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Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Manager, Upstream Manufacturing Science and Technology Open 301 - Manufacturing Full-Time Cambridge Massachusetts USA May 9th, 2018 12:00AM

Solid Biosciences is currently recruiting for a Manager, Manufacturing Science and Technology to join our Manufacturing team. In this position you will be responsible for leading a team of engineers and overseeing upstream aspects of tech transfers to contract manufacturing organizations, providing technical oversight of ongoing manufacturing operations through process monitoring, troubleshooting, and process improvements.  Solid is looking for candidates with experience providing technical support to cGMP biopharmaceutical manufacturing upstream processes and with demonstrated people management or project leadership capabilities.

Key Duties & Accountabilities:

  • Manage upstream tech transfer and startup activities to ensure project timelines and process requirements are met. Includes onsite presence at our contract manufacturing organizations
  • Support ongoing manufacturing operations through process monitoring, trending, and identifying risks and opportunities for improving yields, product quality, and process robustness. Includes onsite presence during key operations
  • Evaluate facility and equipment design for ability to meet process and regulatory expectations
  • Supports the development of Solid’s Quality systems and regulatory documentation
  • Perform other related duties and ad hoc projects as required

Core competencies required:

  • Cell culture, with viral vector manufacturing a plus
  • Work individually and as part of a team
  • Interpersonal/collaboration
  • Communication – oral and written
  • Analytical and strategic thinking
  • Data analysis – statistics a plus
  • Project management
  • Ability to lead and influence others

Knowledge: Education, Experience, & Skills:

Bachelor’s degree in life sciences, engineering, or equivalent with 8+ years of experience working in a technical role within the upstream biopharmaceutical process development, design, or cGMP manufacturing environment. Or Master’s degree with 5+ years of experience.

 Preferred Skills

  • Cell culture or viral vector manufacturing
  • Strong technical ability demonstrated by experience in process design, data analysis, and problem solving
  • Experience working with contract manufacturing organizations

Travel Commitment:

  • Up to 20% travel will be required at times

Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Associate Director/Director, Biostatistics Open 303 - Clinical Full-Time Cambridge Massachusetts USA Sep 14th, 2018 12:00AM

Summary:

The Associate Director/Director will be responsible for leading all statistical activities pertaining to Solid’s clinical development programs including clinical trial design, interim analyses, and analysis and reporting of cumulative and final clinical trial data. The Associate Director/Director will oversee outsourced routine statistical and data management activities as well as drive more sophisticated aspects of statistical strategy for the advancement of Solid’s clinical programs. In addition, the Associate Director/Director may be called upon to provide statistical support to Solid’s non-clinical and translational projects as needed.  

Key Duties & Accountabilities:

  • Serve as in-house biostatistician for Solid’s clinical development programs
  • Manage outsourced biostatisticians/programmers/data managers
  • Perform trial statistician responsibilities including participation in study team meetings as needed, development of SAPs, reviewing shells and CRFs, design of early, mid and late-stage clinical trials, review of protocols/amendments, and conducting/supervising exploratory and ad hoc data analyses as appropriate
  • Apply innovative statistical approaches to study design, data analysis, and use of external data sources
  • Represent Solid/participate in collaborative external data-sharing consortia as needed
  • Help establish and maintain appropriate Solid data standards, data review/oversight practices, and related SOPs in alignment with contract research partners
  • Serve as a general clinical development and statistical resource
  • May perform additional duties and ad hoc projects as required 

Core Competencies Required:

  • Excellent oral and written communication, presentation, and teaching skills
  • Effective cross-functional collaborator
  • Leadership
  • Communication

Knowledge: Education, Experience, & Skills:

  • PhD in Biostatistics or related discipline with at least 5 years’ biopharmaceutical industry experience; MS in Biostatistics or related discipline with 8+ years’ biopharmaceutical experience may be considered
  • Experience with Bayesian methods and novel clinical trial designs preferred
  • Demonstrated expertise in biostatistics and its applications to clinical development
  • Adept in the use of current statistical software
  • Able to discuss and convey statistical concepts clearly to non-statistical colleagues
  • Innovative, open-minded, and nimble thinker
  • Able to work proactively and independently in a fast-paced, dynamic environment

Travel Commitment: 

  • Some travel may be required
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Senior Validation Engineer Open 551 - Operations Full-Time Cambridge Massachusetts USA Oct 5th, 2018 12:00AM

Summary:

You will be responsible for validation activities related to the following areas: DQ, IQ, OQ, PQ, requalification/validation life-cycle, cleaning, sterilization, and computer systems. Provides C&Q support to projects/programs. Provides Engineering support for process and utility systems, maintaining these systems in a validated state of control, ensuring uninterrupted business continuity.

