MSAT Senior Manager - Data Science

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AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

We have an opportunity for a Senior Manager, Data Science to join the Manufacturing Science and Technology (MSAT) organization at AGC Biologics, Copenhagen, Denmark. Based on a product lifecycle's concept, this team member will manage and apply data to drive and reach strategic decisions across the organization, regarding late stage and commercialized manufacturing processes.

This is a key position in the MSAT organization that is responsible for implementation of appropriate workflows to enable secure, compliant access to data throughput the process life cycle with a key emphasis on Continuous /Ongoing Process Verification (C/O PV).

The MSAT organization is responsible for process transfer, process validation, commercialization, manufacturing support, and implementation of new processes, technologies and systems used in GMP operations.

This position specifically reports into the Process Validation function.

Your responsibilities include:

  • Interface with AGCs external partner to finalize the design for a fit-for-purpose database with focus on managing data for input into CPV programs.
  • Liaise with key stakeholders across MSAT to ensure data flow is captured throughout the Development / early Process Validation stages.
  • Align database implementation internally with AGC IT partners as required.
  • Design and implement workflows which ensure the database meets regulatory expectations (FDA, EMA).
  • Implement database within the MSAT organization (including SOP generation and training).
  • Act as Database Administrator to ensure smooth day-to-day running of the system.
  • Lead the transfer of data from existing CPV programs into database as required.
  • Conduct periodic reviews of data output for each CPV program.
  • Utilize statistical analysis software (mainly SAS JMP) to monitor and analyze data.
  • Supervise/Manage 1-2 Data Scientists/Analysts to ensure accurate information and inferences from the data are provided and presented.
  • Improve alignment of Data Science activities globally, together with MSAT leaders at our other sites.
  • Review/author relevant technical sections of regulatory dossier or other communications to health authorities, as well as, provide leadership in support of inspections/audits.
  • Interface with the project teams to support product life cycle change management projects, including drive long-term process improvements execution.
  • The position offers interaction with a large number of internal stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development and manufacturing. You will be introduced to biopharmaceutical companies globally and be an active player in their projects.

To be considered for this position, our ideal data-driven candidate will possess the following:

Your knowledge, skills and abilities are:

  • Analyze and utilize complex datasets to make strategic, rationale-based decisions in accordance with Site Leadership and Customer agreement.
  • Possess a range of statistical tools and knowledge to implement in the analysis of data.
  • Experience in establishing CPV (OPV) programs is preferable.
  • Experience in handling and managing databases.
  • Understanding of computer systems validation is desirable.
  • Knowledge of CFR21 Part 11; and data integrity requirements is a must.
  • Understanding of Process Validation guidelines (FDA, EMA, ICH) related to data management.
  • Must be self-motivated, organized and proactive.
  • Great communication and presentation skills are important for this role.
  • Ability to mentor, educate and supervise junior team members.
  • Knowledge of Process Development or Technology Transfer or Process Validation (in particular, process commercialization) within the biopharma industry is preferable.
  • Demonstrated ability to interface/communicate extensively with internal and external clients, including senior management on matters concerning several functional areas, divisions, and/or customers.

Your professional and educational background:

  • Master´s Degree in Engineering, Statistics or Science-related field.
  • At least 7 years of experience, in Data Science or related fields.
  • Must have experience writing, reviewing and approving GMP documentation.

Familiarity with Quality Management Systems is desirable.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


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Jobbet er oprettet på vores service den 8.3.2022, men kan have været deaktiveret og genaktiveret igen.

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