Associate Director - TSMS Laboratory

Eli Lilly and CompanyHouston, TX
1dOnsite

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. 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 40,000 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. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations. Main Purpose and Objectives: The TSMS (Technical Services & Manufacturing Sciences) Laboratory Associate Director is responsible for leading the Lilly Houston TS/MS laboratory in small molecule and oligonucleotide API process troubleshooting and continuous improvement. Lead laboratory staff in designing and executing laboratory experiments in support of technology transfer, process validation, manufacturing operations and continuous improvement. This position will interact with Process Teams composed of TSMS, engineering, manufacturing, validation, quality assurance, and quality control representatives. Interaction will also be required with other Lilly site and potential contract producers of Lilly products. Knowledge of API chemical synthesis including small molecule, peptide, and/or oligonucleotide and support systems used in the manufacturing of chemical synthesis APIs is required.

Requirements

  • Bachelors or Masters in Chemistry, Microbiology, Biochemistry, Biochemical engineering or related science field.
  • 5+ years of cGMP API manufacturing and/or process development experience in Technical Services or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Development, Regulatory Sciences or Engineering.

Nice To Haves

  • Experience in small molecule, peptide, or oligonucleotide manufacturing.
  • Technical leadership, administrative and organizational skills.
  • Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional.
  • Demonstrated Project Management skills and ability to coordinate complex projects.
  • Strong analytical and quantitative problem-solving skills.
  • Ability to communicate and influence effectively across functional groups and stakeholders.
  • Strategic thinking and ability to balance short term needs with long term business evolution.
  • Demonstrated ability to learn & apply technical/scientific knowledge.

Responsibilities

  • Manage for Results /Strategic Planning: Laboratory Startup & Ongoing Capability
  • Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
  • Hire, manage and grow a team of laboratory scientists and engineers tasked with support of manufacturing operations, continuous improvement, process validation and technology transfer.
  • Accountable for the performance and results of the TSMS laboratory.
  • Hiring, performance management, and development of staff
  • Partner within TSMS and across functional disciplines to influence and implement the technical agenda according to site business plan objectives
  • Install and qualify laboratory process models for commercial and technology transfer candidate molecules.
  • Commission new laboratory equipment at lab build-out and subsequently identify additional capabilities and/or new technologies to keep lab at optimal productivity.
  • Forecast resource needs and manage allocated budget.
  • Plan and schedule lab activities to ensure the successful and timely execution of various studies.
  • Define strategic direction and provide oversight for setting the technical agenda to improve process capability, process control, yield, and/or productivity for all products within the site portfolio.
  • Network globally to share lab best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
  • Manage Relationships with Key Stakeholders and Customers:
  • Contribute to the site planning processes (such as business and strategic plan)
  • May be required to travel offsite to other Lilly or partner sites within the global network, other pharmaceutical companies, conferences, networking events, or off-site training.
  • Develop strong working relationships with both Synthesis Molecule Design and Development (SMDD) and plant sites to ensure success
  • Represent TS/MS on cross-site teams exploring process/platform optimization, best practices, and other technical excellence initiatives.

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).
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