Advisor/Sr Advisor Technical Services Manufacturing Science

BioSpace; Indianapolis (IN); On-site; USD 122,000 - 196,000; Full time

Job summary

An opportunity at a leading company in the pharmaceutical sector. As the Advisor/Sr Advisor Technical Services in Manufacturing Science, you'll provide expertise in drug substance manufacturing, focusing on peptides. Candidates should have a Ph.D. or extensive experience in relevant scientific disciplines, and the role will require maintaining compliance with regulatory standards. The position is primarily onsite in Indianapolis, with expectations of technical leadership and collaboration with team members.

Benefits

Comprehensive benefit program

401(k) participation

Company bonus eligibility

Qualifications

• Proven experience leading technical agendas in pharmaceutical manufacturing.
• Demonstrated experience in peptide manufacturing.
• Understanding of regulation and compliance in pharmaceutical settings.

Responsibilities

• Provide technical oversight for manufacturing processes.
• Lead resolution of technical issues related to manufacturing.
• Ensure compliance with US and global regulations.

Skills

Technical oversight

Manufacturing processes

Regulatory compliance

Communication

Education

Ph.D. in Biochemistry, Chemistry, Organic Chemistry, or Chemical Engineering

BS or MS in Biochemistry, Chemistry, Organic Chemistry, or Chemical Engineering

Job description

Advisor/Sr Advisor Technical Services Manufacturing Science

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Advisor/Sr Advisor Technical Services Manufacturing Science

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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.

Job Description

Join the energetic and growing Active Pharmaceutical Ingredient -Technical Services Manufacturing Science Central Peptide Team that delivers a diverse portfolio of drug substances essential to Lilly! The Central API TS/MS Sr. Director will provide technical and scientific expertise within a dynamic Peptide team that is supporting delivery of commercialization efforts including technical transfers, process validations, and process optimization for the peptide portfolio, including Mounjaro. The Sr Director leads technical aspects of drug substance manufacturing including process optimization, technical transfers and development of the technical agenda. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real-world solutions. The successful candidate should have a proven track record of driving technical agendas and influencing externally in the peptide space.

Key Objectives/Deliverables

• Provide technical oversight and stewardship for peptides and manufacturing processes.
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Proven experience at leading post launch technical agendas and delivering projects that have driven substantial step changes in manufacturing.
• Employ excellent communication skills to manage internal and external relationships.
• Build and maintain relationships with development and central technical organizations.
• Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, and specifications (and the justification of these measures, acceptable ranges, and specifications).
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Maintaining peptide processes in a state of compliance with US and global regulations
• Understanding the scientific principles 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.
• Operate with ‘TeamLilly’ in mind – including coaching and mentoring of peers and other scientists.
  
  
  

Basic Requirements

• Ph.D. in scientific disciplines of Biochemistry, Chemistry, Organic Chemistry, Chemical Engineering, or related fields with at least 3-5 years of relevant experience
  
  
  

OR

• BS or MS in scientific disciplines of Biochemistry, Chemistry, Organic Chemistry, Chemical Engineering, or related fields with at least 10+ years of relevant experience
  
  
  

AND

• Demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
  
  
  

Additional Preferences

• Peptide manufacturing experience
  
  
  

Additional Information

• Occasional travel required 5 – 10%.
  
  
  

LOCATION:

• Indianapolis, IN
• This is an onsite position that will require onsite presence the majority of the time. This is not a remote position.
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$122,250 - $195,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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