Senior Process Development Scientist I

The incumbent will provide technical and scientific expertise to develop novel formulations of plasma derived or recombinant proteins. Develop intermediate and final formulations of protein therapeutics including liquid and lyophilized drug products in appropriate container closures. Support the development of downstream purification processes. May represent functional area on cross-functional teams. May have responsibility to mentor/train junior staff in relevant protein analyses and characterization methods.

Primary responsibilities for role:

• Design and manage execution of studies to identify novel formulations of plasma derived or recombinant proteins.
• Apply various protein characterization methods to examine protein properties.
• Develop intermediate and final formulations of protein therapeutics including liquid and lyophilized drug products in appropriate container closures.
• Support the development of downstream purifications processes.
• Ability to perform protein purification unit operations such as chromatography filtration precipitation phase separation and lyophilization is also desired.
• Execute action plans independently as part of a team or as the lead for a departmental team.
• Develops actions plans in support of departmental goals.
• Independently designs executes and interprets results for novel and scientifically rigorous experiments. May direct others in study execution.
• Independently prepares and edits procedures or technical reports of a complex nature including data interpretation suitable for inclusion in regulatory submissions.
• Prepares and effectively communicates technical results in cross-functional settings.

Knowledge skills and abilities:

• Has extensive knowledge in professional field of specialization (e.g. protein biochemistry protein characterization) and canmentor/train junior staff in relevant principles and/or guidelines.
• Experience designing studies to identify suitable protein formulations; performing and analyzing results from protein assays relevant to formulation development: experience in analytical methods including HPLC DLS viscosity and UV/Vis spectroscopy; experience in DSC and SDS-PAGE is preferred.
• Experience in the execution of bench-scale process unit operations: chromatography UF/DF precipitation and filtration.
• Expertise in drafting Instructional Processes
• Strong ability to creatively apply scientific or engineering principles in problem solving in potentially novel areas.
• Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams.
• Must have advanced written communication and excellent oral communication skills.
• Understands and applies standardized root cause analysis investigation tools and methodologies.
• Must be skilled in use MS Office Suite.

Requirements:

• Degree in Biochemistry Chemistry or relevant life science field.
• 7 years of relevant experience with a Bachelors degree 5 years relevant experience with a Masters degree 3 years relevant experience with a PhD

Occupational demands:

Work is performed in a clinical and/or a laboratory environment. 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 15-30lbs. with a maximum lift of 35 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.

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 religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location:NORTH AMERICA : USA : NC-Clayton:custbuilding

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