Quality Control Analyst II

Relay Therapeutics is seeking a dynamic and experienced Director of Analytical Development and Quality Control to lead our analytical efforts in drug development. In this leadership role, you will oversee the development and implementation of analytical methods to support our innovative drug discovery pipeline. You will work closely with cross-functional tea…

Scholar Rock is a pioneering biopharmaceutical company dedicated to discovering, developing, and delivering transformative therapies for individuals battling serious diseases with significant unmet needs. Renowned as a global authority in the biology of the transforming growth factor beta (TGFβ) superfamily, our clinical-stage organization is passionately focused on advancing innovative treatments that are fundamentally reliant on protein growth factors. Over the last decade, we have cultivated a robust pipeline aimed at elevating the standard of care for neuromuscular diseases, cardiometabolic disorders, cancer, and various conditions where growth factor-targeted drugs can have a revolutionary impact. Scholar Rock proudly stands as the sole company to have demonstrated clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our commitment to unlocking novel therapeutic avenues is driven by the extensive application of a proprietary platform that has developed unique monoclonal antibodies designed to modulate protein growth factors with remarkable precision. By leveraging cutting-edge science in disease areas that have traditionally been overlooked by conventional therapies, we strive each day to create new possibilities for patients. To learn more about our innovative approach, visit ScholarRock.com and follow us on Twitter and LinkedIn.Position Overview:We are actively seeking a highly experienced and driven Senior Director of Global Quality Control to join our team. This pivotal role reports directly to the Head of Global Quality and serves as the senior leader responsible for establishing and maintaining a scalable, phase-appropriate, and inspection-ready global QC strategy across a fully outsourced development and manufacturing network. The Senior Director will provide both strategic and technical leadership for Quality Control activities carried out through external contract laboratories, CMOs, and other testing partners, supporting drug substance, drug product, raw materials, in-process, release, and stability programs.

We are seeking a dedicated and detail-oriented Quality Control Manager to join our dynamic team at Integrated Resources Inc. in Cambridge, Massachusetts. The ideal candidate will be responsible for ensuring the highest standards of quality across our products and services, implementing rigorous quality management systems, and leading a team of quality assurance professionals.As a Quality Control Manager, you will play a crucial role in driving continuous improvement initiatives and collaborating with cross-functional teams to enhance operational efficiency. Your expertise will help us maintain compliance with industry regulations and exceed customer expectations.

Join our dynamic team as a Quality Assurance/Quality Control Specialist III. In this pivotal role, you will ensure the highest quality standards are maintained throughout our processes and products. As a QA/QC Specialist, you will be responsible for developing and implementing quality assurance programs, conducting audits, and collaborating with cross-functional teams to drive continuous improvement.

Company Overview Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative small molecules aimed at enhancing the quality of life for patients with genetically defined rare diseases. We are steadfast in our mission to provide hope and new treatment alternatives for individuals afflicted by rare hematologic disorders and are actively expanding our pipeline of clinical and preclinical assets. Our flagship clinical asset, pociredir, represents a groundbreaking small molecule engineered to boost fetal hemoglobin expression, offering potential treatment for sickle cell disease and other hemoglobinopathies. We are seeking a dynamic and strategic leader to direct our Analytical Chemistry function as we grow our portfolio of clinical-stage assets. Position Overview In this pivotal role, reporting to the Head of Technical Operations, the Director of Analytical Chemistry will spearhead the formulation and implementation of control strategies for the manufacture of drug substances and products within Fulcrum’s developmental programs. The successful candidate will provide expert oversight of all Quality Control (QC) operations at contract manufacturers for drug substances (DS) and drug products (DP). Responsibilities include collaborating with pharmaceutics on pre-formulation tasks, engaging with Quality Assurance (QA) on Out of Specification (OOS) and Out of Trend (OOT) investigations, managing CMC risks, and assisting Regulatory CMC in drafting essential sections of regulatory submissions. Key Responsibilities Deliver technical leadership to Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) for drug substance and product development, incorporating cGMP method development, validation, method transfer, method remediation, data analysis, and reporting to uphold compliance with GCP, GLP, and cGMP standards. Collaborate with cross-functional teams including Drug Substance, Drug Product, QA, and Regulatory CMC to ensure plans are cohesive, phase-appropriate, and timely. Design and oversee stability studies, including managing shelf-life and retest dates, to guarantee uninterrupted clinical supply. Lead and manage strategies for reference standards, in-process controls, and specifications throughout the asset pipeline. Review and approve a diverse array of documents, such as Test Methods, Qualification/Validation Protocols, Specifications, and Reports at CMOs. Generate, review, and authorize documentation related to the control of DS and DP for Regulatory submissions (IND/IMPD and NDA/MAA). Travel to contract manufacturing sites both domestically and internationally to support crucial production milestones and foster strong business relationships.

