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Director/Senior Director - Manufacturing Science

Eli Lilly and Company

Indianapolis (IN)

On-site

USD 80,000 - 150,000

Full time

30+ days ago

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Job summary

An established industry player is seeking a skilled professional to lead technical stewardship for parenteral drug products. This role involves collaborating with cross-functional teams to enhance manufacturing processes and drive advancements in technical capabilities. Ideal candidates will have extensive experience in commercial parenteral product manufacturing and a strong educational background in relevant scientific fields. This position offers opportunities for recognition and promotion within a dynamic environment that values innovation and teamwork. If you are passionate about making a difference in healthcare, this role is for you.

Benefits

Recognition and future promotion on the Technical Ladder
Domestic and international travel (10-20%)

Qualifications

  • 10+ years of experience in commercial parenteral product manufacturing for PhD holders.
  • Strong leadership and problem-solving skills are essential for this role.

Responsibilities

  • Provide technical stewardship of parenteral drug products.
  • Collaborate with teams to support manufacturing sites and improve processes.

Skills

Biomolecule characterization
Leadership skills
Problem-solving skills
Data analysis and interpretation
Communication skills

Education

PhD in Biochemistry, Chemistry, Chemical Engineering, Biology, or Pharmaceutical Science
Master's degree in relevant field
Bachelor's degree in relevant field

Tools

Statistical design of experiments
Regulatory submissions preparation (BLAs, NDAs)

Job description

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:

The mission of Technical Services/Manufacturing Science (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow. The Parenteral drug product network TSMS provides product stewardship for all parenteral products across multiple manufacturing sites.

Responsibilities:

  • Provide technical stewardship of parenteral drug products.
  • Collaborate with a cross-functional team to support global parenteral manufacturing sites in new product commercialization, process improvements, and technology transfers at internal and external manufacturing sites.
  • Collaborate with process engineers and development scientists to design and transfer robust manufacturing processes to commercial and third-party manufacturing operations. This includes serving as a liaison to CM&C teams to shepherd new pipeline products from development into manufacturing.
  • Leverage and influence the internal and external scientific community to impact Lilly’s ability to commercialize life-changing medicines, improve productivity, and create long-term value.
  • Integrate cross-functional and/or external information and apply technical knowledge to data-driven decision-making.
  • Define the vision and drive advancements of technical capabilities.
  • Suggest and evaluate opportunities for molecule, product, and business process improvement. This includes driving the molecule/product technical agenda with a specific focus on process/productivity improvements in partnership with the global manufacturing sites.
  • Act with speed, agility, and decisiveness to identify the critical issues to resolve; influence team and/or stakeholders on the critical risks and plan for resolution.
  • Champion changes that increase the effectiveness of overall business objectives.
  • Develop, motivate, and create opportunities to deliver business impacts.
  • Coach and mentor junior associates.

Basic Requirements:

  • A degree in a relevant area such as Biochemistry, Chemistry, Chemical Engineering, Biology, or Pharmaceutical Science with one of the following:
  • PhD degree with a minimum of 10 years of practical experience in commercial parenteral product manufacturing, or
  • Master’s degree with a minimum of 15 years of practical experience in commercial parenteral product manufacturing, or
  • Bachelor’s degree with a minimum of 20 years of practical experience in commercial parenteral product manufacturing.
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences:

  • Proficient in biomolecule characterization and product development.
  • Demonstrated examples of leadership, influence, and problem-solving skills.
  • Demonstrated ability to analyze and interpret complex technical data and troubleshoot data issues.
  • Strong written and oral communication skills.
  • Preparation, review, and response preparation of global regulatory submissions, such as BLAs, NDAs, and other technical communications.
  • Ability to lead teams to successfully deliver projects on time and in scope.
  • Working knowledge of statistical design of experiments and analysis.
  • Working knowledge and scientific understanding of product distribution, drug delivery devices, and advanced drug delivery systems.

Additional Information:

  • Recognition and future promotion on the Technical Ladder.
  • 10-20% domestic and international travel.
  • Position is in person and based in Indianapolis, Indiana, at one of Lilly's parenteral manufacturing sites.
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