2,581 jobs found in Massachusetts

SUMMARY: The Advanced R&D Technician provides assistance to Technology (Research & Development) staff in the testing, analysis, and reporting of new material development in conjunction with product development efforts undertaken in the laboratory, pilot plant facilities and production machines. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: •Extensive hands-on experimental work in lab environment. •Prepare fibrous/chemical mixtures in the laboratory and produce handsheets of experimental prototypes. •Perform physical, analytical and chemical testing on raw materials, and new product prototypes according to specified test procedures. •Record and summarize test data and observations from product and raw material testing. Formats computer spreadsheet and provides other computerized documentation of lab experiments and results. •Should be comfortable with safely handling laboratory chemicals and materials including sulfuric acid and lead. •Build lead acid battery prototypes in the lab. Disassemble the prototypes after testing •Good computer skills desirable. CAD design experience desirable. This role will monitor battery testing using different testing software. •For battery testing, some basic electrical knowledge desirable. •Assist in the construction of small test devices for new applications. •Reviews and modifies test methods to ensure accurate and useful data. •Assists with pilot & production machine trials, monitoring checkpoints and collecting samples and data. •Carries out pilot paper machine trials for product development. •Fills in for supervisors on mill trials when necessary. •Formulates standardized reports, as required. •Maintains laboratory notebook. •Receives training on specialized equipment and may be responsible to operate and maintain this equipment. •Assists customers with technical service using expertise on specialized equipment. •Instructs others on test procedures, methods and techniques used for laboratory studies. •Assists in the development of new test procedures and protocols used in testing prototype products and raw materials. EDUCATION AND EXPERIENCE: •Associates degree with 3-5 years of lab experience or bachelor's degree in Mechanical Engineering, Chemical Engineering or equivalent. •Experience in a laboratory environment preferred •Demonstrated proficiency in math and science, with mechanical aptitude. PHYSICAL REQUIREMENTS AND ENVIRONMENT: •Work requires repetitive motion of arms/hands, standing for prolonged period, performing frequent bending and twisting motions, which may potentially result in musculoskeletal stresses. •Steady hands and dexterity to perform tasks repeatedly and accurately. •Ability to lift 25 lbs •Work performed in laboratory environment with potential exposure to hazardous materials. •Work performed in production area with potential exposure to large equipment/machinery and loud noises. The position is based in West Groton, MA. Hollingsworth & Vose is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sexual orientation, gender identity or expression, religion, national origin, marital status, age, disability, veteran status, genetic information, or any other protected status.

Head Cellular/Molecular Profiling and Biomolecular Screening Technologies Location : Cambridge, MA We are seeking a Leader (Executive Director or VP level) for our Biochemistry and Cellular Profiling team. The person will be responsible for implementing and directing the company's global efforts in regards to cellular, molecular, biochemical and biophysical assays and their use for target mode of action (MoA), hit finding, hit validation, compound MoA studies and medicinal chemistry profiling. The person will direct a fundamentally important core capabilities crucial for the company's long term strategy and success. The ideal candidate has a high level of experience in directing innovative approaches in the area of biochemical, biophysical, proteomic based and cellular assays. A proven track record of supporting drug discovery teams with high quality data is required. The ideal candidate must be exceedingly well organized, highly motivated (and able to motivate others), have outstanding interpersonal skills and be extremely flexible. The candidate should be recognized in the community for her/his high degree of innovation and quality of science. The candidate must also bring a high level of enthusiasm for working in a fast paced environment. Principal Duties and Responsibilities: Responsible for developing and implementing strategy for supporting teams and projects across the company with high quality biochemical and biophysical assays. Oversee selection and strategy of CRO's while leading build out of internal screening capabilities Design, develop, and implement bmolecular,cellular,biochemical and biophysical assays suitable for the identification, characterization and optimization of compounds. These assays should elucidate the mechanism of compound action on the target and enable project teams to evaluate the compounds and develop structure-activity relationships as part of the overall hit-to-lead process Set the vision & establish and manage the workflows for the Automated Screening that enables productivity, creativity, and integrates new technologies to ensure that Lead Discovery operates at the leading edge of drug discovery. Enable small molecule Discovery efforts by conducting in vitro experiments using biochemical & molecular interaction techniques. Support the primary and secondary screening of small molecules including developing assays, screening compounds to advance compounds to lead status as well as characterizing the molecular MOA of lead candidates Generate innovative proposals and drive the implementation of new technological approaches and capabilities. Develops and maintains the group's infrastructure optimal for providing high quality assays to the organization. Create and implement project plans, and coordinate workflow and logistics to meet project goals and milestones. Oversees build out and maintains expertise in state-of-the-art enzymology and biophysical methods that facilitate target ID and validation Provide coaching, leadership, and management to facilitate effective solutions for projects and the functional area. Sets scientific directions for the group and contributes to managing priorities of company's portfolio. Works with leadership team to ensure strategic plans align with corporate goals and long term company plans. Job Qualifications: Ph.D. in Enzymology, Biochemistry, Biology, or other relevant field Minimum 10 years of industrial experience developing Biochemical or Cellular assays for application in Oncology discovery Experience working in a drug discovery environment, especially in Oncology, is preferred. In-depth knowledge of enzymology and biophysics is required, and experience with enzyme and biophysics assay development is essential. Experience with compound screening formats, laboratory instrumentation and automation, data analysis and management, and a sound knowledge of the drug discovery process is highly desirable. Proven track record for striving for high level of innovation and scientific excellence. Excellent management, training and education skills. Excellent interpersonal skills with a proven record of empowering world class science and energizing teams. Flexibility to accommodate to rapidly changing priorities and deadlines. Ability to work in a team-based environment Superior oral and written communication skills Interested Candidates may forward CV and Cover Letter to Monte Rosa Therapeutics rational approach in targeting disease-causing proteins for degradation will deliver pioneering therapies for cancer and other diseases. Delivering this new generation of treatments to the patients requires a conceptual change. Monte Rosa recognizes this urgent need and is missioned to develop innovative protein degraders as a solution. Combining deep knowledge, insight and leading-edge science, our integrated engine is built for that purpose.

Description Job Title: Molecular Science Liaison (MSL) Position Summary MS Ls are responsible for communicating the value of Caris Molecular Intelligence (CMI) to external clients, such as physicians, scientists and other interested parties. This communication primarily involves face-to-face discussions with customers, including Key Opinion Leaders (KOLs) in the field of oncology. These customer presentations will involve frequent travel throughout an assigned region (approximately 80% travel). The individual will gather, evaluate published literature and attend relevant conferences to ensure that Caris has the most up-to-date information regarding drug/biomarker associations. This information will also be utilized to further enhance the knowledge base of the targeted customer base within an assigned region. Job Responsibilities Act as a conduit of information/feedback between the medical community and Caris Life Sciences regarding current products and the needs of the medical community to enhance patient care, new research developments, clinical trial activities and therapeutic approaches. Present clinical data and educational materials to physician sites and/or conferences within an assigned region or nationally, as required by Sales and Marketing. Promote CMI to physician sites across the [Northeast/Southeast/Western/Central] United States, as required by Sales and Marketing. Read and understand the scientific and technical literature in order to maintain knowledge of the therapeutic oncology field for customer engagement. Assists with other related duties and special projects as required by sales and marketing. Assist in field training contracted speakers as part of the Caris Speaker's Bureau. Function as a field trainer of assigned region to provide an extension of our Director of Training. Regional speaking engagements (Roundtables, Grand Rounds, Tumor Boards, etc.) with physicians to broaden CMI understanding clinically. Attend select regional tradeshows, national tradeshows and participate in sales meetings to present relevant data necessary to promote CMI and educate clients in the marketplace. Commercial input/review of marketing material to reflect current molecular landscape. Qualifications Knowledge, Skills, and Experience Ability to think creatively and initiate new ideas or solutions to business issues. Independence of thought and sound judgment relating to business needs. Demonstrated commitment, self-motivation, and drive. Possess strong interpersonal skills Self-starter, ability to work in a fast-past, competing deadline driven environment. Proficient in Microsoft Office Suite and Internet for business use. Drive for Results (Service, Quality, and Continuous Improvement) - Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement. Communication - Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Teamwork - Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team. Customer Service Focus - Demonstrate a focus on listening to and understanding client/customer needs and then satisfying the client/customer by exceeding service and quality expectations. Education, Certification/Licensure, and/or Experience M.D. or Ph.D. in a biological science related to pharmacology, cancer biology, or molecular and cellular biology or equivalent training and experience required. Prior experience in a commercial atmosphere such as Pharmaceuticals or Commercial Lab space a plus.

Computational Biologist/Senior Computational Biologist - Contract TouchDown Therapeutics is rapidly growing biotech company developing transformative gene therapies for devastating diseases. We are backed by a strong syndicate of life science investors and have ambitious plans to have a dramatic impact on the lives of patients around the world. We are looking for an accomplished, outgoing Bioinformatics programmer/Computational biologist to work on Rshiny tools and database development. Under the supervision of the Director of computational biology, the Bioinformatics Programmer will help to develop/modify existing RShiny code to aid in visualization of our AAV variant data sets. Responsibilities Installation and configuration of RStudio/Rshiny environment in AWS cloud settings. Create Mysql databases and associated user interface. Develop computational programs and scripts to support the bioinformatics needs of the Company. Develop/modify pipelines to analyze NGS data analysis. nteract and educate other research scientists to create a collaborative and enriching culture that most effectively supports the company's mission. Basic Qualifications A Bachelor's or Master's in Bioinformatics, Computer Science, Biology, Genetics or equivalent, and a minimum of 3 years of experience in computational biology and genomics required. Proficiency in evaluating large-scale datasets. Ability to create interactive visualizations with RShiny or similar tools is the main requirement of this position, along experience in Mysql databases. Experience with statistical methods and machine learning algorithms is a big plus. Ability to work in AWS/cloud environment. Experience with working with developer tools such as Rstudio teams/Rstudio server pro is a big plus. EEO Statement: TouchDown Therapeutics is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.

The Company: C4 Therapeutics (C4T) is pioneering a new class of oncology small-molecule drugs that selectively target disease-relevant proteins for degradation using the innate machinery of the cell. This targeted protein degradation approach has the potential to treat a range of diseases and offers advantages over traditional drugs. C4T started as a spin-out from Dana-Farber and today is 85 employees and growing. They currently occupy a 40,000 square foot state-of-the-art Research and Development facility in Watertown, MA. The company is well-situated for continued growth with a commitment to transforming the treatment of cancer, neurological, and other important diseases with novel therapies that eliminate disease-causing proteins. The Role: C4 Therapeutics is seeking an experienced oncologist to lead clinical development teams in a rapidly growing company. Reporting to the Chief Medical Officer, will be responsible for the creation of the clinical development plan for new compounds, designing and executing clinical studies, and collaborating with Program (Research & Development) Teams to establish the path towards regulatory approval. This person will work closely with scientists in discovery research and translational medicine , as well as non-clinical, DMPK/clinical pharmacology, program management, biostatistics, regulatory affairs, and clinical operations. The Senior Medical Director will: Lead the design and writing of oncology clinical study protocols from first-in-human phase 1 through pivotal studies that will support regulatory approvals Act as Medical monitor for multiple ongoing clinical trials, including evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase 1, and assessing early pharmacodynamics and clinical signals of activity Write clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs Lead Planning and execution of publication plans Lead regular teleconferences with academic clinical investigators Attend and support clinical site initiation visits and lead investigator meetings Provide strategic leadership in existing and planned clinical programs to support global filings Perform medical review, assessment, and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws Serve as a clinical face of the company both internally and externally, including the scientific community and key opinion leaders S/he will have the following mix of personal and professional characteristics: An M.D. with experience in adult or pediatric oncology or hematology Strong leadership skills and proven experience developing, planning, designing and executing early and late stage programs. Experience with high-complexity first-in-human studies is highly desired 5 years of relevant experience in clinical development in oncology Thorough understanding of the drug development process from IND through NDA, including clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance Experience leading the clinical aspects of interactions with Regulatory Authorities, such as FDA and EMA Experience presenting to a wide variety of audiences including internal teams, medical and scientific communities Ability to travel domestically and internationally

COMPANY INFORMATION We are a Boston-based epidemiology and biomedical research organization run within the VA HealthCare system. We are actively engaged in several clinical trials, pharmaco-epidemiology, chronic disease epidemiology, genetic epidemiology, biostatistical, and genomics research. Our Boston-based Research Team is taking part in the All of Us Research Program in collaboration with the National Institutes of Health (NIH) and is seeking a Research Assistant to support the establishment and execution of a multi-center epidemiological cohort study. The All of Us Research Program is a multi-agency government initiative examining the intersection of human genes, lifestyle, and environment to revolutionize individualized healthcare. The research assistant will work closely with a multidisciplinary team to provide support in participant facing outreach, engagement and program enrollment as part of a regional outreach team working in the Boston area. Come be a part of a dynamic, goal and mission orientated team aiming to expand representation of Veterans in biomedical research! Read more about All of Us Research Project here: Who You Are Experienced: You have relevant education in a scientific field such as biology, epidemiology, chemistry, or public health, preferably with 1-2 years of research experience. Applicants with previous experience in human subjects research are especially encouraged to apply. Outgoing and Composed: You're an excellent communicator (verbal & written), organized, and confident in communicating with patients, researchers and medical center personnel. You're comfortable with providing critical problem solving to support participant centered practices and you're comfortable juggling multiple tasks at once while producing quality results. Tech Savvy: You're familiar with databases, wikis, SharePoint, and Microsoft Office. You have no problem learning new software and navigating digital platforms. Leader: You can strictly stick to deadlines and have the drive to help the study team achieve theirs. Confidential & Compliant: You are able to operate 100% confidentially and able to comply with study protocols and human subjects research rules and regulations. Must be a US Citizen living in or wiling to relocate to the Boston Area What You'll Do Working closely with all members of the program coordinating team and the regional outreach team you would contribute to day-to-day patient facing program activities of outreach, engagement, and enrollment into the research study. Become an expert knowledge center for the program and all aspects of the engagement and enrollment process from the participant's perspective. Nurture relationships with clinical staff in the medical facilities where the program is enrolling. Facilitate in study recordation via websites, wikis, and sharepoint to fulfill human subjects research requirements. Assist team members in various ongoing projects by providing constructive, informed, and insightful feedback for the betterment of the program. What You'll Get A generous benefits package including health, dental, vision, and life insurances, commuter benefits, FSA, and a retirement plan with matching after a year. A unique environment with fun, outgoing, and intelligent co-workers. The ability to contribute to making a difference in the lives of Veterans. A supportive culture where your professional growth is as important as ours. Lots of laughter! Equal Opportunity Employer BVARI is an equal opportunity employer, thereby ensuring equal opportunity for employment and advancement to all qualified persons without regard to race, color, religion, national origin, sexual preference, gender identity, lawful political affiliation, marital status, non-disqualifying physical or mental handicap or age.

