Eli Lilly
Sr. Scientist, TSMS Process Support - ADN RAMP Team
Eli Lilly, Indianapolis, Indiana, United States, 46201
Lilly Scientist - Api/Dry Product Network
At Lilly, 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. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview
At Lilly, we serve an extraordinary purpose. 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 also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Brand Description
The Lilly Scientist - 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. The Scientist - ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly's vision of serving more patients. Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration
and development of the local technical and operational teams to be ready for full operation. The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director. Key Objectives/Deliverables
Responsible for support of site start-up within TSMS through documentation preparation and review; monitoring of the processes through start-up/validation and on-going manufacture and establishing strong deviation investigation support and technical writing, as follows: Work with the Process Teams in support of start-up of processes
providing hands-on support of documentation preparation, review and approval. Understand the electronic batch record, process flow document (PFD) and validation of the process of process/product being supported. Ensure the PFD accurately describes the process, control strategy, process parameters, CQAs and references to supporting material. Engage regularly with Molecule Steward to ensure all TSMS documentation is accurate and reflective of new facility. Where necessary, understand the historic and potential failure modes of the process as part of the Process Team support. Have access to development history of the product and process and manufacturing history which has increased knowledge of operational control strategy. This will allow better support of deviations. Be very familiar with site quality systems; change control, deviation reporting, annual product reviews, stability, homogeneity etc. Complete appropriate training to ensure access to all relevant quality management systems required to fulfil your role. Support where necessary the Process Team on the key quality and operational parameters of the process as determined in the Process Monitoring Plan. Have expertise in root cause analysis to lead team in troubleshooting efforts. Utilize root cause analysis techniques to investigate process issues and deliver robust and sustainable corrective and preventative actions. Utilize experience in technical writing to document robust and effective deviations post root cause analysis and work with Process Team members to coach and train on effective Technical Writing. Ensure the process remains in a validated state by monitoring the process during the campaign and documenting a review of the process in campaign reports, CPV, APR. Execute and document revalidation when appropriate. Lead or contribute to PHRs and Risk Assessments (e.g. FMEA), identifying actions/countermeasures, tracking actions/countermeasures. Act as a mentor/coach to TSMS representatives and other technical support staff. Basic Requirements
BSc Chemistry, Biochemistry or related science field with 3-5 years' experience in pharmaceutical manufacturing. MSc Chemistry, Biochemistry or science-related field with 3+ years' experience in pharmaceutical drug substance manufacturing support. Additional Skills/Preferences
Technical depth in manufacturing science and understanding of documentation requirements 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 manufacturing and deviation investigation Ability to coach others Ability to influence without authority Ability to clarify and simplify complex issues Strong trust building with peers and leaders Willing to work off-shift hours as needed to support project milestones and training of new employees Other Information
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.
At Lilly, 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. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview
At Lilly, we serve an extraordinary purpose. 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 also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Brand Description
The Lilly Scientist - 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. The Scientist - ADN RAMP (Rapid Access to Medicines for Patients) team is a cross-functional team that will bring deep manufacturing expertise and will support each site start-up through Operational Excellence knowledge, rapid troubleshooting and problem-solving capability, and surge capacity resources. This unique opportunity will enable team members to work at our new sites, create a larger Lilly network, build and use their technical skills, and learn leadership skills through formal training and on-the-ground experiences. This team will also build strategies to help other new Lilly sites to start up faster, helping to accelerate Lilly's vision of serving more patients. Success in this challenging role will require supporting the sites through startup, through direct technical execution, coaching next employees, and strong collaboration
and development of the local technical and operational teams to be ready for full operation. The team will directly report through their respective functions but will be coordinated by the Ramp Team Sr. Director. Key Objectives/Deliverables
Responsible for support of site start-up within TSMS through documentation preparation and review; monitoring of the processes through start-up/validation and on-going manufacture and establishing strong deviation investigation support and technical writing, as follows: Work with the Process Teams in support of start-up of processes
providing hands-on support of documentation preparation, review and approval. Understand the electronic batch record, process flow document (PFD) and validation of the process of process/product being supported. Ensure the PFD accurately describes the process, control strategy, process parameters, CQAs and references to supporting material. Engage regularly with Molecule Steward to ensure all TSMS documentation is accurate and reflective of new facility. Where necessary, understand the historic and potential failure modes of the process as part of the Process Team support. Have access to development history of the product and process and manufacturing history which has increased knowledge of operational control strategy. This will allow better support of deviations. Be very familiar with site quality systems; change control, deviation reporting, annual product reviews, stability, homogeneity etc. Complete appropriate training to ensure access to all relevant quality management systems required to fulfil your role. Support where necessary the Process Team on the key quality and operational parameters of the process as determined in the Process Monitoring Plan. Have expertise in root cause analysis to lead team in troubleshooting efforts. Utilize root cause analysis techniques to investigate process issues and deliver robust and sustainable corrective and preventative actions. Utilize experience in technical writing to document robust and effective deviations post root cause analysis and work with Process Team members to coach and train on effective Technical Writing. Ensure the process remains in a validated state by monitoring the process during the campaign and documenting a review of the process in campaign reports, CPV, APR. Execute and document revalidation when appropriate. Lead or contribute to PHRs and Risk Assessments (e.g. FMEA), identifying actions/countermeasures, tracking actions/countermeasures. Act as a mentor/coach to TSMS representatives and other technical support staff. Basic Requirements
BSc Chemistry, Biochemistry or related science field with 3-5 years' experience in pharmaceutical manufacturing. MSc Chemistry, Biochemistry or science-related field with 3+ years' experience in pharmaceutical drug substance manufacturing support. Additional Skills/Preferences
Technical depth in manufacturing science and understanding of documentation requirements 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 manufacturing and deviation investigation Ability to coach others Ability to influence without authority Ability to clarify and simplify complex issues Strong trust building with peers and leaders Willing to work off-shift hours as needed to support project milestones and training of new employees Other Information
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.