Senior development scientist job description

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, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific 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.

FUJIFILm, Irvine Scientific had a new opportunity for a Senior Scientist II in Process Developent. In this position, our team member willl provide technical leadership in support of commercialized products, late-stage product development, process development, and new product evaluations to meet company standards and customer expectations.
External US
• Develop experimental strategies and plans to improve manufacturing processes for commercialized products and products in development.
• Work closely with the Technical Support team to investigate technical issues with commercialized products, develop plans of action, execute on plans, and achieve a resolution. This may be in the form of corrective action preventive actions (CAPA).
• Apply scientific/engineering principles and techniques to develop, characterize, analyze and implement processes to solve technical challenges.
• Supervise and conduct experimental work related to support and/or improve marketed products.
• Develop new applications for products and processes to meet customer needs based on feedback from customers.
• Design and execute scale-up and tech transfer of products for products in late stage product development depending on project needs.
• Perform technical evaluations on internal products or external products (e.g. potential OEM or licensing opportunities) considered for addition to the portfolio as needed.
• Provide scientific support, as needed, for the preparation of regulatory submissions for FDA/EU/CMDR or other regulatory agencies.
• Work with internal legal team to organize and facilitate administrative actions to support the intellectual property portfolio.
• Support marketing and new products through presentations, publications, collaborative studies, interactions with key customers and as a participant in conferences.
• Contribute to development of long-range plans for R&D.
• Learn, maintain and advance expertise in areas relevant to company's products and strategic goals.
• Effectively and consistently communicate with management, cross-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs.
• Effectively manage employees if managing is required.
Requisites:
Ph.D. with more than 5 years of relevant experience in Life Science, Biochemistry, Cell Biology, or related science. Minimum five years of relevant experience, with emphasis in cell culture. Cell culture experience. Broad scientific knowledge of Chemistry, Biochemistry, Cell Biology and Microbiology. Experience with conducting and creating new assays as needed.

• PhD in Chemistry, Biochemistry, or Analytical Science with 3+ years (Scientist), or 5+ years (Senior Scientist) of pharmaceutical CMC industry experience and a demonstrated technical leadership in process development, vaccine and/or ophthalmology experience
• Proven ability to provide process expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies
• Experience working in a GMP regulated
• Strong scientific and operational background in the optimization and validation of downstream processing for harvesting, filtration, capture and purification methodology
• Strong understanding of method development, technical transfer, and GMP Experience with IND and/or BLA submissions
• Detail oriented, exceptional documentation practices, technical writing and verbal communication skills
• Excellent contingency planning and time management skills and demonstrated ability to manage several projects
• Possess strong problem solving and analytical skills and be an independent and creative
• Ability to navigate and be successful in a fast-paced, highly matrixed work

Working Conditions:

This job requires a person to work in laboratories and offices to conduct experiments, analyze the results, and create reports and scientific presentations. The employee will be spending 70% of work hours at the process development and research and development laboratory and is expected to work with biological materials, microorganisms, cells, and laboratory chemicals. They are expected to work with vendor, CROs, and CMOs in drafting and reviews of various documents such as study design, protocols, batch records, and reports. This position requires travel to CRO/CMO sites as needed.

Physical Requirements:

Person may have to stand and sit for longer duration during experiments.

Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.

This individual will join a team of scientists to support the predevelopment of cell based AAV gene therapy potency assay methods at the Sarepta Andover facility. The position requires a strong background in cell culture and experience in cell-based assay method development. The individual needs demonstrable experience in managing cell lines, both wild type and KO cell lines. The candidate should have hands on experience of SDS-PAGE, Western blotting, enzyme activity measurements, protein extraction methods, antibody screening, and protein quantification methods using recombinant protein. The individual will be responsible to support analytical method development. This person will interface with the internal and external cross-functional teams. Some level of people management experience would be beneficial.

Hands on experience with cell culture to create and maintain unique mammalian wild type and KO cell lines for cell-based assays. Testing new cell lines for use in potency assays for multiple new gene therapy programs.Managing the production, screening, and testing multiple recombinant protein standards and antibodies for multiple target proteins under several gene therapy programs Conduct laboratory experiments involving in vitro potency methods to select the suitable cell lines, antibody and recombinant proteins.Redesign multiple cell lines to enhance the expression of surface receptors in a reproducible manner to increase infectability Create and maintain clear and concise lab records and documentation.Author test methods, predevelopment reports, and study protocols.Support the existing development team , transfer and qualification/validation activities Act as company liaison with CMOs to coordinate in method development and method transfer across various CMO/CRO sites as needed
Education and Skills Requirements:
Ph.D in molecular biology, cell biology or virology with at least 3+ years of industrial experience.Working experience in a cGMP environment is preferred
A strong understanding of AAV related cell culture methods, capillary based electrophoresis, SDS-PAGE electrophoresis, and cell banking is necessary.Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.Experience in developing, validating and deploying molecular biology test methods is useful.Must have effective written and verbal communication skills Operate as part of a team; assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency

This position requires work on site at one of Sarepta's facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify