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Track Vertex Pharmaceuticals hiring and firing trends, filtered by title, location, type, date, category and date of posting.

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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:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Director Open Oct 31st, 2018 12:00AM 25119, Intl Access & Reimbursement , Director, International Market Access, Overview:
This position will work closely with country access teams, commercial/medical teams, regional leadership, Government Affairs, finance, global marketing, HEOV, clinical development, etc. to support the implementation of global market access strategies during global product launches and label expansions. 

Key Responsibilities include but are not limited to:
Lead market access project planning and management, coordinate global initiatives/deliverables (clinical trials, observational studies, regulatory timelines, pricing strategies, value dossier generation, etc.) with regional and country-level activities (dossier development, submission dates, payer interactions, etc.) , accounting for launch sequencing and other global considerations.
· Develop global reimbursement support materials (global value story, reimbursement negotiation guide, payer objection handler, etc.).
· Lead reimbursement negotiation training workshops to prepare local access colleagues for launch activities.
· Collaborate directly with country access/commercial/medical colleagues to support activities to attain reimbursement at a price consistent with the global policy.
· Collaborate with country access colleagues to establish innovative reimbursement agreements.
· Collaborate with country access colleagues and other stakeholders (regional leadership, global marketing, corporate leaders) through product lifecycle, addressing various pricing/access challenges.  Establish the Vertex process for managing access challenges in a collaborative manner.
 
#LI-DP1, Full-Time , 4372, No, 1, Director, 31-Oct-2018, London, UK , 2200183, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Vice President Open Nov 12th, 2018 12:00AM 25119, BD - External Innovation & Outreach , Vice President, External Innovation, Vertex is targeting some of the world's most devastating diseases in new and unconventional ways. Our work takes cutting-edge science, but also the right people. We take great pride in the culture we've fostered and people we've attracted to work with us. We are looking for passionate, innovative, fearless, and collaborative people to join our team.

Our business development activities are focused on complementing our internal research and development capabilities with external innovation that may help further our mission to bring new medicines to people with serious diseases.  We seek to collaborate with cutting-edge academic institutions, scientific leaders, companies and organizations to collaborate on both development-stage programs and to new drug discovery, and development technologies that could complement our own internal capabilities.  Furthermore, as a company of only 2,000 employees, many of our senior-level executives are engaged throughout all stages of the process to ensure early support and rapid decision-making.  As a result, we can execute transactions quickly and with the full commitment of the organization.

Our business development process usually begins with a technical evaluation of an opportunity by our External Innovation group and a cross-functional team of scientists and physicians with strong knowledge of specific diseases. The technical assessment is followed by thorough management discussions and in-depth due diligence to gain a better understanding of the opportunity.

Vertex Pharmaceuticals has an exciting opportunity for someone to lead Search and Evaluation of potential strategic in-sourcing opportunities. Reporting to the SVP of Corporate Strategy and Business Development, you will generate deal flow through the identification and initial business fit and scientific evaluation of potential strategic opportunities for Vertex to in-source, including complementary assets and new technologies. Sourcing of new opportunities will involve a broad Vertex outreach that will include the Venture Capital community, early stage biotech companies, opportunistically larger pharma and biotech companies, and scientific and partnering conferences, among other sources.

Key Responsibilities:
  • Lead therapeutic area and/or technology focused sourcing projects aimed at identifying in-licensing and/or acquisition opportunities.
  • Be Vertex’s initial interface with VCs, their portfolio companies and other early stage companies. Similarly interface with large pharma and biotech (in close coordination with the Business Development Execution team), where relevant, to monitor the availability of potential opportunities for Vertex to insource.
  • Create a presence at key scientific and partnering conferences and in coordination with the Business Development Execution team, develop a “Vertex Partnering” message and collateral to increase profile of the Company and its in-sourcing goals, at such meetings.
  • Conduct initial high level business fit and scientific evaluation of potential opportunities to determine if they are worthy of further, detailed functional evaluation.   If yes, work in a highly coordinated fashion with Business Development Execution team to transition opportunity in a manner that will appear seamless to the potential partners. Ensure that the transition to the Business Development Execution team includes a thorough transfer of all early findings/learnings/considerations (relating to scientific, business and personality aspects, as applicable).
, Full-Time , 4739, No, 1, Vice President, 12-Nov-2018, Boston, MA , 2259177, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Therapeutic Specialist Open Nov 23rd, 2018 12:00AM 25119, Commercial International (SCAND) , Key Account Manager, Commercial International,

We are currently looking for a Key Account Manager (KAM) for our Swedish market. This is an incredibly exciting opportunity to be a part of the launch effort of innovative breakthrough treatments for Cystic Fibrosis (CF).

