(Archived) Senior Advisor - Technical Services

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

POSITION TITLE: Advisor / Senior Advisor, Technical Services / Manufacturing Science (TS / MS)

Why Join Elanco as a TS/MS Advisor?

Elanco TSMS Advisors, as functional Leaders, have a meaningful impact and significant influence on Elanco’s “IPP” Strategy relating to excellence in Innovation, Portfolio and Productivity of our finished drug product dosage forms.

As a TSMS Advisor you can leverage and apply your experience to embark on the best work of your career; grow both professionally and personally, grow others and be in a position of Influence on a Global scale.

You will be a part of a company culture and team that is energized, open to diversity of thought and speaking up, focused and vested into your personal and professional development. This role also exposes you to business insights and core elements of technical agenda strategy and leadership that supports opportunity for future advancement.

Role overview

The role is responsible for providing both technical expertise and functional guidance of the TS/MS organization for sites globally within Elanco’s Finished Product Networks covering a broad range of product manufacturing technologies (e.g., Liquids, powders, solid forms, suspensions, and sterile injectables).

The role is responsible for successfully driving “Science, Capability, and Control” as the center of a functional Strategy to assure uninterrupted supply of existing products and excellence in the launch of new products. This Role requires a high level of organizational skill and capability and will link governance and monitoring of KPIs across the function. The incumbent will steward management of process capability, remediation, and productivity projects. The incumbent will also support and develop TSMS personnel and functional execution capabilities at internal /external sites and hubs across the Drug Product Networks globally.

This role is also accountable for coordination of TSMS Network Technical reviews, integrating robust science, and key project milestones. Support and ensure site/hub TSMS and central function activities are all aligned in the creation and execution of technical agenda projects. The role is responsible for the oversight and cadence of network level TSMS functional metrics and providing status updates to defined governances and executive management.

This role establishes key paths for cross functional communication and for a proper escalation path to ensure actions are taken to successfully support, deliver and complete robust technical projects and technical reviews complying with the Elanco quality, business and functional standards. Furthermore, this role will also provide direct support and may lead specific productivity, process capability and remediation projects as warranted and defined.

Core Responsibilities

• Ensure TSMS accountability and function capabilities within the organization’s TSMS teams in scope.
• Accountable for support and coordination of Network level Product Technical Capability Reviews and Network Function Metrics.
• Establish dashboard/scorecard/KPIs at a global Network level
• Drive and support of the drug product networks TSMS mission to ensure and maintain robust product manufacturing Control Strategies.
• Partner with manufacturing sites to advance productivity and remediation project portfolios including guidelines, business processes, tools, prioritization, and governance.
• Communication to provide transparency and support decision making by senior management bodies including Technical Agenda Steering Team (TAST), Elanco External Manufacturing and Small Molecule Network lead teams and Elanco Manufacturing Policy Committee.

• Ensure that key regulatory milestones are integrated within technical strategy regarding projects to support regulatory submissions and readiness for inspections as applicable.
• Align with Manufacturability Review Stage gates ensuring that supply remains uninterrupted throughout any technical projects, productivity projects or remediation.
• Initiate and/or support continuous improvement projects (for quality improvement, productivity & cost reduction), proactively interfacing with the relevant functions involved (e.g. QA, Reg Affairs, CMC, R&D and Marketing).
• As a functional leader with subject matter expertise, work closely with the Network or Site TS/MS Directors, lead and support significant investigations related to deviations & complaints.
• The TSMS Advisor may train as well as advise colleagues by providing scientific & technical coaching.

Key Performance Indicators

• Ability to partner with global functions and leaders across Networks including Manufacturing Site Heads, TS/MS Leaders, Quality Directors and Regulatory leads to assess and support:

-Process and Product Capability, Remediation

-Governance for Productivity Efforts

-TSMS Functional and Personnel Development

-Control Strategy Implementation

• Deliver high quality Technical Guidance and Influence in Function: Strategic Projects: Due Diligence, Technical Transfers, Critical review and support to CMC Lifecycle activities documentation and associated reports available and complete through associated stage gates.
• Provide input to long-term site capabilities and capacity planning (investments, divestments, project management) in accordance with business needs.

Financial responsibility

• Responsible for team travel/budget expense. Liaison for key Technical Cost savings Initiatives.

Required Education

Education

• An advanced university degree or demonstrated strong career proficiency in life sciences or engineering (e.g. chemistry, chemical engineering, biochemistry, Pharmaceutical Sciences). Advance degrees (Ph.D., MBA) are an additional asset.

Languages

• Fluent in English, other languages are an additional asset.

Preferred skills and experience

• Minimum 10 years’ experience in Pharmaceutical or Biopharmaceutical finished product manufacture, TSMS, Pharmaceutical Drug Development and/or Life sciences
• Thorough understanding of drug product commercial manufacturing processes and life cycle activities.
• Working knowledge of pharmaceutical quality systems and regulatory requirements across multiple health authorities.
• Working knowledge of applied statistics in data review and analysis, root cause/problem solving and process monitoring
• Fundamental understanding of standard pharmaceutical analytical testing.
• Expertise in reviewing and writing technical reports including regulatory relevant documentation (Dossier CMC sections, Authority responses, Position statements/ reports)
• Strong Project management skills, strong communication skills, experience in working with global, interdisciplinary, and multicultural teams.
• Experience, dedication, and flexibility to be able to engage across multiple time zones globally.

Reporting Relationships

• Reports to: Sr. Director Technical Services / Manufacturing Sciences (TS/MS), Direct reports: 0-3. Functional, indirect: 0 - 8+

Location & Expected Travel Percentage

• Location/Site: United States, Europe (France, Germany, or United Kingdom)
• Travel: Frequent international travel required (up to 20-25%)

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status