R&D, Analytical Development Manager
Overview:
FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines.FUJIFILM Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support.
For over 50 years, FUJIFILM Irvine Scientific, Inc. has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation.
We are hiring an Analytical Development Manager. The Analytical Development Manager will manage analytical method development for supporting the recombinant growth factors and cytokines development and manufacturing.
External US:
Responsibilities- Manage development of analytical methods (for determination of purity, bioactivity, sterility, endotoxin, strength, amino acid sequence, etc.) to support development and production of recombinant growth factors and cytokines.
- Design and carry out Method Development experiments.
- Support technology transfer of the methods to Quality Control team and support qualification and validation activities, as needed.
- Provide analytical/technical support to R&D and Manufacturing teams.
- Provide technical leadership to cross-functional teams involved in tech transfer.
- Participate in the promotion of technical services through interactions with customers and technical presentations.
- Prepare formal method development reports, instruments SOPs and presentations.
- Troubleshoot equipment and experimental problems.
- Ph.D. in Analytical Chemistry, Biology, Cell Biology, Biochemistry, Molecular Biology, or relevant fields. MS with 12 years of productive and relevant experience
- More than 8 years productive and relevant experience
- More than 2 years’ hands on management and involvement in aspects of analytical research, development and support.
- General lab safety
- Successful track record of analytical method development.
- Hands on management and involvement in aspects of an R & D organization’s day-to-day operations. Proven leadership and management ability, including analytical thinking, market differentiation and business results required.
- Experience with GMP and QA compliance
- Proficient in MS Word, Excel, PowerPoint, Outlook
- Ability to speak, write and read English fluently.
EEO/AGENCY NOTES
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place.In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.
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