This role will provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for implementation of analytical assays on new instrumentation. This scope includes QC Instruments (both portable and computer-controlled). • Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short term/completed remediations • Performing supporting remediation work in the form of SOP revisions as well as authoring and executing change controls and validation test plans/protocols when required per remediation plans • Develop, drive and perform comparability studies for implementation of analytical assays on new instrumentation. Successful candidate requires: • Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures. • Working knowledge of data integrity regulations, guidance, and principles • Working knowledge of CAPA and change control processes • Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions. • Knowledge and experience with a wide variety of analytical techniques including HPLC, UV/VIS, CGE, FT-IR and ICE. • A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.) • Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required. At least 2 years experience working in a GMP environment outside of an academic setting.

Job Overview: The accounting manager will primarily be responsible for driving the month-end close, reconciliation review, financial statement preparation, and internal review processes. This position is also accountable for the analysis of financial results and the ongoing oversight of process improvement. The ideal candidate will have substantive knowledge of generally accepted accounting principles, practices, processes, and procedures and will be involved in laying the foundation of a scalable finance and accounting operations function. Responsibilities: - Responsible for driving the month-end close process, including the timely completion and review of balance sheet and P&L reconciliations, general ledger analyses, trial balance reviews and financial statement preparation. - Responsible for reviewing general ledger activities across multiple subsidiaries - Improve account reconciliation process, drive deadlines, enhance deliverables as they pertain to the month-end close and financial statement preparation processes - Liaise with the Company's outside audit and tax firms on related matters - Interact with cross-functional teams to resolve challenges, affect operational improvements and enhance financial processes - Assist with special projects, ad-hoc reporting/analysis and initiatives unique to a fast-growing technology start-up, such as system implementations/updates and business processes improvements - Maintain and review current accounting processes and recommend changes as needed - Provide support to corporate controller and VP of finance in the budget and forecasting process Requirements: - Degree in accounting or finance - 4+ years of related experience in high-growth technology or life science companies - Prior experience in building and managing successful teams - Ability to work independently and with various levels of management - Ability to prioritize and meet deadlines in a fast-paced environment - Eye for detail and accuracy - Excellent communication skills - Maintain a high level of integrity, confidentiality and professional skepticism - Substantive understanding of U.S. GAAP - Experience using various financials systems and Microsoft Excel - Strong knowledge of Microsoft Office applications - Prior public accounting experience or experience working with external auditors highly desirable - Specific experience with QuickBooks, NetSuite and Sage Intacct a plus Benefit package includes competitive sick/vacation/holiday package, equity, health, dental, life insurance, short and long-term disability, and 401k plan. The Company: Located in Kendall Square in Cambridge, MA, the Company is a rapidly-growing technology organization focused on marketing our software solutions and technology platforms to the world's foremost life science and biotechnology companies, academic institutions and hospitals to assist them in solving their most significant questions and challenges in order to serve patients. The Company is an equal opportunity employer.

As a highly contributing member of a small team, you will work closely with the founding team and other team members to support Immuno-oncology drug discovery. The main function of this role is to support Drug Discovery efforts via Immuno-oncology programs using in vitro & in vivo models. Responsibilities include but are not limited to; • Design and develop novel in vitro assays for characterizing target expression in normal and tumor tissues • Mammalian cell culture, specifically isolating and propagating in vitro culture of human/mouse tumor tissue • Use of animal models of oncology, immunology, and/or immuno-oncology • Effectively interface with other scientific groups to facilitate the success of projects • Coordinate research projects evaluating strategies to improve efficacy of therapeutic candidates • Prepare all technical reports needed in support of an exploratory project moving to process development • Exercise independent judgment in development of new methods, techniques and evaluation criteria Formal descriptions can be supplied for interested candidates. Qualified candidates will have a BS/MS degree in a Life Sciences discipline and several years of industry experience or a PhD with post-doctoral and/or 0 - 3 years of industry experience. Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

