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Technical Representative - Clinical Trial Manufacturing

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Lilly

3d ago

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare
  • Cork

AI generated summary

  • You need a B.S. in a scientific field, 5+ years in GMP Drug Product Manufacturing, knowledge of formulations, experience in advanced modalities, strong communication skills, and problem-solving abilities.
  • You will plan cGMP activities, oversee manufacturing, ensure quality compliance, manage deviations, and facilitate site selection while collaborating with internal teams and external partners.

Requirements

  • Minimum of a B.S. in Chemistry, Engineering, Pharmacy, Pharmaceutical Sciences, or similar scientific field
  • Preference of 5+ years in GMP Drug Product Manufacturing, External Manufacturing, Formulation Development or other related function.
  • Knowledge of oral (small molecule), parenteral (small and/or large molecule) formulation
  • Experience in advanced therapeutic modalities including genetic medicines & nucleic acid-based drug delivery via intravenous, subcutaneous, intrathecal and/or inhaled routes of administration. This experience may include gene therapy, siRNA-antibody or siRNA-peptide conjugates, oligonucleotides, mRNA, viral nanoparticles, non-viral particles (lipid nanoparticles, liposomes, exosomes/extracellular vesicles), microparticles (traditional polymeric and cross-linked), viral vectors, adeno-associated virus (AAVs)
  • Excellent oral and written communication skills with an ability to communicate clearly with peers and leadership.
  • Ability to clearly identify key issues in manufacturing and lead a team to the appropriate solution(s).
  • Comfortable working in a dynamic environment with changing priorities and short lead times.
  • Initiative and ability to handle multiple independent projects
  • Proven experience in partnering and problem solving across both an internal and external networks.
  • Knowledge of cGMP’s
  • Some domestic and/or international travel required (< 10%)

Responsibilities

  • The CT Manufacturing Technical Representative (Tech Rep) must demonstrate the technical ability to plan and perform cGMP activities for drug product manufacturing. These activities include batch record preparation, oversight of manufacturing execution, sample submission, and batch record review and disposition with Quality for multiple types of manufactures.
  • The CT Manufacturing Technical Representative partners with Development Scientists, Third Parties and other Lilly groups (e.g., CT Packaging, Regulatory, Quality Assurance, Analytical, Project Management, and Commercial Manufacturing) to enable the manufacturing and delivery of drug product and technical information deliverables. Additionally, the Technical Representative works closely with the CT Manufacturing Operations group to enable planning, scheduling, material movement, budget development and testing.
  • Drug Product Manufacturing Technical Lead: Responsible for all activities associated with cGMP (Good Manufacturing Practices) Drug Product Manufacturing. Partner with internal team members and manufacturing site to facilitate all required activities leading up to GMP Manufacturing. These activities include technical transfer, authoring of required technical documentation, and batch record review and approval. The Technical Representative is also responsible for manufacturing partner oversight and facilitating decision-making discussions during GMP activities. Finally, the Technical Representative is responsible for final review of batch record and collaborating with quality assurance representatives for final disposition of drug product batch.
  • Ensure Quality Supply of Drug Product: Partner with Quality Assurance to ensure drug product manufactured for clinical trials complies with Quality Assurance requirements. Facilitate all discussions associated with deviations at external manufacturing sites and provide technical insight and recommendations for deviations. Finally, the technical representative manages significant manufacturing process modification.
  • Regulatory Compliance: Interact with regulatory scientists to ensure clinical trial drug product matches the appropriate global regulatory documents. The Tech Rep contributes to the preparation of IND Regulatory Content required to support drug product submission.
  • Facilitation of Drug Product Manufacturing Site Selection and Contracting: Partner with internal teams to evaluate the proper technical requirements for new drug product requests. CT Tech Reps influence appropriate site selection based upon product requirements and capacity and capabilities at partners within Lilly’s internal and external manufacturing network. Partner with procurement representatives, technical teams (formulation development, analytical methods development, engineering, device development, packaging, labeling), and commercialization manufacturing counterparts to draft contractual request for manufacturing at external sites, when applicable.

FAQs

What is the purpose of the Technical Representative - Clinical Trial Manufacturing role at Lilly?

The role is focused on planning and performing cGMP activities for drug product manufacturing that support clinical trials, ensuring the manufacturing and delivery of drug products and technical information.

What qualifications are required for the Technical Representative position?

A minimum of a B.S. in Chemistry, Engineering, Pharmacy, Pharmaceutical Sciences, or a similar scientific field is required, with a preference for 5+ years of experience in GMP Drug Product Manufacturing or related functions.

What key responsibilities does the Technical Representative have?

Key responsibilities include overseeing cGMP activities, facilitating discussions with internal and external partners, ensuring compliance with Quality Assurance standards, and contributing to regulatory documentation.

What type of formulations should candidates be knowledgeable about?

Candidates should have knowledge of oral (small molecule) and parenteral (small and/or large molecule) formulations, as well as experience in advanced therapeutic modalities like gene therapy and nucleic acid-based drug delivery.

Is there a travel requirement for this position?

Yes, some domestic and/or international travel is required, but it is limited to less than 10%.

What skills are preferred for this role?

Preferred skills include excellent communication abilities, problem-solving skills, comfort in a dynamic environment, initiative to handle multiple projects, and knowledge of cGMP regulations.

Does Lilly promote diversity and inclusivity in the workplace?

Yes, Lilly is committed to diversity, equity, and inclusion, ensuring a welcoming environment for all employees regardless of their background or identity.

Are there benefits associated with working at Eli Lilly Cork?

Yes, benefits include flexible hybrid working options, healthcare, pension and life assurance benefits, subsidized canteen, onsite gym, travel subsidies, and various professional development opportunities.

How does the Technical Representative contribute to regulatory compliance?

The Technical Representative interacts with regulatory scientists to ensure that clinical trial drug products align with global regulatory documents and assists in preparing IND Regulatory Content for drug submissions.

What is the focus of the Clinical Trials Manufacturing organization at Lilly?

The organization focuses on leading the technical transfer of cGMP activities for drug products supporting clinical trials, ensuring the effective manufacturing and delivery of these products.

Lilly

We're a medicine company turning science into healing to make life better for people around the world.

Manufacturing & Electronics
Industry
10,001+
Employees
1876
Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.