Scientist, Product Development
- Indianapolis, IN
- $79,700-113,800 per year
- Permanent
- Full-time
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
- This position will be responsible for the adaptation, setup, transfer, and maintenance of sponsor drug products with strict adherence to cGMP, GDP, environmental health and safety and related guidelines, and internal policies and procedures.
- Specific duties will at a minimum comprise technical evaluation, material selection, process equipment configuration, document creation, and process validation, as well as occasional testing activities typical for a cGMP pharmaceutical manufacturing operation, including the preparation of chemicals and components, the operation/maintenance/repair of laboratory equipment, and the execution of standard operating procedures for routine testing of radiopharmaceutical products.
- Evaluate, create, adapt, and transfer testing procedures established by internal product development teams and external product sponsors for our Indianapolis Theranostics cGMP radiopharmaceutical manufacturing facilities.
- Generate study protocols and controlled documentation necessary to enable the technology transfer and qualification of contracted products.
- Execute testing activities required for analytical method validation according to study protocols and standard operating procedures. Generate study reports where required.
- Complete equipment qualification and computer system validation protocols developed in partnership with Validations personnel.
- Lead investigations and document deviations and exceptions occurring during technology transfer.
- Train facility personnel on new procedures and provide routine support following completion of technology transfer.
- Facilitate day-to-day operation, maintenance and repair of testing instrumentation. Clean and maintain all testing and related laboratory equipment during technology transfer.
- Communicate all issues related to safety, quality, and compliance to leadership.
- Bachelor's degree in related field, or equivalent work experience, preferred.
- At least 5 years of experience working in a GMP environment in the pharmaceutical or biotechnology industry highly preferred.
- A background in product research and development preferred.
- The preferred individual will possess sufficient technical, functional, and administrative competence to work largely independently, in a team environment, to meet program timelines and occasional production demands.
- Foundational expertise in the setup, operation, and maintenance of conventional analytical instrumentation (HPLC/GC/TLC/etc.) and modern chromatography data systems
- Ability to work in a controlled environment requires special attention to environmental, health, and safety regulations.
- Position may require lifting or moving equipment weighing up to 40 lbs.
- Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements, including the ability to clearly document all work activities in a timely manner.
- Motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
- Desire to create, develop, and mature processes, and facility and systems infrastructure, to streamline operational efficiency across a broad range of products.
- Flexibility to work periodic off-shift hours to accommodate routine production schedules among qualified facilities.
- Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
- May contribute to the development of policies and procedures
- Works on complex projects of large scope
- Develops technical solutions to a wide range of difficult problems
- Solutions are innovative and consistent with organization objectives
- Completes work; independently receives general guidance on new projects
- Work reviewed for purpose of meeting objectives
- May act as a mentor to less experienced colleagues