Location: Boston, MA
Company: Takeda Pharmaceutical
About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Senior Director, GRA medicals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence changing regulations and guidance documents; interface with outside regulatory agencies and trade
associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy. How you will contribute: Leads the Early Development medicals GRA CMC TAK-279 regulatory team in the development and implementation of global CMC regulatory strategies during development , commercialization and post approval LCM stages Combines knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time.
Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective
and proactive implementation. Globally influences and is generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry.
Responsible for demonstrating Takeda leadership behaviors. - Serve as a member of the GRA-CMC - medicals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions. - Provides leadership of GRA CMC medicals - TAK-279 franchise, and in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them. Inconjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.
Builds and manages relationships through active partnering with key internal (GRA, GRA CMC, medical Sciences, GMS, GQ etc. ) and external stakeholders (Health authorities, Industry counterparts/associtions, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics. Ensures team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.
Build and maintain communication strategy and platform for all staff across the organization. - - Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities. Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice. Represents, as required, the regulatory function in the evaluation of new product opportunities internally and externally. Leads or plays a key role on the relevant internal Takeda governance committees. Technical/Functional (Line) Expertise Comprehensive understanding of the medical industry with significant experience in regulatory filings across various stages of development.
Ability to simplify and streamlineclinical, commercialization and LCM submissions and increase the efficiency of the team through standardization and creation of templates, Expert knowledge of API and product development, registration and maintenance regulations with experience in championing innovation in technical areas. Experience in operating in a multi-disciplinary drug development environment, including working within and managing across an international exposure. Demonstrated track record of successful interactions with FDA, EMA, and other global health authorities to enable informed decision making that are targeted to provide the skeleton from commercialization stage submissions Understanding of scientific principles and regulatory requirements relevant to global drug development and regulatory submissions Knowledge and understanding of relevant emerging regulations and related processes Knowledge of diverse therapeutic areas and recent innovative treatments Leadership Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view.
Sound judgment and independent initiative. Ensures that every employee knows what is expected of their role and what it takes to be successful. - Helps employees grow through challenging assignments so they may realize their full potential. Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Executive leadership presence and confidence Decision-making and Autonomy Ability to collaborate with and achieve results through others; builds strong and sustainable relationships and interact within all levels of the organization A member of Global CMC RA medicals Leadership team and an extended/ad-hoc member of the GRA CMC leadership team and related councils across the enterprise Ad-hoc participation in senior leadership teams as needed Responsible for internal processes and systems to support external representation are implemented and effectively working.
Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.
Effectively represent Takeda in high-level negotiations with the ability to resolve conflict in a constructive manner Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to GMS, GQ, medical sciences, clinical pharmacology and the therapeutic areas. Innovation A solid grasp of industry, scientific, and regulatory trends to leverage innovations to make Takeda a model for the industry Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines Minimum Requirements/Qualifications: Advanced Degree or Ph D in Life Sciences, shop or Medicines, or related discipline.
Languages: Fluent in English (oral and written); additional languages desirable - - - Minimum of 15 years of experience within regulatory agencies or the medical Industry including significant leadership experience in Regulatory Sciences Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e. g. US FDA, EU, PMDA, NMPA, WHO). Actively engaged in major industry associations (e.
g. CPC, EFPIA, BIO, Ph RMA, CASSS, PDA, ISPE, DIA) and joint regulator/industry initiatives (e. g. ICH). Strong communication, collaboration, negotiation, problem solving and interpersonal skills. - Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients. High organization awareness (e. g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty medicals and best in class patient support programs.
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as " hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Base Salary Range: $194,600 to $278,000 based on candidate professional experience level.
Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations Boston, MAWorker Type Employee Worker Sub-Type Regular Time Type Full time
Boston, Massachusetts, this law firm focuses on biotechnology, chemistry, and medicine to deal with complex issues of intellectual property. The firm also focuses particularly on technology licensing, patent prosecution, corporate and investment diligence, patent portfolio management, and freedom-to-operate analysis.
This firm has represented different types of clients including medical centers, universities, and all sizes of corporations. This firm represents clients in technological innovation and scientific discovery. Additional Skills: The candidate should possess excellent analytical and communications skills; must think, write, and speak clearly.
The optimal project outcome will see the new assay(s) implemented in Selux's second-generation AST platform in addition to publications. The successful candidate will work closely with Selux's senior scientists and engineers, have direct access to Selux's esteemed scientific and clinical advisors, and build industry and academic partnerships necessary to make the project successful.