As Field Applications Scientist at Stilla, you will be assisting the Sales Rep in the pre-sale of the Naica system, performing client trainings, while providing experimental design support, data analysis, logistical, and troubleshooting support. You are a key contact for Technical Support for responding to issues and maintaining relationships with customers. The primary goals of this position are to ensure rapid NAICA adoption and maximum customer success. Key Responsibilities are: Actively participate in pre-sale with the Sales representatives (trade shows, seminars, demo prequalification and post demo review…) Act as the technical account manager as bridge between the customer and company and sales. Coordinate and perform customer site trainings and demonstrations. Identify, document and communicate customer complaints and concerns to management, Zendesk and devise resolutions. Contribute to white papers and technical SOP's/technical with the goal of expanding support documentation. Scientifically partner with customers to develop application notes about their research with Naica while cultivating long term relationships. Manage expectations of "Sell What is Available Today" and position the Naica with the correct customer profile making the purchase a win-win. Gather and deliver strategic and competitive customer feedback and share with marketing and your team members. Troubleshoot and diagnose Naica issues with clients and find solutions relative to their technical skills, biochemistry and assay design, experimental plans, software and instrument. Interpret customer needs and identify the proper issue escalation pathway within Stilla. Support field sales team at trade shows, demos, seminars and technical symposia. This will include presentations and networking with thought leaders. Ability to maintain composure and professionalism in potentially stressful situations. Show self-driven initiatives to address gaps in a startup environment with mindset of "ask what you can do for Stilla rather than what Stilla can do for you".

Primary Duties and Responsibilities -Lead business growth in assigned territory using consultative selling methods at CMs and OEMs -Develop global relationships with multiple decision makers and influencers at large key accounts -Coordinate global team to accelerate and synchronize key account project progress across regions. -Team with manufacturer representatives and drive independent direct sales activities to win business. -Develop relationships with multiple decision makers and influencers at large accounts in territory. -Timely and accurate CRM software entries to improve team communication, planning and execution. - Support territory manufacturer representatives on performance improvements to achieve goals. - Prospect for new business with regular planning, progress reviews, and adjustments to achieve plan. - Prioritize collaboration with Application Technology Engineering on critical customer technical support. - Team with Marketing on territory and key account marketing activities to increase new business leads. - Assist in resolving conflicts with customer expectations and Operations capabilities. - Willing to travel throughout assigned region 60-70% including potentially 10% international. Qualifications - Bachelor's Degree with 5 years successful B2B technical sales experience into OEMs and CMs for printed circuit board (PCB) or integrated circuit (IC) packages. - 5 years preferred selling of consumable products to PCB or IC package OEMs and CMs in SW USA. - 5 years preferred managing sales growth to key global PCB or IC package OEM and CM accounts. - Formal strategic selling training preferred or a willingness to learn. - Familiar with all stages of a complex high-value sell up to including influencing decision makers. - US Resident or Citizen due to ITAR applications. - Working knowledge and proficiency in Microsoft applications (Excel, Word, PowerPoint, and Outlook).

The Company: C4 Therapeutics (C4T) is pioneering a new class of oncology small-molecule drugs that selectively target disease-relevant proteins for degradation using the innate machinery of the cell. This targeted protein degradation approach has the potential to treat a range of diseases and offers advantages over traditional drugs. C4T started as a spin-out from Dana-Farber and today is 85 employees and growing. They currently occupy a 40,000 square foot state-of-the-art Research and Development facility in Watertown, MA. The company is well-situated for continued growth with a commitment to transforming the treatment of cancer, neurological, and other important diseases with novel therapies that eliminate disease-causing proteins. The Role: Reporting to the Chief Medical Officer, the Head of Regulatory Affairs will be responsible for developing and executing global regulatory strategies to maximize regulatory success towards achievement of program objectives for multiple clinical development programs. The Head of Regulatory Affairs will provide strategic and operational leadership to cross-functional teams responsible for global development and registration and will be a member of the CMO's Leadership Team. A genuine interest and understanding of FDA /global regulatory requirements supporting the C4 therapeutics pipeline, an ability to work collaboratively in a multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success. The Head, Regulatory Affairs will: Lead development and execution of global regulatory strategies and operations for clinical development programs through collaboration with the Program Team Lead (Medical Director), Program Management, Clinical Operations, and cross functional teams Develop and implement regulatory standard operating procedures, processes, infrastructure, and systems to support regulatory affairs and operations Manage global filing plans and global registration dossier submissions and approvals Prepare strategy for and lead global meetings and interactions with Health Authorities Provide regulatory input for key documents, including Investigator's Brochures, IND summary documents/annual reports, CTAs for initiation of studies ex-US, and NDAs Triage queries from Health Authorities including authoring responses and gathering cross functional input Develop and monitor long- and short-term product regulatory plans including: oversight of implementation of the project plan, decision making on issues that could delay project schedules or activities, communicating issues/risks to key stakeholders in a timely and consistent manner, providing input on budget requirements, monitoring both functional and project performance against goals Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws S/he will have the following mix of personal and professional characteristics: Bachelor's degree; advanced scientific related degree a plus with minimum of 10+ years of regulatory experience Must have filed INDs, CTAs, and/or NDA/BLAs to FDA and ex-US regulatory agencies Experience in reviewing, authoring, and managing components of regulatory submissions Proven track record of successful health authority negotiations/interactions Experience in managing multiple global programs/filings required Experience in oncology and/or rare disease drug development preferred Experience in both early and late development preferred Solid working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus Collaborates and communicates in an open and clear manner, listening effectively and inviting response and discussion with Sr. Leadership, internal teams, and external service providers Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority Anticipate and proactively resolve issues when and where possible, applying logical methodology Ability to travel domestically and internationally, approximately 10%

