Lilly
Pharmaceutical
Advisor/Sr.Advisor-PeptideAnalyticalScientist
Neural analysis suggests this role is
optimal for Senior candidates.
“Advisor/Sr. Advisor - Peptide Analytical Scientist at Lilly. Skills: Peptide Analytical Science, Analytical Method Development, Process Development, Technical Transfer, Regulatory Affairs. Lead technical aspects of drug substance process optimization. Lead technical aspects of technical transfers”
What You'll Achieve.
Make life better for people around the world; Discover and bring life-changing medicines; Improve the understanding and management of disease; Give back to our communities through philanthropy and volunteerism; Improve process control; Improve yield; Improve purity; Improve productivity; Commercialize products; Ensure analytical methods and techniques are robust, cost effective and can be transitioned safely and rapidly into production environment
Industry & Context.
Solve analytical problems
Some travel (domestic and international) less than 5% may be required
What They're Looking For.
Must Have
Ph. D. in scientific disciplines of Chemistry and Analytical chemistry /Ph. D + Post Doc in Analytical Chemistry (focusing more process chemistry) with 5-12 years, Comprehensive knowledge of the pharmaceutical industry, Knowledge of Good Manufacturing Practices (GMP), Knowledge of regulatory requirements, Proven track record of driving technical agendas, Proven track record of influence externally in the small molecule space, Hands on experience supporting method development and transfer activities, Proven track record of working with diverse groups across the value chain and in multiple locations, Significant experience with registration, including authoring technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies, Understanding the scientific principles(analytical front) required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment, Understand the chemistry and stability of peptides from a first principles perspective, Proven record of embracing advanced digitization efforts by deploying digital tools to enable advanced modelling and seamless digital technology transfer, Exhibit coaching and mentoring of peers and other scientists, Provide technical support to process development areas if needed, Document all work in an appropriate manner, Interpersonal skills required to work effectively with a broad spectrum of people
Nice to Have
Experience with LC, GC, titration, and mass spectrometry, Expertise in PAT tools, Experience with peptide synthesis/Process development process development through design and execution of experiments and development of analytical methods
What You'll Do.
Lead technical aspects of drug substance process optimization
Lead technical aspects of technical transfers
Develop the technical agenda
Provide technical support and perform analytical development work for peptide synthesis/Process development process development through design and execution of experiments and development of analytical methods
Ensure appropriate personal protective equipment in the laboratory premises are available and follows the safety precautions
Ensure the good administration and housekeeping of the PRD department work area
Provide analytical support to commercial process optimization team
in peptides down and up streams
Improve existing production processes
Ensure analytical methods and techniques are robust
cost effective and can be transitioned safely and rapidly into production environment
Lead the successful transfer of new/developed analytical methods across the globe
Maintain a thorough understanding of the state of the art of analytical and regulatory requirements and build these into our processes
Develop working relationships with both R&D and plant sites to ensure success
Serve as a member of multidisciplinary product development teams responsible for the analytical method for commercial scale processes
Direct laboratory activities and development of one or more junior staff members
Participate in the Science Lead Team– part of scientific governance/oversight as needed
Provide technical stewardship on all products they are accountable for
Define and lead assigned technical projects (experimental
and/or production data analysis) to improve process control
Commercialize and solve analytical problems
Support method development and transfer activities
Work with diverse groups across the value chain and in multiple locations
Manage registration activities including authoring technical reports
Development History Report
or direct interactions with regulatory agencies
Understand scientific principles required for manufacturing intermediates and drug substances
Embrace advanced digitization efforts by deploying digital tools to enable advanced modelling and seamless digital technology transfer
Coach and mentor peers and other scientists
Provide technical support to process development areas if needed
Participate in technology transfer of analytical methods
Document all work in an appropriate manner
Work closely with fellow scientists across the various disciplines
Build up a network of contacts across the corporation and the broader scientific community
How You'll Work.
Team & Collaboration
Work in the lab along with the team; Develop working relationships with both R&D and plant sites; Serve as a member of multidisciplinary product development teams; Work very closely with fellow scientists across the various disciplines; Build up a network of contacts across the corporation and the broader scientific community; Work effectively with a broad spectrum of people
Process & Methodology
Define and lead assigned technical projects
Full Job Description
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. **Company Overview** Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world’s most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world! **Manufacturing and Quality Technical Hub Hyderabad** Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub. This hub will oversee the significant investment in contract manufacturing of starting materials and intermediates for API manufacturing in India and the technical services responsible for managing the sc
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