Advisor - TS/MS - Oligonucleotides Technical Steward

BioSpace; Houston (TX); On-site; USD 131,000 - 211,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical insurance

Dental

Vision and Rx benefits

Flexible benefits

Life insurance

Time off and leave

Job summary

Lilly is constructing an advanced manufacturing facility in Houston, TX for API production, seeking experts to lead oligonucleotide stewardship and site transfer for commercial molecules. The role interfaces with engineering, manufacturing, quality, development, and regulatory teams to enable GMP manufacturing readiness.

Qualified candidates will have a strong cGMP background, 10+ years in API manufacturing, and proven leadership in process validation and transfer activities.

Qualifications

• Bachelor's degree required in Chemistry, Microbiology, Biochemistry, Biochemical engineering or a related science field.
• Minimum of 10 years of experience in cGMP oligonucleotide, peptide, or small molecule API commercial-scale manufacturing.
• Masters or PhD preferred.
• Process validation, cleaning validation, and commercialization experience a plus.
• Demonstrated leadership skills.
• Excellent communication skills, both oral and written.
• Process and equipment knowledge of chemical synthesis active pharmaceutical ingredients.
• Thorough understanding of cGMP requirements for a large-scale manufacturing facility.

Responsibilities

• Provides technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility.
• Leads technical transfer of processes between facilities and addresses scale-up issues.
• Mentors Process Team members and analyzes production data to support daily operations.
• Writes technical reports and reviews manufacturing documentation.
• Supports start-up and validation of new facilities and equipment in Houston.
• Leads or assists in process validations and change controls as needed.

Skills

Leadership skills

Communication skills

cGMP knowledge

Education

Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biochemical engineering or related science field

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, Texas. This facility is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations.

Main Purpose And Objectives

This position is part of the Technical Services & Manufacturing Sciences (TSMS) function and is responsible for Oligonucleotide stewardship and site transfer of commercial molecules, as well as commercialization support for new molecules. This position will interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments. Interaction may be required with other Lilly site/contract producers of Lilly products.

Key Responsibilities

• Provides technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility. If necessary, leads the technical transfer of processes from one production facility to another, anticipating and addressing complex scale-up issues.
• Provides mentorship and scientific expertise to Process Team members monitoring, trending, and analyzing production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. May present process data and analyses with Process Team members at Manufacturing Process Team meetings. Drives solutions impacting results across sites or function.
• Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies. Reviews/approves Annual Product Review and presents annual Global Product Assessment for stewarded molecule(s).
• Leads resolution of technical issues including those related to control strategy and manufacturing
• Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves key technical or operational problems that impact function or geography. Communicates issues in a timely manner. May lead process-related investigations and assess technical impact. Influences complex regulatory or technical issues within the TSMS area/function. Influences others to adopt a different point of view on difficult concepts.
• Writes standard operating procedures as they relate to the activities of the TSMS group. Reviews and approves manufacturing batch records and other manufacturing documentation.
• Works with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor. Assists in process-related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.
• As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement medium to large continuous improvements to manufacturing processes.
• Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. Helps to define and implement control strategies for Lilly Houston processes.
• Leads post launch technical agendas and delivers projects that drive substantial step changes in Manufacturing.
• As required, may lead, or assist in the planning and execution of process validation activities.
• As required, may own, or assist in the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity.
• Makes decisions that impact a function or geography. Builds relationships with internal and external partners.
• Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.

Minimum Requirements

• Bachelor's degree in Chemistry, Microbiology, Biochemistry, Biochemical engineering or related science field.
• Minimum of 10 years of experience in cGMP oligonucleotide, peptide, or small molecule API commercial-scale manufacturing.

Additional Preferences

• Masters or PhD preferred.
• Process validation, cleaning validation, and commercialization experience a plus.
• Demonstrated leadership skills.
• Excellent communication skills, both oral and written.
• Process and equipment knowledge of chemical synthesis active pharmaceutical ingredients.
• Thorough understanding of cGMP requirements for a large-scale manufacturing facility.

Additional Information

• Off-hours support may be needed, by request.
• Required to respond, off shift, to operational issues.
• Minimal travel required.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$130,500 - $211,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

WeAreLilly