Senior Stability Research Scientist II

Description:

The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins. The position provides support to the Stability Group by overseeing all facets of the stability program that are related to oversight of stability related investigations, the stability chamber areas, storage, delivery and documentation of the sample inventory in order to maintain a compliant stability program for licensed products and developmental projects, ensuring continued safety and quality of our products.

The incumbent will provide technical or scientific expertise and leadership in the research development of plasma derived or recombinant proteins or in support of the manufacture of plasma derived or recombinant proteins. May lead cross functional teams or represent functional area on cross functional teams. The incumbent is a technically competent professional who assists in leading a compliant Stability program to support licensed products and developmental projects, ensuring the continued quality and safety of marketed material, in addition to implementing solutions to a variety of company related objectives.

Responsibilities of this position include but are not limited to:

• Responsible for independently identifying actions required to support departmental objectives and capable of making decisions within designated assignments that influence the goals of the department
• Executes 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 or BLA
• 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 area
• 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
• Knowledge in usage of site systems applicable to stability studies (such as DCM, SAP and Apogee)
• Develops alternative solutions to problems, handles complex problems independently
• Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions

• Collects, reviews, and analyzes Stability data
• Generates, reviews and approves stability documentation in accordance with project and site requirements
• Authors and/or reviews stability reports/documents to support the annual product reviews and regulatory submissions
• Executes assignments of high complexity for the business unit
• Provides departmental training
• Provide support for Grifols products (marketed and/or development)
• Provide stability support for the research and development of plasma derived proteins
• Knowledge in the use of SAP program
• Position requires organizational and experimental design skills
• Knowledge of the Regulatory guidelines, licensed product lines, routine test methods, and developmental projects related to stability studies and serve as subject matter expert for the Stability program
• Demonstrated ability in technical report writing and attention to detail

Knowledge in usage of an electronic based Document Control Management (DCM) system

Additional Responsibilities:

• Maintains work areas in accordance with company policies and industrial best practices
• Provides support for research and developmental stability studies, and clinical or commercial manufacturing, as needed
• Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations
• Previous experience in creating and delivering presentations to a wide variety of audiences
• Execute assignments of high complexity for the business unit

Ability to lead projects for the business unit

Provides training for new employees

Acts as subject matter expert for audits/inspections during the absence of the department Manager

Educational Requirements, Knowledge, Skills and Abilities beneficial to position (but are not limited to):

• Education: Completed PhD + 0-2 years of experience, MS + 8 years of experience, or BS + 10-11 years of experience. Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology).
• 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.
• 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
• Statistical data analysis (including use of SAS JMP or equivalent statistical software)
• Has considerable knowledge in professional field of specialization
• Proficient with the use of MS Office software
• Fully qualified professional who requires minimal supervision
• Demonstrated ability in technical report writing and attention to detail
• Technical knowledge sufficient to conduct and resolve stability investigations is expected
• Knowledge of cGMP practices
• Sample management experience
• Experience with monitoring and upkeep of validated temperature-controlled units
• FDA and ICH guidelines concerning stability studies

• An understanding of ICH guidelines and GMP requirements set forth by regulatory agencies associated with the storage of Stability product is required.
• Good communication skills are needed to generate effective written and oral reports that are clear, accurate, and logical. The incumbent must possess excellent interpersonal and communication skills to interact effectively and promptly with all levels of the organization, supporting departmental objectives and management decisions, and maintaining good working relations with multiple cross-functional teams.
• The incumbent must possess a working knowledge of equipment and storage facility operations and be able to quickly resolve problems associated with chamber related issues.
• The incumbent must possess excellent skills regarding determination of the impact of a deviation upon the stability program and be able to ensure corrective actions for each discrepancy have been implemented and are effective to prevent reoccurrence.
• The incumbent must possess computer skills regarding working use of word-processing, spreadsheet, and e-mail programs. Training and working knowledge on the following are required for consideration for this position: DCM, SAP, Fiori, Apogee Monitoring System, and TempTale Monitoring Devices.
• Prior experience with shipment of biological samples.
• This position requires the ability to perform basic calculations in addition to the need for keen assessment skills and extreme attention to detail.
• The incumbent must keep neat, accurate, complete, and timely records.
• They must demonstrate initiative and willingness to learn.
• The incumbent must be able to carry out tasks independently or with minimal supervision and be able to function in a team environment.
• The responsibilities of this position directly affect the quality of marketed and developmental products stored in the Stability program, which are valued in the millions of dollars.

Occupational Demands:

Work is performed in an office and/or a laboratory environment. Possible exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-40lbs. with a maximum lift of 50 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.

*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.

The estimated pay scale for Senior Stability Research Scientist II role based in California, is $127,500.00 to $172,500.00 per 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, 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.

Location: NORTH AMERICA : USA : CA-Los Angeles:US401 - LA CA-Headquarters

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