nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 11th, 2020 12:00AM
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Senior Manager, Donation Collection Facility (DCF)
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Open
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CMC - Donor Operations
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Cambridge, MA
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MA
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Cambridge
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USA
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Senior Manager, Donation Collection Facility (DCF)
Department:
CMC - Donor Operations
Location:
Cambridge, MA
START YOUR APPLICATION
Senior Manager, Donation Collection Facility (DCF)
Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics.
The Senior Manager, Donation Collection Facility will work closely with the manufacturing, scientific and quality assurance teams to drive biologic material procurement in support of C. difficile patients. This is a business-critical position; the impact you have on Seres as a key contributor is tremendous. This is a fantastic opportunity for a very experienced professional with strong experiences in operational management and oversight of a novel biologics procurement program.
Whats in it for you?
Youll learn all about our microbiome research and gain an understanding of the biology of specific microbes and the composition of the microbiome in healthy and diseased individuals that allows us to identify keystone organisms and functional pathways whose absence or over-abundance may be driving a particular form of dysbiosis. Learn that our Ecobiotic® drugs are compositions of commensal microbes that are designed to catalyze the transition to a healthy ecology of the microbiome and treat serious human conditions including inflammatory, metabolic, and infectious diseases. In a nutshell, come to Seres and put your many years of experiences to great use while learning something different that is beyond exciting.
How do you know if youre the right fit?
This is an incredible opportunity for someone who will get excited about leading the charge on a unique program in support of a pioneering new therapeutic. You are someone who challenges himself/herself on meeting operational milestones with seamless execution and within established budgets and quality assurance parameters. You know what it takes to be successful managing operational sites and teams and have demonstrated full competence in continual process improvement and documentation development.
If you have worked in an organization where you managed the procurement of donor derived products, plasma, or blood products, or have experience in facility design and management, you would find this novel leadership opportunity incredibly engaging.
START YOUR APPLICATION
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Dec 10th, 2020 08:27PM
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Dec 10th, 2020 08:27PM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 11th, 2020 12:00AM
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Manager Clinical Supply
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Open
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CMC - Supply Chain
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Cambridge, MA
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MA
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Cambridge
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USA
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Manager Clinical Supply
Department:
CMC - Supply Chain
Location:
Cambridge, MA
START YOUR APPLICATION
Clinical Supply Manager
Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics. Come join our effort!
Whats in it for you?
Aside from demonstrating your prowess in clinical supply management, youll get to work cross-functionally with CMC, QA, Clinical Teams, and external vendors to forecast clinical supply needs and implement strategy for timely supply and oversight of trial materials. You will be generating, maintaining, and owning supply plans to enable proactive forecasting of trial needs to drive both internal and external production activities for supply of trials at all phases. You will oversee packaging, labeling, and distribution vendors. You will implement the strategy to ensure availability and distribution of finished goods for studies across Seres full portfolio. Implementing, testing, and overseeing Interactive Response Technology (IRT) systems to ensure seamless supply of trial materials is just one of the ways you will be able to demonstrate your attention to detail, organizational, and collaborative skills in this role. You will coach and mentor junior staff and support new-hire trainings. Youll also make your mark by helping to shape and develop the Clinical Supply processes at Seres as we continue to grow.
How do you know if youre the right fit?
First, you will be a person who can demonstrate your project management chops as well as your creative approach to problem solving. While this role requires a solid background of Clinical Supply experience, ranging from packaging to clinical distribution, we are also looking for demonstrated ability to work both independently and as part of cross-functional teams that span the Clinical Operations, CMC, Regulatory, Quality, R&D, and Finance groups. Youll be excited to show off your strong organizational and technical skills, including your ability to manage competing priorities in a fast-paced work environment. The right fit will exhibit excellent written and communication skills with a strong proficiency in Microsoft Excel.
