Product Support Scientist III

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

Grifols Diagnostic Solutions is seeking a Product Support Scientist III in San Diego, CA. This role will be reporting to the Product Support Principal Scientist.

The Manufacturing Support Organization supports the industrial business as they compliantly and successfully produce NAT-based products in line with commercial cGMPs. The main responsibilities for the Product Support Scientist III are to provide front-line technical support to the commercial manufacturing group for routine manufacturing processes, lead/participate in projects associated with process improvements and qualification of new investments. The Product Support Scientist III will act as a primary technical support for Manufacturing and Quality Control product/process failure investigations. Product Support Scientist III may provide assistance for customer complaint product investigations. Product Support Scientist III act as NAT products technical leads for internal and external audits.

Primary responsibilities for role:

• Lead a team in complex investigations in support of release/disposition of raw material, intermediate, and final product within the required timeframe.
• Design/lead complex investigations through experimentation, evaluation of data, and use of root cause analysis tools. Determine product impact, perform risk assessment and provide/implement corrective/preventative actions as necessary.
• Responsible for successful transfer of new products from development to commercialization.
• Design and execute complex study protocols/reports for process improvements, scale-ups, cost savings initiatives, and equipment validation.
• Lead new vendor raw material qualifications by determining requirements and designing testing protocols.
• Evaluate and monitor QC performance by trending data. Pro-actively identify potential future out of trend alerts. Ensure quality control specifications are appropriate for all development, in-house, and commercialized products/instruments. Plan appropriate experiments and perform statistical analysis required to revise when needed and complete FDA submissions.
• Demonstrate competence in design and execution of experiments to test assay performance at the extreme operating parameters of the assay/instrument or to transfer successfully an assay fully developed on one platform to another
• Demonstrate competence in the design of feasibility experiments related to: sample processing or assay formulation experiments.
• Demonstrate competence in Problem-Solving/Analysis – in-depth knowledge of statistical design of experiments, ability to analyze data and formulate valid scientific conclusions, ability to troubleshoot and solve complex technical issues across multiple assays and platforms, strong understanding of scientific method.
• GMP -Solid knowledge of GMP, required documentation, excellent technical writing skills. Display ability to identify required document updates and revise applicable department documentation, including Manufacturing work instruction and/or Test Plan documents (MI/TP) and Standard Operating Procedures (SOP)
• Own and drive cross-functional projects and present data to external groups.
• Mentors and trains Product Support Scientist I and II
• Assist department staff with product support activities and performs job responsibilities of Product Support Scientist I and II as needed
• Acts as technical SME for product and processes during PRT and external/internal audits

Education:

Minimum Requirements: BS in biological sciences, physical sciences, or engineering (Title of Engineer II, Manufacturing Support can be conferred upon candidates with an engineering degree) with a minimum of 8 years' experience in a regulated biotechnology / medical device industry, or 12 years of relevant work experience.

Master degree with 6 years' experience in biological sciences or physical science.

PhD degree a plus.

Experience:

Must have a thorough knowledge of cGMPs, including equipment, technology, and Quality systems requirements. Significant experience supporting and/or leading Quality deviation investigations. Strong technical knowledge of, and exposure to, biotechnology processing unit operations. Established troubleshooting abilities including process monitoring. Strong interpersonal and cross-functional team building skills. Strong project management skills. Excellent communication skills, organizational skills, writing and problem-solving skills. Must be able to work independently, manage multiple priorities, with the ability to prioritize and complete activities on time. Must be able to establish and maintain effective working relationships with cross-functional co-workers. Exposure to SAP is a significant plus. Previous experience supporting FDA and other Regulatory inspections, 5S, OpEx, and LEAN manufacturing experience.

Equivalency:

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.

Occupational Demands:

May occasionally lift, carry, push, pull, or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull, or otherwise manipulate objects up to 10 pounds in weight frequently or continuously. May be exposed to biohazardous materials, high titer heat-treated materials, and potentially infectious materials/waste. May be exposed to radioactive material, corrosive chemicals, flammable materials, and possible inhalation hazards.

Pay Scale

The estimated pay scale for this Product Support Scientist III ranges between $124,200 to $155,250 year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool . We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, PPL, 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

#LI-DC1

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

Learn more about Grifols