Associate Director, Analytical R&D NBPI008

Job Description

Nitto BioPharma, Inc.

JOB DESCRIPTION

Position: Associate Director, Analytical R&D

Reporting To: Director, Chemisty

Core Competencies

· Strong skills to lead, motivate, train, and develop staff in analytical R&D group.

· Experience on the characterization of oligonucleotide, antibody-conjugate, and liposomal drug products.

· Strong knowledge of GMPs/GLPs. CMC authorization, regulatory audit, and inspection experiences are preferred. Familiar with ICH and FDA Guidance.

· Experience in analytical method development, validation, and transfer.

· Extensive experience with CMOs and CROs are highly desired.

Responsibilities

· Lead and oversee the Analytical Team for the physico-chemical characterizations, method development, qualification/validation, and transfer to CMOs or CROs.

· Provide analytical support for internal discovery, development, and stability programs.

· Monitor analytical activities in CROs/CMOs to support siRNA drug substance and liposomal drug product pipelines.

· Author relevant CMC sections for IND/NDA filings. Addresses technical inquiries from regulatory agencies to support preclinical and clinical studies.

· Write standard operating procedures, analytical test methods, protocols/reports for various analytical projects, or stability reports, when required.

· Provide subject matter expertise in analytical support of manufacturing campaigns for GLP and GMP programs.

· Conduct Technical audit to CROs and CMOs. Involve in CROs /CMO selection and technical transfer.

Education and/or Experience:

· Post graduate academic qualifications (M.S. or Ph.D. preferred) in Analytical Chemistry or related scientific discipline with a minimum 10 years experience in the pharmaceutical industry for analytical development.

· Demonstrate broad knowledge and experience in the development and validation of test methods for API and drug product candidates, physic-chemical characterizations, general analytical analysis, assay/impurity analysis, and specifications development.

· CMC experience with thorough understanding of the regulatory requirements for different phases of drug development.

· Expertise in impurity analysis and separation science such as HPLC, LC-MS, GC, including special chromatographic techniques (SEC, IEX, RPC, HILIC), spectroscopic techniques (UV-vis, fluorescence, FTIR), as well as, product release testing (bioburden, endotoxin).

· Proven track record of managing CROs/CMOs is must.

· Experience in oligonucleotides, and/or lipid, and/or antibody-conjugate based drug products 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.

Date Job description Created:

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
Los Angeles, CA
90033 USA
Website http://nittobiopharma.com
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