Process 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 Scientifice has a new opportunity for a Scientist I. In this position, our team member will conduct research under the direction of a supervisor leading to the support of product and process development.
External US
• Design experiments related to media and buffer preparation processes
• Develop scale-down models that represent particular risk factors of full-scale media and buffer prep processes
• Identify critical factors required for a successful technology transfer from bench scale to production
• Analyze data and build statistical models to predict process performance
• Develop and perform various physicochemical assays to predict and troubleshoot process failures
• Use professional concepts and company's policies and procedures to performed a wide range of assigned work and solve difficult problems in practical ways
• Prepare formal reports and presentations for group meetings
• Actively participate in group/project meetings
• Update job knowledge by participating in educational opportunities and reading technical publications
• Good Documentation Practices & Good Laboratory Practices
Requisites:
Minimum 2 years of relevant working experience BS. >2 years or M.S. with <2 years of relevant working experience General lab safety Knowledge of Chemistry, Biochemistry, and Process Science Knowledge of basic laboratory equipment (scales, pH meters, etc.) Knowledge of commonly used experimental/research concepts, practices, and procedures. General knowledge of computer systems and productivity software General knowledge of project management General knowledge of GMP and GLP procedures

At C16 Biosciences, we believe that palm oil doesn't have to be a problem. Our team is building a sustainable and environmentally-friendly alternative to “conflict palm oil,” which relies on tropical rainforest deforestation and emits over 1 billion tons of CO2 into the atmosphere every year. C16 Bio's technology platform harnesses naturally-occurring biological processes, improved by the latest innovations in strain engineering, fermentation, and low-cost lipid extraction to produce a better kind of palm oil.

Please note: This is a posting for general consideration of future Scientist roles at C16 Biosciences. At present, we are not actively looking to fill this position, but intend to be in the coming months. All candidates will hear back regarding next steps upon review of their application.

C16 is seeking a Scientist to drive the development of novel processes to improve the recovery of our fermentation products. You will be heavily involved in the planning and execution of laboratory experiments to evaluate and optimize key process parameters and develop cost modeling to provide insight in future laboratory work. You may help with scale up efforts to our pilot facility or to contract manufacturers. You will be a critical member of a tight-knit R&D team focused on developing a sustainable path for palm oil production. The ideal candidate will be motivated, independent, and has strong organization and communication skills.

What you'll do:Lead the lab scale extraction and purification experiments Help lead the experimental design of downstream experiments Help maintain techno economic models for our processes Record and manage data in our laboratory database Perform data analysis to understand the tradeoffs between process parameters and key performance indicators Think critically about data and apply fundamental principles to understand our systems Troubleshoot equipment and process issues and implement corrective actions Apply creative problem solving to improve laboratory operations Collaborate and communicate effectively with internal teams

Minimum education and experience:B.S in chemical engineering or related field with 8 or more years research experienceM.S. in chemical engineering or related field with 6 years of research experience Ph.D. in chemical engineering or related field Technical knowledge of extraction and purification processes required

Preferred qualifications:Experience in techno-economic analysis strongly preferred Scale up experience of downstream processes preferred Liquid extraction or solvent processes a plus Technical knowledge of fermentation processes a plus

C16 offers:Competitive salary within the industry Unlimited PTO401k matching Medical, dental & vision insurance coverage Access to well-being tools and development opportunities (e.g. mental health, CitiBike memberships, and more)401(k) retirement plan options

Diversity at C16 Bio:We celebrate diversity in all its forms. We are committed to EEO regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, marital or parental status, disability, veteran status, and more.
Legal authorization to work in the U.S. is required.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

Do you desire both autonomy and collaboration in tackling scientific challenges that interest you? Be a part of a hardworking team where everyone has a voice. Use your scientific skills to help us achieve our mission of saving lives by curing neurodegenerative diseases.

As a Purification Scientist, you will be part of our Downstream Process Development team where you will work closely with members of the Upstream and Analytical Development teams. This is an exciting management track position where you will have the opportunity to lead a team within the Downstream organization. This role is part of a cross-functional team, requiring you to communicate and work well with multiple departments, including Preclinical and Research teams. Alector is seeking a candidate that has broad experience purifying various types of proteins and possesses broad experience with purification, TFF operations, and supervising development. You will be responsible for and own the development of product-specific, purification processes for Alector's lead molecules as well as purification of research reagents to support drug discovery efforts. You will identify and provide support for ongoing programs and your work will be central to Alector's strategic goals. You will be influential in championing and developing Alector's culture.

During your first year, your goals will include:Scout and optimize purification steps for yield, product quality, reduction of impurities, and loading conditions Perform robustness testing of chromatography unit operations and scale-up purification processes. Conduct hold-stability studies of intermediate eluate product pools Design and implement formulation studies, including short and long-term hold stability studies of formulated proteins Mentor junior research associates in process development best-practices Evaluate new technologies (e.g. automation, novel resins and membranes, etc.) to further enhance internal process development capabilities Lead a team in the manufacture, proper documenting, and final filling of larger-scale Drug Substance batches for Non-GLP tox studies Author, review, and edit documents related to downstream processes, such as SOPs, batch records, and development reports

We'd love to hear from you if you have: PhD in relevant scientific fields with 2-5 years OR a B.S degree with at least 8 years of increasing responsibility, relevant proven experience Hands-on experience developing, optimizing, and scaling-up purification process unit operations for various chromatography methods using AKTA FPLC systems Familiar with Unicorn software and able to author and customize purification methods for various techniques Possess technical mastery of industry-standard chromatography techniques and methods for the purification of antibodies like: Protein A affinity chromatography, IEX chromatography, membrane chromatography, HIC chromatography, mixed mode chromatography, and TFF formulation unit operations Experience in design of experiments (DOE) for purification optimization is highly desirable Extensive experience purifying monoclonal antibodies and highly desirable if candidate has familiarity with fusion proteins, tagged proteins, and bi-specific molecules Strong organization skills in recording and summarizing data with strong attention to detail Must possess the ability to multitask and prioritize work to support organizational needs and meet deadlines in a fast-paced environment Ability to design, execute and analyze experiments and problem-solve independently Excellent communication skills to work collaboratively in a team environment

Additional desirable skills: Experience with basic analytical assays (e.g. SDS-PAGE, SEC-HPLC, UV-Vis, LAL), liquid protein formulation development, and large-scale purification.
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Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune's "Best Workplaces in Biopharma" top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other's assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.