As part of the Commercial International team you will be responsible for ensuring that all barriers to usage of our rare disease medicines are addressed and that all patients who could benefit from the products have access to them. This goal will be achieved by the development and execution of specific account level business plans at all CF centres; communicating disease and product knowledge to healthcare professional customers and ensuring that the full long-term value of the products are fully understood by all relevant stakeholders.

You will be a best-in-class individual capable to thrive in a fast-paced, highly collaborative environment, work towards results, understand market dynamics, demonstrate excellent judgment, and be motivated by the desire to improve patients' lives. You will have the ability to see the world through the eyes of the varied customers and stakeholders with which this role will interact will be a necessary and differentiating quality.
 

Key responsibilities:

  • Provide relevant disease state information
  • Promote safe and effective use of our portfolio of CF drugs, in accordance with the product labels to ensure that the benefits and long-term value of the products are fully understood
  • Interact with wide variety of key stakeholders in Sweden and Finland
  • Responsible for individual performance at the country level and contribute to the regional team’s performance
  • Ensure appropriate resource allocation to meet customer needs and address gaps in the care system
  • Stay current on the CF environment; maintain in-depth knowledge of disease, local drivers, treatment and referral patterns, key account profiles, influence patterns, reimbursement, and barriers to optimal care
  • Responsible for developing and executing account level business plans that are insight driven and will move the business forward, including promotional activities for customers; forecasting and tracking promotional budget
  • Work collaboratively across functional areas to achieve common goals
  • Facilitate the coordination of internal and external resources to enhance patient care and ensure delivery of account plan targets
  • Embody Vertex's core values and leadership behaviours
  • Participate in meetings, and take on projects, as requested by management
  • Exercises good judgment and adheres to relevant regulatory and compliance guidelines and company policies

, Full-Time , 4372, No, 1, Therapeutic Specialist, 23-Nov-2018, Sweden - Field , 2311167, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Associate Medical Director Open Nov 26th, 2018 12:00AM 25119, Global Patient Safety , Medical Director, Safety and Benefit-Risk Management, The Medical Director, Safety and Benefit-Risk Management will provide medical safety expertise for assigned products, pre- and post-approval.
 
KEY RESPONSIBILITIES:
 
  • Broad knowledge of medicine, pharmacovigilance and relevant regulations
  • Extensive evidence of effective delivery of high quality safety relevant documents.
  • Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information
  • Effectively communicates in written and spoken English
  • Communicates complex issues in an understandable, effective and relevant manner.
  • Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition
  • Strategic focus regarding activities, with proactive planning and prioritization skills.
  • Effective leader and team member
  • Takes ownership of appropriate issues and appropriately delegates
  • Technical expertise in pharmacovigilance and clinical safety
  • Excellent analytical and problem solving skills, with sound autonomy and applied judgment
  • Provide effective and relevant review of complex documents
 
