Associate Director TS/MS

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.

Patients are at the center of everything we do at Lilly. We are currently hiring a Associate Director TS/MS.

This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. #WeAreLilly

Associate Director – Technical Services/Manufacturing Science (TS/MS) Drug Substance

The associate director is primarily responsible to lead TS/MS scientists’ team on the technical oversight of the manufacturing process with the purpose of ensuring the reliable and compliant manufacturing of bulk drug substance.  Additionally, this role partners with other roles within the TS/MS organization and other functional disciplines to support the functional and site objectives.  The successful candidate is responsible for:

• Ensuring that the team has a full understanding of protein chemistry, control strategy, and manufacturing platform related to large molecule drug substance processes. 
• Prioritization and execution of routine process monitoring, manufacturing support and that processes remain in control and capable in accordance with regulatory requirements and current good manufacturing practices (cGMPs).
• Development of technical capabilities within the technical staff and performance management.
• Providing technical leadership for the preparation, review and approval of technical documents including investigations, change controls, manufacturing tickets, periodic product reviews, process validation and other technical documents.
• Acts as the primary technical representative in a cross-functional setting on Flow Team Meeting, Deviation Board, etc
• Leads the development and execution of process validation, process changes and implementation of technical agenda projects with the collaboration of the secondary loop (subject matter experts) and other functions.

Basic Qualifications

• Bachelors or master’s or PhD Degree or equivalent in scientific disciplines of Chemistry, Biochemistry, Microbiology, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, or Bio/Chemical Engineering are minimum requirements.
• Relevant industrial experience (greater than 5 years) in any of the following disciplines such as Technical Services, Pharmaceutical Manufacturing, Protein Manufacturing, Quality Control, Quality Assurance, product and/or process development or Engineering is required.
• At least 1 year of experience in a supervisory role in the pharmaceutical industry.
• Fully bilingual (English/Spanish)
• Technical writing and presentation skills
• Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment. 
• Knowledge of cGMP, applicable global regulatory manufacturing guidance, and the process/cleaning validation in drug substance pharmaceutical manufacturing. 
• Flexibility is required to support site needs in a 24/7 environment

• Teamwork oriented
• Demonstrated ability to learn and apply technical/scientific knowledge
• Ability to communicate and effectively influence across functional groups and stakeholders
• Technical leadership, administrative and organization skills
• Strong problem-solving skills
• Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
• Strategic thinking and ability to balance short term needs with long term business goals

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

"Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

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

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.

#WeAreLilly