We are looking for a candidate with experience working with bacteria and assay development, including use of time-resolved Forster resonance energy transfer (TR-FRET), fluorescence polarization/anisotropy. Selux Diagnostics' platforms will enable clinicians to administer personalized therapies to Infectious
Diseases patients within hours rather than days. These advances promise to improve patient care, shorten hospital stays, and combat the growing antibiotic resistance epidemic.
Selux's NGP AST platform offers uncompromised accuracy and an unprecedented speed to results and breadth of menu. The company's Grow-on-the-Go Blood Culture system completes the microbiology laboratory transformation by slashing the time to culture positivity for all samples and incubation during sample transport for integrated health networks. The 35-person company is funded with a combination of Federal and private investment and will begin FDA trials on its initial NGP AST product in this quarter (Q1-2020). The
ideal candidate will have/be: A Ph D in Microbiology, Biochemistry, Molecular Biology, Biomedical Engineering or a related field Experience performing phenotypic assays on bacteria Experience working with a variety of bacterial species Experience developing no-wash assays Experience performing TR-FRET and/or fluorescence polarization A desire to learn industrial R&D and see his/her work come to fruition in a product A desire to continue publishing An independent thinker and problem-solver, who is an enthusiastic and collaborative professional Excellent written and oral communication skills and proven ability to work well in a team environment Passion about an early-stage start-up that aims to change industry and how healthcare is delivered!
recblid 30k3bj2puip0ojss7rrj9os3kdftk0 Ph. D.
massively parallel computation. We're seeking a motivated Associate Computational Biologist with an interest in synthetic biology to join our interdisciplinary team and contribute to the development of CATALOG's DNA-based data storage and computation platform.
In this role, you will: Build custom software tools to backss DNA sequencing metrics Assist research and development activities for developing bioinformatics pipelines Support the translation of new technology from bench protocol to a fully automated solution at scale with cloud-based software tools Collaborate with hardware and software teams to implement new software tools to backss the end-to-end platform performance Analyze
NGS data, present findings, and make recommendations to internal and external stakeholders Continuously backss current literature for innovation opportunities We are looking for someone with experience in the following areas: Programming with Python and C/C++, in a Linux environment, and with relevant tools Understanding of molecular biology with an emphasis on nucleic acid chemistry Experience with and understanding of NGS platforms and software tools Experience interfacing with computation platforms via the Unix CLI in both commercial (Azure, GCP, AWS) and academic settings Experience with long-read, solid-state, and/or protein sequencing is preferred Familiarity with lab automation, though
not required, is a plus We are looking for someone driven by: The excitement of building novel tools and technologies at the intersection of synthetic biology and engineering The opportunity to contribute to a supportive and collegial team with a growth mindset The challenge of teaching and learning from colleagues of diverse academic/industry backgrounds The prospect of wearing many hats as we pioneer the future of DNA-based data storage and computation You will also need to be able to: Thrive in a fast-paced environment Exhibit creativity and proactivity in problem-solving Collaborate effectively in small, cross-disciplinary teams Be a dependable team player with strong verbal and written communication skills Plan and execute tasks independently We are looking for someone with: A B.
S. or M. S. in computational biology, molecular biology, biomedical engineering, or a related discipline, coupled with ideally with 1+ years of industry experience, showcasing a strong academic and practical background Breadth of experience in and ability to design and build DNA sequence analysis software tools from conceptualization to implementation At CATALOG, we empower you to think critically, work creatively, and conquer uncharted problems in a groundbreaking field.
We prioritize building an inclusive team that embraces diverse viewpoints, supports workforce diversity, and offers competitive compensation packages, including medical, dental, and vision insurance, 401(k) with company matching. Please note, visa sponsorship is not available for this positio Powered by Jazz HR
including 105A CMR 725 and 935 CMR 500. The Retail Associate position is designed to provide the people that we serve with a consultative buying experience to consistently provide a transformative guest experience by making every effort to partner with each guest to find the best available.
Responsibilities: Assist qualifying patients and caregivers and adult use guests in obtaining their cannabis/cannabis infused or medicated products Participate actively in ongoing training in customer service delivery Assist with dispensary opening and closing, to include the protection of dispensary assets by following Temescal Wellness operational policies and procedures Compliance with program regulations
as they relate to retail operations and to the dispensing of medicated products, including the use of seed to sale software Maintenance of a well-stocked and beautifully merchandised dispensary Uphold all standards pertaining to dispensary cleanliness and Serv-Safe for infused product handling Consistently provide a transformative guest experience by making every effort to partner with the guest to find the best available product for their stated need Maintain store security, including building security and the security of all company assets to include the handling of cash and other financial instruments All other duties assigned by management This job posting is intended to describe the general
requirements for the performance of this role.