We are seeking a highly skilled and experienced Director of Clinical Quality to join our dynamic team at Integrated Resources, Inc. In this pivotal role, you will be responsible for overseeing the clinical quality management systems, ensuring compliance with regulatory standards, and driving continuous improvement in clinical processes.Your leadership will be vital in fostering a culture of quality and safety, collaborating with multidisciplinary teams to enhance patient outcomes and operational efficiency.

The Director of Institutional Research and Analytics will spearhead the Office of Institutional Research and Analytics (OIRA), a vital component of the Office of the Provost that empowers Harvard’s leadership through comprehensive institutional data analysis and reporting. OIRA acts as a reliable resource committed to implementing best practices in data integration and translation, thereby supporting a diverse array of university functions.In this influential role, the director will oversee the creation and execution of a strategic portfolio of analytics projects in collaboration with the Associate Provost for Institutional Research and Analytics and the Associate Director for Analytics. The Director will also provide strategic oversight and management of the office's institutional reporting initiatives. Within OIRA, the Director will lead both the Institutional Research and Strategic Analytics teams.Additionally, the Director will engage with stakeholders across the University on institutional research, survey, and analytics consulting projects, leveraging existing data assets and promoting the integration of various data sets while employing robust statistical methodologies.The ideal candidate will possess expertise in research design, statistical analysis, and data visualization, with a proven capacity to convey complex findings to diverse audiences. This position reports directly to the Associate Provost for Institutional Research and Analytics and plays a prominent role within Harvard's analytics community.Key Responsibilities:The Director of Institutional Research and Analytics will hold a crucial position within OIRA by identifying opportunities to enhance efficiency in institutional reporting and managing the office's expanding suite of analytics and consulting projects. Below are the primary focus areas for this role, with the understanding that responsibilities may evolve as OIRA’s portfolio grows.Analytics Strategy Development and ImplementationCollaborate with the Associate Provost and Associate Director for Analytics to formulate an analytics portfolio strategy and establish a technical framework for effective communication.Lead the execution of the analytics strategy.Curate and manage the portfolio of analytics projects, ensuring adherence to scope and timelines.Provide leadership on emerging trends and technologies in institutional analytics.Analytics Consulting LeadershipLead discovery and scoping efforts for new analytics consulting projects.Advise stakeholders on optimal designs for analytics consulting initiatives.Align with stakeholders regarding timelines for project milestones and completion.

