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    • Principal Scientist, TSMS Cleaning Validation - Indianapolis - BioSpace, Inc.

    BioSpace, Inc.
    BioSpace, Inc. Indianapolis

    3 weeks ago

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    Description
    Job Details
    At Biospace Inc., we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

    Organization Overview
    We serve an extraordinary purpose at Biospace Inc. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

    Position Brand Description:
    The Lilly API/Dry Product Network is rapidly expanding to meet the demand for new products, and several new greenfield sites are under construction and will be starting up in the coming years. The new sites are staffed based on full-scale, steady state production, however additional surge capacity is needed to support the site start-up and help quickly ramp to full capacity rates.

    Key Objectives/Deliverables:
    Responsibilities include:
    • Developing, implementing, and establishing ongoing monitoring of the Cleaning Program for new site facilities.
      • Supporting new site TSMS cleaning teams on developing Cleaning Validation Master Plan for the facility, using expertise and benchmarking from other sites.
        • Developing a standard and clear procedure for conducting a Cleaning Assessment and training relevant personnel on how to implement and maintain.
          • Standardizing Cleaning procedures and operating instructions - ensuring critical information is present and critical operating parameters for effective cleaning are integrated into electronic tickets.
            • Standardizing pre-start safety review for Cleaning and ensuring correct involvement of EHS, Engineering and Operations personnel.
              • Ensuring cleaning demonstration/validation protocols and reports are standardized and technically correct.
                • Developing appropriate metrics for Cleaning. Supporting site teams on reporting metrics at Flow Team level.
                  • Improving efficiency on cleaning processes and identifying projects for improvement (e.g. activities that can run in parallel and those that need to run in sequence).
                    • Engaging on the development of a training program/education for TSMS, Process Engineering, QA and Ops based on the Cleaning Process with site Cleaning team. Working on the roll out of communicating the requirements of each step of the process and ensuring groups have a holistic view of the process.
                      • During cleaning execution, providing support to the process teams for cleaning activities ensuring all aspects of the flow are coordinated appropriately. Attending and leading (if required) process team meetings.
                        • Coordinating investigations related to cleaning. Trending events across equipment trains and products and driving improvements.
                          • Driving improvements in the cleaning program based on external benchmarking / industry trends.
                            • Transferring deep understanding of the GQS/Compliance requirements associated with Cleaning.
                            Basic Requirements:
                            Requirements include:
                            • BSc Chemistry, Biochemistry or related science field with 8-10 years' experience in pharmaceutical manufacturing.
                            • MSc Chemistry, Biochemistry or science-related field with minimum 5 years appropriate industry experience.
                            Additional Skills/Preferences:
                            Preferrred skills include:
                            • Deep technical interest and understanding of Cleaning within Small Molecule, Peptide or Biotech.
                              • Excellent verbal and written communications skills
                                • Strong analytical and problem-solving skills
                                  • Collaborative skills with operations, process engineering, QCL and other process team members
                                    • Technical knowledge of cleaning control
                                      • Ability to coach others
                                        • Ability to influence without authority
                                          • Ability to clarify and simplify complex issues
                                            • Strong trust building with peers and leaders
                                              • Willingness to work off-shift hours as needed to support project milestones and training of new employees.
                                              Work Environment:
                                              The ADN RAMP team will support multiple new API/Dry Products sites in various locations (US and OUS). Significant travel may be required to current startup sites in order to meet business needs, along with potential short-term assignments across the network (can include international relocations). Candidates must be mobile and flexible.
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Principal scientist, tsms cleaning validation