The other stuff
This is typically a role best suited for an experienced (5+ years) clinical supply manager, but someone from a related field with clinical supply chain experience and a BS in Supply Chain, Life Sciences, Engineering, or related discipline shouldnt hesitate to apply. Successful candidates will have experience starting up clinical trials and the IRT/IxRS systems customized to help run them. Candidates should have working knowledge of GMP/GCP processes as well as experience with international labeling, shipping, and import/export of clinical supplies. Strong understanding of clinical trial management requirements from primary packaging to finished goods distribution to study sites is desirable.
START YOUR APPLICATION
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Dec 10th, 2020 08:27PM
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Dec 10th, 2020 08:27PM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 11th, 2020 12:00AM
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System Engineer, Bioinformatics & Scientific Computing
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Open
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R&D - Bioinformatics
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Cambridge, MA
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MA
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Cambridge
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USA
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System Engineer, Bioinformatics & Scientific Computing
Department:
R&D - Bioinformatics
Location:
Cambridge, MA
START YOUR APPLICATION
System Engineer, Bioinformatics & Scientific Computing
Who are we?
Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics. Our research and discovery efforts are elucidating the mechanisms that microbes employ to modulate host immunity and inflammation. The power of the Seres platform has demonstrated therapeutic potential in infectious and inflammatory disease, immune regulation, and immuno-oncology. Seres is conducting multiple clinical trials, including a Phase 3 study of SER-109 to treat multiply recurrent C. difficile infection, a Phase 2b study of SER-287 in ulcerative colitis, and a Phase 1b study in collaboration with the Parker Institute of Cancer Immuno-Therapy to evaluate how treatment with SER-401 can improve response to anti-PD-1 therapy in metastatic melanoma. Our clinical programs provide industry-leading data, driving our preclinical efforts to elucidate how commensal microbes modulate the human immune and metabolic state and guiding our preclinical pipeline of the next generation of microbial therapeutics.
What is in it for you?
The System Engineer in the Bioinformatics & Scientific Computing group will have the opportunity to aid in the maintenance and improvement of shared R&D compute infrastructure. You will work closely with a Senior Engineer to monitor, develop, deploy, and update physical and virtualized servers using DevOps tools. As part of Research and Development, your work will affect every part of drug design, from basic microbiome research to clinical data analysis. You will be part of a great team that emphasizes collaboration and learning new skills.
Your initial responsibilities will include:
Performing backup, file replication, and script management for servers
Planning, coordinating, and managing installation and maintenance activities of complex systems
Collaborating with DevOps colleagues to improve processes or resolve complex technical problems
Working with R&D colleagues directly to troubleshoot platform or connectivity issues
Analyzing networks and data centers, recommending improvements and technology upgrades
Enhance infrastructure and reconfigure software/hardware
Configuration, installation, and deployment of new infrastructure
Performing operational support tasks as required to maintain infrastructure uptime
Owning problem resolution, facilitating discussions, and providing status updates
We seek candidates with these qualifications:
Technical aptitude with an attention to details and a curious mind
BS degree in CS, Engineering, or a related technical discipline
Must be able to lift (up to 50 lbs.) and install server equipment using provided tools.
3+ years of experience supporting end-user systems including datacenter operations
Strong background in Linux Administration and data center operations with a working knowledge of scripting: Unix shell, Perl, Python, and/or Ansible
Good knowledge of storage platforms and file systems (XFS, ZFS, Spectrum Scale)
Good understanding of network protocols, experience with InfiniBand a plus
Experience with monitoring and logging tools
Experience with the Atlassian toolkit
AWS and/or containerization experience a plus
START YOUR APPLICATION
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Dec 10th, 2020 08:27PM
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Dec 10th, 2020 08:27PM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 12th, 2020 12:00AM
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Scientist, Analytical Development
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Open
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CMC - Analytical Development
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Cambridge, MA
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MA
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Cambridge
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USA
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Scientist, Analytical Development
Department:
CMC - Analytical Development
Location:
Cambridge, MA
START YOUR APPLICATION
Scientist, Analytical Development
Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics in areas as diverse as infectious and inflammatory disease, immune regulation, and immuno-oncology.
The Scientist, Analytical Development will work closely with our Analytical Development, Quality Control, and Research & Development teams in the development of microbial and molecular assays to ensure safe and effective bacterial therapeutics for the patients who need them. This is a fantastic opportunity for a creative scientist who can apply their expertise to the unique challenges faced when characterizing and releasing therapeutics comprised of communities of bacteria.