Iterative Health is at the forefront of healthcare technology and services, driving the evolution of clinical research to enhance patient outcomes. Our Site Network features over 70 premier clinical research sites across both the US and Europe, facilitating the rapid development of innovative gastrointestinal (GI) and hepatology therapies. We are dedicated to the success and expansion of our partner sites through the provision of tech-enabled services. By merging extensive clinical trial expertise with state-of-the-art AI technology, we empower research teams and study sponsors to broaden and accelerate access to transformative therapeutics for patients in need.About the RoleWe are on the lookout for a dynamic and driven Director of Operational Finance & Analytics to become an integral part of our expanding team. In this pivotal role, you will collaborate closely with executive leadership, finance, and operational teams to oversee the operational finance aspects of our growing network of research sites and enhance the company’s enterprise analytics capabilities, ensuring precision, consistency, and governance of critical metrics for a reliable single source of truth.Your contributions will be vital in constructing and scaling our Enterprise Data Warehouse (EDW) and executing Adaptive Insights, utilizing these essential systems to provide dependable reporting and forecasting that supports operational decision-making. This hands-on leadership position offers a unique opportunity to make a significant impact as the company evolves.

Role overview The Senior Director of Business Analytics at Scholar Rock will play a central role in shaping the company's analytics strategy. Based in Cambridge, MA, this leader will drive efforts to support business growth and enable data-informed decision-making throughout the organization. What you will do Create and implement analytics strategies that support Scholar Rock’s goals Work closely with teams across the company to move data-driven projects forward Encourage and foster a strong analytics mindset among colleagues Use business analytics expertise to help set strategic direction and find ways to improve how the company operates Location This role is located in Cambridge, MA.

Scholar Rock is a leading biopharmaceutical firm dedicated to discovering, developing, and delivering transformative therapies for individuals suffering from serious diseases with significant unmet needs. As a pioneer in the understanding of the transforming growth factor beta (TGFβ) superfamily of proteins, we are named for the resemblance of a scholar rock to protein structures. Our clinical-stage organization is committed to advancing groundbreaking treatments where protein growth factors play a crucial role. Over the past decade, we have built a robust pipeline aimed at enhancing the standard of care for neuromuscular diseases, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted treatments can have a profound impact. Scholar Rock stands out as the only company that has demonstrated clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our dedication to pioneering innovative therapeutic approaches is driven by the extensive application of our proprietary platform, which has developed novel monoclonal antibodies to selectively modulate protein growth factors with remarkable precision. By leveraging advanced science in areas historically underserved by conventional therapies, Scholar Rock is consistently working to unlock new possibilities for patients. Discover more about our approach at ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:We are in search of a highly skilled and driven Senior Director of US Quality Assurance to join our team. Reporting directly to the Head of Global Quality, this role will provide both strategic and operational leadership for US Quality Assurance. A strong emphasis will be placed on managing external partner governance, implementing quality risk management strategies, and establishing a scalable quality infrastructure to support our development through commercialization efforts.

Amylyx Pharmaceuticals Inc. is on a bold mission to innovate the treatment landscape for diseases with significant unmet needs. Instead of viewing challenges as roadblocks, we embrace them as opportunities to advance solutions with urgency, scientific rigor, and a steadfast commitment to the communities we serve. As a clinical-stage company, we are currently addressing conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on the passion of our people. We embody core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of care. With a seasoned team ready to make impactful changes, we invite you to join us in this endeavor if you share our enthusiasm for tackling some of the most challenging issues in medicine.The OpportunityAmylyx Pharmaceuticals Inc. is seeking a seasoned Senior Director of Chemistry, Manufacturing, and Controls (CMC) to lead our CMC organization in the development of our pipeline, including Phase III synthetic peptide Avexitide and Phase I antisense oligonucleotide AMX0114. The CMC team partners with external CDMOs to implement robust, scalable, and compliant processes for clinical and commercial supply. This role may involve direct leadership or managing leads of internal matrix CMC Asset teams, serving as the CMC representative on Asset program teams. This leader will collaborate across functions to drive technical excellence and ensure CMC alignment with program objectives.The ideal candidate will exhibit strong strategic leadership while actively engaging in hands-on execution as needed. This position reports to the Senior Vice President of Global CMC and External Manufacturing.

