Associate VP Technical Services/Manufacturing Science (Indianapolis Parenteral Mfg) at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Manufacturing, HealthcareIndustries

Requirements

B.S. or equivalent in a scientific field of study
10+ years of prior leadership experience leading in parenteral manufacturing technical services
Demonstrated regulatory inspection experience interacting with regulators directly
Understanding of manufacturing and cGMPs (preferred)
Ability to prioritize efforts (preferred)
Effective written and oral communication skills (preferred)
Effective interpersonal skills (preferred)
Involvement in external pharmaceutical industry associations (preferred)

Responsibilities

Maintain a safe work environment, lead safety initiatives, and work safely while supporting all HSE Corporate and Site Goals
Provide strategic direction to TS/MS organization
Provide leadership and governance to the technical/scientific agenda for the site via the Science Lead Team (process monitoring)
Represent the TS/MS organization at the Site Lead Team
Develop administrative and technical leadership with the organization
Assure that appropriately trained and qualified staff are in place to provide day-to-day support and project support for new and existing products
Conduct process monitoring for continuous improvement of control strategy, risk reduction, maintenance of the validated state, and manufacturing productivity
Establish reward and recognition initiatives for staff
Communicate effectively with Parenteral TS/MS Network Director and other Parenteral TS/MS leaders to ensure alignment of technical agenda and Central TS/MS initiatives for molecule, sterility, and components
Serve as a key technical resource for regulatory interactions
Manage commercialization agenda in partnership with PR&D and central TS/MS
Provide management and governance of the technical agenda, support of the deviation and change control quality systems, ownership of operations batch records and applicable standard operating procedures
Document and maintain product control strategies including risk assessments, and document and maintain the state of process/sterility assurance/cleaning validation

Skills

Key technologies and capabilities for this role

Manufacturing ScienceTechnical ServicesProcess MonitoringDeviation ManagementChange ControlRisk AssessmentSterility AssuranceCleaning ValidationBatch RecordsSOPsProcess ValidationLeadershipSafety Initiatives

Questions & Answers

Common questions about this position

What experience is required for this Associate VP position?

The role requires 10+ years of prior leadership experience leading in parenteral manufacturing technical services and demonstrated regulatory inspection experience interacting with regulators directly.

What is the salary or compensation for this role?

This information is not specified in the job description.

Is this position remote or does it require on-site work?

The position requires working in various areas within the Parenteral Plant in Indianapolis, with minimal travel required.

What education is needed for this job?

A B.S. or equivalent in a scientific field of study is required.

What makes a strong candidate for this leadership role?

Strong candidates will have an understanding of manufacturing and cGMPs, ability to prioritize efforts, effective written and oral communication skills, effective interpersonal skills, and involvement in external pharmaceutical industry associations.

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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