Advisor-TS/MS Dry External Manufacturing

Eli Lilly and Company • Carolina, PR

6d • $114,000 - $180,400

About The Position

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. Responsibilities DRY-EM TS/MS will be a member of the Secondary Loop providing support to the Dry External Manufacturing (DRY-EM) is responsible for making medicine at contract manufacturers located globally, selected by Lilly to make drug product for commercialization that will bear the Lilly brand. DRY-EM manages technical, quality, supply, and financial aspects of all issues with the contract manufacturers and alliances who supply product to Lilly to ensure risks to Lilly in manufacturing product outside Lilly is appropriate and provides optimum protection to the Lilly brand. This role is responsible for providing technical oversight and formal mentoring to primary loop TS/MS representatives. This role is responsible for all technical activities related to the identification, selection, implementation, and maintenance of CM operations and on-going process improvements. Additionally, this role will include project management of key continuous improvement/Technical Agenda and/or post-launch technical transfer projects at DRY-EM. Including resource planning, timeline management, and scope development. This role will participate on new resources hiring process with the Functional Sr. Director. Key Objectives/Deliverables: Support On-Going CM Operations by providing technical oversight. TS/MS Senior staff is responsible to drive CM technical excellence connected to DRY-EM lead team and central functions and interact with primary loop and members of DRY-EM. They're expected to possess deep technical knowledge and understanding which allows them to assess process vulnerabilities and provide informed, science-based support to deliver the objectives. Including: Improve technical capabilities of the DRY-EM. Provide mentoring and guidance on technical knowledge development to primary loop, assuring the adequate knowledge management. Support and/or own the most critical or complex deviations/complaints and provide a lesson learned transfer to the primary loop. Provide guidance and Lead (if required) product/process related Root Cause Analysis and provide product/process expertise in incident investigation and troubleshooting. Support and/or Led Major Change Controls. OPV and APR. Ensure maintenance of process control and capability for manufacturing processes. Definition and improvement of control Strategy/PFD. Review periodically control strategy/PFD is still valid for the intended use. Technical Report. Provide technical review and technical guidance as SME for writing technical report to primary loop. Lead/coordinate regular technical reviews of processes, process optimization and variability reduction efforts as well as process and validation studies. Review and approve technical/validation document including studies and reports. Assumes the role of the subject matter expert for key molecules. Active participation in DRY-EM Governance as a core member of DRY-EM Flow Team and Science Lead Team. Integration and alignment of different JPTs from the same platform, product, and process. Integration with corresponding network/Platform and provide regular communication with Global Molecular Steward (Tertiary Loop)., Global Packaging SME. Lead the technical agenda, drive continuous improvement initiatives, and actively participate on the GPLOT (if required). Support audit/inspection preparation, observations answers and 3-day field alerts upon requirement. Perform internal notification to management as necessary. Identification/Selection of CMs: Assist Global Procurement on Due Diligence of prospective new partners as required. Assess new contract manufactures, particularly with regards technical capabilities, level of implementation of Lilly and GMP standards and recommended their suitability as a future partner. Assist Strategic Facilities Planning and Business Development in defining business opportunities (if required). Develop options for increasing/improving/creating manufacturing opportunities of existing and new CMs. Assess the technical capabilities of existing contractors to produce additional products. Assist to Global Procurement in provide cost estimates and timelines for options. Assist in the preparation of business case proposals. Ensure critical technical elements are incorporated in contracts. Support Start-Up and Implementation of CMs: Act as technical lead or project leader as appropriate (if required). Develop, maintain, and communicate project charter and project plans (if required). Ensure the creation of project timelines include key milestones related with technical project deliverables (if required). Report monthly measures and project summaries related to project milestones (if required). Prepare technical transfer documents. Ensure the technical transfer of robust processes and establish appropriate critical process parameters and specifications. Liaise with engineering consultants and equipment suppliers in defining facilities and equipment needs (if required). Support installation of equipment at CM operations (if required). Provide help and guidance, in conjunctions with QA on development of appropriate manufacturing and quality systems. Consult, review, and revise manufacturing tickets, packaging orders, qualification protocols, and validation plans. Design studies and provide data to support regulatory submission requirements. Author expert reports. Supervise manufacturing start up and validation to ensure success and review documentation and summary reports. Initiate strong working relationship with Contract Manufacturers. Department Initiatives: Maintain regular communication with management and network leaders through effective participation in S&OP meetings, GPLOT and MR review, Flow team, Science Lead Team etc. Provide input in monthly reports and metrics as a core member of the Flow Team. Actively pursue opportunities for continuous improvement (both process and procedural). Model Safety behaviors. Relationship: All functions at the contract manufacturers from senior management to shop floor personnel. Lilly Affiliate personnel and senior Country and Area management. Lilly TS/MS, QA, Auditing groups, Laboratories at Lilly sites. All relevant functions at the Lilly Geneva office (if required). Senior TS/MS management, Product and Technical leaders, GPLOT leaders and molecule stewards.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, or similarly related fields.
• Minimum of 10 years’ experience in pharmaceutical manufacturing and/or technical services, specifically in Solid dosage technology.
• Ability to represent Eli Lilly’s mission, policies and practices in a positive, professional, and ethical manner and to influence CMs.
• A thorough understanding of cGMPs and drug product manufacturing.
• Good communication skills, especially attention to detail in written procedures and protocol development.
• Strong leadership, interpersonal and teamwork skills.
• Ability to lead and manage highly complex technical projects.
• Use of data and science to support decisions, capable of making independent informed decisions.
• Willingness to learn new technologies.
• Capability to work in a virtual and complex environment.
• Willingness to travel.
• Appreciation for cultural diversity.