As the Director of Biomarker Development at Scholar Rock, you will lead our innovative team in the discovery and validation of biomarkers that drive the development of transformative therapies. Your expertise will be crucial in guiding our biomarker strategies, collaborating with cross-functional teams, and ensuring alignment with our overall scientific objectives. We are seeking a visionary leader who is passionate about advancing precision medicine and dedicated to improving patient outcomes.

Imagine a scenario where you could be a part of a pioneering organization that not only creates but also nurtures life sciences companies dedicated to pioneering transformative technologies in healthcare and sustainability.Montai Therapeutics is a forward-thinking, privately held biotechnology firm that leverages artificial intelligence to unlock the potential of diverse chemistry, aiming to develop innovative oral medicines that effectively address longstanding unmet needs in chronic diseases. Through our cutting-edge CONECTA™ platform, we have established the world's premier foundation models that decode the intricate relationship between nature's bioactive chemistry and human biology, thus revolutionizing the drug discovery process with unmatched versatility and predictability.We have meticulously curated a collection of over 1 billion Anthromolecules™ and Anthrologs™, derived from compounds that humans have historically consumed through food, supplements, and herbal remedies. This extensive database has provided us with efficient access to a vast array of chemical diversity, enabling us to selectively and precisely influence complex biological systems. Montai is rapidly progressing a pipeline of groundbreaking oral medications targeting validated biological pathways in inflammation and immunology, with a focus on developing biologic replacements for traditionally challenging transcription factors.Position Overview:We are actively seeking a seasoned Head of Clinical Development to report directly to our Chief Executive Officer. This individual will hold primary responsibility for the strategic development and implementation of clinical programs for small molecules within the therapeutic realms of immunology and inflammation at Montai Therapeutics. We invite applications from highly motivated, collaborative, and results-driven professionals who possess the adaptability, creativity, and resourcefulness necessary to thrive in our dynamic environment.The Head of Clinical Development will be instrumental in steering the seamless transition of programs from research to clinical phases, as well as shaping comprehensive clinical strategies that encompass everything from candidate discovery to human proof-of-concept trials. As a pivotal leader in our clinical development efforts, this role involves the formulation and integration of clinical development plans that align with our research, translational, nonclinical, regulatory, and strategic goals. Additionally, this individual will oversee the teams responsible for supporting program operations, resource allocation, and interactions with both internal governance and external partners. This role is ideal for an experienced professional who is passionate about transforming innovative scientific discoveries into groundbreaking therapies through meticulous and collaborative planning and execution.

Amylyx Pharmaceuticals is dedicated to revolutionizing the treatment of diseases with significant unmet needs. We embrace challenges as opportunities, driven by a sense of urgency, rigorous scientific methodology, and a steadfast commitment to the communities we serve. Our focus is on clinical-stage development for conditions such as post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).Our mission thrives on our talented team, which embodies core values of audacity, curiosity, authenticity, engagement, and accountability — all of which foster a culture of care. Amylyx has curated a skilled workforce ready to act swiftly because the communities we support cannot afford to wait. If you are passionate about addressing some of the most challenging issues in medicine, we invite you to explore the opportunity below and apply.The OpportunityThe Associate Director of Computer System Validation (CSV) & Quality Compliance will provide enterprise-level leadership, strategic direction, and governance for the validation, lifecycle management, and continuous compliance of GxP-relevant computerized systems, particularly focusing on the Veeva Quality Suite. This position is pivotal in ensuring that our digital quality solutions and supporting systems comply with global regulatory standards (FDA, EMA, ICH, GAMP 5), safeguard data integrity, and maintain a sustainable, inspection-ready status across the organization.This role entails close collaboration with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, oversee new system implementations and significant enhancements, and promote harmonized, risk-based validation practices. Additionally, this position supervises quality compliance processes such as Change Control, Deviations, CAPA, and continuous improvement, ensuring timely resolutions, trend analysis, and effective governance through leadership of key forums, including Quality Management Review and cross-functional compliance meetings.

