Scientist-Technical Services/Manufacturing Science at Elanco in greenfield, Indiana

Job Description:

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The Scientist will provide and ensure technical oversight of powder and solids blending formulation products (premixes and nutritional 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 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 Scientist TS/MS role may lead, oversee or support product launches, technology transfers and significant EEM Americas network and cross network initiatives.

Additionally, as a subject matter expert, the role will serve as a key 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 powder and blended formulation process technology,  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 TS/MS 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/ Regulator 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.

  Consultant –Key Responsibilities

• Consultant point of contact and subject matter expert for validation lifecycle aspects for EEM managed powder, premix and nutritional 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 or relevant requirements in aspects of premix / nutritional 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.

Minimum 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 10 years’ experience in pharmaceutical or Chemical Production / TS/MS / Pharmaceutical Drug Development / Quality Assurance.


• 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

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