Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet?
Are you naturally curious? Have a passion to lead technical projects? Do you enjoy cross functional collaboration? When presented with a problem, do you instinctively find proactive solutions? Join our team.
We are seeking a self-motivated, analytical, innovative, and collaborative thinker to join our unique and highly skilled team. In this manufacturing scientist role, you will drive strategic technical initiatives throughout the lifecycle of the product, improve the robustness and productivity of the process while ensuring safe, effective, compliant, and reliable products are delivered to our customers.
The Manufacturing Scientist will provide and ensure technical oversight of products within Elanco External Manufacturing (EEM)–Americas (North and Latin America) scope. This key role is to ensure technical excellence and effective supply production across a portfolio of products (which may include solid dosage, sterile injectables, nutritional health, premixes, API’s, or liquids) produced at external contract manufacturers and suppliers. The role is responsible to maintain and improve product process capability, quality and compliance as well as drive gross margin improvement through a technical productivity agenda. The TS/MS role may lead, oversee or support product launches, technology transfers and significant EEM Americas network and cross network initiatives.
Additionally, the role will serve as a key technical interface for groups inside and outside of the Elanco External Manufacturing- Americas network (e.g., Hub Network Lead teams, Quality, CM&C Regulatory, etc) in principles of process validation and validation strategy, on-going monitoring / continued verification, and process capability. Incumbent is to ensure adherence to governance processes in place for product and process oversight, validation and for successful facilitation of Elanco’s Manufacturability Review stage gate process.
- Participate in Joint Process Team (JPT) meetings with contract manufacturers and external suppliers as primary technical manufacturing science point of contact; ensure technical requirements of global standards and oversight are met
- Change management, Deviation and Investigation Management
- Maintain oversight of key batch processing records used at CMs, including SOP’s, Master Production Records, Standard Packaging Instruction’s
- Write technical reports to convey status of product performance, capability and to communicate process metrics
- Participate in site visits to the CM, to assess ongoing capability and, as required, to support resolution of complex technical issues and/or support implementation of significant process or procedural changes
- Ensure that assigned products have an appropriate control strategy and process flow documentation (PFD’s) are developed and maintained.
- Author Annual Product Review (APRs) / Product Quality Review (PQR) reports.
- Prepare or coordinate technical inquiry Position Papers / Technical briefing documentation within network for support of submissions, internal inspections or Health Authority reviews related to key products in scope.
- Demonstrated troubleshooting skills.
- Interpersonal and influencing skills.
- Proven ability to understand and analyze process data.
- Excellent interpersonal skills with the ability to work as an individual or as part of a close working team with clear business objectives delivered as required.
- Can build relationship with direct team members as well as external partners.
- Collaboration and influence are key to being successful in this role.
- Multi-tasking and priority management are essential.
- Technical point of contact and subject matter expert for validation lifecycle aspects for EEM managed products
- Support product recall investigations
- Working closely with the Network Quality, Supply Chain and Operations functions to support continuous supply of products by preventing and mitigating significant deviations & complaints.
- Confident in team environment to contribute and challenge the status quo and take a technical stand when required – can represent technical information to senior management in a clear and concise manner
- Current with cGMP requirements in aspects of process manufacture, process validation, process change design and process monitoring compliance.
- Can apply excellent problem solving methodology to complex technical situations within required deadlines using statistical data analysis as a tool and means to identify improvements.
- Experience delivering technical projects at manufacturing scale (scale up, optimization, productivity and cost of product/goods improvement).
- Ability to directly manage cross-functional teams and/or support new product introductions and technical transfer of existing processes to and between external contract manufacturers.
- Flexibility in travel (sometimes at short notice) to support business deadlines and customer requirements.
- An advanced university degree or Bachelors of Science degree with demonstrated career experience in related life science or engineering (e.g. pharmacy, chemistry, chemical engineering, veterinary medicine)
- Fluent in English (other languages of additional advantage)
- Minimum 7 years’ experience in Pharmaceutical or Chemical Production, Technical Science/Manufacturing Science, Pharmaceutical Drug Development, and/or Quality Assurance in solid dosage, sterile injectables, nutritional health, premixes, API’s, and/or liquids.
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Fundamental understanding of standard pharmaceutical analytical testing.
- Strong proficiency in reviewing and writing technical documentation and reports.
- Strong Project management skills, clear and concise communication skills, experience in working with interdisciplinary, multicultural teams.
- Scientific curiosity and problem solving drive
- Understanding of analytical methods.
- Additional knowledge of statistical methods and applicable software.
- Working knowledge of Regulus.
- Working knowledge of Trackwise.
- Reports to: Director, TS/MS Americas (North and Latin America).
- Travel required (15-25%)
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