Whats in it for you?
This is an opportunity to have a significant impact on the development of a novel class of therapeutics for various disease areas while learning about the exciting science of the microbiome and its impact on human health and disease.
How do you know if youre the right fit?
This is an incredible opportunity for someone who will get excited about developing assays that are robust and capable of supporting key decisions to move our programs forward. If you are flexible and driven, have worked in a fast-paced organization, and enjoy the challenge of forging a path forward in a new field, you would find this novel opportunity very engaging.
In order to develop the sorts of assays Seres needs, you should be a PhD-level scientist, or equivalent, with significant assay development experience in the area of molecular biology and/or microbiology. You should have an excellent attitude with an infectious excitement around learning and teaching your craft. Experience with assay qualification or validation is a plus. Other desirable skills include sequencing, qPCR/dPCR, probe-based hybridization assays, LC-MS, IC, and automated liquid handlers.
START YOUR APPLICATION
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Dec 12th, 2020 04:41AM
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Dec 12th, 2020 04:41AM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 12th, 2020 12:00AM
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Associate, Manufacturing
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Open
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CMC - Manufacturing
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Cambridge, MA
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MA
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Cambridge
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USA
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Associate, Manufacturing
Department:
CMC - Manufacturing
Location:
Cambridge, MA
START YOUR APPLICATION
Job Summary
Seres Therapeutics is seeking an Associate, CMC Manufacturing to join our team who will be responsible for supporting manufacturing operations and clinical supplies across several phases of clinical trials. This individual will be involved in the execution and documentation of cGMP manufacturing processes, and operations pertaining to drug substance and drug product manufacturing. S/he will also ensure proper safety and aseptic protocols for floor operations. This individual will collaborate with multiple support groups such as Quality Control, Quality Assurance, Bioprocess and Facilities to support the transfer of process changes to manufacturing operations.
Job Responsibilities
Operation of bioprocess equipment for microbial cultures, recovery and purification
Execution of Batch Records and Author Standard Operating Procedures
Troubleshooting of manufacturing and process challenges
Management of raw materials and consumables required for manufacturing
Proactive identification and mitigation of risks
Identification of process changes and improvements
Initiation and support of deviation/quality event investigations and close-out
Required Skills and Qualifications
Bachelors degree in Life Sciences or Biotechnology Certificate with 0-1 years experience in Biotech manufacturing
Experienced with aseptic techniques
Exposure to cGMP standards for clinical and/or commercial manufacturing
Knowledge of biotech manufacturing process and equipment in some aspects of fermentation, filtration, purification, and formulation processes
Flexible with schedule and willingness to work long shifts if necessary
Ability to work in a fast-paced and constantly changing environment to meet current challenges
Works well independently and in group settings
START YOUR APPLICATION
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Dec 12th, 2020 04:41AM
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Dec 12th, 2020 04:41AM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 12th, 2020 12:00AM
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Principle Associate, Manufacturing
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Open
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CMC - Manufacturing
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Cambridge, MA
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MA
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Cambridge
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USA
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Principle Associate, Manufacturing
Department:
CMC - Manufacturing
Location:
Cambridge, MA
START YOUR APPLICATION
Job Summary
Seres Therapeutics is seeking a Principle Associate, CMC Manufacturing to join our team who will be responsible for supporting manufacturing operations and clinical supplies across several phases of clinical trials. This individual will be involved in the execution and documentation of cGMP manufacturing processes, and operations pertaining to drug substance and drug product manufacturing. S/he will also ensure proper safety and aseptic protocols for floor operations. This individual will collaborate with multiple support groups such as Quality Control, Quality Assurance, Bioprocess and Facilities to support the transfer of process changes to manufacturing operations.
