Senior Director, Drug Substance Manufacturing

<div class="content-intro"><h3>Company Overview:</h3> <p>Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at <a href="https://www.dyne-tx.com/">https://www.dyne-tx.com/</a>, and follow us on <a href="https://x.com/dyne_tx">X</a>, <a href="https://www.linkedin.com/company/dynetx/">LinkedIn</a> and <a href="https://www.facebook.com/DyneTherapeutic/">Facebook</a>.</p></div><p><strong><span data-contrast="none"><span data-ccp-parastyle="heading 1">Role</span><span data-ccp-parastyle="heading 1"> Summary:</span></span></strong><span data-ccp-props="{"335559685":1,"335559738":1}"> </span></p> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto"><span data-ccp-parastyle="Body Text">The </span></span><span data-contrast="auto"><span data-ccp-parastyle="Body Text">S</span><span data-ccp-parastyle="Body Text">enior</span><span data-ccp-parastyle="Body Text"> Director, D</span><span data-ccp-parastyle="Body Text">rug Substance</span><span data-ccp-parastyle="Body Text"> Manufacturing</span> <span data-ccp-parastyle="Body Text">is responsible </span><span data-ccp-parastyle="Body Text">for</span><span data-ccp-parastyle="Body Text"> leading GMP drug substance manufacturing, process performance qualification (PPQ), ensuring commercial supply, and overseeing all CMC activities related to Fab-oligonucleotide conjugates (drug substance).  </span><span data-ccp-parastyle="Body Text">This role includes strategic vendor management for commercial drug substance production and coordination of external development and manufacturing activities with contract development and manufacturing organizations (CDMOs), contract testing laboratories (CTLs), and other key suppliers.</span></span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto"><span data-ccp-parastyle="Body Text">This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities </span><span data-ccp-parastyle="Body Text">required</span><span data-ccp-parastyle="Body Text"> to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.</span></span><span data-ccp-props="{"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"none","469789802":"none","469789806":"none","469789810":"none","469789814":"none"}"> </span></p> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-contrast="auto">This role is based in Waltham, MA.</span><span data-ccp-props="{}"> </span></p> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="auto"><span data-ccp-parastyle="Body">Primary Responsibilities</span><span data-ccp-parastyle="Body"> Include</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Responsible for </span><span data-ccp-parastyle="Body">bioconjugation activities including</span><span data-ccp-parastyle="Body"> validation, characterization, scale-up</span><span data-ccp-parastyle="Body">,</span> <span data-ccp-parastyle="Body">clinical</span><span data-ccp-parastyle="Body"> and commercial manufacturing.</span><span data-ccp-parastyle="Body"> </span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Establish</span><span data-ccp-parastyle="Body"> and </span><span data-ccp-parastyle="Body">manage contracts</span><span data-ccp-parastyle="Body">, </span><span data-ccp-parastyle="Body">supply agreements</span><span data-ccp-parastyle="Body"> and </span><span data-ccp-parastyle="Body">C</span><span data-ccp-parastyle="Body">DMOs</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Oversee suppliers and vendors involved in materials planning, inventory control, </span><span data-ccp-parastyle="Body">logistics</span><span data-ccp-parastyle="Body">, distribution to ensure that batch manufacturing is completed on </span><span data-ccp-parastyle="Body">a timely</span><span data-ccp-parastyle="Body"> basis</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Work closely with </span><span data-ccp-parastyle="Body">CMC Technical Development</span><span data-ccp-parastyle="Body"> to support bioconjugation</span><span data-ccp-parastyle="Body"> improvement</span><span data-ccp-parastyle="Body"> activities and enhance the tech transfer process</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Support QA compliance with </span><span data-ccp-parastyle="Body">cGMPs</span><span data-ccp-parastyle="Body">, </span><span data-ccp-parastyle="Body">cGLPs</span><span data-ccp-parastyle="Body"> and guidance for clinical trial materials</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Prepare and review CMC documentation for biologic INDs and BLAs and support FDA and EMEA interactions</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Support the development of regulatory CMC documentation and partner due diligence</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are </span><span data-ccp-parastyle="Body">initiated</span><span data-ccp-parastyle="Body">, </span><span data-ccp-parastyle="Body">addressed</span><span data-ccp-parastyle="Body"> and closed within target </span><span data-ccp-parastyle="Body">timeframes</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Provide patents and creative ideas to provide protection or creation of new or better products or processes</span></span><span data-ccp-props="{}"> </span></li> </ul> <p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-ccp-props="{"335559739":120}"> </span></p> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><strong><span data-contrast="auto"><span data-ccp-parastyle="Body">Education and Skill</span><span data-ccp-parastyle="Body">s</span><span data-ccp-parastyle="Body"> Requirements</span><span data-ccp-parastyle="Body">:</span></span></strong><span data-ccp-props="{"335559739":120}"> </span></p> <ul> <li><span data-contrast="auto"><span data-ccp-parastyle="Body">Bachelor’s degree in biology, biochemistry, chemistry, or a related scientific field </span><span data-ccp-parastyle="Body">required</span><span data-ccp-parastyle="Body">; advanced degree preferred.</span></span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Minimum 12 years of experience in biopharmaceutical manufacturing, including CMC management and oversight of complex development programs.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Proven expertise in bioconjugates, as well as strong knowledge of biologics and small molecule manufacturing, materials management, quality control/assurance, and CMC regulatory requirements.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Demonstrated experience in leading contract manufacturing and managing external partners such as CDMOs and CTLs.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Comprehensive experience with CMC regulatory submissions across all phases of development, ideally including post-approval activities, global regulatory interactions, and negotiations with health authorities on CMC issues related to biologic APIs.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Strong understanding of processes and systems supporting biopharmaceutical development, with the ability to challenge current practices and drive continuous improvement.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Exceptional leadership and interpersonal skills, including the ability to influence without authority, motivate teams, and collaborate effectively across functions and organizational levels.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Highly organized with demonstrated ability to prioritize workload, manage multiple programs in a fast-paced, deadline-driven environment, and consistently deliver on objectives.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Skilled in strategic thinking and problem-solving, with the ability to evaluate options, identify pros and cons, and implement creative solutions.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Excellent communication and negotiation skills, capable of building consensus and achieving win-win outcomes across diverse stakeholders.</span><span data-ccp-props="{}"> </span></li> <li><span data-contrast="auto">Self-directed and adaptable, able to work independently with limited guidance in a complex and evolving environment.</span><span data-ccp-props="{}"> </span></li> </ul> <p data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-ccp-props="{"335559685":720}"> </span></p> <p> </p> <p>#LI-Onsite</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">MA Pay Range</div><div class="pay-range"><span>$217,280</span><span class="divider">—</span><span>$266,750 USD</span></div></div></div><div class="content-conclusion"><p> </p> <p>The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.</p> <p>The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.</p> <p class="Body"><em><span style="font-family: 'Arial',sans-serif; color: #626262;">Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.</span></em></p></div>