Original Beschreibung
# API Manufacturing Science & Technology Manager (m/w/d)
**CH - Basel** | **Full time**
Elanco Animal Health, is a global research-based company that develops and markets products to improve the health and production of animals in more than 100 countries. Elanco products enhance animal health, wellness, welfare, and performance to help the food industry produce an abundant supply of safe and affordable food. Elanco Companion Animal is the source of product innovations that enable veterinarians to help pets live longer, healthier, higher quality lives.
Elanco External Manufacturing (EEM) is the virtual manufacturing plant for Elanco Animal Health. Therefore, contract manufacturers produce all EEM API and drug products. The purpose of this **Manufacturing Science& Technology Manager (MS&T, internally named Technical Services / Manufacturing Science TS/MS at Elanco)** position is to provide technical support and oversight for established products managed by the EEM Global API Hub, ensuring a reliable supply of quality products at minimum cost.
This TS/MS position partners with Quality, Operations, supply chain, and R&D throughout the commercial launch and lifecycle manufacture of various active intermediates/APIs, and collaborate with relevant functions from internal and external drug product manufacturing sites. This position focuses on ensuring a robust API manufacturing process capable of supplying market demand, and it includes a wide variety of project assignments and work experiences. This position assists with the impact assessment and implementation of manufacturing changes of API encompassing validation activities, creating supporting information for Regulatory submissions and interactions with Elanco finished product manufacturing sites.
**Functions, Duties, Tasks:**
**API commercial Manufacturing**
* Serve as primary technical resource for assigned API processes and their impact on finished product sites
* Provide technical support for responsible API manufacturing activities and maintain appropriate manufacturing presence (person in plant) when required.
* Lead tech transfer, process implementation, and process validation activities.
* Technical review of manufacturing documents for EEM governance (MBRs/eBRs, PQRs, Validation, Deviations, Stability, Manufacturing reviews, Metrics Dashboard reporting).
* Identify, evaluate, and implement process improvements with a focus on capability, compliance, and cost and regulatory impact.
* Review process and product data for adverse trends; assess and understand process capability, CAPA planning and implementation to mitigate associated risks.
* Author technical/manufacturing documents (Change Controls, Process Flow Documentation/PFDs, Annual Product Quality reviews (aPQRs), Registration supporting reports) as needed.
**Cross Functional support**
* Work across internal and external sites with cross-functional groups to troubleshoot issues with intermediate, API and Drug Product manufacturing, including but not limited to deviations
* Support the commercialization of new products by partnering with R&D colleagues in the later phase of the development process; Ensure manufacturing concerns are addressed at phase-appropriate points of development; effectively apply principles of QbD as applicable
* Support the identification, selection, and approval of contract manufacturers with a focus on technical support for API RFP processes including preparation of Tech Package.
* Significant Regulatory support for many API (and DP) registration revisions; Support geo-expansion launches in secondary markets, ensuring regulatory commitments are aligned with process capabilities
* Knowledge Mentoring with many cross-functional EEM team members assisting colleague transitions (QC/QA, Reg CMC, Operations, Supply Chain, DP teams/sites)
**Minimum Qualification (education, experience and/or training, required certifications):**
* Bachelors of Science degree in Chemistry or Chemical Engineering with research/development/manufacturing work experience.
* Prior relevant API manufacturing experience (minimum 5 years)
* Understanding of cGMP requirements for drug substance and drug product manufacturing.
* Strong problem-solving skills, including facilitation, strategic and creative thinking.
* Strong interpersonal skills for stakeholder management.
* Clear, concise and proactive communication skills (both written and verbal)
* Cross-functional networking skills: demonstrated ability to influence others.
* Strong analytical skills.
* Ability to handle multiple priorities and deal with ambiguity.
* Computer literacy.
* Demonstrated ability to achieve results with people
**Additional Preferences:**
* PhD degree in Chemistry or Chemical Engineering
* API process development, TechTransfer, process validation, and product commercialization experience.
* Understanding of and experience in multiple technology platforms (small molecule, large molecule, material science, chemical engineering, oral solid dose, premixes etc.)
* Prior experience driving continuous improvement, leading change and deviation management
* Understanding of regulatory requirements (e.g., EDQM, CVM) and ability to create Regulatory support documents (Reports and Comparability Protocols).
* Knowledge of statistical methods and applicable software (e.g. JMP, minitab etc).
* Understanding of analytical methods.
* Working knowledge of quality document management system (e.g. Veeva).
* Working knowledge of AI tools related to task management, technical writing etc.
* **Other Information:**
* Approximately 15-25% travel to global contract manufacturing sites supporting commercial oversight, project delivery and technical Due Diligence activities.