Grifols Shared Services North America, Inc PD Sr Scientist II Upstream in Emeryville, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
The incumbent will provide technical or scientific expertise and leadership in the upstream process development of mammalian cell culture derived recombinant proteins and monoclonal antibodies.
Primary Responsibilities for Role:
Responsible for developing cell culture medium, feeding strategies, process parameter optimization, and scale-up to support large scale production of material for preclinical and clinical activities.
A good working knowledge of quality be design approaches and process analytical tools to drive provess undesrtanding and develop robst processes is highly desirable.
Proficient in writing development reports, protocols, batch records and technology transfer reports.
Applies scientific and engineering expertise to develop recombinant protein production processes suitable for large-scale cGMP manufacturing.
Must demonstrate strong scientific/technical and interpersonal skills as well as the ability to communicate effectively.
Responsible for independently identifying actions required to support departmental objectives.
Execute action plans independently, as part of a team, or as the lead for a departmental team.
Responsible for representing the functional area or capable of leading a cross-functional team to achieve identified objectives.
Independently prepares and critically edits procedures or technical reports of a complex nature, assimilating information across functional areas, suitable for inclusion in IND, BLA, or equivalent regulatory submission.
Develops creative, novel programs to meet departmental objectives.
Leads others in problem-solving efforts.
Advanced ability to creatively apply scientific principles in problem solving in potentially novel areas.
Mentors/trains staff in relevant principles and/or guidelines.
Responsible for serving as technical consultant within functional area or site.
Independently designs, executes, and interprets results for novel and scientifically complex study programs.
Mentors others in experimental design.
Responsible for directing others in study execution.
Maintains laboratory facilities in accordance with company policies and industrial best practices.
Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.
Knowledge, Skills, and Abilities:
Strong ability to set and meet deadlines, multitask, as well as identify, request, and prioritize resources based on project needs.
Demonstrates strong critical judgment and strategic thinking skills in representation of functional area concerns on cross functional teams.
Capable of representing the functional area on a cross-functional team and presenting technical data at team meetings.
Can identify and request needed resources within or across functional areas.
Capable of supervising up to eight scientific personnel.
Effectively communicates functional area and departmental results in cross-functional settings.
Must have advanced written and oral communication skills.
Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
Skilled in application of standardized root cause analysis, investigation tools and methodologies.
Has considerable knowledge in professional field of specialization.
Proficient with the use of MS Office software.
Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology).
PhD + 5years, or MS with 8+ years. Industry experience working with mammalian cells and in upsteam process development is a must. Prior GMP experince is required. BS + 10-11.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Learn more about Grifols at http://www.grifols.com/es/web/international/home