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Senior Process Engineer, Tech Transfer

Company: Solid Biosciences
Location: Somerville
Posted on: May 3, 2021

Job Description:

Position: Senior Process Engineer, Tech Transfer Location: Cambridge, MAJob Id: 210118 # of Openings: 1Summary:Solid's Start: Solid is the English translation of Eytan, the Hebrew name of Solid's co-founders Ilan and Annie Ganot's son, Eytani, who was diagnosed with Duchenne muscular dystrophy (Duchenne) in 2012 at the age of 3. Unsatisfied with the existing Duchenne treatment landscape, the Ganots built a disease-focused company with the people and potential to advance innovative science quickly and responsibly.Solid's Culture:Much of what you can learn about Solid and our culture can be found in our name. We come to work each day for the Duchenne community, and that community is our family. We have a collective strength and determination that propels us to embrace innovation and challenge the status quo because central to all that we do is the unwavering commitment to advance meaningful therapies for the Duchenne community. We are a fiercely passionate and committed team, driven to collaborate with thoughtfulness and respect. We value exceptional skills, scientific curiosity, entrepreneurial spirit, diversity and adaptability. #TogetherWeAreSolid in our mission to find a cure for Duchenne muscular dystrophy and we will not stop until we've done it.Solid Biosciences is seeking a Senior Process Engineer to lead the transfer and implementation of Solid's manufacturing processes to receiving site CDMO's.Key Duties & Accountabilities:Lead technical transfer activities of drug substance and drug product manufacturing activitiesCollaborate with MS&T colleagues, other functions at Solid, and Contract Manufacturing Organization (CMO's) to ensure alignment of technology transfer activitiesEnsure robust facility fit and risk assessments for technology transfers are performedEnsure process and project timeline issues are escalated and addressedEnsure process data for projects is compiled and summarized with the support of all involved groups (Process and Analytical Development, MS&T colleagues, Quality, and CDMO's). Serve as primary author of technology transfer plans and reportsProvide technology transfer status updates to key stakeholdersServe as Person-in-Plant (PIP) for critical steps during manufacturing campaignsSupport GMP manufacturing operations, especially for initial campaigns following technology transferAuthor regulatory filing updates for major process changes and new site or process introductionsMay lead or support the development of MS&T business processes and procedures pertaining to technology transfer, data reviews, process control strategies, and process validationPerform other related duties as required by positionCore Competencies Required:Strong interpersonal and collaboration skillsExperience working on complex projects with aggressive timelinesExcellent oral and written communication skillsSkilled at analytical and strategic thinkingAbility to lead and influence others in a matrix teamKnowledge, Education, Experience & Skills:Basic QualificationsRequired:Bachelor's degree in Engineering, life sciences or equivalent with 12years of experienceMaster's degree in Engineering, life sciences or equivalent with 9years of experiencePhD in Engineering, life sciences or equivalent with 2years of experiencePreferred SkillsExperience working in a process engineering role within a viral vector or biologics GMP manufacturing environmentExperience with scale-up or technology transferStrong technical ability demonstrated by experience in process design, data analysis and problem solvingExperience in supporting regulatory filings and participation in regulatory inspectionsExperience working with contract manufacturing organizationsGood technical writing skillsTravel Commitment: Average of 10-25% Travel May Be Required (Post COVID) Apply for this PositionSDL2017

Keywords: Solid Biosciences, Somerville , Senior Process Engineer, Tech Transfer, Other , Somerville, Massachusetts

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