
MeiraGTx · London
YOUR MISSION The main purpose of the Advanced Bioprocessing Scientist is to perform advanced manufacturing and continuous improvement activities for the produc...
The main purpose of the Advanced Bioprocessing Scientist is to perform advanced manufacturing and continuous improvement
activities for the production of sterile gene therapy products in line with current Good Manufacturing Practice (cGMP).
practices to manufacture the required products.
safety, quality and flow.
operations.
manner.
to the agreed schedule.
alternative solutions; works well in group problem solving situations.
standard of excellence;
and objectives.
consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
skills; participates effectively in meetings.
needs; presents numerical data effectively; able to read and interpret written information.
undertaken in accordance with applicable procedures.
BMRs & audit/inspection actions is closed timely and in a RFT state.
Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Team Coordinator, R&D is a pivotal support role at the heart of Compass' scientific engine. As a key partner to our research and development teams, you will provide the essential administrative and executive support that enables our Research & Development Leadership Team (RDLT) to pioneer the future of mental health treatment. Location: Hybrid in our London office (2x/week in-office). Reports to: VP, Manufacturing & Supply. This position will support various leadership roles within the R&D function. Roles and responsibilities (Include but are not limited to): * Provide administrative support to VP Manufacturing, VP Clinical Operations and VP Statistics & Data Management and their teams * Manage calendars and organise meetings (including team meetings and events) * Book and arrange travel, transport and accommodation * Administrative support including purchase order processing, PDF editing, DocuSign coordination, and contract management * Manage execution and storage of key documentation * Implement and maintain standard operating procedures * Collate and file expenses * Assist with all necessary literature database management and reference management * Project coordination of discrete R&D activities * Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety, data integrity, and accuracy throughout the trial process Candidate Profile: * Excellent written and oral communication skills * Prior administrative experience preferred * Very good implementation, logistical and administrative skills, including proficiency in Microsoft Office suite (particularly Outlook, Word, PowerPoint, OneDrive), Adobe (including advanced PDF handling), and DocuSign * Great relationship skills; flexible and able to to work collaboratively in a team * and independently * Strong organisational skills and good attention to detail * Discreet and trustworthy * Ability to multi-task and work in multidisciplinary teams * Relevant educational background desirable; experience in mental health care or life sciences an advantage * Demonstrates COMPASS values BENEFITS & COMPENSATION: For an overview of our benefits package and compensation information, please visit "Working at Compass". EQUAL OPPORTUNITIES: Reasonable accommodation We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. SPONSORSHIP: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. DATA PRIVACY: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.
About CCRM Nordic CCRM Nordic breaks down the bottlenecks that slow life-changing therapies from lab to patient. Based at GoCo Health and Innovation City in Mölndal, we provide ATMP teams across Sweden, the Nordics and Europe with the infrastructure, know-how and partner network they need, whether that means a single consultation or a long-term manufacturing collaboration. We have invested in a brand-new GMP manufacturing facility with five processing rooms on floor 16 of GoCo House. We are now building the founding team that will shape how this facility runs, and are looking for a Manufacturing Team Lead ready to be part of something genuinely exciting. The opportunity This is a founding role. As one of the first hires into the manufacturing team, you will help build the structure, not just step into it. From authoring SOPs and batch records to training operators and leading quality investigations, this role sits at the operational heart of CCRM Nordic's