About ACES, LLC Amaka Consulting and Evaluation Services (ACES), LLC is highly skilled in mixed methods evaluation, and we approach our work with a lens of cultural humility and equity. As a minority and woman owned business, ACES prides itself on maintaining a team of evaluation experts with diverse expertise and backgrounds in both quantitative and qualitative methods. ACES Research and Evaluation associates have provided their expertise to clients including, the March of Dimes, the American Public Health Association and the Centers for Disease Control and Prevention. Examples of previous deliverables include: evaluation plans, literature reviews, creating survey and interview guides, and synthesizing results of data analysis in executive summaries and reports. Research and Evaluation Associates of ACES apply an equity lens to all of our work, with a focus on dismantling and calling out "ism's". For example, we recently completed a three year mixed methods evaluation of a group prenatal care program to assess the impact of the social determinants of health on birth outcomes for women of color. After conducting multiple interviews and collecting both primary and secondary data from administrators, front desk staff, nurses and other providers, we devised a set of recommendations that the hospitals could use to improve their relationship with women of color and retain them in care. About the Project We are currently looking to staff a senior research associate for an exciting new multi-year project spanning several key public health issues: reducing HIV/AIDS, advancing knowledge around sexuality and reproductive health, increasing access to health services for low-income/vulnerable populations. This project's overarching framework is centered around health equity. Ideal candidate will possess deep cultural humility and a keen understanding of the salient issues that affect minority populations. Senior Research Associate Description Under the supervision of the Project Director, the Senior Research Associate will lead a team the collection, analysis and presentation of research and evaluation data in support of the current research/evaluation project. Senior Research Associate Duties & Responsibilities The job generally requires the ability to perform the following duties: Conduct literature reviews Collect and analyze data Prepare materials for submission to granting agencies and foundations Manages and replies to project-related correspondence Prepare key-informant interview questions Maintain accurate records of key-informant interviews, safeguarding the confidentiality of subjects, as necessary Summarize key informant interviews Travel to field sites to collect and record data and/or samples as appropriate to the specific objectives of the research and/or evaluation study Conduct and record face-to-face and/or telephone interviews with subjects, in accordance with predetermined interview protocol, data collection procedures and documentation standards As appropriate to the specified position, code and verify data in accordance with specified research protocol and coding procedures and enter data into a computer database and/or spreadsheet application for subsequent analysis Prepare graphs and spreadsheets to portray results Prepare other articles, reports, and presentations Check facts, proofread, and edit research documents to ensure accuracy Performs routine clerical duties as instructed, if essential to the research activities of the supervisor or project to which the research associate is assigned. Demonstrates respect toward and cooperation with the Project Director and Team Lead Perform other related duties as required Education, Training, & Certification Education: Masters in Public Health or related field required Experience: At least two to three years of data analysis and evaluation experience preferred. Certification: Certified Health Education Specialist (CHES), Certified in Public Health (CPH) preferred. CITI IRB certification required upon hiring Skills & Competencies Analytical skills Ability to collect and analyze data Manage and update existing databases. Able to conduct literature reviews or field research. Observational skills Able to work in a highly accurate manner, paying close attention to detail and keeping records of their work. Time-management skills Able to meet project deadlines and manage time to meet client goals. Language Preferably bi-lingual, fluent in English and/or Spanish Location Ability to travel in and around the greater Boston/New England area. Car preferred, not required. To apply: Please email Jacqueline Gifuni-Koutsouris at 1) A cover letter describing: Your interest in this position and how you learned about it The start and end dates during which you would be available to fill this position Your familiarity, if any, with statistical programming languages (e.g. Stata, SAS, Matlab, ArcGIS) Your familiarity, if any with qualitative software ( e.g. Nvivo, Atlast ti, Dedoose etc) Your prior experience as a research associate and/or with independent research projects (e.g. a thesis or other research project) Names, email addresses, and phone numbers of 2-3 references (letters not required) 2) A current resume 3) A sample research paper Applications will be accepted on a rolling basis, however a timely response is required and preferred. Women, minorities, and people identifying as LGBTQIA are strongly encouraged to apply.