Key Duties & Accountabilities:

  • Lead the C&Q project team from the design and build phase of projects to the completion of validation activities, deliver projects which meet GMP requirements and regulatory agency expectations
  • Direct activities associated with process equipment and GMP utility commissioning, qualification, and validation
  • Evaluate and manage facility, utility, equipment, and computerized system change controls, ensuring compliance with the Solid Biosciences QMS
  • Write policies and procedural SOPs as needed to define Solid Biosciences’ validation program
  • Technical lead for project protocols, execution, and reporting to ensure the appropriate level of detail and compliance is maintained throughout the C&Q lifecycle
  • Manage contract resources and contracts under the responsibility of C&Q
  • Work with Capital Project Management to generate and issue periodic progress and cost reports
  • Performs other related duties and ad hoc projects as required by position

Core Competencies Required:

  • Organization
  • Communication
  • Problem Solving/Critical Thinking
  • Judgement and Decision-making

Knowledge: Education, Experience, & Skills:

  • Bachelor of Science Degree in a Life Sciences or Engineering discipline
  • 10+ years Validation experience required
  • Minimum of 10 years’ experience in either of 1) engineering 2) validation or 3) automation in a life sciences environment
  • Knowledge of regulatory requirements as relates to C&Q for a pharmaceutical facility
  • Experience leading a team of internal and external engineering resources
  • Capital project experience, project management experience preferred with a focus on C&Q
  • Automation validation experience a plus
  • Gene therapy facility experience a plus
  • Excellent communication skills and ability to build key networks and business relationships across all levels of the business 

Travel Commitment:

  • Some travel may be required
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Associate/Senior Associate Scientist, Analytical Development Open 306 - Process Development Full-Time Cambridge Massachusetts USA Nov 20th, 2018 12:00AM

Summary:

The Associate/Senior Associate Analytical Development will be part of a Biophysical Characterization team whose focus is on characterization of proteins and adeno-associated virus-based products using an array of biophysical, MS-based, and traditional biochemistry tools to support Solid Biosciences’ ongoing program at all phases of development. The Associate/Senior Associate will be responsible for method development and qualification, performing and trouble-shooting experiments, processing and interpreting analytical data, preparing and maintaining test protocols, and data reports. Solid Biosciences’ leading candidate is an adeno-associates virus (AAV) based gene therapy product for the treatment of Duchenne Muscular Dystrophy (DMD). 

Key Duties & Accountabilities:

  • Execute experiments in support of development and qualification of biophysical characterization assays with guidance from senior scientist
  • Plan and execute experimental studies to meet project goals and timelines
  • Provide concise and quantitative analysis of data and interpretation of experimental results
  • Conduct experiments to evaluate physicochemical properties and identify any liabilities that could impact drug substance and drug product development 
  • Write up methods, qualification reports, results and share with team; present data in group and department meetings
  • Maintain records of analytical data, laboratory notebooks, execution of assays, and stability data
  • Performs other related duties and ad hoc projects as required by position

Competencies Required:

  • Excellent communication, technical, and organizational skills required
  • Must be a team player prepared to work in, and embrace a team-based culture
  • Proven troubleshooting, technical writing, problem solving, and investigational skills

Knowledge: Education, Experience, & Skills:

  • Bachelor's degree or equivalent with at least 5 years of relevant experience, or master’s degree with 2+ years’ experience
  • Experience in development and optimization of biophysical/biochemical characterization assays, such as AUC, DLS, TEM, MALS, DSC/DSF, UV-vis, fluorescence spectroscopy, HPLC, LC-MS, SDS-PAGE, CE-SDS, cIEF, etc.
  • Problem solving and troubleshooting skills, along with proficiency in data analysis, and lab documentation
  • Understanding of compliance and cGMP considerations

Travel Commitment:

  • Some travel may be required
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Senior Scientist, Downstream Process Development Open 306 - Process Development Full-Time Cambridge Massachusetts USA Nov 20th, 2018 12:00AM

Summary:

This role will support late phase downstream purification process development activities, process scale up, internal and external technology transfer, and manufacturing on floor activities. Solid is looking for downstream process development candidates with experiences in purification process development, process characterization, engineering scale up/down and technology transfer. Some experience in managing more junior members is preferred.