Company Overview Fulcrum Therapeutics, Inc. (NASDAQ: FULC) is a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative small molecules aimed at enhancing the lives of patients with genetically defined rare diseases. Our mission is to instill hope and offer new treatment options for individuals affected by rare hematologic disorders. We are actively advancing a robust pipeline of clinical and preclinical assets, with our flagship product, pociredir, being a first-in-class small molecule designed to elevate fetal hemoglobin levels in the treatment of sickle cell disease and other hemoglobinopathies. As we expand our portfolio of clinical-stage assets, we are seeking a dynamic and strategic leader to oversee our Pharmaceutical Development function. Job Description As the Director of Pharmaceutical Development, you will report directly to the Head of Technical Operations. You will spearhead all drug product development initiatives encompassing technical, managerial, and financial dimensions. Your responsibilities will include formulation development, clinical trial material production, process optimization, scale-up, and validation. The ideal candidate will adeptly lead, plan, and manage both the technical and business-related components associated with drug product development and manufacturing at contract development and manufacturing organizations (CDMOs) for various dosage form programs. Key Responsibilities Direct and oversee all strategic and operational facets of drug product development at Fulcrum. Design and implement pharmaceutical product development plans aligned with corporate objectives for all development programs. Collaborate with cross-functional teams, including Drug Substance, Analytical, Clinical Operations, Quality Assurance, and Regulatory CMC, to ensure that plans are comprehensive, phase-appropriate, and executed on schedule. Lead pharmaceutical development efforts for the pociredir program, covering clinical trial material for pivotal studies, pre-validation studies, validation plans, and commercial launch supply. Manage product development, technology transfer, and clinical manufacturing activities at contract manufacturing organizations (CMOs), ensuring adherence to Regulatory and Quality standards. Oversee pediatric formulation development initiatives as needed. Review and approve a wide range of documents (e.g., MBRs, Specifications, Protocols, Reports) at CMOs. Generate, review, and approve documentation related to Drug Product (formulation, process development, manufacturing) for Regulatory submissions (IND/IMPD and NDA/MAA).

Director of Business Development - USVCLS: Accelerating the Path to PatientsSince 1997, VCLS has been at the forefront of supporting innovators in biotech, Medtech, and Healthtech on their journey from discovery to market. We have a simple yet ambitious mission: to accelerate the delivery of life-changing products to patients. With over 230 industry experts globally, we are dedicated to our long-term vision of delivering 500 new healthtech products by 2050.We are currently on the lookout for a Director of Business Development - US—an experienced, hands-on leader—to implement our US commercial strategy with clarity, intention, and urgency. This role is perfect for an individual who views business development as a consultative art rather than just a transactional process, characterized by curiosity, empathy, and a genuine passion for Life Sciences.Key Results & AccountabilitiesDriving Growth Through Consultative Partnerships Propel significant revenue growth by cultivating strong, trust-based relationships within the biotech, medtech, healthtech, and investment sectors. Take charge of the complete business development lifecycle including listening, identifying opportunities, crafting solutions, and securing strategic partnerships. Exhibit total ownership of the sales process ensuring every client feels comprehensively understood and supported without any handoffs or gaps.Excellence in Client Engagement & Sales OwnershipThis role is committed to delivering a world-class consultative experience, anchored in scientific curiosity and deep client insight: Actively listen and convert client challenges into clear, actionable opportunities. Ensure that clients connect with the right VCLS experts at the right time to maximize value. Coordinate internal teams to facilitate meaningful discussions rather than generic interactions. Lead the development of proposals with meticulous attention, ensuring that each reflects a deep understanding and tailored solutions. Maintain outstanding responsiveness, clarity, and follow-through throughout the client engagement journey.Market Presence & Brand Elevation Represent VCLS credibly and passionately across the US market. Establish a prominent presence at industry events, within accelerators, investor networks, and innovation hubs. Enhance VCLS’s reputation as a reliable partner in regulatory strategy, clinical development, CMC, evidence generation, and commercialization.Stakeholder Leadership & Internal Alignment Collaborate closely with Business Unit leaders, scientific experts, and senior management to ensure seamless execution of business development initiatives. Encourage cross-functional teamwork to optimize client outcomes.

TetraScience is at the forefront of the Scientific Data and AI revolution, creating AI-native scientific datasets that power next-generation lab data management solutions and drive transformative scientific outcomes.About UsAs a leader in the Scientific AI market, TetraScience is recognized for generating more revenue than any of our competitors combined. In the past year, major players in computing, cloud, data, and AI have chosen TetraScience as their go-to partner for co-innovation and market strategies. For more information, visit our Newsroom.As part of your application, we encourage you to review the Tetra Way letter, written by our co-founder and CEO, Patrick Grady. This document will provide you with insights into our values and culture, helping you determine if TetraScience aligns with your professional ethos.Your RoleAs a Scientific Business Analyst, you will leverage your analytical mindset and strategic thinking to connect scientific insights with advanced technology. You will collaborate with scientists, product managers, and engineers to derive actionable insights from complex scientific data.With your expertise in Analytical Development and synthetic route optimization, you will identify innovative applications for AI and machine learning. Your strong communication skills will enable you to engage effectively with both scientific and business stakeholders, maximizing the value derived from scientific data.We seek a proactive, disciplined individual who is passionate about defining requirements for sophisticated solutions within R&D and Quality sectors of Life Sciences. You will embody principles of extreme ownership, demonstrating a proven ability to extract maximum value from data through enrichment, analysis, and integration with AI technologies.This position demands self-discipline and determination as we strive to revolutionize the life sciences industry.

Job Summary: The Associate Director of Development at Harvard's Division of Continuing Education (DCE) will be instrumental in crafting, executing, and enhancing impactful annual giving and stewardship programs.As a vital part of DCE's Advancement team, the Associate Director of Development will report directly to the Director of Advancement, while also collaborating closely with the Faculty of Arts and Sciences (FAS) Development team. This reporting structure facilitates seamless coordination with FAS development teams, strategic alignment, and access to shared resources.The primary aim of DCE is to ensure consistent annual support while increasing awareness of the diverse engagement opportunities available across FAS.Key Responsibilities: Development StrategyEstablish and supervise strategies aimed at acquiring, retaining, and upgrading non-rated and non-managed donors contributing between $100 and $10,000, thereby creating a robust and sustainable donor pipeline for FAS Development.Formulate and direct DCE annual fund strategies, aligning fundraising priorities with institutional objectives and working closely with FAS to maximize donor engagement and opportunities.Ensure all fundraising communications adhere to content standards and align with best practices and University branding, utilizing FAS Development resources for strategic insights.Lead cross-functional, project-based initiatives that support DCE's fundraising goals, including outreach to emerging donor and volunteer communities.Develop, implement, and refine policies and procedures that promote consistent, scalable, and effective fundraising operations.Participate in various FAS, DCE, and University-wide meetings with teams involved in marketing, stewardship, annual giving, and research.Annual GivingOversee the strategic direction of annual giving programs in close collaboration with DCE's Director of Advancement and the FAS Development team, ensuring alignment with institutional priorities and revenue targets.Manage a portfolio of annual fund priorities, establishing goals, identifying value propositions, allocating resources, and assessing performance to drive sustainable growth.Utilize the alumni database to enhance annual giving strategies, focusing on donor segmentation and accurate management of biographical records. Initiate programs that encourage alumni to update their information, ensuring data integrity and enhanced engagement.Recruit, guide, and manage volunteer leaders within the Harvard Extension Alumni Association.

Join Harvard University as the Assistant Director of Development for the Harvard College Fund. In this pivotal role, you will be instrumental in shaping fundraising strategies and engaging with alumni and donors to enhance support for the college. You will work closely with senior leadership to develop and implement innovative approaches to fundraising that resonate with a broad audience.