ESSENTIAL JOB FUNCTIONS: Manage and maintain Executives' calendars, contacts and schedules Handle details of confidential nature that are critical/time sensitive. Coordinate internal and external meetings, conferences, catering arrangements, equipment, agendas and presentation materials Responsible for creating and coordinating all travel with expected changes etc.; also create expense reports and provide travel information to Finance dept. Manage flow of information from internal and external sources Draft, format and edit correspondence/documents, slides, etc. utilizing appropriate word processing, spreadsheets, database or graphics software to achieve appropriate results May provided guidance to other Administrative Assistants, as needed Assist executive and senior management with interviewing efforts as needed Handle Executives' personal agendas as needed Support the Clinical team on their day to day activities Correspond and coordinate with CRO's Perform other duties as required. JOB SPECIFICATIONS: BA is required. Biotech or Pharma experience is required, working with a Clinical function is preferred. Possess at least 5 years of experience supporting C-level management. Proficient with basic computer skills including typing and 10-key by touch, Word, Excel, Outlook, Concur, WebEx and PowerPoint Project management experience strongly preferred. Ability to exercise discretion and independent judgment regarding highly sensitive and external communications. Excellent communication skills, verbal and written coupled with strong command of English grammar. Ability to work well with diverse personalities Excellent professionalism and strong interpersonal skills Displays strong initiative and ability to work well independently as well as with others Must be flexible and adaptive to plans changing PHYSICAL DEMANDS: While performing the duties the employee is: 1. constantly required to sit, and to reach to use computers and other office equipment 2. occasionally stand for extended periods of time, up to four (4) hours/time. 3. occasionally required to lift up to 10 pounds 4. constantly required to view objects at close and distant ranges 5. frequently required to communicate with others Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time. WORK ENVIRONMENT: Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity. Employee may occasionally be required to travel. The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Universal Sequencing Technology, a biotech startup headquartered in Canton, MA (~15 miles southwest of Boston) with a location in Carlsbad, CA, is looking for a highly talented Software Engineer for Signal Processing to join the team, located in Canton, MA.* We are excited to provide novel DNA sequencing technology for the Next Generation Sequencing (NGS) platforms that enables many previously unachievable applications. The successful candidate will provide technical leadership for company's efforts in developing instrumentation-oriented software and hardware/firmware interfaces and computational algorithms for real-time instrument control, data acquisition, data processing and data analysis. This position is a unique opportunity to work on the development of a very advanced DNA sequencing system. * Please note that we are only considering local candidates at this time. Duties and Responsibilities: Work closely with product management, instrument engineers, analytic and simulation scientist, manufacturing and technical support to define requirements and specifications Architect, design, develop and test software for real-time instrument control, data acquisition, processing and analysis Design and develop software systems for on-device data storage and interfacing with external systems for data egress (streaming) Actively participate in all phases of SDLC Write and maintain good documentations, such as, software specifications, architecture designs, testing plans and deployment plans Other work and project assignments as required, such as participate in on-going bioinformatics software development, testing, bug fixing and user support, etc. Desired Skills: Strong knowledge of electronic measurement and instrumentation principles, able to make simple firmware test devices, good understanding of computer hardware Extensive real-world and expert level experience in LabVIEW, Matlab programming, embedded frameworks and SDKs Extensive programming experience in C/C++, Python, Shell Scripts, Java, etc., with a life science instrument, or medical device environment highly desirable Real world experience in data acquisition, processing and analysis for microelectronic signal is strongly desirable Experience in machine learning and strong background in statistics Experience with design control processes, design control tools, and software build systems and configuration management tools Experience with software version control systems such as Git, Subversion, ClearCase Experience with software SDLC methodologies, such as, Waterfall, RUP, Agile Excellent verbal, written communication and problem-solving skills Cloud Computing experience with AWS, GCP and Azure a plus Qualifications: Ph.D. with 2+ years, MS with 5+ years or BS with 8+ years relevant experience, in a technical discipline, such as Electrical Engineering, Physics, Computer Science Ability to work in a fast-paced and quickly changing environment Work well both independently and in a team environment

Title: Associate Scientist: Research Analytical QC Location : Cambridge, MA Duration: 09+ months (Possible Extension) JOB DESCRIPTION: The Research Department is seeking a highly motivated Associate Scientist to join our RNA QC and annealing group and support RNAi-based research and drug discovery. The successful candidate will help in the quality control and annealing of oligonucleotides and siRNA's for research studies. Additionally, they will evaluate new formulation approaches for CNS and ocular delivery applications and develop suitable assays such as the Bacterial Endotoxins Test (BET) for improved quality control. Summary of Key Responsibilities Preparation of siRNA duplexes and QC of siRNA to support research and drug discovery. Analysis and analytical method development of newly chemically modified oligonucleotides (single strands and siRNA duplexes). Improve upon existing analytical methods and processes to expand the current capabilities. Support siRNA formulation development for ocular and CNS applications. Utilize analytical instrumentation such as UV-Vis spectroscopy, HPLC, and LC-MS for the analysis of both crude and purified synthetic products. Effectively aid in troubleshooting synthetic/process issues and independently find solutions. Improve upon and/or develop new methods and automation for the downstream processing of synthetic oligonucleotides and their subsequent analysis/purification and annealing into siRNA duplexes. Analyze, interpret, and organize analytical data to present to team members. Skills: Experience with instrumentation such as HPLC, LC-MS, UV-Vis spectrometry, etc. is required. Experience in developing new chromatographic methods (IEX/RP HPLC, SPE, LC-MS) is a plus. Experience in solid-phase synthesis of biomolecules and a good understanding of the procedures involved in SPS are preferred. Ability to function within a highly interdisciplinary environment is a must. Excellent written and oral communication skills, good organization skills, the ability to multitask, and the ability to work within a team and/or independently are required. Complete record-keeping and excellent laboratory documentation practice (electronic notebook) are required. Strong commitment to high laboratory and scientific standards and the ability to maintain a safe, clean, and orderly laboratory work environment and assist in routine lab and equipment maintenance, vendor contract and requisitions. Education: Bachelor's or Master's degree in Chemistry, Biochemistry, or a related scientific field. 0-8 years of work experience, preferably in an industrial setting.