Key Duties & Accountabilities:

  • Development of scaleable and robust downstream processes 
  • Design experiments related to development, optimization, scale-up of all steps in a viral vector purification process, and viral clearance study; execute studies together with junior members
  • Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
  • Apply DOE and other advanced statistical techniques to design experiments related to process characterization
  • Authoring documents, including technical reports, SOPs, and experimental protocols
  • Serve as PD representative and participate in both internal and external manufacturing meetings
  • Contribute to scale up activities and draft tech transfer related documents (e.g. process descriptions and process flow diagrams)
  • Conduct facility fit exercise
  • Review batch records and provide feedback
  • Support manufacturing floor activities
  • Provide technical support (e.g. process/operational gap identification and troubleshooting) to manufacturing group
  • Support Solid’s Quality Assurance team to help evaluate deviations, CAPA, and Change Controls (both internal and external)
  • Support regulatory filings and responses to agency
  • Performs other related duties and ad hoc projects as required by position

Core Competencies Required:

  • Self-motivated, accountable, inquisitive, with excellent organizational and communication skills
  • Flexibility to switch between projects
  • Ability to lead/manage junior team members

Knowledge: Education, Experience, & Skills:

  • PhD in a scientific discipline or equivalent and 5-8 years’ experience OR Masters’ degree and 8+ years, OR BS and 10+ years related experience; may include post-doctoral experience
  • Experience in purification process development, scale-up and scale down, as well as technical transfer
  • Solid theoretical basis and hands-on experience in protein purification and analytical characterization
  • Hands-on experience with purification unit operations including filtration, different mode chromatography, TFF, UF/DF, AKTA, UNICORN, and HPLC systems  

Travel Commitment:

  • Up to 30% travel may be required at times
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Senior Associate Scientist, Immunology Open 305 - Development Full-Time Cambridge Massachusetts USA Nov 28th, 2018 12:00AM

Summary:

Solid Biosciences is looking to hire a Senior Associate Scientist, Immunology. We are seeking a highly motivated scientist with knowledge and experience in immunology to help our internal research efforts to understand the immune response to gene therapy. This person will be part of the R&D team with the goal of advancing our understanding of the immune response to introduced AAV vectors, including innate and adaptive immune activation, and how to modulate or suppress these responses in the clinical setting.  Under direction of the Senior Scientist you will carry out preclinical studies to explore immunological aspects of gene therapy that have application to clinical trial design.

Key Duties & Accountabilities:

  • Perform experiments to demonstrate proof of concept and generate mechanistic understanding of immune response to gene therapy using cellular models
  • Establish immunoassays for internal testing of humoral and cellular immune response to AAV  
  • Contribute to in-depth characterization of immune mechanism studies as directed
  • Analyze and communicate data to the project team
  • Performs other related duties and ad hoc projects as required by position

Core Competencies Required:

  • Strong problem solving, data analysis, and interpretation skills
  • Attention to experimental detail
  • Good lab safety and documentation practice
  • Strong communication and collaboration skills
  • Strong motivation and ability to work in a high-paced multidisciplinary environment

Knowledge: Education, Experience, & Skills:

  • BS with 5+ or MS with 2+ in biology and related field with 3+ years’ lab experience in immunology or cell biology
  • Experience in ELISA, ELISpot, and primary cell culture required
  • Experience in cell-based assays
  • Skilled in flow cytometry, immune subset cell, and PBMC isolation, and functional analysis of immune cells preferred
  • Knowledge in AAV vector research a strong plus

Travel Commitment: 

  • Travel may be required up to 10%
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Senior Scientist/Senior Engineer Open 306 - Process Development Full-Time Cambridge Massachusetts USA Jan 10th, 2019 12:00AM

Summary:

Solid Biosciences is seeking an experienced and highly motivated Scientist or Engineer to join the Upstream Process Development team to lead tech transfer activities for transfer of clinical and commercial scale upstream processes to internal and external partners. The position is also responsible for providing technical leadership around bioreactor scale-up and process characterization activities.

