Scientist/Engineer TSMS Process Validation in Branchburg

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Scientist/Engineer TSMS Process Validation in Branchburg, Apply Lilly careers in Branchburg New Jersey.


Position : Scientist/Engineer TSMS Process Validation

Location : Branchburg Township, New Jersey

Job id: R-34393


Job Details

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 35,000 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.Organization Overview:At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Each Lilly employee will embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world. Position Brand Description:This position is responsible for designing and implementing process validation protocols for manufacturing processes, writing the subsequent validation reports, planning of process validation (PV) activities, and authoring related protocols and subsequent reports, as applicable. The individual may be a member of a team providing support to the Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) organization. Responsibilities also may include assisting colleagues in process troubleshooting efforts and supporting Regulatory CMC filings; supplying the technical content for the CMC sections of investigational drug applications (INDs, CTAs), initial marketing applications (BLAs/MAAs), and required amendments; helping compile responses to health authority requests; and coordinating information from technical experts during the synthesis of regulatory documents, as applicable.This position will interact with Engineering, Manufacturing, Validation, Quality Assurance, Quality Control and Regulatory departments. Interaction with other Lilly sites/contract producers of Lilly products may be required. The position may represent the PV team at cross-functional technical meetings, such as the Science Lead Team, involving the technical transfer of a manufacturing process between sites. The incumbent may be assigned to serve as a molecule steward, as applicable. Knowledge of cell culture, purification and the support systems used in the manufacture of biotech products is required, as applicable.Key Objectives/Deliverables:Manage for Results /Strategic Planning:Plans and executes process validation activities such as process consistency, comparability, process intermediate hold and resin lifetime studies.Requires depth of expertise within this discipline and the ability to anticipate and resolve key technical and operational problems. Takes a leadership role to ensure the success of these activities. Makes decisions that impact the process validation group’s work.Anticipates and resolves complex problems during the planning, authoring and execution of process validation protocols and studies for Lilly’s products. Establishes relationships with key contacts outside of Branchburg TS/MS. Gains support for ideas or positions on difficult issues.Trends and analyzes production data. Authors campaign summary reports as needed. Applies process knowledge and data analysis skills to support manufacturing operations. Presents process data and analyses in cross-functional meetings. Drives solutions for products and processes across a large business area.Reviews protocols and technical reports, both within and external to TS/MS. Assists in the preparation and review of CMC sections of regulatory filings.Authors technical documentation supporting technology transfers, product commercialization, and process deviations. Serves as a key resource within TS/MS. Provides data and collaborates with the Process Development and the Statistics and Quantitative Sciences groups in support of data trending and the establishment of process limits. Manages development of TS/MS sections of APRs.Authors department program documents, as required, in support of the Quality System.Collaborates with manufacturing, sample coordination and QC to ensure required samples are processed and tested as required by the executed protocols. Uses engineering principles to analyze commercial scale process and product data. Drives solutions impacting results for the site.May lead medium-scale projects or programs with moderate risks. Requires comprehensive business and technical knowledge to improve products or processes. Makes decisions that impact a range of standard and non-standard operational, process, or project activities.Understands and performs all job responsibilities in compliance with safety and regulatory expectations, as well as, cGMP.Basic Requirements:BS degree in Biochemistry, Chemistry, Microbiology or an applicable science, as applicable. BS/BA degree in a life science, engineering, or related field, as applicable.Minimum of 5 years experience, as applicable, in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment. Lesser years of experience will be considered under extraordinary circumstances or where consistent high-level performance measures have been sustained.A working knowledge of US regulatory requirements.Knowledge of cGMPs as they apply to the Regulatory environment.Additional Preferences:Strong organizational and project management skills.Excellent oral and written communication skills, including demonstrated skills in the preparation of regulatory filings.Ability to effectively operate in a cross functional, team-based environment.Proficiency with software such as Microsoft Office Suite and Adobe Acrobat.A working technical knowledge of the biopharmaceutical manufacturing process, preferably in the area of antibody manufacturing. Expertise in a technical discipline is a plus.Global regulatory experience a plusFamiliarity with TrackWise and LIMS a plus.Additional Information: 10% Travel required.Lifting not required.Required to be on call.Shift work may apply.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). #WeAreLilly



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