\nTHE ROLE\n\nThe Lead of Quality Control and Analytical Development is responsible for managing a team that provides quality oversight in support of clinical and commercial operations and analytical development of early and late-stage clinical products.\n\nFrom a QC standpoint, the individual will assist in the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing on clinical/commercial pharmaceutical products and Active Pharmaceutical Ingredients (API). The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This includes, but is not limited to, assisting with QC checks and preparation of regulatory filings (Supplements and Annual Reports).\n\nFrom an AD standpoint, the individual will support analytical development activities at CMO/CRO, troubleshoot analytical method issues, manage the reference standard program for development projects, manage stability study programs and generate shelf-life projections. As necessary, the individual will write CMC sections relevant to analytical methods, specifications, and stability studies.\n\nRESPONSIBILITIES\n\nManages a team and directly performs the following:\n\n\n* Review testing data (release, stability, etc.) from studies performed for Amylyx.  Identify trends and ensure data is analyzed to help understand degradation pathways and to help develop specifications.\n\n* Lead and partner with Contract Laboratories through investigations (OOS and atypical results), and process change assessments through data mining, statistical analysis, and visualization. Conduct trend analysis of data including writing Annual Product Review sections.\n\n* Develop, review and approve specifications, stability protocols, method validation and method transfer reports.\n\n* Develop and maintain statistical models such as statistical process control, multivariate analysis, and process analytics. Conceptualize and deploy data science solutions in support of continuous improvement.\n\n* Work with internal teams, CMOs and testing laboratories to establish methods and specifications.\n\n* Oversee management of the reference standard program to ensure compliance and timeliness of certificates of approval.\n\n* Author and or review QC sections (e.g., batch analysis, analytical methods, reference standard, etc) of regulatory filings (CTD/NDA/BLA or IND/IMPD).\n\n* Lead the analytical development activities for early and late late-stage clinical products at CMO/CRO.\n\n* Manage the analytical activities for process performance qualification, continuous process verification, cleaning studies/validation, shipping studies/validation, etc. for clinical products at CMO/CRO.\n\n* Manage developing, validating, and standardizing complex GC, GC/MS, HPLC, LC/MS, ICP/MS analytical methods for isolation, detection, identification, and quantification of both drug substances and drug products of small molecules or/and large molecules.\n\n* Lead analytical activities for formulation development, process development, forced degradation, extractable and leachable studies for commercial and clinical products as required.\n\n* Manages the analytical testing, evaluates material and products at all stages of development process under stringent quality and time requirements.\n\n* Provide analytical testing assessment for contract laboratories, and other contracted vendors used for clinical product manufacturing at CMO/CDMO as required.\n\n* Ensure GMP compliance from analytical testing perspectives for the drug products manufactured and tested for clinical studies.\n\n* Collaborate with Quality Assurance for quality audits, investigations of OOS, deviations, change controls, CAPA, and temperature excursions as required. Review/approve deviations, OOSs/OOTs, Change Controls, CAPAs and any other related Quality records.\n\n* Support tracking, trending, stability data, batch failures, OOS/OOT, investigations, deviations, change controls, CAPA, product complaints as required.\n\n* Manage authoring/review/approve SOP and policies related to CMC as required.\n\n* Provide mentorship and guidance to junior associates.\n\n\n\n\nREQUIREMENTS\n\n\n* Bachelor’s (BS) degree in analytical chemistry, biochemistry, biology, chemical sciences or in a relevant scientific discipline or equivalent\n\n* Minimum (8) years of experience (or MS with 5+ years of experience) in the pharmaceutical/bio-pharm manufacturing industry (managerial experience a plus)\n\n* Managerial/Supervisory Experience a plus\n\n* Experience with Oligonucleotides and Peptide development programs as plus\n\n* Analytical/QC laboratory experience\n\n* Proven ability to achieve results and success in a group environment and on cross-functional teams is required\n\n* Strong communication and interpersonal skills\n\n* Ability to manage multiple tasks and deadlines with attention to detail\n\n* Exhibit strong technical skills and the ability to critically evaluate raw data and results\n\n* Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities\n\n* Knowledgeable in cGMP regulations and ICH and/or other industry guidance\n\n* JMP and/or other statistical application experience a plus\n\n* Knowledge of Microsoft Office (Teams, Excel, SharePoint, etc.)\n\n* Good understanding of product process and development, from discovery to commercialization\n\n* Travel may be required up to 10%, which may include on-site review of third-party laboratory and manufacturing operations.\n\n\n\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Junior and Junior jobs that are similar:\n\n $20,000 — $50,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nCambridge, Massachusetts, United States

\nReports to: Manager, Security Operations Center\n\nLocation: Remote, based in East Coast USA\n\nCompensation Range: $95,000 to $115,000 base plus bonus and equity \n\nWhat We Do:\n\nFounded in 2015 as a fully remote company by former NSA cyber operators, Huntress was built on a simple premise: to force hackers to earn every inch of their access. \n\nToday’s cyber-attacks aren’t limited to large organizations with the security tools that can ward off threats. Hackers don't discriminate and will find a way to penetrate any vulnerability in any size business, which is why Huntress focuses on protecting those small to midsize businesses that make up the backbone of our economy.\n\nHuntress stops hidden threats that sneak past preventive security tools by utilizing our award-winning security platform and expert human threat hunters through dynamic products including Managed EDR, MDR for Microsoft 365, and Managed Security Awareness Training.\n\nJoin the hunt and help us stop hackers in their tracks!