Universal Sequencing, a biotech startup headquartered in Canton, MA (~15 miles southwest of Boston) with a location in Carlsbad, CA, is looking for a highly talented Software QA/DevOps Engineer to join the team, located in Canton, MA.* We are excited to be developing novel DNA Sequencing technology for the Next Generation Sequencing (NGS) platforms that enables many previously unachievable applications. The successful candidate will work close with software developers to manage and automate the build and deployment of our genomic data analysis pipeline in AWS. In addition to strong technical skills, the candidate must have a keen interest in biology and working with real-world data. Strong interpersonal skills, a desire to understand user needs/requirements, and the ability to communicate with customers clearly are a must. This position will interact closely with colleagues in molecular biology as well as external users. * Please note that we are only considering local candidates at this time. Duties and Responsibilities: Responsible for deployment and operational of the product at AWS and possibly other datacenters (DC) Drive infrastructure as code and DevOps philosophies Establish and implement QA/QE standards and best practices Drive automation of build, test and deployment process Assist the development team in implementing and executing manual/automated tests based on the agreed-upon acceptance criteria - testing new software features and regression testing existing functionality Work with the development team to ensure high-quality software and deliverables Write and maintain good documentations, such as, software specification, testing plans, deployment plans, backup and recovery plan, support and maintenance plan, upgrade plans Other work and project assignments as required Desired Skills: DevOps experience including architecting Continuous Integration / Continuous Deployment / Continuous Delivery systems Experience with Gradle, Jenkins, Chef, Docker, Kubernetes DevOps experience with AWS environment or other cloud platforms Experience with disaster recovery strategies in the cloud environment. Cloud provisioning via IaC · Linux OS, scripting, bash, Python etc. Familiar with workflow frameworks such as Snakemake, etc. Familiar with software package and dependency management tools such as Conda, etc. Git/Github experience, either in open source or commercial software. Experience managing project repos and releases Strong technical troubleshooting skills, perseverance, and patience Highly organized self-starter with attention to detail and a strong agile practice Must have the ability to work in a fast-paced, rapidly changing environment, be able to handle multi-tasking and juggling priorities Qualifications: BS in computer science, or related field with at least 3 years of post-graduate experience, MS preferred 2+ years of experience in a software quality engineering function 1+ year of experience programmatically testing products, developing test automation, and driving diagnostic ability into a product

A rapidly growing Biotechnology company is seeking a Senior Accountant to join their team. Reporting to an Associate Director, this highly visible role focuses on all monthly, quarterly and annually close processes. This role also has the opportunity to get exposure to Revenue, SEC Reporting, and Collaborations. The company is at an exciting stage - more than doubled in size over the past few years; and offers great perks including: Energetic culture with laid back atmosphere and attire Free parking Above-market compensation packages - student loan repayments, 90% covered benefits Great work/life balance - office closes for Winter break and one week in Summer Responsibilities: Monthly close processes - reconcile AR, general ledger maintenance, revenue invoices Assist with revenue recognition procedures Maintain necessary KPI's Collaborate with other business units - Commercial, FP&A etc. Ad-hoc projects Qualifications: Bachelor's in Accounting or related field 2+ years accounting experience Self-starter who thrives in a fast-paced environment Strong communication skills Organized with the ability to prioritize important tasks

Overview As an Environmental Scientist for Civil & Environmental Consultants, Inc. (CEC), you will be responsible for working on a variety of diverse environmental projects. The majority of your time will be spent in the field and traveling to and from sites. Your duties will include: Collection of environmental samples on a variety of project sites; Observation of remediation activities such as oversight of excavation and operation of treatment systems; Inspection of construction sites to monitor progress and ensure conformance with Engineering Plans, Specifications and construction and safety standards; Data tabulation, evaluation and review; Preparation of technical reports. Qualifications 0-2 years' experience in environmental monitoring, construction observation or related field; Attention to detail; Ability to speak and write professionally; Valid driver's license and clean driving record; Ability to work independently in the field in varying weather conditions with strict adherence to operating procedures and safety policies; Technical degree (engineering, science or related field); 40-hr HAZWOPER training and 8-hr refresher (if applicable); and Working knowledge of Microsoft Word and Excel. About Us CEC offers big firm opportunities with a small firm culture . We understand the importance of professional growth and offer career advancement and leadership opportunities. You will work on diverse projects providing high quality services to our clients. Join our team where your contribution matters. CEC is an EEO employer - M/F/Veterans/Disabled.