It is not a complete statement of duties, responsibilities or requirements. The role of the PSA will expand and evolve based upon the needs of the organization and the demands of our guests. Requirements: Authentic passion to serve the qualifying patients and caregivers of the state of Massachusetts, as well as adult use guests Affinity for handling multiple demands simultaneously and proficiency with time management Ability to learn and to use seed to sale POS software in compliance with program regulations Strong attention to detail High-energy, enthusiasm and positivity, a general can-do spirit Exemplary customer service skills as observed by supervisors and as validated by guest and patient feedback Ability to actively listen to guests and to assist in guiding their product choices.
Thorough knowledge of all program guidelines and relevant Temescal Wellness policies and procedures Strong verbal and written communication skills Ability to visually examine products for quality and signage/labeling accuracy Exhibit a " can-do" attitude and a willingness to take on new responsibilities and tasks as they become necessary Ability to assure compliance by demonstrating attention to detail and the aptitude to process and internalize a large volume of information, most specifically around state regulations Relentless pursuit of accuracy and of achieving efficiency through technology and scalable processes Bilingual in English/Spanish or English/Portuguese is a plus Essential Job Functions: Ability to stand and walk for extended periods of time Bend and stoop to grasp objects, bend and twist neck and waist, reach above and below shoulders and squat Bend and lift loads, not to exceed 50 pounds Repetitive use of hands for grasping, pushing, pulling and fine manipulation Compensation and Benefits: Starting wage: $17.00 - $18.00 per hour Employer pays approximately 70% of medical, dental and vision insurance, including for family members Generous time off policy Mission-driven organization with an excellent work-life balance This position is not eligible for visa sponsorship.
Temescal Wellness is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer. We are committed to fair hiring practices and to creating a welcoming environment for all team members. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, interactionual orientation, national origin, genetics, disability, age, or veteran status.
No Agents
Boston, Massachusetts, this law firm focuses on biotechnology, chemistry, and medicine to deal with complex issues of intellectual property. The firm also focuses particularly on technology licensing, patent prosecution, corporate and investment diligence, patent portfolio management, and freedom-to-operate analysis.
This firm has represented different types of clients including medical centers, universities, and all sizes of corporations. This firm represents clients in technological innovation and scientific discovery. Additional Skills: The candidate should possess excellent analytical and communications skills; must think, write, and speak clearly.
The optimal project outcome will see the new assay(s) implemented in Selux's second-generation AST platform in addition to publications. The successful candidate will work closely with Selux's senior scientists and engineers, have direct access to Selux's esteemed scientific and clinical advisors, and build industry and academic partnerships necessary to make the project successful.
We are looking for a candidate with experience working with bacteria and assay development, including use of time-resolved Forster resonance energy transfer (TR-FRET), fluorescence polarization/anisotropy. Selux Diagnostics' platforms will enable clinicians to administer personalized therapies to Infectious
Diseases patients within hours rather than days. These advances promise to improve patient care, shorten hospital stays, and combat the growing antibiotic resistance epidemic.
Selux's NGP AST platform offers uncompromised accuracy and an unprecedented speed to results and breadth of menu. The company's Grow-on-the-Go Blood Culture system completes the microbiology laboratory transformation by slashing the time to culture positivity for all samples and incubation during sample transport for integrated health networks. The 35-person company is funded with a combination of Federal and private investment and will begin FDA trials on its initial NGP AST product in this quarter (Q1-2020). The
ideal candidate will have/be: A Ph D in Microbiology, Biochemistry, Molecular Biology, Biomedical Engineering or a related field Experience performing phenotypic assays on bacteria Experience working with a variety of bacterial species Experience developing no-wash assays Experience performing TR-FRET and/or fluorescence polarization A desire to learn industrial R&D and see his/her work come to fruition in a product A desire to continue publishing An independent thinker and problem-solver, who is an enthusiastic and collaborative professional Excellent written and oral communication skills and proven ability to work well in a team environment Passion about an early-stage start-up that aims to change industry and how healthcare is delivered!
recblid 30k3bj2puip0ojss7rrj9os3kdftk0 Ph. D.