manufacturing capability. You will lead a team of up to six GMP operators across multiple processing rooms, manage day-to-day scheduling and training, and act as the department's SME for quality systems. You will work alongside PD and MSAT colleagues on new product introductions and technology transfers, and collaborate with our Validation team on equipment qualification and process establishment. Key responsibilities Manufacturing Operations Lead day-to-day GMP manufacturing operations across multiple processing rooms, ensuring clinical materials are delivered on time and to the highest quality standard. Perform and oversee hands-on processing including cell culture, bioreactor operation, Tangential Flow Filtration (TFF) and chromatography. Schedule and manage housekeeping, environmental monitoring and cleaning activities, internally and with external contractors. Maintain full inventory control, ensuring consumables and raw materials are stocked and within expiry. People & Team Leadership Line manage a team of up to six pharmaceutical operators, including performance management, workload planning and day-to-day support. Design and deliver training plans to ensure every team member is qualified for all processing and ancillary activities. Act as a role model for a collaborative, high-performance culture: mentoring and developing the people around you. Quality & Compliance Serve as the manufacturing SME for all GMP quality matters, leading incident investigations, root cause analyses, change controls and CAPAs. Ensure all operations are executed in strict accordance with approved SOPs, Batch Manufacturing Records and current GMP guidelines. Author and review SOPs, batch records, logbooks, COSHH assessments and User Requirement Specifications for new equipment. Support regulatory inspections and ensure the facility is always inspection-ready. Collaborate with the Validation Department on equipment calibration, qualification and shutdown planning. New Product Introduction & Tech Transfer Partner with PD and MSAT teams to introduce new products and processes into the GMP suite. Support technology transfers into and out of the facility, including handovers to clients or CMOs. What we are looking for Essential Minimum 5 years' GMP manufacturing experience, with a strong focus on bioproduction or ATMPs. Proven track record as a line manager of a GMP manufacturing team. Hands-on experience with ATMPs, ideally including Viral Vectors or similar advanced modalities. Degree in bioprocessing, microbiology or a related life science discipline, or equivalent experience. Deep working knowledge of GMP QMS systems: quality incidents, change controls and CAPA management. Experience authoring SOPs, batch records and validation documentation. Strong communication skills and ability to collaborate across functions. Highly Desirable Experience in Tech Transfer and process validation. Hands-on operation of TFF systems, including Repligen platforms. Experience supporting or participating in regulatory inspections. The person We are looking for someone who is: A strong team player who invests in the people around them and understands that great manufacturing is a collective achievement. Adaptable and calm under pressure, able to pivot when processes change, timelines shift or unexpected challenges arise. Energised, not overwhelmed, by the complexity of a new facility and evolving product portfolio. Service-oriented and delivery-focused, with high personal standards for accuracy and thoroughness. An excellent organiser who can hold multiple priorities without letting quality slip. Why join CCRM Nordic? CCRM Nordic is an innovation-led organisation at the frontier of ATMP development. Joining now means helping to shape the team, culture and operational standards of a facility that will directly contribute to getting advanced therapies to patients faster. A rare opportunity to join a founding manufacturing team and leave your mark on how things are built. Work alongside world-class scientists and process development experts on cutting-edge ATMP programmes. A collaborative, supportive environment where your expertise is genuinely valued. Clear pathways for growth as the team expands from Phase 1 through to full multi-project manufacturing capacity. Competitive salary in line with the Swedish pharmaceutical market. Ready to build something important? We'd love to hear from you.