Job Responsibilities
Prepare raw materials, media culture, solutions and consumables according to Standard Operating Procedures and safety regulations for manufacturing operations
Leading and or performing on floor activates
Author Standard Operating Procedures, Batch Records, Corrective and Preventative Actions and Deviations
Trouble shoot process issues and communicating to supporting teams
Participate in investigations and quality events
Ensure availability of required materials and equipment for manufacturing operations
Follow and complete daily standard operation procedures by completing reports, performing batch records, logging equipment, maintaining safety procedures and reviewing manufacturing documentation to ensure compliance
Maintain cleanliness and orderliness of manufacturing facilities
Ensure Manufacturing Suite is inspection ready at all times
Provide training to and review safety procedures with junior employees
Plan production activities within assigned area
Adjust activities and resources as needed
Perform as Subject Matter Expert or system owner for specific pieces of equipment
Model Manufacturing Core Behaviors
Collaborate with affected group or individuals to resolve or mitigate effects of an error or abnormality
Thoroughly understand the process critical path
Provide Manufacturing daily updates
Understand how to spread the knowledge/experience and utilize talent of the team members to maintain SMEs across process steps
Required Skills and Qualifications
Bachelor's degree in Science, Engineering or a related field with 5-8 years of experience in biopharma clinical manufacturing or relevant industry
Previous experience in a cGMP or clinically regulated environment
Strong organizational skills and attention to detail
Excellent communication skills and strong team player
Flexible and adaptable work schedule
START YOUR APPLICATION
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Dec 12th, 2020 04:41AM
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Dec 12th, 2020 04:41AM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 12th, 2020 12:00AM
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Senior Medical Director, Clinical Development
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Open
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Clin Dev - Clinical Operations
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Cambridge, MA
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MA
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Cambridge
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USA
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Senior Medical Director, Clinical Development
Department:
Clin Dev - Clinical Operations
Location:
Cambridge, MA
START YOUR APPLICATION
Senior Medical Director, Clinical Development
Reporting to the CMO, this Senior Medical Director will serve as the Medical Lead for Graft vs Host disorder trials. Working closely with the CMO, the Senior Medical Director will set the clinical development strategy and will work with cross-functional multidisciplinary study teams on clinical trial design and execution.
Key Responsibilities
Prepare and execute the clinical development plans, in conjunction with other relevant functional areas,
Serve as medical monitor for the assigned trials, assessing issues related to protocol conduct and subject safety.
Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
Interface with regulatory authorities as appropriate
Act as liaison between clinical development and other internal groups at Seres for assigned studies
Provide medical and development leadership for cross-functional teams, including for external innovation/business development
Represent the company to outside medical personal in the development of clinical protocols and study conduct
Represent the company to outside stakeholders
Education/Experience
MD, or DO
Minimum of 5 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs
Board certification/eligibility, another relevant specialty area, is highly desired
Clinical development and/or clinical experience in rare disease
Ability to work collaboratively in a fast-paced, team-based matrix environment
START YOUR APPLICATION
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Dec 12th, 2020 04:41AM
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Dec 12th, 2020 04:41AM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 12th, 2020 12:00AM
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Director, Regulatory Operations
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Open
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Clin Dev - Regulatory
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Cambridge, MA
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MA
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Cambridge
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USA
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Director, Regulatory Operations
Department:
Clin Dev - Regulatory
Location:
Cambridge, MA
START YOUR APPLICATION
Seres is seeking a Director of Regulatory Operations to lead the submission activities for multiple products across their diverse portfolio. The chosen candidate will have the opportunity to break new ground and be part of filing and potentially winning approval for the first microbiome therapeutic in the United States.
Director, Regulatory Operations will lead the regulatory operations function as well as cross-functional teams in the successful delivery of Regulatory submissions for all development programs and projects. This person will be accountable for ensuring health authority submissions are compiled accurately, in their entirety, within specified timelines while maintaining quality. This person will be responsible for leading the collaboration with Seres staff, as well as external vendors, regarding health authority submission logistics (content, deliverable timing, status, issue resolution, review and QC). This includes recording and tracking content and eCTD lifecycle of all applications, ensuring proper archiving of each submission, and providing eCTD/submission guidance and training to Seres staff.
Essential Responsibilities:
Leads the submission planning efforts for all development programs.
