Senior Scientist I (Downstream Process Development)
CA-San Carlos, US
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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GigaGen, a subsidiary of Grifols, discovers and develops next-generation recombinant antibody therapeutics. Our core technology utilizes a microfluidic droplet system to capture and immortalize diverse immune repertoires, which can then be mined for exceptional monoclonals or enriched and used as high-potency polyclonal therapeutics. Our preclinical and clinical pipeline includes several recombinant polyclonal products for infectious diseases and a monoclonal antibody with a unique mechanism for oncology.
We are seeking a Senior Scientist I to lead our downstream process development and technology transfer efforts for our diverse recombinant monoclonal and polyclonal antibody therapeutics pipeline. The Process Development team at GigaGen consists of a small group working closely together on upstream, downstream, and analytical method development, with the opportunity to contribute critical results to early-stage and clinical-stage products.
Primary Responsibilities:
- Stay abreast of technical advancements in the CMC area of downstream process development for biologics
- Design and execution of experiments to establish purification processes for novel polyclonal antibody products. This includes proposing and running experiments or supervising execution of experiments, and reviewing and analyzing data
- Communication with the upstream process development and analytical teams and technical leadership regarding downstream tasks for routine protein production
- Optimization and scale-up of processes in preparation for transfer to manufacturing
- Lead and support various elements of early-stage CMC development activities, including technical support of non-GMP and clinical manufacturing, as well as development and implementation of process improvements, as programs advance through development
- Work with contract development manufacturing organizations (CDMOs) to help define project scope, review proposals, and oversee technical work, including review and approval of batch records, data, and reports
- Authoring of specific process development and manufacturing sections (CMC/Quality modules) for global regulatory submissions
- Data analysis, interpretation, and effective communication to management
Additional Responsibilities, Skills & Requirements:
- Bachelor with 8+ years of experience or Master with 5+ years of experience or PhD. with 3+ years of experience
- Significant technical expertise in antibody purification, including use of multiple types of chromatography and filtration
- Ability to work independently to troubleshoot processes and develop new methods
- Experience in oversight of technology transfer to CDMOs
- Exceptional communication and interpersonal skills to establish positive relationships with internal stakeholders, CROs/CDMOs, and multi-functional/multi-cultural teams
- Accuracy and attention to detail
- Proactively introduce new methods, provide technical mentorship to colleagues, and identify and execute ways to keep the lab running efficiently
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
The estimated pay scale for Senior Scientist I (Downstream Process Development) role based in California, is $130,000-$170,000 per year. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
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Location: NORTH AMERICA : USA : CA-San Carlos:USSCAR2 - San Carlos CA-Shoreway Road-GG