KEY RESPONSIBILITIES
 
  • Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for  assigned products (marketed or in development)
  • Optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle
  • Responsible for the safety assessment activities of assigned products under the supervision of a GPS Disease-area Safety Head
  • Autonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
  • Lead the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
  • Lead the development of safety-related responses to Safety queries from health authorities
  • Identify, prioritize and analyze clinical safety signals, in accordance with GPS procedures
  • Perform ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
  • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues
  • Conduct medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed
  • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
  • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports
  • Effectively contribute to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
  • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter
  • Participate in departmental development activities including SOP and Work Instructions development
  • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
  • Provide a contributory role in Partner/Affiliate agreements and interactions, as needed
  • Other activities, as needed or as requested by GPS management
#LI-SO1
 , Full-Time , 4739, No, 1, Associate Medical Director, 26-Nov-2018, Boston, MA , 2314870, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Director Open Jan 3rd, 2019 12:00AM 25119, Clinical, Quality and Mfg Systems , IT Director, Medical Affairs, Vertex is currently looking to expand its Medical Affairs Systems team within the IT department to support a growing number of exciting new projects. The department is responsible for accelerating the drug development process through technology. The goal is to enable innovation in Clinical Development and Medical Affairs while efficiently getting medicine to our patients. Be ready for something different….Careers in IT at Vertex offer employees broad and deep exposure to the business areas they support. You will be working closely with a team of passionate and dedicated leaders within Development. When you join our IT department, you will see that our culture is fast-paced, collaborative and we are “fearless” in striving to do what has never been done before. Employees can expect to be challenged, gain exposure to cutting-edge technologies, and feel valued by the Vertex community. Be fearless, be innovative, be passionate…. join us and help build something different and redefine what IT can be for Vertex and our patients!
The Medical Affairs IT Director will be a leader within GIS (Global Information Services). You will ensure the definition and delivery of solutions in support of GIS’ business customers in Global Medical Affairs, which relies on a cadre of commercial-off-the-shelf (COTS) and internally developed systems. You will work with leadership in the business organization to develop strategies for supporting their evolving needs. You will be strategic partner to our global medical affairs organization. You will collaboratively define a pragmatic technology strategy satisfying both the immediate and longer-term needs of our growing global medical affairs team. Adept of lean practices you will effectively manage a distributed team of in-house technologists and managed services providers. Your focus will be the success of the global medical affairs team in achieving its mission.
As team member of the Drug Development IT leadership team, you will provide your perspective on key industry issues and technology trends participating in the management of the group.

Responsibilities
 
  • Lead and grow relationships at all level of the medical affairs organization and act as a strategic partner to the global medical affairs leadership team
  • Own, define and evolve the global medical affairs strategic technology roadmap
  • Manage team of GIS technologists and business analysts supporting the global medical affairs team. Accountable for budget definition and management in collaboration with other members of the drug development IT leadership team
  • Lead and drive project teams in solution delivery: from solution definition to final delivery and acceptance. keeping the project within budget, status reporting, and delivering solutions to client expectations.
  • Lead the transition of newly delivered solutions into long term production operations via managed services. Work with Vertex managed service providers to take over day-to-day maintenance and support activities. Ensure optimal ongoing service performance of the solution through oversight and direction of managed services staff.
  • Integrate global medical affairs technology strategy with the overall IT strategy.
#LI-RS1
 , Full-Time , 4739, No, 1, Director, 03-Jan-2019, Boston, MA , 2318302, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Director Open Jan 8th, 2019 12:00AM 25119, Australia Region Market Access , Associate Director/Director Market Access Australia,

Do you want to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society?

We are looking for a dynamic, business focused and creative individual to be responsible for the execution of Vertex’s Market Access strategies and key tactics in Australia to support access to Vertex’s Cystic Fibrosis (CF) products.

Reporting to the Country Manager, you will develop and coordinate the market access strategies and relationships with market access consultants to promote rapid uptake access to Vertex products in Australia.


Key responsibilities:


The Market Access Associate Director/Director will develop market access materials (submissions, responses) for Vertex medicines leading up to and during their Australian launch with a particular emphasis on leading the adaptation of global economic models to meet Australia-specific health technology assessment (HTA) requirements and presenting these models to PBAC and Department of Health Pharmaceutical Benefits Division authorities.

This role will report to the Country Manager, Australia, and will work closely with MAV colleagues to support best-in-class reimbursement negotiations and market access excellence. It will collaborate extensively with country-based colleagues to support their reimbursement negotiation processes.

  • Collaborate with Australian colleagues and external consultants to prepare reimbursement submissions, develop Australia-specific economic models and present economic evidence to PBAC and Pharmaceutical Benefits Division staff.
  • Adapt and implement the global value story, reimbursement negotiation guide, payer objection handler, and other evidence-based materials that demonstrate product value in a manner that is meaningful to PBAC.
  • Support the development of local reimbursement negotiation strategies through continued collaboration with Australian and international-based colleagues.
  • Make specific recommendations on clinical trial designs and provide input on the design of HEOR projects (i.e. patient-reported outcomes, observational studies and economic models) to optimize their role in supporting market access strategies.
  • Work closely with Vertex’s medical affairs, legal, regulatory, market access and commercial teams, building and leveraging relationships with relevant stakeholders in line with Vertex’s approved and agreed business strategy
  • Travel and spend time in the International HQ office in London as well as travel to customer meetings as required
  • Exhibit ownership and accountability for all projects and internal assignments
  • Provide market place feedback in a timely manner to corporate management, on customer business trends, competitive updates and industry issues and opportunities.
  • Exemplify Vertex’s core values in fulfilling these job duties

, Full-Time , 4372, No, 1, Director, 08-Jan-2019, Sydney, Australia , 2310055, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Sr. Medical Director Open Jan 10th, 2019 12:00AM 25119, Global Patient Safety , Sr Medical Director- Safety and Benefit-Risk Management,
Senior Medical Director, Safety and Benefit-Risk Management
 
GENERAL POSITION SUMMARY
Senior Medical Director, Safety and Benefit-Risk Management will provide strategic and clinical leadership for all safety-related activities for investigational and/or marketed products, including the continuous assessment of their safety and benefit-risk profile.
 
GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
 
  • Broad knowledge of medicine, pharmacovigilance and relevant regulations
  • Extensive evidence of effective delivery of high quality safety relevant documents, including IB, ICFs, Protocols, CSRs, DSURs, PSUR/PBRERs, Signal Evaluation Reports, Briefing documents
  • Broad knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics, including the interpretation of complex data and information
  • Effectively communicates in written and spoken English
  • Communicates complex issues in an understandable, effective and relevant manner.
  • Strong influencing skills with the ability to explain and defend positions regarding significant issues in the face of opposition
  • Strategic focus regarding activities, with proactive planning and prioritization skills.
  • Effective leader and team member
  • Takes ownership of appropriate issues and appropriately delegates
  • Technical expertise in pharmacovigilance and clinical safety
  • Excellent analytical and problem solving skills, with sound autonomy and applied judgment
  • Provide effective and relevant review of complex documents
 
KEY RESPONSIBILITIES
 
  • Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for  assigned products (marketed and/or in development)
  • Optimizes patient safety of Vertex products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of Safety activities through the product life cycle
  • Responsible for the safety assessment activities of assigned products
  • Autonomously monitors the benefit risk profile of assigned products/portfolio in an ongoing fashion and in accordance GPS processes and procedures
  • Lead the safety and risk management processes including chairing assigned Disease-area Safety and Product Safety Teams
  • Lead the development of safety-related responses to Safety queries from health authorities
  • Identify, prioritize and analyze clinical safety signals, in accordance with GPS procedures
  • Perform ongoing review of emerging safety data from various sources including single case reports, published literature, aggregate reports, and other sources
  • Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues
  • Conduct medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed
  • Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans
  • Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports
  • Effectively contribute to preparation and review of periodic reports (DSUR, PSUR, PADER) contributing medical strategy and expertise to content, authoring applicable analysis and content
  • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter
  • Participate in departmental development activities including SOP and Work Instructions development
  • Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
  • Provide a contributory role in Partner/Affiliate agreements and interactions, as needed
  • Other activities, as needed or as requested by GPS management
, Full-Time , 4739, No, 1, Sr. Medical Director, 10-Jan-2019, Boston, MA , 2323527, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Research Scientist I Open Jan 22nd, 2019 12:00AM 25119, Modeling & Informatics , Research Scientist, High Throughput Experimentation - Reaction Informatics, We are seeking a creative scientist to join the Global Computational Chemistry group at Vertex and contribute to chemical reaction informatics.  The successful candidate will address data analysis, visualization and decision support needs for high throughput reaction screening and synthesis planning. We are looking for a candidate with a strong background in chemistry & cheminformatics, and experience working with large reaction datasets.
 
This position resides between medicinal and process chemistry and plays a key role in our continuing efforts to find novel, innovative treatments for serious human diseases.
 
The ideal candidate will be responsible for the visualization of high throughput reaction screening experiments for rapid analysis and will work with chemists in the design of these experiments. In addition the candidate will work with Scientific Computing to contribute to the design of software tools to access, search, visualize and analyze datasets from such experiments. A key goal of this effort is to use reaction screening datasets to implement (or develop) methods that will enable the identification of optimal conditions/reagents for reactions and also enable prospective recommendation of reaction conditions and reagents, using modern machine learning approaches.
 
In addition to high throughput reaction screens, the candidate will play a significant role in evaluating and applying synthesis planning tools. Given the active research on synthesis planning, the candidate will be responsible for investigating and benchmarking published approaches and commercial tools in this domain. Where relevant the candidate will perform research to develop novel methods to enhance our current capabilities.
 
These activities will be performed in collaboration with chemists in process and medicinal chemistry and automation engineers to enable effective discovery, development and optimization of reactions across projects. Strong collaboration and communication skills are therefore essential.

