalable, robust processes.

·        Oversee analytical activities in conjunction with analytical scientists at Skylark to support characterization, release, comparability, stability, and lifecycle management.

·        Develop and maintain integrated CMC plans that connect process, analytical, manufacturing, and regulatory activities to program milestones and clinical supply needs.

·        Lead technology transfer, manufacturing readiness, and campaign oversight at CDMOs to support compliant, high-quality AAV production.

·        Manage CDMOs and contract analytical laboratories, including scope, governance, performance monitoring, and issue resolution.

·        Partner cross-functionally with Regulatory, Quality, and Program Management to drive timelines, align deliverables, and achieve milestones.

·        Author and review CMC sections of regulatory submissions and support responses to health authority questions.

·        Provide technical leadership and mentorship to team members to foster accountability, collaboration, and continuous improvement.

·        Stay current on industry trends and advancements in AAV development, manufacturing, and regulatory expectations.

Qualifications

·        Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field with 8+ years of relevant industry experience OR Master’s degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or a related field with 10+ years of relevant industry experience.

·        Extensive experience in CMC development for AAV gene therapies and/or biologics, with a strong understanding of drug substance, drug product, analytical development, and manufacturing.

·        Demonstrated technical depth in process development and analytical development, with the ability to provide end-to-end oversight, exercise strong technical judgment, and lead cross-functional execution across internal teams and external partners.

·        Proven experience leading technology transfers, external manufacturing, and CDMO oversight, including management of timelines, deliverables, technical issues, and partner performance.

·        Experience authoring and reviewing CMC sections of regulatory filings and supporting interactions with health authorities.

·        Strong knowledge of regulatory requirements, quality standards, and phase-appropriate CMC expectations for gene therapy products.

·        Ability to solve complex technical problems, assess and mitigate CMC risk, and operate effectively in a fast-paced, dynamic environment.

·        Past experience developing medical devices, including catheter-based devices, is preferred.

To apply, please submit your CV and cover letter to careers@skylarkbio.com