Associate Director, Analytical R&D NBPI018
Reporting To: Senior Director, Pharmaceutical Sciences
- Strong skills to lead, motivate, and develop the people in analytical R&D group.
- Experience on the characterization of oligonucleotide and liposome 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.
- Experience with IND authorship.
- Working experience with CMOs and CROs is essential.
- Lead the Analytical Team for the physico-chemical characterizations and bioanalytical method development, qualification/validation, and transfer to CMOs or CROs.
- Monitor analytical activities in CROs/CMOs to support siRNA drug substance and liposome drug product pipelines.
- Author relevant CMC sections for IND/NDA filings. Addresses technical inquiries from regulatory agencies to support preclinical and clinical studies.
- Provide analytical support for internal discovery, development and stability programs.
- Provide subject matter expertise in analytical support of manufacturing campaigns for GLP and GMP programs.
- Oversee internal development and transfer methods to CMOs and contract labs
- Conduct Technical audit to CROs and CMOs. Involved in CROs /CMO selection and technical transfer.
- Works in a team environment, regularly interacting with others in writing, by phone, email, and in person.
- This is a professional full time position that may require more than 40 hours per week to achieve project objectives. Approximately 10% travel.
Education and/or Experience:
- Post graduate academic qualifications (Ph.D.) 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.
- Knowledge of bioanalytical method development, including analyte extractions from biological fluids and related analytical methodologies.
- Expertise in impurity analysis and separation science such as HPLC, LC-MS, GC, including special chromatographic techniques (SEC, IEX, RPC, HILIC) as well as spectroscopic techniques (UV-vis, fluorescence, FTIR).
- Experience in oligonucleotides and/or lipid based drug products is a plus.
Physical and Other Job Requirements:
- Office/Lab environment. Lifting up to 50 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.
- This position splits its time between an office and laboratory environment. Lab work may include the use of centrifuges, microscopes, spectrometers and other laboratory tools. Will be required to wear personal protective equipment and comply with all safety regulations in the lab.
- Software used will include most typical office applications such as word processing and spreadsheets, and may include project management and analytical or scientific technology.
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.