Senior Manager, Analytical Chemistry NBPI008

Location
San Diego, CA, United States
Posted
Sep 16, 2020
Ref
1149482499
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
Job Description

Nitto BioPharma, Inc.

JOB DESCRIPTION

Position: Sr. Manager, Analytical R&D
Reporting To: Director, Chemistry

Core Competencies
 Solid knowledge on bioanalytical/analytical method development, validation, and transfer
 Supervisory experience and project management experience
 Excellent troubleshooting / problem-solving skills
 Experience on the characterization of impurities/degradants of raw materials, drug substances, and drug products
 Knowledge of GMP/GLP requirements and IND/NDA submission experience is a plus
 Extensive experience in working with CMOs/CROs
 Strong oral and written communication skills

Responsibilities
 Manage and supervise the research and development tasks of drug substance/drug product group
 Provide bioanalytical, analytical and technical support for lipid, siRNA, and liposomal drug product manufactured in CMOs
 Participate in OOT/OOS/deviation investigations, risk assessment, and evaluate CMO's or CRO's corrective and preventative actions
 Design/monitor in-house and CMO/CRO stability studies, and review/evaluate stability data
 Act as the liaison between NBPI and external CMOs/CROs
 Draft CMC analytical and stability section for IND and NDA regulatory submissions

Education and/or Experience:
 M.S. with 10+ years experience or Ph.D., with 8+ years experience in Analytical Chemistry, or Bioanalytical, or related discipline in the pharmaceutical industry, or an equivalent combination of education and experience
 Extensive experience in liquid chromatography and mass spectrometry is required
 Knowledge and expertise in handling and preparation of biological samples. Experience in a variety of biochemical methods
 Experience in oligonucleotide and liposomal drug development is a plus

Physical Job Requirements:
Office/Lab environment. Lifting up to 20 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.

Disclaimer: The duties and responsibilities of position may change as need arises. The employee will be notified of the change. Relevant work experience may also be substituted for education or certification, at company's discretion.

Company Description
Nitto BioPharma, Inc. is a clinical stage biopharmaceutical company located in San Diego focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Nitto BioPharma offers unique drug and RNA delivery solutions by designing novel biodegradable drug delivery systems with the ability to target specific cells and efficiently deliver the cargo into the cells. Clinical assets include two Phase 2 clinical programs, a first-in-class drug for the treatment of fibrotic diseases of the liver (with Bristol-Myers Squibb), and idiopathic pulmonary fibrosis, as well as a Phase 1 oncology program to treat non-small cell lung cancer.
Nitto BioPharma's mission is to develop and deliver innovative life-transforming therapies for patients with unmet medical needs. Leveraging the long-standing success and track record of Nitto Denko Corporation (Nitto), Nitto BioPharma has created a new and efficient business unit that allows pharmaceutical products to be brought to market at a fast pace. Our long-term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make Nitto BioPharma a vibrant and exciting work environment.

Nitto BioPharma is a key asset of Nitto. Since its establishment in 1918, Nitto has created over 13,500 products based on its core technologies and has contributed to customers' value creation with innovative ideas. The core of Nitto's life science business consists of contract manufacturing and drug discovery.

Nitto BioPharma, Inc.
Why Work Here?
55-person small company atmosphere with stable 102-year-old parent company backing. 33,000 employees globally; headquartered in Japan.
Nitto BioPharma, Inc. is a clinical stage biopharmaceutical company located in San Diego focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Nitto BioPharma offers unique drug and RNA delivery solutions by designing novel biodegradable drug delivery systems with the ability to target specific cells and efficiently deliver the cargo into the cells. Clinical assets include two Phase 2 clinical programs, a first-in-class drug for the treatment of fibrotic diseases of the liver (with Bristol-Myers Squibb), and idiopathic pulmonary fibrosis, as well as a Phase 1 oncology program to treat non-small cell lung cancer. Nitto BioPharma's mission is to develop and deliver innovative life-transforming therapies for patients with unmet medical needs. Leveraging the long-standing success and track record of Nitto Denko Corporation (Nitto), Nitto BioPharma has created a new and efficient business unit that allows pharmaceutical products to be brought to market at a fast pace. Our long-term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make Nitto BioPharma a vibrant and exciting work environment. Nitto BioPharma is a key asset of Nitto. Since its establishment in 1918, Nitto has created over 13,500 products based on its core technologies and has contributed to customers' value creation with innovative ideas. The core of Nitto's life science business consists of contract manufacturing and drug discovery.

Address
10618 Science Center Drive
San Diego, CA
USA
Website http://nittobiopharma.com
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