Amylyx Pharmaceuticals

You would oversee CMC quality for drug substance manufacturing, packaging, and distribution, review quality records, and support regulatory submissions and inspections. | You need at least five years of relevant experience, a bachelor’s or advanced degree, and specific peptide or oligonucleotide manufacturing experience plus knowledge of FDA cGMP regulations and ICH guidance. | Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity This position is responsible for providing CMC quality oversight of drug substance manufacturing, packaging and distribution. As the CMC quality expert, this role is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the CMC Quality department performs to a standard that ensures the quality of products and materials produced by Amylyx contracted partners. Responsibilities Provide quality oversight of drug substance production activities. Provide QA review and approval on drug substance validation documents, equipment validation documents, master production records, product specifications (in-process, release, and stability), analytical method qualification/validation documents, method transfer documents, and stability plans. Review executed Batch Production and QC Control Records to ensure all approved procedures were followed and all specifications are met. Prepare and /or approve batch disposition packages. Provide QA review and approval on quality system records, including but not limited to deviations, OOS, change controls, CAPAs, and product quality complaints. Lead or participate in regular meetings internally and externally as Quality SME to ensure Amylyx’s quality expectations are met in the areas of Good Manufacturing Practice, Good Distribution Practice, and Good Documentation Practice. Write, review and/or approve SOPs as QA SME for manufacturing, labeling, packaging, and transportation of late stage and commercial products. Provide QA review on NDAs. Assure that source data and information used in regulatory submissions and validation activities is maintained and traceable. Support FDA, EMA or other regulatory agency inspections. Requirements Minimum 5 years of experience with B.S. in Pharmaceutical Sciences or minimum 3 years of experience with advanced degrees in Pharmaceutical Sciences. Minimum 3 years of experience directly related to peptide and or oligonucleotide (ASO) manufacturing, including but not limited to quality operations, QC, MSAT, etc. Experience with authoring and reviewing NDA CMC sections and addressing Regulatory Filing requirements in FDA cGMP regulations, Eudralex and ICH Guidance, as well as other Biopharma industry guidance and regulations. Ability to work with all levels of the organization and external contract service providers to ensure compliance with current regulations. Travel may be required up to 10% within US, which may include on-site review of third-party operations. Preferred Qualifications QC experience is a plus. Work Location and Conditions At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii. You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested. You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity. Base salary is one component of Amylyx’s total rewards package. In addition to competitive base pay, eligible employees may receive annual performance-based bonuses and equity awards, providing an opportunity to share in the company’s long-term success. Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees. Estimated Pay Range $129,000—$145,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

You would oversee customer and commercial data flows, quality, documentation, targeting, territory alignment, roster maintenance, field-user support, and assessment of new data sources. | The role requires a bachelor’s degree, at least five years of relevant experience, hands-on commercial customer data and recurring data-feed experience, and advanced Excel skills, with SQL, CRM, and field operations experience preferred. | Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Reporting to the Director, Field Operations & Data Management, the Senior Manager, Field Operations & Customer Data Management is a hands-on, execution-focused role within Commercial Operations. This position will support the reliable movement and use of customer and field data across the commercial data ecosystem, including CRM, specialty pharmacy, claims, hub, and other third-party data sources. The Senior Manager will work closely with data aggregators, source-data vendors, Information Technology, analytics partners, and field stakeholders to ensure data is delivered accurately, consistently, and on schedule into Amylyx data warehouses and downstream reporting solutions. This role is highly tactical and detail oriented. The successful candidate will be comfortable working in the data, investigating issues, coordinating fixes, validating outputs, documenting processes, and resolving the daily operational challenges that can affect field execution. The role will also provide substantial support for customer targeting, field force sizing, territory alignment, roster and assignment maintenance, and the evaluation of new commercial data sources. Responsibilities Customer data operations: Support the day-to-day receipt, processing, integration, validation, and availability of customer and commercial data, including CRM, specialty pharmacy, claims, affiliations, customer reference, field activity, and other vendor-supplied datasets. Data quality and issue resolution: Monitor recurring data deliveries and warehouse outputs; identify missing, late, incomplete, duplicated, or inconsistent data; conduct root-cause analysis; coordinate corrective actions; and follow issues through resolution. Vendor management: Serve as an operational point of contact for data and field operations vendors, including possible data aggregator. Manage delivery calendars, file specifications, data transfer dependencies, service expectations, issue logs, status updates, and follow-up actions. Data validation and reconciliation: Perform detailed quality control checks and reconciliations across source files, staging layers, warehouse tables, CRM outputs, vendor reports, and downstream dashboards; document findings and escalate material risks. Ensure quality data is available for incentive compensation administration. Data documentation and controls: Maintain business rules, source-to-target mappings, data dictionaries, file layouts, standard operating procedures, validation checklists, issue histories, and other documentation needed for repeatable and auditable operations. New data source evaluation: Support the assessment of potential new data sources by documenting business use cases, reviewing coverage and field definitions, evaluating quality and usability, coordinating sample-data testing, identifying integration requirements, and summarizing findings and tradeoffs. Stakeholder needs and data recommendations: Engage field teams, field leadership, Commercial leadership, Analytics, and other stakeholders to clarify business questions and operational needs. Translate requests into defined data requirements and recommend the data sources, measures, analyses, or reporting approaches best suited to answer the question, while clearly communicating data limitations and tradeoffs. Customer master and alignment support: Help maintain accurate customer, account, affiliation, territory, roster, and assignment data across relevant systems. Investigate and resolve alignment, ownership, hierarchy, and customer identity issues that affect field teams. Field targeting & alignment: Execute and maintain customer targeting processes, including data preparation, business-rule application, final list deployment. Support territory alignment activities, including geographic and customer-level analyses, scenario development, balance assessments etc. CRM and field support: Partner with CRM owners and field operations colleagues to troubleshoot customer, roster, territory, targeting, and data visibility issues; provide timely updates and practical solutions to field users and leadership. Operational coordination: Maintain project plans, action logs, decision records, recurring status materials, release calendars, and stakeholder communications across concurrent data and field operations workstreams. Continuous improvement: Identify recurring pain points and opportunities to improve data quality, vendor performance, controls, documentation, automation, and the efficiency of field operations processes. Requirements Bachelor’s degree required in business, analytics, information systems, data management, life sciences, or a related field. 5+ years of experience in pharmaceutical, biotechnology, healthcare, commercial operations, data operations, sales operations, CRM operations, analytics, or a related discipline. Hands-on experience working with commercial/customer data such as CRM, specialty pharmacy, claims, affiliations, customer master, targeting, roster, territory, or field activity data. Experience working with healthcare or commercial data aggregators and translating stakeholder questions into practical data requirements, source recommendations, or analytical approaches strongly preferred. Experience managing recurring data feeds and working with vendors and technical teams to investigate and resolve data delivery, transformation, quality, or availability issues. Working knowledge of commercial data warehouses, data integration processes, master data concepts, business rules, data quality controls, and downstream reporting dependencies. Experience supporting customer targeting, territory alignment, field force sizing, roster management, or other field operations processes strongly preferred. Advanced Excel skills required; experience with SQL, business intelligence tools, CRM platforms, data quality tools, geographic mapping tools, or data warehouse environments preferred. Strong analytical and problem-solving skills, with the curiosity and persistence to trace issues across datasets, systems, vendors, and business processes. Exceptional attention to detail and the ability to manage recurring operational deliverables while responding effectively to urgent, unplanned issues. Clear written and verbal communication skills, including the ability to document technical and business rules, explain issues, coordinate decisions, and provide concise status updates. Ability to build productive working relationships across Commercial Operations, field leadership, Analytics, Information Technology, Finance, Compliance, and external partners. High degree of accountability, organization, judgment, and comfort working in a fast-paced environment with evolving priorities and incomplete information. Work Location and Conditions: At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii. You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving or public transportation. You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range $162,000—$182,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Lead market research and competitive intelligence for PBH commercialization, translating patient, HCP, market, and competitor insights into launch, pipeline, and business decisions. | Requires 10+ years of relevant experience, a bachelor’s degree, pharmaceutical market-research leadership across the full project lifecycle, and experience with tracking research, competitive intelligence, vendors, and executive communication. | Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity Reporting to the Senior Director, Market Insights, the Associate Director, Market Research & Competitive Intelligence will lead primary market research and competitive intelligence to support commercialization of avexitide in post-bariatric hypoglycemia (PBH). This highly visible, hands-on role will develop and execute an integrated insights plan spanning foundational, strategic, communications, and tracking research, including HCP and patient attitudes, trial, and usage (ATU) studies. The role will also lead competitive intelligence efforts that provide timely, objective, and actionable perspectives on the PBH disease state, emerging treatment landscape, competitor activity, and market implications. While PBH and avexitide commercialization will be the primary focus, this individual will provide fit-for-purpose market research and competitive intelligence support for New Products Planning (NPP), pipeline assets, and selected business-development needs. Responsibilities • PBH insights leadership: Serve as the primary market research and competitive intelligence partner for PBH commercialization, translating business questions into an integrated insights plan that informs market development, launch strategy, and execution. • Patient Journey: Partner with Forecasting, Analytics, Marketing, Market Access, Medical Affairs and other stakeholders to integrate research and secondary data to maintain a deep understanding of the Patient Journey. • Integrated Insights: Share key insights with the organization as needed and as a core team member to the Central Insights Team. Oversee updates to the Facts and Insights document so that it provides an accurate view of insights to the organization • Primary market research: Lead end-to-end qualitative and quantitative research with healthcare professionals, patients, caregivers, and other relevant stakeholders, from problem definition and study design through vendor oversight, analysis, synthesis, and action planning. • Tracking and ATU research: Lead HCP and patient ATU and other tracking research, including KPI definition, questionnaire evolution, wave-to-wave comparability, trend interpretation, and integration of findings into commercialization decisions and launch-readiness planning. • Competitive intelligence leadership: Establish and lead the PBH competitive intelligence process, covering competitor pipelines, clinical data, scientific activity, regulatory developments, business and investor activity, partnerships, market-entry signals, and relevant disease-state developments. • Strategic implications: Move beyond news reporting to assess potential impact, identify risks and opportunities, and recommend actions for brand, medical, market access, commercial, and corporate stakeholders. • CI communication and governance: Maintain competitor profiles, landscape assessments, timelines, trackers, SWOTs, source documentation, and recurring updates, with clear escalation criteria for high-impact developments. • NPP and pipeline support: Provide fit-for-purpose primary research and competitive intelligence for NPP and pipeline assets, including opportunity assessments, target product profile input, unmet-needs exploration, indication prioritization, differentiation, and commercial potential. • Vendor and budget management: Select and manage market research and CI partners, including RFPs, scopes of work, budgets, timelines, quality standards, compliance requirements, and performance expectations. • Executive communication: Translate complex and sometimes conflicting evidence into concise, objective, decision-oriented narratives and visual outputs for senior leadership and cross-functional teams. • Research excellence and compliance: Apply rigorous research standards, protect respondent confidentiality, support appropriate adverse-event and product-complaint reporting, and document methods, limitations, and sources. Required Qualifications • Bachelor’s degree required in business, marketing, market research, social sciences, public health, life sciences, statistics, or a related field; advanced degree is a plus. • 10+ of relevant experience in pharmaceutical, biotechnology, healthcare, life sciences consulting, primary market research, competitive intelligence, commercial insights, or related discipline. • Demonstrated experience leading qualitative and quantitative pharmaceutical market research across the project lifecycle, including business-question framing, research design, vendor management, analysis, synthesis, and stakeholder activation. • Experience with strategic and tracking research, including HCP or patient ATU studies; patient journey, segmentation, demand, positioning, messaging, campaign, or launch-readiness research strongly preferred. • Experience developing or leading competitive intelligence programs, including secondary monitoring, landscape assessments, conference intelligence, synthesis of implications, and executive communication. • Experience supporting launch-stage brands, specialty or rare-disease markets, and pre-commercial assets strongly preferred. • Ability to integrate primary research, secondary data, competitive intelligence, clinical evidence, and internal perspectives while clearly distinguishing facts, assumptions, and implications. • Excellent written, verbal, and visual communication skills, including the ability to distill complex findings into clear strategic choices and recommendations. • Strong vendor, project, and budget management skills, with the ability to manage concurrent studies, recurring intelligence activities, and urgent ad hoc requests. • High degree of curiosity, objectivity, judgment, attention to detail, and comfort operating in a fast-paced environment with evolving priorities and incomplete information. Work Location and Conditions • At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii. • You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested. • You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range $195,000—$219,000 USD To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Remote Skills: Analysis Skills, Biology, Biotech and Pharmaceutical, Budget Management, Budgeting, Campaigns, Clinical Data, Clinical Research, Communication Skills, Competitive Analysis/Strategy, Competitive Research, Consulting, Cross-Functional, Detail Oriented, Disease, Documentation, Establish Priorities, Forecasting, Genetics, Healthcare, Insurance, Internet Privacy, Leadership, Linux Media Players, Market Development, Market Research, Marketing, Medical Affairs, Medicine, Military, New Product Planning, News Reporting, Presentation/Verbal Skills, Product Support, Project Lifecycle, Public Health, Qualitative Research, Quality Metrics, Quantitative Market Research, Quantitative Research, Regulations, Regulatory Compliance, Request for Proposals (RFP), Risk Analysis, Social Science Research, State Laws and Regulations, State Tax, Statistics, Tax Regulations, Telephone Skills, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Management, Videoconferencing, Visual Communication, Willing to Travel, Work From Home, Writing Skills Amylyx Pharmaceuticals