Key Duties & Accountabilities:

  • Lead and manage multiple projects as upstream tech transfer representative including fit-to-plant, process risk analysis, batch record review/approval, managing technical relationships, internal and external teams, campaign monitoring and support, performance analysis and interpretation, investigation support
  • Builds and maintains relationships with partner groups
  • Generate tech transfer documentation
  • Represent upstream process development group on cross-functional teams
  • Lead lab-scale experimentation to support process changes, generate robustness data, and/or resolve manufacturing deviations
  • Lead lab-scale experimentation to support characterization of bioreactor scale-up parameters such as mixing and gas transfer
  • Provide input on process development strategies
  • Write technical reports and deliver presentations
  • Work closely with internal/external manufacturing teams on process troubleshooting and improvement
  • Additional duties and responsibilities as required

Core Competencies Required:

  • Skilled in root cause analysis and problem-solving
  • Demonstrated critical thinking skills
  • Excellent written and verbal communication skills
  • Sound decision making with limited data and guidance
  • Demonstrated initiative and drive for results
  • Must be able to work independently
  • Experience with data and statistical analysis
  • Proven experience in preparing detailed and thorough technical protocols and reports

Knowledge: Education, Experience, & Skills:

  • Degree in process engineering or scientific discipline (e.g. chemical or biochemical engineering) with an appropriate amount of relevant industry experience (PhD 4+ years, MS 6+ years, BS 10+ years)
  • Upstream tech transfer and development experience
  • Hands on experience with bioreactors (bench and pilot/production scale)
  • Fundamental understanding of upstream unit operations
  • Demonstrated knowledge of the scale-up/scale-down principles of cell culture processes
  • Knowledge of GMP manufacturing principles and documentation
  • Experience with Microsoft Office Suite

Travel Commitment:

  • Domestic travel (up to 15%) to CMO/partner sites may be required
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Process Engineer II, Manufacturing Science & Technology Open 301 - Manufacturing Full-Time Cambridge Massachusetts USA Jan 15th, 2019 12:00AM

Summary:

This position will provide process engineering support for tech transfers of downstream operations (chromatography, Ultrafiltration/Diafiltration, and vial fill) to contract manufacturing organizations (CMOs) and for design, build, and validation phase of projects.

Key Duties & Accountabilities:

  • Support scale-up, technology transfer, and plant start-up activities. Includes onsite presence at our contract manufacturing organizations
  • Support ongoing manufacturing operations through process monitoring, trending, issue resolution, and identifying risks and opportunities for process improvement of downstream operations
  • Assist with evaluation of facility and equipment design for its ability to meet process requirements
  • Support regulatory filing updates
  • Support the development and execution of MS&T business processes and procedures such as data reviews, tech transfer protocols, and process control strategies
  • Performs other related duties and ad hoc projects as required

Core Competencies Required:

  • Work individually and as part of a team
  • Interpersonal/collaboration
  • Communication – oral and written
  • Analytical and strategic thinking
  • Ability to lead and influence others
  • Ability to adhere to strict guidelines in a regulated environment

Knowledge: Education, Experience, & Skills:

Basic Qualifications Required:

  • Bachelor’s degree in Engineering, life sciences, or equivalent with 5+ years’ experience
  • Master’s degree in Engineering, life sciences, or equivalent with 2+ years’ experience
  • PhD in Engineering, life sciences, or equivalent with 0 years’ experience

Preferred Skills:

  • Experience working in a process engineering role supporting protein purification within a biologics GMP manufacturing environment
  • In-depth understanding of equipment used in Single-Use biologics manufacturing, chromatography, and Ultrafiltration/Diafiltration
  • Strong technical ability demonstrated by experience in process design, data analysis and problem solving
  • Good knowledge of aseptic processing/techniques, and equipment validation
  • Experience supporting regulatory filings, and participation in regulatory inspections
  • Experience working with contract manufacturing organizations

Travel Commitment:

  • On average 20 to 25% travel will be required
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 2nd, 2019 12:00AM Associate Process Engineer, Upstream Manufacturing Science & Technology Open 301 - Manufacturing Full-Time Cambridge Massachusetts USA Jan 25th, 2019 12:00AM

Summary:

This position will provide engineering support in the upstream process for tech transfers to contract manufacturing organizations as well as technical support for ongoing manufacturing operations through process monitoring, troubleshooting, and process improvements.

