Cmc Analytical Scientist

il y a 1 mois


Paris, France Persuaders RH Temps plein

**Entreprise**:
Our client, a gene therapy biotech, spin-off of Genethon, is searching for his/her CMC Operational Manager.

**Poste**:
Within a high growth, fast paced small organization, the CMC Analytical Scientist is responsible for providing analytical expertise and leadership in the development and manufacturing of recombinant
- adeno associated virus vectors (rAAV).

ln this position, he/ she will manage the analytical development activities for the company’s programs through coordination of contract research organization (CROs) and contract development and manufacturing organization (CDMOs) to support all stages of the drug development, from preclinical to commercial.

This includes methods development/ re-evaluation/ optimization, troubleshooting of methodologies as requested, methods transfer and validation. The ability to be productive and successful in an intense work environment is critical.

**Key activities**:

- Work with the CMC Operational Manager and the CDMOs /CROs to define the Critical Quality Attributes (CQAs), conduct comprehensive rounds of testing on starting materials, raw materials, intermediates and final products,
- Propose new analytical methods or refine existing ones, in response to changing requirements during the pharmaceutical development.
- Oversee the analytical development for the pipeline products. Conduct transfer and validation for the methods’ official use,
- Oversee the stability studies for drug substance and drug product. Evaluate and monitor the data,
- Manage the company’s inventory for Reference Materials. Coordinate the manufacturing and characterization of new reference material as well as the stability studies and shelf-life extension of the existing one.
- Provide the CMC supportive data/documentation to prepare regulatory packages (IND/ IMPD/ MAA/ BLA). Review the CMC sections.
- Proactively maintain knowledge in CMC analytical sciences. Investigate advanced technology and research opportunities,

**Profil**:

- Advanced degree in Biology Sciences, Molecular Biology is a plus (MD, PharmaD, PhD) with 5 to 10 years’ experience in analytics for Biological Products (Biotech, BioPharma, CRO, CDMO).
- Expertise in relevant analytical techniques, including but not limited to, qPCR/ ddPCR, RT-PCR, bioassays spectroscopy, chromatography (SEC, HPLC), electrophoresis, immunoassays, microbiology testing.
- Good comprehension of cGMP/USP/Ph. Eur and applicable FDA and EMA regulations.


  • Cmc Officer 833

    il y a 1 mois


    Paris, France Product Life Group Temps plein

    About usProductLife Group is looking for a CMC Officerto join our dynamic team in France. **Responsibilities**: Prepares CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files) Reviews CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files) Defines strategies for writing documents, Defines...

  • Research Scientist

    il y a 2 semaines


    Paris, France Centeon Temps plein

    Company Mission:Centeon (stealth mode) is a low-carbon chemicals company. Our vision is to develop and to scale a breakthrough pathway for the low-energy, low-carbon production of commodity chemicals in service of today’s energy transition.  Job Mission:We are looking for a research scientist/engineer with a strong background in analytical chemistry....


  • Paris, France MAC-ERCI International Temps plein

    Descriptif du poste Rattaché au Team Leader Analytical Sciences, vous aurez pour mission principale de participer à la création des solutions technologiques innovantes permettant de répondre aux besoins des consommateurs. Pour cela, vous managerez une équipe composée de deux collaborateurs. En tant qu’acteur clé, vous développerez des...


  • Paris 1er, France MAC ERCI International Temps plein

    Descriptif du poste Rattaché au Team Leader Analytical Sciences, vous aurez pour mission principale de participer à la création des solutions technologiques innovantes permettant de répondre aux besoins des consommateurs. Pour cela, vous managerez une équipe composée de deux collaborateurs. En tant qu’acteur clé, vous développerez des méthodes...

  • Data Scientist

    il y a 4 semaines


    Paris, France Enzo Tech Group Temps plein

    Role: Data Scientist Location: Paris (3 days) / Remote (2 days)Searching for a Data Scientist partnering with a global customer who are searching for multiple Data Scientist's as they continue to invest in designing and building high-quality AI solutions.ResponsibilitiesAnalyze raw data: assessing quality, cleansing, structuring for downstream...

  • P&C Data Scientist

    il y a 3 semaines


    Paris, Ile-de-France JCW Group Temps plein

    P&C Data Scientist – Paris1. PurposeJoin a leading insurance company and be at the forefront of innovation as a P&C Data Scientist in Paris. This role combines actuarial expertise with data science to enhance risk assessment and support strategic decision-making through advanced analytics.2. Key Result Areas and Deliverables:Develop strong relationships...

  • P&C Data Scientist

    il y a 4 semaines


    Paris, France JCW Group Temps plein

    P&C Data Scientist – Paris1. PurposeJoin a leading insurance company and be at the forefront of innovation as a P&C Data Scientist in Paris. This role combines actuarial expertise with data science to enhance risk assessment and support strategic decision-making through advanced analytics.2. Key Result Areas and Deliverables:Develop strong relationships...

