Analyst I–Technical Services/Manufacturing Services(TS/MS) Process Data - FDE
Posted on: 5 Sep 2021
Branchburg Twp, NJ
Job Description
General Summary:
Entry level position responsible for ensuring the accuracy of data and providing data analysis support for data generated during manufacturing processing at the Lilly Branchburg, NJ site. This position will interact with the manufacturing, quality assurance and quality control departments. Some interaction with other Lilly sites or contract manufacturers may be required. Knowledge of cell culture, purification and support systems is a plus. Spreadsheet experience required, database experience a plus.
Responsibilities:
Verifies the accuracy of the data entered into the in-process database by the operations staff and ensures that all the data entries are complete.
Assists with the trending and analysis of manufacturing production data to support: deviations, process validation protocols and reports, technology transfer documentation, BLA filings, annual manufacturing summaries for regulatory documentation, etc.
Assists with the maintenance of local databases.
When requested, provides data for technical reports supporting technology transfers, deviation/adverse event reporting and process analysis/trending.
May lead small to medium-scale projects or programs. Makes decisions that impact own priorities and allocation of time to meet deadlines.
Provides sound problem solving skills to complex issues.
Writes SOPs as they relate to the activities of the TS/MS group. May assist with SOPs from other manufacturing groups.
Understands and performs all job responsibilities in compliance with safety and regulatory expectations, as well as, cGMP.
Basic Requirements:
Bachelor of Science degree in a scientific or engineering discipline with 0 - 3 years of relevant experience
Additional Skills/Preferences:
Strong mathematical and analytical skills
Excellent communication skills, both oral and written
WORD, EXCEL, and Powerpoint experience required, coding experience a plus
SQL database experience a plus
Experience in cell culture and/or protein purification manufacturing a plus
An understanding of current Good Manufacturing Practices a plus.
Familiarity with TrackWise and LIMS a plus
Eli Lilly
Indianapolis, IN
Eli Lilly and Company discovers, develops, manufactures, and markets pharmaceutical products worldwide. The company operates in two segments, Human Pharmaceutical Products and Animal Health Products. It offers endocrinology products for the treatment of diabetes; osteoporosis in postmenopausal women and men; and human growth hormone deficiency and pediatric growth conditions.
The company also provides neuroscience products for the treatment of depressive disorder, diabetic peripheral neuropathic pain, anxiety disorder, fibromyalgia, and chronic musculoskeletal pain; schizophrenia; attention-deficit hyperactivity disorder; obsessive-compulsive disorder, bulimia nervosa, and panic disorder; and positron emission tomography imaging of beta-amyloid neurotic plaques in adult brains, as well as migraine prevention. In addition, it offers immunology products for the treatment of rheumatoid arthritis and plaque psoriasis; oncology products to treat non-small cell lung, colorectal, head and neck, pancreatic, metastatic breast, ovarian, bladder, and metastatic gastric cancers, as well as malignant pleural mesothelioma; and cardiovascular products to treat erectile dysfunction and benign prostatic hyperplasia, and acute coronary syndrome.
Further, the company provides animal health products, such as cattle feed additives; leanness and performance enhancers for swine and cattle; antibiotics to treat respiratory and enteric diseases in swine and poultry; anticoccidial agents for poultry use; and chewable tablets that kill fleas and prevent heartworm diseases. Additionally, it offers vaccines to prevent bordetella, Lyme disease, rabies, and parvovirus.
The company has collaboration agreements with Daiichi Sankyo Co., Ltd.; Incyte Corporation; Pfizer Inc.; AstraZeneca; Nektar Therapeutics; NextCure, Inc.; Dicerna Pharmaceuticals; AC Immune SA; and Avidity Biosciences, Inc. Eli Lilly and Company was founded in 1876 and is headquartered in Indianapolis, Indiana.
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IndustryBiopharmaceuticals
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No. of Employees38,680
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Website
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Jobs Posted195