#LI-BS1, Full-Time , 4739, No, 1, Research Scientist I, 22-Jan-2019, Boston, MA , 2351740, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Fellow II Open Jan 29th, 2019 12:00AM 25119, Drug Metabolism & Pharmacokinetics (BOS) , Director Drug Metabolism and Pharmacokinetics,

We are seeking an exceptional scientist and leader to join our Drug Metabolism and Pharmacokinetics (DMPK) team in Boston. As a Director/Fellow, you will develop scientific strategies, lead and mentor a team, and build partnerships cross-functionally to advance Vertex's programs. You will be part of the global and local DMPK site leadership teams and help advance discovery and development of groundbreaking therapies for serious unmet medical needs.

Key Responsibilities:

  • Develop and execute scientific strategies to address ADME challenges on discovery and development programs
  • Build and maintain strong collaborative partnerships with Medicinal Chemistry, Biology, Preclinical Safety, Clinical Pharmacology, CMC and other R&D disciplines to advance Vertex programs through discovery and development
  • Represent DMPK function on drug discovery and development teams and at Vertex R & D governance bodies
  • Implement creative DMPK technologies and approaches to enhance scientific impact and/or efficiencies
  • Provides scientific and/or managerial leadership to their team in prioritizing and executing on key deliverables and project needs
  • Ensure completion of necessary DMPK regulatory documentation and reports to support drug development including Investigator Brochures, INDs (or equivalent), and marketing applications
  • Hire, develop, mentor, manage and retain key talent to maintain a high-performing team
  • Develop internal and external sourcing strategies and liaise across sites to best meet portfolio needs
  • Contribute to developing Global DMPK resource allocation, staffing needs, expenses, and capital budget and implementation plans
  • Participate in assessment of business development opportunities
 #LI-BS1
 , Full-Time , 4739, No, 1, Fellow II, 29-Jan-2019, Boston, MA , 2352547, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology
nasdaq:vrtx www.vrtx.com www.vrtx.com Jun 29th, 2019 12:00AM Scientist II Open Jan 30th, 2019 12:00AM 25119, Formulation , Scientist Formulation Development,

Vertex is seeking a highly motivated and talented scientist to join our dynamic and high energy Formulation Development group in Boston, MA. As a member of our dedicated team you will be responsible for advancing parenteral formulations for small molecules from exploratory development through commercial line extension in a Quality by Design (QbD) environment. You will explore alternative approaches, develop strategies supporting regulatory submissions, and ensure optimization of processes.

Your Skills and Experience:

  • Hands-on experience developing various parenteral formulations and manufacturing processes, which include but not limited to IV solutions or suspensions for small molecules with poor aqueous solubility
  • Experience with technology transfer for a drug product manufacturing process to a 3rd party CMO, which might encompass development and scale up activities with subsequent GMP manufacture
  • Consistent track record of applying fundamental scientific and engineering principles to formulation design, development, and process understanding
  • Drive development activities working in a cross-functional environment
  • Application of statistical analyses

Key Responsibilities:

  • Explore different approaches to formulate a small molecule (e.g. cosolvent, in situ salt formation, nanoformulation) to enhance solubility and promote physicochemical stability of drug product. In addition, for the drug product fill-finish, activities might include understanding impacts of buffer type/ concentration, pH, and container closure on stability of the drug product.
  • Build a strategy for formulation and process development starting from preclinical through all clinical stages in support of corresponding regulatory submissions.
  • Deliver and oversee the optimization of formulation and process understanding through rational experimental design, thoughtful execution and clear data interpretation, with a heavily emphasis on statistical analysis.
  • Collaborate within CMC teams and actively contribute to deliverables and engage in team discussion on issue resolution. Serve as CMC project lead as needed.
  • Execute and oversee technical transfers, scale up and clinical manufacture at external drug-product GMP facilities.
  • Draft and review presentations related to formulation development activities and present to various management levels.
  • Author and review technical reports, regulatory filings, source documents, patents and external publications.
  • Accountable for troubleshooting and resolving high complexity formulation challenges.
#LI-BS1
 , Full-Time , 4739, No, 1, Scientist II, 30-Jan-2019, Boston, MA , 2356315, 5134
Jun 29th, 2019 04:39PM Jun 29th, 2019 04:39PM Health Care Pharmaceuticals & Biotechnology

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