Oligonucleotide Advisor – TSMS External Mfg Position Available In Durham, North Carolina

Job Description:

At Lilly, we unite caring with discovery to make life better forpeople around the world. We are a global healthcare leaderheadquartered in Indianapolis, Indiana. Our employees around theworld work to discover and bring life-changing medicines to thosewho need them, improve the understanding and management of disease,and give back to our communities through philanthropy andvolunteerism. We give our best effort to our work, and we putpeople first. We’re looking for people who are determined to makelife better for people around the world. Join the energetic andgrowing Active Pharmaceutical Ingredient – External ManufacturingOrganization (API-EM) that delivers a diverse portfolio ofmedicines essential to our patients around the world. The

API EMTS/MS

Advisor will provide technical and scientific expertisewithin a dynamic external manufacturing environment. The Advisor isresponsible for ensuring delivery of commercialization effortsincluding technical transfers, process validations, and processoptimization for the oligonucleotide portfolio. This positionrequires comprehensive knowledge of the pharmaceutical industry,Good Manufacturing Practices (GMP), regulatory requirements, andthe essential role scientists play in making medicine and creatingreal-world solutions.

Key Objectives/Deliverables:

Providetechnical oversight and stewardship for oligonucleotidemanufacturing processes, including synthetic processing steps anddownstream purification. Leads resolution of technical issuesincluding those related to control strategy and manufacturing.

Employ excellent communication skills to manage internal andexternal relationships. Build and maintain relationships withdevelopment and central technical organizations to influenceprocess control strategies. Ensure proper characterization ofprocesses and products and ensure effective documentation of theprocess description, measures, acceptable ranges, andspecifications (and the justification of these measures, acceptableranges, and specifications). Ensure that processes are compliant,capable, in control, and maintained in a validated or qualifiedstate. Optimize and execute site control strategies. Successfullydeliver on strategic initiatives. Authors and provides guidance onRegulatory Submissions, IRs, and changes. Influence and implementthe network technical agenda and drive continuous improvement.

Maintaining processes in a state of compliance with US and globalregulations Understanding the scientific principles required formanufacturing intermediates and drug substances, including theinteraction of chemistry and equipment. Understand the chemistryand stability of biomolecules. Operate with ‘Team Lilly’ in mind -including coaching and mentoring of peers and other scientists.

Basic Requirements:

Ph.D. in scientific disciplines ofBiochemistry, Chemistry, Chemical Engineering, Pharmacology, orrelated fields, or equivalent industry experience (8 years ).Demonstrated experience and proficiency with pharmaceuticalmanufacturing and working knowledge of regulatory expectations.

Additional Information Occasional travel required 5 – 15%.

LOCATION

Indianapolis, IN or Kinsale, Ireland Lilly is dedicatedto helping individuals with disabilities to actively engage in theworkforce, ensuring equal opportunities when vying for positions.

If you require accommodation to submit a resume for a position atLilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation ) forfurther assistance. Please note this is for individuals to requestan accommodation as part of the application process and any othercorrespondence will not receive a response. Lilly is proud to be anEEO Employer and does not discriminate on the basis of age, race,color, religion, gender identity, sex, gender expression, sexualorientation, genetic information, ancestry, national origin,protected veteran status, disability, or any other legallyprotected status. Our employee resource groups (ERGs) offer strongsupport networks for their members and are open to all employees.

Our current groups include: Africa, Middle East, Central AsiaNetwork, Black Employees at Lilly, Chinese Culture Network,Japanese International Leadership Network (JILN), Lilly IndiaNetwork, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQAllies), Veterans Leadership Network (VLN), Women’s Initiative forLeading at Lilly (WILL), enAble (for people with disabilities).Learn more about all of our groups. Actual compensation will dependon a candidate’s education, experience, skills, and geographiclocation. The anticipated wage for this position is $123,750 -$198,000 Full-time equivalent employees also will be eligible for acompany bonus (depending, in part, on company and individualperformance). In addition, Lilly offers a comprehensive benefitprogram to eligible employees, including eligibility to participatein a company-sponsored 401(k); pension; vacation benefits;eligibility for medical, dental, vision and prescription drugbenefits; flexible benefits (e.g., healthcare and/or dependent daycare flexible spending accounts); life insurance and deathbenefits; certain time off and leave of absence benefits; andwell-being benefits (e.g., employee assistance program, fitnessbenefits, and employee clubs and activities).Lilly reserves theright to amend, modify, or terminate its compensation and benefitprograms in its sole discretion and Lilly’s compensation practicesand guidelines will apply regarding the details of any promotion ortransfer of Lilly employees. WeAreLilly