Principal Technical Services Representative

The position of Principal Technical Services Rep - APIEM reports to the TSMS Director - Peptides API EM and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialisation of medicines, with safety first and quality always, by:

Responsibilities:

Developing and sustaining process knowledge to ensure the execution of the appropriate product, process, and operational control strategy at the Contract Manufacturer (CM).

Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.

Participation with internal or CM resources in technical transfer, process validation, and process data monitoring.

Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM's CMs.

Key Objectives/Deliverables:

The candidate will be responsible for process monitoring, response to issues, and improvements where necessary.

A strong understanding of manufacturing principles and Lilly systems is required to ensure those same standards are applied to the external contract manufacturers.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards.

The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

Build and Sustain Process Team Relationships:

Utilise past experiences with unit operation control to provide insight and feedback to members of the Lilly / CM Joint Process Team (JPT).

Employ excellent communication skills to manage internal and external relationships.

Build and maintain relationships with development and central technical organisations.

Operate with Team Lilly in mind - including coaching and mentoring of peers and other scientists.

Develop and Sustain Process Knowledge:

Provide technical oversight and stewardship for peptide manufacturing processes.

Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.

Enable the development and maintenance of process knowledge infrastructure such as validated process monitoring spreadsheets

Review and track key process parameters (i. e., CPPs, rOPP's, IPC, etc. )

Provide Process Support:

Leads resolution of technical issues including those related to control strategy and manufacturing.

Ensure proper characterisation of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).

Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.

Identify systemic issues affecting production and reliable supply from CMs.

Lead or participate in root cause analysis and CAPA development.

Process Optimisation and Continuous Improvement:

Influence and implement the network technical agenda and drive continuous improvement.

Maintain peptide processes in a state of compliance with US and global regulations.

Understanding the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.

Support development and technical analysis for ongoing continuous improvement activities.

Review and identify cost reduction opportunities, as well as process capacities and bottlenecks.

Assist in prioritisation of opportunities with respect to overall business objectives.

Perform and promote optimisation of unit operation cycle time, loading, and yield performance.

Requirements:

Bachelor of Science in Chemistry or Biochemistry.

5+ years of demonstrated experience and proficiency with GMP pharmaceutical manufacturing and working knowledge of regulatory expectations.

Demonstrated ability to function in a team environment as a technical leader and as a member of teams.

Demonstrated ability to manage and prioritise competing priorities and to appropriately communicate verbally and in writing to various audiences.

Additional Preferences:

Successful application of root cause analysis and systematic problem solving.

Knowledge and experience with Regulatory requirements.

Knowledge of data management practices across manufacturing.

Enthusiasm for change, team spirit and flexibility.

Ability to influence and communicate to diverse groups on business or technical issues within the site and function.

Proficiency in delivering complex tasks and/or tasks that are cross-functional.

Demonstrated Project Management skills and ability to coordinate complex projects.