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Scientist-Technical Services / Manufacturing Services - United States  

Lilly (company)

Posted on : 07 May 2017

Project Description

Scientist-Technical Services / Manufacturing Services
United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Scientist, Sr. Scientist and Assoc. Consultant Scientist positions are technical positions that support the commercialization activities associated with parenteral drug products. Primary objectives include but are not limited to, understanding of the scientific and technical aspects of the molecule, successful transfer of the manufacturing process and the reliable and compliant manufacture of parenteral drug commercialization products to predetermined global quality standards via a detailed set of manufacturing instructions and procedures.

Key Objectives/Deliverables

  • Understand the scientific principles required for the transfer and manufacture of parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
  • Prepare and Review as required, relevant technical documents such as: Change controls, Deviations, Validations, Tickets, Procedures, VMPs, NMP, QPPA etc.
  • Provide technical support to investigations (e.g. deviations, process removal) including consultation on quality and stability issues.
  • Ensure that an accurate instruction set (tickets and procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
  • Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
  • Understand, justify and document the state of validation (process and cleaning, sterility assurance etc.) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
  • Act as the main point of contact to support operations on the floor during the manufacture of commercialization products.
  • Work within or lead cross-functional teams (Development, QC, QA, Regulatory, Engineering etc…) in positive fashion to implement TSMS commercialization objectives and deliver on business plan objectives.
  • Participate in development and implementation of process improvements, including capital expansions and technical projects.
  • Support and or lead TSMS technical projects (experimental, modeling and/or production data analysis) to improve process controls, yield, purity and/or productivity.
  • Bachelors (BSc) in Chemistry, Biochemistry, Protein Chemistry, Bioanalytical Chemistry, Analytical Chemistry, Biophysical Chemistry, Microbiology, Pharmacy, engineering, or other related scientific discipline
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
  • Technical/Scientific knowledge
  • Good written and oral communication skills
  • Clear understanding of cGMPs
  • Teamwork and interpersonal skills
  • Computer skills
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and site goals.
  • Decision making
  • Mutli-tasking
  • Ability to influence groups
  • Problem solving
  • Some travel (domestic and international) may be required.
  • Task requires entering manufacturing areas which require wearing appropriate PPE.
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.