Associate Director - TSMS Laboratory

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.

Responsibilities

• Manage for Results / Strategic Planning:
  • Maintain 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.

Basic 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.

Additional Preferences

• Experience in small molecule, peptide, or oligonucleotide manufacturing.
• Techical 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.