\n\nWhat You’ll Do: \n\nDo you like puzzles or do you like to take things apart just to figure out how they work and then put them back together? Or do you look at everyday things and question “why” and try to improve them? Or perhaps you enjoy researching security-related topics and sharing your findings/knowledge with people to help them grow? If so, then keep reading! \n\nThe Huntress SOC team has the unique honor of waking up every morning knowing we’re going to make hackers regret targeting our partners and customers. As a Senior Security Operations Center Analyst, we're looking for a seasoned expert possessing extensive knowledge of cybersecurity and IT principles. The successful Huntress Senior SOC Analyst will have but not be limited to a well-established track record of leading and actively participating in critical team and business unit initiatives. Such activities include a technical escalation point, creating training sessions/content associated with the training, and sharing important milestones while welcoming feedback for project-based endeavors with other senior members of the SOC and management team. \n\nWe defend over 2 million endpoints, which continues to grow monthly. Considering this market’s tighter budget, it’s not financially possible to dedicate human analysts to each client. Our global SOC team addresses this by using highly automated efficiencies that make intruders earn every inch of their access.\n\nThe following is what Huntress is looking for in a Senior SOC Analyst candidate.\n\nResponsibilities:\n\n\n* Lead SOC training programs and contribute to content creation ensuring the team is well-equipped with the latest knowledge and skills\n\n* Offer guidance/mentoring to the junior analysts for their daily operations and tasks while also reporting to management how to better close any seen gaps across the team\n\n\n\n* We're all here to make each other better and to keep pushing each other to a higher standard while being accountable to each other as well\n\n\n\n* Provide technical guidance and expertise to the other parts of Huntress as required.\n\n* Work with other teams to identify and mitigate threats as they appear on a day-to-day basis\n\n* Continually growing your knowledge of the internal procedures and processes, the Huntress product, the threat landscape, and customer environments\n\n* Using analytical thinking and problem-solving skills to gain greater efficiencies in the Security Operations processes and procedures or other business processes that impact the SOC team\n\n* Contribute to external facing huntress content such as blogs, webinars, presentations, and speaking engagements\n\n\n\n\nWhat You Bring To The Team:  \n\n\n* 3+ years experience in a SOC, Incident Response, or IT role\n\n* Excellent verbal and written skills with the ability to explain possible complex alerts/events in a non-complex way\n\n* Proven mentoring experience and skills to junior team members allowing them to grow individually and as a team\n\n* Equivalent self-guided study experience or Bachelor’s degree in Information Technology, Computer Science, System Administration, or Cyber Security\n\n* Understanding of Malware Analysis (Configuration of isolated Malware Analysis VM, Identification of File Formats, Basic Static & Dynamic analysis)\n\n* Demonstrated experience with Windows OS, and/or Mac OS as an attack surface.\n\n\n\n* MacOS equivalent of the above is a plus\n\n\n\n* Demonstrated experience with basic Threat Actor Tools and techniques: (MITRE ATT&CK Framework, PowerShell & Command Prompt Terminals, WMIC, Scheduled Tasks, SCM, Windows Domain and host Enumeration Techniques, Basic Lateral Movement Techniques, Basic Persistence Mechanisms, Basic Defense Evasion Techniques, other offensive/Red Team TTPs)\n\n* Demonstrated experience with Windows Administration or Enterprise Domain Administration and upkeep: (Active Directory, Group Policy, PowerShell, Windows Server Update Service, and Domain Trusts)\n\n* Network Administration Skills: (Network Protocols and ports, OSI Layers, Network Segmentation techniques such as VLANs, Network Address Translation, Public and private IP Addresses, Default Gateways, Subnet Masks, IP Address assignment, DNS, Firewalls, IDS, Load Balancers, and Proxy Servers, Remote Access Methods such as VPNs, RDP, SSH, VNC, and Telnet)\n\n* Network Analysis: (Familiarity with Wireshark, network logging, and basic networking ports used)\n\n* Understanding of web technologies (web servers, OWASP top 10, web services, etc.)\n\n\n\n\nPreferred Qualifications:\n\n\n* Experience with scripting languages (such as PowerShell, Python, Bash, PHP, JavaScript, or Ruby) \n\n* Familiarity with MSP tools such as RMMs\n\n* Demonstrated experience on platforms such as HackTheBox, TryHackMe, Blue Team Labs Online, etc. \n\n* Participation in cybersecurity competitions such as Capture the Flags, the Collegiate Cyber Defense Competition, etc.\n\n* Previous experience working at or with an MSP/MSSP\n\n\n\n\nWhat We Offer: \n\n\n* 100% remote work environment - since our founding in 2015\n\n* Generous paid time off policy including vacation, sick time, and paid holidays\n\n* 12 weeks paid parental leave\n\n* Highly competitive and comprehensive medical, dental, and vision benefits plans \n\n* 401(k) with 5% contribution regardless of employee contribution\n\n* Life and Disability insurance plans\n\n* Stock options for all full-time employees \n\n* One-time $500 reimbursement to build/upgrade home office\n\n* Annual allowance for education and professional development assistance \n\n* $75 USD/month digital reimbursement\n\n* Access to both Udemy and BetterUp platforms for coaching, personal, and professional growth\n\n\n\n\n \n\nHuntress is committed to creating a culture of inclusivity where every single member of our team is valued, has a voice, and is empowered to come to work every day just as they are. \n\nWe do not discriminate based on race, ethnicity, color, ancestry, national origin, religion, sex, sexual orientation, gender identity, disability, veteran status, genetic information, marital status, or any other legally protected status.  \n\nWe do discriminate against hackers who try to exploit small businesses. \n\nAccommodations: \n\nIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or participating in the employee selection process, please direct your inquiries to [email protected]. Please note that non-accommodation requests to this inbox will not receive a response. \n\nIf you have any questions about your personal data privacy at Huntress, please visit our privacy page.\n\n#BI-Remote \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Education, Microsoft and Senior jobs that are similar:\n\n $60,000 — $90,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nColumbia, Maryland, United States