Works closely with Regulatory Affairs to effectively identify, plan for and manage timely completion of development programs regulatory milestones.
Sets priorities on upcoming submissions to health authorities and maintains status of assigned submissions. Prepares and manages the Health Authority Application Tracker as appropriate.
Manages regulatory budgets to support all phases of drug development projects.
Closely interacts with team members and authoring community to define submission logistics, scheduling and priorities.
Set and manage expectations, highlighting and resolving issues, ensuring regular communications and managing internal and external activities.
Supports Development Teams in understanding the document requirements for Health Authority submissions
Manage Management System for all regulated documents to ensure proper lifecycle management, to track and monitor development programs regulatory objectives/goals, archival and storage of regulatory submissions.
Manage and track the internal review of larger Health Authority applications to ensure accuracy/completeness prior to submission. This includes maintaining constant communication with internal team and eCTD vendor to ensure timely issue identification, resolution and implementation.
Acts as primary liaison with publishing vendor(s) for all eCTD submissions. Oversees the compilation and collaboration with the eCTD vendors for all major and routine submissions (including but not limited to NDAs, IND, MAAs, amendments, supplements, promotional material (OPDP/APLB).
Provides guidance and feedback to colleagues in terms of eCTD standards for electronic submissions (e.g., templates, style guides, hyperlinking, bookmarking, technology, Regulations, EDMS).
Aids in the proper management, retention, and version control of all applicable submission documentation.
Prepares and maintains SOPs, work instructions and checklists related to templates, electronic document management, electronic submission processes, submission document QC, and archiving.
Manages and develops a competent and technically skilled submission operations organization (both FTEs and Contract).
Experience and Qualifications:
Bachelors degree or equivalent is required
10 years of directly related experience, preferably in Regulatory Operations.
Experience with an electronic document management system and/or workflows.
Prior interaction with eCTD vendors and experience with outsourcing.
Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs, NDA/BLA/MAA).
Knowledge of eCTD content/format requirements and working knowledge of ICH and FDA guidance relevant to electronic regulatory submissions
Proficient with Microsoft Office products and Adobe Acrobat.
Experience and knowledge of eCTD and publishing tools (e.g., metadata, STF, ISIToolbox).
Experience working in a team environment.
Ability to manage people and projects.
Ability to work both independently with direction and within project teams.
Excellent verbal and written communication skills are essential.
Proactive, strong organizational skills, the ability to prioritize workload and pay close attention to detail.
Demonstrates personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments.
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
Critical Skills:
Strategic problem-solving skills.
Excellent organizational and multitasking abilities.
A team player with leadership skills.
Superior communication skills.
Scientific curiosity strongly preferred
START YOUR APPLICATION
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Dec 12th, 2020 04:41AM
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Dec 12th, 2020 04:41AM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 12th, 2020 12:00AM
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Senior Director, Commercial Regulatory Strategy
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Open
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Clin Dev - Regulatory
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Cambridge, MA
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MA
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Cambridge
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USA
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Senior Director, Commercial Regulatory Strategy
Department:
Clin Dev - Regulatory
Location:
Cambridge, MA
START YOUR APPLICATION
Seres is seeking a Senior Director, Commercial Regulatory to lead the advertising, promotional, and labelling activities for multiple products across their diverse portfolio. The chosen candidate will have the opportunity to break new ground and be part of filing and potential launch for the first microbiome therapeutic in the United States.
The person will be responsible for providing strategic guidance on the development and implementation of a creative and compliant labeling, advertising and promotion program for pre-launch and commercial microbiome portfolio. She/he will work with limited supervision to review and provide strategic advice on advertising & promotion materials, in accordance with the requirements of the US Food and Drug Administration (FDA), company policy, and business goals and objectives. He/she will also ensure effective communication and constructive working relationships with regulatory authorities and internal/external collaborators.
Responsibilities
Serves as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Boards (PRB) for the successful launch of the companys commercial programs, and on Medical Review Boards (MRB) for the compliant scientific exchange of information of investigational programs.
Acts as primary contact with FDAs Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.
Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.
Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
Participates in training of personnel on advertising and promotional materials, as required.