Arbetsuppgifter Cell Technology Group (CETEG, Dept. Industrial Biotechnology, CBH Skola, KTH, Stockholm), har en lång erfarenhet av utveckling av biofarmaceutiska och biologiska läkemedelsbioprocesser för humanterapi. CETEG:s ledare är Prof. Veronique Chotteau, som är Föreståndare av AdBIOPRO, en Competence Centre for Advanced Bioproduction by Continuous Processing, i samarbete med Lund University, Karolinska Institutet, Linköping University, Karolinska Sjukhus samt 15 svenska företag inom proteinläkemedel/bioteknik industri. I CETEGs verksamhet ingår bioprocessing av perfusion processer med väldigt hög celltäthet och fed-batch processer, metabolic flux analysis modellering och on-line process monitorering, alla inriktade mot processutveckling av industriell produktion av proteinläkemedel, virala vektorer eller humana celler för terapi. Gruppen, på 10 personer, är ett multidisciplinärt team, med forskare, post-docs samt doktorander och master studenter. CETEGs aktiviteter präglas av samarbete med akademiska grupper på KTH, i Sverige och i Europa samt internationella företag och SME. Cell Technology Group har nu en ledig vikariattjänst som Forskningsingenjör. Det praktiska arbetet kommer att ske på KTH, AlbaNova Centre. Forskningsingenjören kommer att stödja verksamheten av CETEG med följande uppgifter: Koordinering av labbfunktioner för olika labbaktiviteter, samt stöd för AdBIOPRO Stödja forskningsprojekt och uppdragsforskning, t. ex. odlingsprocess, analyser, reningsprocess, samt rapportering Kontakt med leverantör ang. utrustning och reagens samt tillämpning av regler enligt KTHs ramverk för beställningar, t. ex. upphandling- Kontakt med övriga grupper inom Industrial Biotechnology Avd. och CBH Skola ang. labverksamhet, miljögranskning och säkerhet Introduktion och utbildning för nybörjare samt praktik inom mammaliecell odling Register i bruk inom CETEG, t.ex. kemikalier inventering, cellbank Kvalifikationer Krav Avlagd examen på grundnivå eller avancerad nivå (högskoleutbildning), såsom civil ingenjör, inom bioteknik eller motsvarande kompetens Kunskap om odling av mammalieceller, inklusivt bioreaktor operation Behärska engelska skriftligt och muntligt då man arbetar i ett internationellt miljö och det krävs i det dagliga arbetet Ämnesskicklighet Yrkesskicklighet. Medvetenhet om mångfalds- och likabehandlingsfrågor med särskild fokus på jämställdhet Självständighet Initiativtagande Personlig mognad God samarbetsförmåga Bra organisations- och planeringsförmåga Benägen att ta ansvar Bra förmåga för skriftlig rapportering Bra förmåga för strukturerat arbetssätt Meriterande Behärska svenska skriftligt och muntligt då det är KTH:s myndighetsspråk Vi kommer lägga stor vikt vid personliga egenskaper. Bli en del av KTH KTH formar framtiden genom utbildning, forskning och innovation. Som ett ledande internationellt tekniskt universitet spelar vi en aktiv roll i att driva och medverka i omställningen till ett hållbart samhälle. Här erbjuds du möjligheten att växa och utvecklas på en kreativ och dynamisk arbetsplats med goda arbetsvillkor och förmåner. Jämställdhet, mångfald och lika villkor är en kvalitetsfråga och en självklar del av KTH:s värdegrund som universitet och statlig myndighet. Läs mer om våra förmåner och hur det är att arbeta och utvecklas på KTH. Fackliga representanter Kontaktuppgiftertill fackliga representanter. Ansökan Du ansöker via KTH:s rekryteringssystem. Du som sökande har huvudansvaret för att din ansökan är komplett när den skickas in. Ansökan ska innehålla: CV inklusive relevant yrkeserfarenhet och kunskap. Kopia av examensbevis och betyg från dina tidigare universitetsstudier. Översättningar till engelska eller svenska om de ursprungliga dokumenten inte utfärdas på något av dessa språk. Personligt brev, max 2 sidor långt. Två referenser. Ansökan ska vara KTH tillhanda senast sista ansökningsdagen vid midnatt, CET/CEST (CentralEuropean Time/Central European Summer Time). Om anställningen Anställningen gäller tidsbegränsat enligt avtal - i upp till ett år, med tillträde enligt överenskommelse. Övrigt För information om behandling av personuppgifter i samband med rekrytering. Det kan förekomma att en anställning hos KTH är placerad i säkerhetsklass. Om så är fallet för just denna anställning görs en säkerhetsprövning av sökande i enlighet med säkerhetsskyddslagen (2018:585) efter samtycke. I dessa fall är en förutsättning för anställning att sökande blir godkänd efter säkerhetsprövning. Vi undanber oss direktkontakt med bemannings- och rekryteringsföretag samt försäljare av platsannonser.