- The scientist should be capable of serving as cell line generation and cell culture lead in CMC teams interacting with external partners. This also includes designing, executing and interpreting appropriate experiments for generation of cell lines and drug substance
- The scientist is also responsible for upstream process development, scale-up / process optimization / control strategy development and technology transfer to Pilot Plant / manufacturing sites for assigned bioproduct projects.
- The scientist will interact closely with other scientists and may be an integral part of multidisciplinary teams that provide support for process and product development as well as working with Discovery / TS& MS / Manufacturing
- Work effectively with external parties on platform development projects, research collaborations and outsourcing efforts.
- Author and review CMC documentation including technical reports and CMC sections of regulatory submissions, technical reports to support filing and responses to regulatory agency questions.
- Support organizational initiatives, as appropriate
- This role requires effective interaction and communication of technical information with, but not limited to; Safety, Environmental and Quality Team members, Cell culture development colleagues, CMC Team members, Discovery team members, Analytical Services, Tech Service/Manufacturing Science representatives, Operations, Engineering, Regulatory and Maintenance personnel.
- The scientist has to adhere to all safety and environmental guidelines and promote a proactive safety culture and environmental compliance in all areas.
- PhD in Chemical Engineering, Bioprocess Engineering, Biology, Biochemistry, Chemistry, or related field with 3-6+ years of industry experience
- Demonstrated competency, experience, and knowledge in CMC development, manufacturing and compliance requirements from early to late clinical phase programs
- Subject matter expertise in upstream process development, including extensive hands-on experience with cell culture process development
- Knowledge of cell biology, cell culture, molecular biology with an emphasis on recombinant protein expression
- Effective oral and written communication skills.
- Strong laboratory skills
- Ability to interact and form dynamic relationships with a wide range of groups
- Experience with process control and documentation systems (Unicorn, Symyx eLN)
- General interpersonal and communication skills; mentoring, feedback, training, and cultivating an environment for learning and open/honest communication.
- Basic analytical skills and understanding
- Advanced problem-solving skills.
Advisor/ Senior Advisor - Bengaluru, India - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, USA. Our 39,000 employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
The Medicines Innovation Hub (MIH) strives to discover, develop, and deliver creative medicines to patients through the development and commercialization of insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with therapeutic business units and manufacturing to deliver the incredibly exciting Lilly clinical portfolio to patients around the world.
The Lilly Capability Centre India (LCCI) located in Bengaluru India is a strategic investment made by Lilly to attract top talent from the vibrant academic and professional environment in India and deploy them to develop and enable critical capabilities for Lilly. The LCCI group in India houses a MIH team that works closely with the MIH team in Indianapolis in enabling the delivery of Lilly's portfolio.
Job Description
Do you enjoy upstream drug substance processes including cell line generation and cell culture process development of monoclonal antibodies, recombinant proteins, viral vectors, or peptides? Do you have experience with process development and tech transfer? Are you skilled in the analytical techniques used to characterize bioproducts? Have you effectively worked in a virtual environment, overseeing outsourced projects to CROs and CMOs? If so, then a role as a Cell Culture Development Scientist at LCCI is waiting for you.
Key Responsibilities:
Educational Requirements:
Experience Requirements:
Lilly 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.
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