The posting
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 monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
The Advisor/Sr. Advisor TS/MS, also known externally as MSAT (Manufacturing Science and Technology), will provide technical stewardship across the start-up advanced manufacturing facility. The successful candidate will be an expert in all aspects of bioconjugate manufacturing processes. This role will have accountability for up- and downstream processing and requires experience and deep knowledge of conjugation chemistry, purification and filtration processes, and the analytical and process controls specific to bioconjugate manufacturing.
The successful applicant will have experience with regulatory guidance and a familiarity with relevant strategies. They will have a strong skillset in data-driven decision-making and problem-solving capabilities, working continuously to drive process performance by implementing new technologies and process improvements. They will maximize the benefits of a digital plant to gain in-depth knowledge of the process through data analytics and process analytical technology. This role is for a cross-functional technical leader and is expected to set the standards for scientific curiosity and technical rigor for the site.
Key Responsibilities:
- Provide mentorship and scientific expertise to TS/MS bioprocess and laboratory scientists for process monitoring, trending, and analyzing production data. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations. Drive solutions to complex situations with impact across the site and functions.
- Understands, and performs all job responsibilities in compliance with safety and regulatory expectations and brings experience and knowledge of cGMP requirements to the role.
- Represent the site technically across the broader manufacturing network including other drug substance sites, drug product sites, global functions and process research and development. Reviews and approves annual product review and global product assessment.
- Partners with site leadership to ensure technical agendas are developed, implemented and managed compliant with all regulatory expectations and in alignment with business needs.
- Mentor scientists, engineers and operations staff and supports troubleshooting. Anticipates and resolves key technical or operational problems with impact across all functions. Communicates issues in a timely manner. May lead complex process-related investigations and assess technical impact.
- Closely partner with the quality assurance and quality control functions to provide technical oversight of the control strategy and ensure manufacturing process remain in a state of compliance.
- Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses and technical studies.
- Own or assist in the implementation of large process-related change controls with greater risk, resource and financial requirements or complexity.
- Supports development of strategy for regulatory submissions and the creation of related documentation.
- Excellence in technical writing and oral communication skills with the ability to effectively communicate and transfer knowledge to all levels of the organization.
- Works with scientists and engineers to ensure successful process knowledge transfer to the manufacturing staff on the production floor and assists in process-related training of manufacturing staff.
- Support the PAT and data science programs to ensure alignment between program execution, process scientists and control strategies.
- 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 the new facilities, process equipment and products during technology transfer. Helps to define, implement and own control strategies for new products.
Attributes for the Role
- Demonstrated technical acumen and high productivity
- Strong proclivity for technical leadership, teaching and mentoring
- Proven track record of curiosity and learning agility
- Self-starter with high initiative and data-driven approach to problem-solving
- Demonstrated strong interpersonal skills
- Demonstrated strong verbal and written communication skills
- Demonstrated adaptability and flexibility to working in fast pace, dynamic manufacturing environments
- Demonstrated ability to participate in and facilitate decision-making
Basic Minimum Requirements:
- MSc in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering or related discipline
- 5+yrs in ADC/mAb development
- Experience in commercial ADC/mAb mfg support
- Experience in inspection support
Additional Preferences:
- PHD in Biochemistry, Cell Biology, Biotechnology, Biochemical Engineering or related discipline
- 10+ years of experience within the biopharmaceutical industry
Work Environment:
- This role is 8-hours, day shift, and onsite. As a manufacturing support role, the need for occasional evening or weekend support can arise
- Occasional travel may be 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
$129,000 - $209,000
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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