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Position Summary:
The Reference Standard Manufacturing Scientist is responsible for ensuring the technical integrity, reliable supply of materials, and overall compliance of Lilly reference standard manufacturing activities.
The Scientist will have influence in all phases of drug development, product registration, and marketed product support by ensuring that reference standard manufacturing strategies are properly established, executed, and maintained to deliver suitable reference standards.
The individual will ensure that materials, manufacturing process, and the certifying documentation are scientifically sound, properly integrated with analytical control strategies, and compliant with all corporate and regulatory requirements. The individual will work closely with global Lilly scientists, internal partners, and external third-party manufacturers to ensure efficient and timely support of material and information deliverables.
Key Responsibilities:
Technical
Uses knowledge of reference standard and manufacturing processes (e.g., vial lyophilization, powder-fill, solution reference standards, large-scale solution manufacture) to establish suitable reference standards and to solve complex technical problems and issues
Broadly understands reference standard sub-division processes, specifically vial lyophilization and solution reference standards
Qualifies and maintains relationships with high-quality vendors to meet capacity and capability required by CRSO
Uses understanding of control strategies to select source materials, design packaging, manage inventory, manage equipment and facilities, and design protocols.
Leads global technical teams to ensure that the manufacturing instructions and associated documentation for in-house production, or manufacturing by vendors, is appropriate and justified for any changes for replacement batches.
Directs the acquisition of data required to disposition a candidate source batch material
Performs activities needed to ensure timely resupply of source batch materials and manufacture of candidate reference standard batches
Establishes and maintains the SOPs that govern these activities
Develops and maintains training materials associated with reference standard manufacturing
Fulfills the role of RS Information Scientist, as needed, by autonomously designing, collaborating on, authoring or reviewing scientific conclusions and content of documents such as reference standard protocols and profiles
Applies statistical techniques, defines appropriate calculations, and makes conclusions to support key suitability decisions
Ensures that activities are compliant with all applicable regulatory and safety requirements
Continually improves the reference standard manufacturing process
Project and Financial Management
Accountable for the successful management and timely delivery of all work in progress associated with reference standard manufacturing
Monitors existing batches and determines which resupply activities must start earlier than normal based on manufacturing or source batch acquisition complexity
Leads the team of laboratories and other key stakeholders associated with executing fill/finish activities, including the authorship of the reference standard protocol
Establishes appropriate plans for material supply, storage, and distribution activities based on material properties and uses
Defines and executes appropriate actions based on trends and the outcome of metrics
Autonomously manages assigned internal project load; acts in a self-directed manner in anticipation of future assignments
Prioritizes work based upon key milestones and uses the principles of project management to consistently meet rigid timelines
Leverages internal and external vendors for appropriate technical deliverables and required capacity
Creates high-quality documentation in conjunction with molecule technical experts, product stewards, and statisticians
Ensures that activities are compliant with all applicable regulatory and safety requirements
Decision Making
Leads the cross-functional team that decides the course for the manufacturing strategies associated with the establishment and maintenance of reference standards
Anticipates and solves technical issues associated with reference standard manufacturing by fully understanding the impact of manufacturing on the suitability for use of the resulting materials
Leads investigations of departures from Quality standards
Responsible for decisions that ensure the reliable supply of reference standard materials
Anticipates potential gaps in the existing quality system and acts to present resolutions in a timely and proactive manner
Provides updates to supervision and relevant stakeholders regarding progress and issues
Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations
Influence
Leads the team of CRSO, development, and commercial manufacturing personnel involved in the reference standard fill/finish process
Influences CRSO partners to fully participate in the reference standard manufacturing process and to understand the aspects of this activity that impact product control strategies
Leads formulators and molecule technical experts to resolve technical issues
Gains laboratory and molecule technical expert support in resolving difficult laboratory, manufacturing, and reference standard issues
Ensures global customers can efficiently procure materials
Impact
Coordinates solutions involving multiple laboratories and business units
Prevents interruptions in deliverables by planning and timely initiation and efficient execution of manufacturing projects
Communicates critical information to formulation scientists, chemists/biologists, quality leaders, regulatory representatives, and key collaborators in a timely manner
Interacts with outside sources to obtain material
Contributes to internal and external scientific forums
Customer Focus/External Focus
Interfaces with various customer groups to allow for positive and continuously improving interactions
Establishes a relationship of trust with customers and partners
Interacts with customers with integrity and respect
Seeks feedback from customers regarding the quality and timeliness of services
Requirements:
Master's degree in Chemistry, Biochemistry, Life Science, or related field with 3 years of relevant experience in the pharmaceutical industry; or Bachelor's degree in Chemistry, Biochemistry, Life Science, or related field with 5 years of relevant experience in the pharmaceutical industry in materials, manufacturing process, documentation, and corporate and regulatory compliance requirements
Knowledge of measurement techniques and statistical analysis of data
Understanding of chemical synthesis, purification techniques, formulation, packaging, and inventory management
Ability to manage multiple complex projects concurrently and respond to changing priorities while maintaining accuracy and attention to detail
Demonstrated scientific problem-solving skills
Experience with computerized inventory management and electronic notebook systems
Proficiency in statistical tools (e.g., Excel and JMP)
Self-management skills
Strong communication skills, both oral and written
Compliance background
Travel 0-15%
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.
Additional Skills/Preferences:
Experience with the science of reference standards preferred
Pharmaceutical analysis or production experience preferred
Strong project management skills, with managing a network of external vendors preferred
Additional Information:
Potential exposure to chemicals, allergens, extreme temperatures, and loud noises
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
$65,250 - $169,400
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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