Manager, Quality Control 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:

The Manager, Quality Control will support and overseestability programs as well as QC testing and release of antibodydrug conjugates and intermediates. This role will also contributeto the management of analytical development and QC activities inPhase 1 through BLA and commercial production. These activitiesinclude coordinating QC efforts and support of analyticalactivities with contract development and manufacturingorganizations (CDMOs), contract test labs (CTLs), and otherexternal suppliers. This role will work closely with stakeholderswithin CMC and cross-functionally with Development, R D,Regulatory, and Project Management on QC related activities toeffectively manage Dyne’s complex clinical supply chain and supporteventual launch and commercialization efforts. This role is basedin Waltham, MA without the possibility of being a fully remoterole.

Primary Responsibilities Include:

Support aspects ofdevelopmental and GMP Stability management for intermediates, drugsubstances and drug products for all Dyne programs at CMOs and CROsSupport aspects of quality systems including OOS/OOTinvestigations, quality investigation records, change controls,deviations, CAPAs, etc. Collaborate in the oversight of stabilitystudies to external vendors for preclinical and Phase I – III CMCactivities Coordinate stability pulls, manage sample shipments withhelp of logistics to and from storage and testing sites, monitorand review data received from external sites Support tracking andtrending of stability tables of data for intermediates, drugsubstance and drug product Conduct raw data review of vendorgenerated QC reports as needed Assist in the oversight of referencestandard program including establishing and maintaining referencestandards, approving qualification protocols and reports, andcoordinating release testing at external laboratories asappropriate Participate in the development and revision of productspecifications; provide scientific input and statistical analysisof results Contribute to cross-functional laboratory investigationsrelated to stability and laboratory operations as needed Contributeto the drafting/revision of QC and CMC sections of regulatorysubmissions as needed Participate in preparation of responses toregulatory agency questions Support testing in the lab as needed(10-15%)

Education and Skills Requirements:

A minimum of4-6 years’experience in GMP QC testing and/or QC stability management Degreein biology, biochemistry, chemistry, or similar related fieldrequired Strong quality and analytical background with experiencein general, compendial and product-specific analytical tools andpractices pertinent to monoclonal antibodies, small molecules, andtheir Mab-conjugates Experience with managing QC external vendorspreferred. Working knowledge of a variety of analytical techniquesincluding SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and massspectroscopy Strong knowledge of c

GMP/ICH/FDA/EU

regulations aplus. Experience and knowledge of data analysis and trendingsoftware (SLIMStat) is highly desirable. Well versed with biologicsand small molecules quality control and QA compliance of analyticalmethods/data Team member who can work collaboratively withcolleagues across all functions Results oriented, establishingclear expectations and priorities, sets objectives and effectivelyapplies resources Ability to set clear goals and consistentlydelivers Flexible and creative problem-solving skills Logicalthinker to develop and evaluates options, identifying pros and consAbility to challenge current processes, practices and strategy anduncover alternative approaches, solutions, or methods Excellentcommunication and interpersonal skills with success in workingacross organizational boundaries at all levels to bring togetherpeople of diverse backgrounds and skill sets to create, influence,and negotiate win-win solutions Highly collaborative team playerwho fosters open communication and facilitates mutual understandingand cooperation between all stakeholders Excellent organizationalskills LI-Onsite The statements contained herein reflect generaldetails as necessary to describe the principles functions for thisjob, the level of knowledge and skill typically required, and thescope of responsibility, but should not be considered anall-inclusive listing of work requirements. Individuals may performother duties as assigned, including work in other functional areasto cover absences or relief, to equalize peak work periods orotherwise balance workload. This description is not intended to beconstructed as an exhaustive list of duties, responsibilities, orrequirements for the position. This position may change or assumeadditional duties at any time. The employee may be requested toperform different or additional duties as assigned. All Employeesare expected to adhere to all company policies and act as a rolemodel for company values. Dyne Therapeutics is an equal opportunityemployer and will not discriminate against any employee orapplicant on the basis of age, color, disability, gender, nationalorigin, race, religion, sexual orientation, veteran status, or anyclassification protected by federal, state, or local law.