Provides oversight to relevant external vendors and consultants, particularly as it relates to ex-US advertising and promotional activities.
Monitors and keeps organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).
Qualifications
BA/BS Degree required.
Advanced degree preferred (MS, PhD, PharmD, or JD).
Significant years of pharmaceutical industry experience, with experience focused on the regulatory review of advertising and promotion materials for prescription drug products.
Experience with launching new products and/or new indications a must
Direct experience interacting with OPDP required.
Experience working on an accelerated approval product a plus.
Strong interpersonal and oral and written communication skills.
Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate.
Solid understanding of business goals and common marketing concepts/tools, including the internet and social media.
Experience in managing multiple global programs a plus
START YOUR APPLICATION
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Dec 12th, 2020 04:41AM
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Dec 12th, 2020 04:41AM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:mcrb
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serestherapeutics.hrmdirect.com
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serestherapeutics.hrmdirect.com
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Dec 12th, 2020 12:00AM
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Senior Director, Regulatory Strategy
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Open
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Clin Dev - Regulatory
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Cambridge, MA
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MA
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Cambridge
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USA
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Senior Director, Regulatory Strategy
Department:
Clin Dev - Regulatory
Location:
Cambridge, MA
START YOUR APPLICATION
Seres is seeking a Regulatory Strategy Leader for multiple products across their diverse portfolio. The chosen candidate will have the opportunity to break new ground and be part of filing and potentially winning approval for the first microbiome therapeutic in the United States as well as other markets.
The Sr Director Regulatory Strategy will have a key role contributing to build a successful clinical regulatory strategy function at Seres and will lead key interactions between Seres and the FDA. The role includes participation in defining and implementing the strategy from first-in-human trial until marketing authorization and subsequent adjustments.
The Sr Director Regulatory Strategy will be responsible for ensuring alignment on regulatory strategy, activities, and timelines between project, product, and program teams. A successful Senior Director of Regulatory Affairs will build effective partnerships with counterparts across the R&D organization, as well as external partners.
Responsibilities:
The areas of responsibilities will include
Participate in the redefinition of the regulatory strategy for the company.
Provide regulatory support in preparation of documents such as Investigator Brochure, clinical study protocols, and Informed Consent.
Provide regulatory advice to all stakeholders in support of the development of clinical study reports.
Plan and supervise preparation and filing of regulatory submissions for assigned products/programs from IND to NDA/BLA as well as Fast Track, Breakthrough, RMAT, and ODD to US agencies and institutions.
Plan, supervise, and represent Seres at regulatory agency meetings.
Interpret and explain regulatory agency communications to stakeholders across Seres program/project teams to ensure accurate functional area responses to agency requests and comments.
Represent Seres on co-development teams and liaison with co-development partners on regulatory planning and strategy.
Participate in building the Regulatory Affairs team.
Stay current on changing regulatory environment, advise Seres on new and changing regulations that may impact ongoing development programs, and work with QA to implement new or changed operating procedures for ongoing programs.
Requirements:
Industry Experience:
Significant experience in regulatory affairs within the biotech or pharmaceutical industry, including direct experience interacting with the FDA; experience with CBER preferred. Experience with foreign regulatory agencies a plus.
Experience with US regulatory submissions, Orphan Drug Designation, Rolling BLA, Fast Track and Breakthrough therapy designations in the US as well as foreign agency equivalents considered a plus.
Experience planning and managing complex regulatory submissions.
Regulatory or scientific experience across a variety of disease areas considered a plus.
Experience collaboratively developing Target Product Profiles is required.
Experience developing and implementing a Clinical Development Plan is required.
Experience working with external medical/scientific experts to support development planning and strategy.
Critical Skills:
Strategic problem-solving skills.
Excellent organizational and multitasking abilities.
A team player with leadership skills.
Superior communication skills.
Scientific curiosity strongly preferred
START YOUR APPLICATION
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Dec 12th, 2020 04:41AM
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Dec 12th, 2020 04:41AM
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Seres Therapeutics
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Health Care
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Pharmaceuticals & Biotechnology
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