Key Duties & Accountabilities:

  • Support scale-up, process optimization, technology transfer, and start-up activities. Includes onsite presence at our contract manufacturing organizations
  • Support the development of new processes and technologies to improve yields, product quality, and process robustness
  •  Assist with the evaluation of facility and equipment design for its ability to meet process and regulatory expectations
  • Support ongoing manufacturing operations through process monitoring, trending, issue resolution, and identifying process risks and opportunities;  Including onsite presence during key operations
  •  Supports the development and maintenance of timelines, cost estimates, and process descriptions 
  • Performs other related duties and ad hoc projects as required

Core Competencies Required:

  • Work individually and as part of a team
  • Interpersonal collaboration
  • Communication – oral and written
  • Analytical and strategic thinking
  • Data analysis – statistics a plus
  • Ability to lead and influence others
  • Ability to adhere to strict guidelines in a regulated environment

Knowledge: Education, Experience, & Skills

  • Bachelor’s degree in life sciences, engineering or equivalent with 0-2yrs experience
  • Cell culture experience preferred
  • Ability to work independently with minimal supervision as well as collaboratively as part of a team
  • Strong verbal and written communication skills
  • Experience with data analysis and statistics a plus
  • Ability to adhere to strict guidelines in a highly regulated environment

Travel Commitment:

  • On average 20 to 25% travel will be required
Jul 2nd, 2019 02:09PM Jul 2nd, 2019 02:09PM
nasdaq:sldb solidbio.bamboohr.com solidbio.bamboohr.com Jul 15th, 2019 12:00AM Manager, Upstream Manufacturing Science and Technology Open 301 - Manufacturing Full-Time Cambridge Massachusetts USA May 9th, 2018 12:00AM

Solid Biosciences is currently recruiting for a Manager, Manufacturing Science and Technology to join our Manufacturing team. In this position you will be responsible for leading a team of engineers and overseeing upstream aspects of tech transfers to contract manufacturing organizations, providing technical oversight of ongoing manufacturing operations through process monitoring, troubleshooting, and process improvements.  Solid is looking for candidates with experience providing technical support to cGMP biopharmaceutical manufacturing upstream processes and with demonstrated people management or project leadership capabilities.

Key Duties & Accountabilities:

  • Manage upstream tech transfer and startup activities to ensure project timelines and process requirements are met. Includes onsite presence at our contract manufacturing organizations
  • Support ongoing manufacturing operations through process monitoring, trending, and identifying risks and opportunities for improving yields, product quality, and process robustness. Includes onsite presence during key operations
  • Evaluate facility and equipment design for ability to meet process and regulatory expectations
  • Supports the development of Solid’s Quality systems and regulatory documentation
  • Perform other related duties and ad hoc projects as required

Core competencies required:

  • Cell culture, with viral vector manufacturing a plus
  • Work individually and as part of a team
  • Interpersonal/collaboration
  • Communication – oral and written
  • Analytical and strategic thinking
  • Data analysis – statistics a plus
  • Project management
  • Ability to lead and influence others

Knowledge: Education, Experience, & Skills:

Bachelor’s degree in life sciences, engineering, or equivalent with 8+ years of experience working in a technical role within the upstream biopharmaceutical process development, design, or cGMP manufacturing environment. Or Master’s degree with 5+ years of experience.

 Preferred Skills

  • Cell culture or viral vector manufacturing
  • Strong technical ability demonstrated by experience in process design, data analysis, and problem solving
  • Experience working with contract manufacturing organizations

Travel Commitment:

  • Up to 20% travel will be required at times

Jul 15th, 2019 04:04AM Jul 15th, 2019 04:04AM

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