Director - API External Manufacturing

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.

Elanco External Manufacturing (EEM) is Elanco’s organization that oversees third party manufacturing. This position will be part of the EEM API Network and will be responsible for all aspects of supply from API contract manufacturers based in the Americas. This includes executing appropriate relationship management, technical and quality oversight, and inventory/capacity management. This role will report to the Senior Director of EEM API Operations, Basel, CH. The Operations director will connect with other Operation Directors and other API specific functions located in China, Germany and Switzerland.

Basic Minimum Qualifications:

• 5-7 years’ experience in a cGMP API manufacturing environment
• Bachelor degree or higher in API related discipline (Chemistry, Chemical Engineering, etc)
• Strong technical proficiency in API small molecule chemistry and quality controls
• Previous successful supervisory experience
• Ability to influence others to obtain business results
• Demonstrated learning agility
• High communication skills
• Excellent mentoring and coaching skills
• Ability to prioritize multiple activities
• Understanding VICH standards and post approval change guidelines applied in the manufacture of API’s
• Understanding of supply chain fundamentals

Key Objectives/Deliverables:

Contract Management: Responsible for working closely with functional leadership in the definition of contract terms and negotiation strategies. Represent EEM by assisting procurement with the negotiation of new contract manufacturing contractual arrangements and renewals. Provide on-going oversight for ensuring site compliance to contractual arrangements.

Operational Management: Responsible for monitoring and influencing all functional activities associated with product supply from the CMs; driving collaboration between functional areas (e.g., Planning/Scheduling, TSMS, Packaging, and Quality) to resolve issues and ensuring reliable product supply and product quality in a cost-effective manner. Governance will include oversight of a balanced scorecard in accordance with EEM standards.

Team Leadership: Direct people leadership and Performance Management responsibilities for supply chain employees. Indirect leadership of functional employees who support external manufacturing operations. Indirect leadership with CM product teams.

Relationship Governance: Responsible for forming, facilitating, and leading the appropriate governance structure in accordance with EEM standards including the establishment of steering teams, joint process teams, setting relationship goals and success indicators, driving continuous improvement activities and overall monitoring of performance.

Continuous Improvement: Responsible for the productivity agenda, continuously improving work practices, quality and reducing costs. Provide technical support to contract manufacturers. Work with cross-functional groups to troubleshoot issues arising at CM sites, including but not limited to deviations. Serve as primary technical point of contact for manufacturing process and quality controls. Identify, evaluate and implement process improvements with focus on capability, compliance and cost. Conduct/support process validation. Approve Annual Product Quality reviews (APQR) together with quality.

Projects/Business Ventures: The role may be required to participate in CM selection and due diligence activities as required. These activities will be driven by global business development and the requirement for new product launches.

Compliance: Responsible for the adherence to appropriate financial, quality, supply chain, HSE, regulatory internal standards as well as internationally recognized standards at the external manufacturers.

Technical Transfers: Responsible for supporting successful technical transfers either into or from contract manufacturers. Ensuring that supply remains uninterrupted throughout any technical transfers or terminations.

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Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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