  • P&C Data Scientist

    il y a 3 semaines


    Paris, France JCW Group Temps plein

    P&C Data Scientist – Paris1. PurposeJoin a leading insurance company and be at the forefront of innovation as a P&C Data Scientist in Paris. This role combines actuarial expertise with data science to enhance risk assessment and support strategic decision-making through advanced analytics.2. Key Result Areas and Deliverables:Develop strong relationships...

  • Analytical Insights Manager IC

    il y a 3 semaines


    Paris, France Boeing Temps plein

    Description Qualifications: Jeppesen/Boeing is currently looking for an Analytical Insights Manager (Individual Contributor Role) to join Our team virtually. The candidate can be located in one of the listed countries: Sweden, Poland, France, Germany, Netherlands or Italy. This position will focus on supporting the Boeing Global Services (BGS)...

  • Principal Data Scientist

    il y a 1 semaine


    Paris, France Talented International Temps plein

    About Us We are a start-up based in Munich, Madrid and in Barcelona. We were founded in Spring 2020 and two and a half years later we are now already a team of +80 super motivated ML Engineers, data scientists and developers. Our mission is to build beautiful Artificial Intelligence products. We’re curious, passionate, and relentless in our drive to...

  • Senior Data Scientist

    il y a 1 semaine


    Paris, France Talented International Temps plein

    About Us We are a start-up based in Munich, Madrid and in Barcelona. We were founded in Spring 2020 and two and a half years later we are now already a team of +80 super motivated ML Engineers, data scientists and developers. Our mission is to build beautiful Artificial Intelligence products. We’re curious, passionate, and relentless in our drive to...

  • Data Scientist

    il y a 4 semaines


    Paris 9e, France SparkyHeads Temps plein

    **Job Brief**: - We are looking for a Data Scientist to join a multinational FinTech company, with offices in Paris. **Responsibilities**: - Collaborate with cross-functional teams to define project objectives, scope, and requirements. - Explore and analyse complex datasets to discover trends, patterns, and insights. - Develop and implement data mining...


  • Paris, France Onward Therapeutics France Temps plein

    Prise de poste : 01/03/2023 Docteurs Paris Nombre de postes : 1 CDI À négocier **Description du poste et des missions**: Reporting to the Director of Preclinical and Translational Development, the Cell Therapy R&D Scientist will have the following missions: - Plan and conduct experiments, record and analyze data - Manage the design of protocols,...


  • Paris, France Onward Therapeutics France Temps plein

    The company is currently involved in the development of a bispecific antibody for immunotherapy that is entering the clinic phase and has invested in a pre-clinical allogenic natural killer (NK) cell technology, which will enter into the clinic by the end of this year. **Site web**: **Poste et missions**: - Reporting to the Director of Preclinical and...

  • Data Scientist H/F

    il y a 6 jours


    Paris, France agap2IT France Temps plein

    Data Scientist H/FDATA – ILE DE FRANCE – CDIAre you passionate about Natural Language Processing (NLP) and eager to lead the charge in this dynamic field? We are seeking a highly motivated Data Scientist to join our data science team and be at the forefront of cutting-edge NLP research and development. As a data scientist, you will play a pivotal role in...


  • Paris, France Coders Connect Temps plein

    Coders Connect and Sanofi are joining forces to bring an electrifying twist to the biopharmaceutical world! Work with a rhythm that suits your style (2 days remote and 3 days onsite magic). Language : Proficiency in English is required for this role to ensure effective communication within our diverse, global team. About Sanofi: Digital & Data:...


  • Paris, France Publicis Groupe Temps plein

    Job DescriptionWe are seeking a highly skilled Generative AI Data Scientist to join our team. The ideal candidate will have a strong background in both machine learning and deep learning techniques, as well as experience in generative modeling. The candidate will be responsible for designing, implementing, and optiizing generative models for a variety of...


  • Paris, France Vestiaire Collective Temps plein

    Vestiaire Collective is the leading global online marketplace for desirable pre-loved fashion. Our mission is to transform the fashion industry for a more sustainable future by empowering our community to promote the circular fashion movement. Vestiaire was founded in 2009 and is headquartered in Paris with offices in London, Berlin, New York, Singapore, Ho...

  • Senior Data Scientist

    il y a 1 mois


    Paris, France Coders Connect Temps plein

    Coders Connect and Sanofi are joining forces to bring an electrifying twist to the biopharmaceutical world!Work with a rhythm that suits your style (2 days remote and 3 days onsite magic).Language: Proficiency in English is required for this role to ensure effective communication within our diverse, global team.About Sanofi:We're not just a company; we're a...

  • Lead Data Scientist

    Il y a 2 mois


    Paris, France Boston Consulting Group Temps plein

    Who We AreBoston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we work closely with clients to embrace a transformational approach aimed at benefiting all stakeholders—empowering...