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. Our employees around the world 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Post : Advisor / Senior Advisor - Formulation
Job Description
Do you enjoy drug product development including pre-formulation, formulation and process development for monoclonal antibodies, recombinant proteins, and other biologic products? Do you have experience with scale-up 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 Drug Product Development Lead at LCCI is waiting for you.
Key Responsibilities :
• As a drug product development scientist, you oversee preformulation, formulation and other characterization studies required to understand the optimum conditions at which the molecule is most stable. You will be working with new biologic candidates, employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities, as they make their way from discovery to the clinic.
• You will be required to guide teams to perform the right set of experiments that can identify to the selection of the ideal formulation for the product. You will also be required to identify the right container closures and the right process required to manufacture the product and deliver consistent and high quality material to the clinic on time
• You will be required to evolve the process and the formulation as the product moves from early phases to later stages of development keeping in mind the commercialization requirements of the molecule and the manufacturing site
• All scientific work in development will occur in CROs and CMOs and the scientist has to work to identify gaps in them and work effectively to ensure high quality product and information is delivered back to Lilly. The scientist should have the technical ability to troubleshoot issues as they occur, and to identify trends and opportunities to reduce process variability, A strong scientific foundation is a prerequisite for this role
• The role requires a lot of flexibility and adaptability in accepting new projects and challenges.
• In addition, the ability to exhibit a high level of attention to detail, a quality-minded approach to experimental design, and record keeping is essential. Maintaining accurate records and interpreting data to provide detailed information and analysis on the execution of experiments will be a daily activity.
• Writing technical reports, tech transfer documents and giving presentations to summarize development activities are important deliverables.
• This role requires effective interaction and communication of technical information with, but not limited to; Safety, Environmental and Quality Team members, Purification 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.
Candidate Profile
• PhD in Pharmaceutical Sciences, Pharmaceutical chemistry, Biotechnology, Biochemistry, Chemical Engineering or related degree focused on formulation development or biophysical characterization of large molecules.
• BS/MS in Chemistry, Pharmaceutical Sciences, Chemical Engineering or related degree with at least 8-10 years relevant experience in formulation development or biophysical characterization of large molecules.
• 3-6 years of relevant experience for PHD candidates and 8-10 years of relevant experience for BS/MS candidates in developing formulations, drug products, manufacturing processes leading to IND, BLA submissions or late stage process scale up, technology transfer and commercialization experience
Experience Requirements :
• Effective oral and written communication skills.
• Strong laboratory skills
• Formulation development, commercial process development and tech transfer experience for simple and complex parenteral formulations
• 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.
Additional Information
Experience : 3-6 years
Qualification : Ph.D, M.Pharm, B.Pharm, M.Sc
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 20th June 2024
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