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
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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