Director, Small Molecule CMC Position Available In Middlesex, Massachusetts

Job Description:

Company Overview:

Dyne Therapeutics is discovering and advancinginnovative life-transforming therapeutics for people living withgenetically driven neuromuscular diseases. Leveraging themodularity of its FORCE™ platform, Dyne is developing targetedtherapeutics that deliver to muscle and the central nervous system(CNS). Dyne has a broad pipeline for neuromuscular diseases,including clinical programs for myotonic dystrophy type 1 (DM1) andDuchenne muscular dystrophy (DMD) and preclinical programs forfacioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Role Summary:

Director, Small Molecule CMC will be accountable forall small molecule development and manufacturing operationsactivities globally for our products. This role will partnerclosely with colleagues across Dyne to ensure seamless supply ofall small molecule components for drug substance used in clinicaltrials and will lead efforts for commercial readiness. Experiencewith conjugatable linkers and ADCs is desirable. This role is basedin Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

Lead small molecule developmentand manufacturing to support drug substance supply; collaboratewith Supply, Quality Control, Quality Assurance, and ClinicalOperations to esnusre continuity of drug supply Lead regulatorydrafting, review and filing support for IND, BLA and other globaldossiers. Act as main point of contact for CDMO(s) includingleading CDMO working teams and strategic business reviewchairperson Responsible for driving execution of the productionplan at CDMO (PO through delivery) Working with Procurement, Legal,and Strategic Sourcing take the lead in identification andresolution of business/contract issues and supply agreementsResponsible for long term strategic supplier management andaccountable for supplier relationship management Partners withSupply, Quality and Regulatory to champion a culture of qualitywith our CDMO’s and to ensure that all activities and documentationcomply with regulatory requirements Partner with Strategic Sourcingto develop and implement long term external manufacturingstrategies that provide a reliable, robust, and cost-effectivemanufacturing network Champion a strong winning culture, fosteringteamwork and commitment to excellent through transparentcommunication, engagement and collaboration

Education and SkillsRequirements:

Bachelor’s Degree in Science or related field, orequivalent with 8-10 years of related work experience, or advanceddegree and a minimum of 6 years of work experience Provenexperience in clinical and commercial small molecule developmentand manufacturing as well as understanding of analytical techniquesspecially with chiral complex small molecules Demonstratedunderstanding of the principles and applications associated withexternal manufacturing operations Strong experience and knowledgeof cGMP manufacturing requirements Strategic thinker with strongresult-orientation and a sense of urgency to deliver qualityresults on time and in a highly ethical and professional manner.

Experience managing complex schedules and priorities in dynamicpharmaceutical, biotech or related environments. Experience in PPQplanning and activities Ability to work, influence, and gainconsensus across multiple functions (CMC, Quality and RegulatoryAffairs) Experience in all phases of CMC regulatory submissions andinteractions regarding CMC issues, including IND, BLA, andpost-approval changes Strong analytical, problem solving andcritical thinking skills. Collaborative work style to be part of ateam to identify process gaps and develop solutions Excellentinterpersonal, verbal, and written communication skills with theability to work in strong cross-functional relationships andcommunicate complex issues enterprise-wide, from the executive teamto the manufacturing floor. Resilient and able to work in ademanding, fast-paced environment and capable of supportingmultiple programs and vendors LI-Onsite The statements containedherein reflect general details as necessary to describe theprinciples functions for this job, the level of knowledge and skilltypically required, and the scope of responsibility, but should notbe considered an all-inclusive listing of work requirements.

Individuals may perform other duties as assigned, including work inother functional areas to cover absences or relief, to equalizepeak work periods or otherwise balance workload. This descriptionis not intended to be constructed as an exhaustive list of duties,responsibilities, or requirements for the position. This positionmay change or assume additional duties at any time. The employeemay be requested to perform different or additional duties asassigned. All Employees are expected to adhere to all companypolicies and act as a role model for company values. DyneTherapeutics is an equal opportunity employer and will notdiscriminate against any employee or applicant on the basis of age,color, disability, gender, national origin, race, religion, sexualorientation, veteran status, or any classification protected byfederal, state, or local law.