Research Scientist - Product development Liverpool, England
Job description
Education : EQUIVALENTEXPERIENCE
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.
The Research scientist is responsible for providing overarching technical and scientific expertise for process development and commercialization activities of new drug substances. The role is focused on ensuring that a robust manufacturing process is developed and successfully transferred to manufacturing, to ensure supply meets market demand.
Functions/Duties/Tasks
- The Research Scientist is a leader within the LMTD Speke site providing technical direction, coaching, and mentoring to all Scientists. The holder of this position is regarded as a technical expert for R&D Elanco globally and works collaboratively with management, CMC, and global project groups to influence project direction and delivery in line with site, functional and corporate business goals.
- Provide technical leadership for early through late phase large molecule development projects, ensuring phase appropriate technical development, driving the MR process, and collaborating closely with relevant functions.
- Support successful commercialization of new products strategically and tactically by partnering across functions including R&D, TSMS, supply chain, launch leaders, QA, and manufacturing sites throughout the development process.
-
Provide technical leadership/expertise for delivery of process development projects based in the development laboratories and pilot plant areas.
- Ensure a sound laboratory/pilot plant program in alignment with CMC requirements for establishment of robust control strategies and successful product launch.
- Ensure that project work is carried out with necessary scientific rigor across the team for quality data output. Ownership for ensuring that all work is appropriately planned, documented, and executed for each project according to agreed timelines.
- Responsible for ensuring use of sound statistical data methodology to design and execute experimental work as part of routine day-to-day projects. Lead Quality by Design and applying principles for development of control strategy and design space through experimentation.
- Play a leadership role in technical transfers, process implementation, and material delivery activities for pivotal Investigational Product (IVP or CT) supply, registration, and validation batches.
- Participate in the evaluation of new business opportunities thru due diligence, product reviews, and cost modelling.
- Serve as a technical resource across Elanco and apply technical expertise to scientific problems to support across the network.
- Responsible for coaching and mentoring development scientists.
- Lead effective communications with key stakeholders, team leader, CMC teams, wider tech groups.
- Ensure development areas are capable and flexible to support development needs. Be responsible for ensuring that safe systems of work and risk assessments are adhered to for all process development activities. Support housekeeping and active monitoring activities.
- Play a proactive role in implementation of any capital projects with respect to planning, document requirements, commissioning, and training.
- Be accountable for spend/cost control for development activities.
- Ensure appropriate training for all activities. Support team, site and functional training as required.
- Ensure delivery of high-quality technical reports and archive documents in accordance with company requirements. Provide technical review for team development reports.
- Foster a collaborative culture, grow global connections, actively participate in CoPs, share knowledge/best practices/lessons learned.
- Develop links and collaborations with external organizations to aid process development according to project and business requirements.
- Highlight new technologies, builds future capabilities, influence strategy and direction.
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