Nice To Haves

• Working knowledge on Commercialization process, manufacturing operations, Process Control and Capability requirements.
• Project coordination or management skills including the ability to lead teams to produce quality deliverables within established timeframes.
• Knowledge and ability to apply basic statistical tools.
• Regulatory related experience.
• Equipment, utility, and facility qualification experience.
• Established technical, quality, and internal networks.
• Prior experience supporting external manufacturing and dry manufacturing operations.

Responsibilities

• Support On-Going CM Operations by providing technical oversight.
• Improve technical capabilities of the DRY-EM.
• Provide mentoring and guidance on technical knowledge development to primary loop, assuring the adequate knowledge management.
• Support and/or own the most critical or complex deviations/complaints and provide a lesson learned transfer to the primary loop.
• Provide guidance and Lead (if required) product/process related Root Cause Analysis and provide product/process expertise in incident investigation and troubleshooting.
• Support and/or Led Major Change Controls. OPV and APR.
• Ensure maintenance of process control and capability for manufacturing processes.
• Definition and improvement of control Strategy/PFD.
• Review periodically control strategy/PFD is still valid for the intended use.
• Provide technical review and technical guidance as SME for writing technical report to primary loop.
• Lead/coordinate regular technical reviews of processes, process optimization and variability reduction efforts as well as process and validation studies.
• Review and approve technical/validation document including studies and reports.
• Assumes the role of the subject matter expert for key molecules.
• Active participation in DRY-EM Governance as a core member of DRY-EM Flow Team and Science Lead Team.
• Integration and alignment of different JPTs from the same platform, product, and process.
• Integration with corresponding network/Platform and provide regular communication with Global Molecular Steward (Tertiary Loop)., Global Packaging SME.
• Lead the technical agenda, drive continuous improvement initiatives, and actively participate on the GPLOT (if required).
• Support audit/inspection preparation, observations answers and 3-day field alerts upon requirement.
• Perform internal notification to management as necessary.
• Assist Global Procurement on Due Diligence of prospective new partners as required.
• Assess new contract manufactures, particularly with regards technical capabilities, level of implementation of Lilly and GMP standards and recommended their suitability as a future partner.
• Assist Strategic Facilities Planning and Business Development in defining business opportunities (if required).
• Develop options for increasing/improving/creating manufacturing opportunities of existing and new CMs.
• Assess the technical capabilities of existing contractors to produce additional products.
• Assist to Global Procurement in provide cost estimates and timelines for options.
• Assist in the preparation of business case proposals.
• Ensure critical technical elements are incorporated in contracts.
• Act as technical lead or project leader as appropriate (if required).
• Develop, maintain, and communicate project charter and project plans (if required).
• Ensure the creation of project timelines include key milestones related with technical project deliverables (if required).
• Report monthly measures and project summaries related to project milestones (if required).
• Prepare technical transfer documents.
• Ensure the technical transfer of robust processes and establish appropriate critical process parameters and specifications.
• Liaise with engineering consultants and equipment suppliers in defining facilities and equipment needs (if required).
• Support installation of equipment at CM operations (if required).
• Provide help and guidance, in conjunctions with QA on development of appropriate manufacturing and quality systems.
• Consult, review, and revise manufacturing tickets, packaging orders, qualification protocols, and validation plans.
• Design studies and provide data to support regulatory submission requirements.
• Author expert reports.
• Supervise manufacturing start up and validation to ensure success and review documentation and summary reports.
• Initiate strong working relationship with Contract Manufacturers.
• Maintain regular communication with management and network leaders through effective participation in S&OP meetings, GPLOT and MR review, Flow team, Science Lead Team etc.
• Provide input in monthly reports and metrics as a core member of the Flow Team.
• Actively pursue opportunities for continuous improvement (both process and procedural).
• Model Safety behaviors.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees