Senior Process Dev Engineer II

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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.

Summary:

The incumbent will provide technical and scientific expertise and leadership to the development, scale-up, transfer, and/or support of plasma derived production processes.  Activities are centered on unit operations such as precipitation, phase separation, chromatography, filtration, lyophilization and process trouble shooting. May lead cross-functional teams or represent functional area on cross-functional teams.  May have supervisory responsibility for up to approximately 8 scientists, engineers, or technicians. 

 

Primary responsibilities for role:

• Responsible for independently identifying action plans to support departmental projects and objectives.
• Execute action plans independently, as part of a team, or as the lead for a departmental or cross-functional team.
• Responsible for representing the functional area or leading a cross-functional team to achieve identified objectives.
• Independently prepares and critically edits procedures or technical protocols and reports of a complex nature, assimilating information across functional areas, suitable for inclusion in IND, BLA, or equivalent regulatory submission.
• Communicates functional area and departmental results in cross-functional settings.
• Develops creative novel process development solutions or technical implementation plans to meet departmental objectives. 
• Develops innovative solutions to complex technical problems and leads others in problem solving efforts.  
• Independently designs, executes, and interprets results for novel and scientifically rigorous study programs and mentors others in experimental design. Provides direction to others in study execution.
• During technical transfer, provides technical review of design documents for assigned systems and supports start-up of new processes.
• Ensures scalability of unit operations during process development and can anticipate equipment related scaling issues and develop sound engineering solutions.

 

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.

 

Additional Responsibilities:

• Provides and/or supervises support for developmental studies, clinical or commercial manufacturing as needed.
• Identifies, implements, and qualifies, as necessary, existing or novel technologies to achieve operational needs in 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.
• Experienced in identifying projects risks.
• Must have advanced written and oral communication skills.
• Experienced in supporting licensed manufacturing processes through process improvement initialtives and incident support.
• Has demostrated understanding of the complexities and constraints associtated with licensed drug manufacturing processes and ability to work cross-functionally to address process support needs.
• Advanced ability to creatively apply scientific or engineering principles in problem solving in potentially novel areas.
• Skilled in application of standardized root cause analysis, investigation tools and methodologies.
• Has extensive knowledge in professional field of specialization (e.g., protein purification, process analysis) and can mentor/train junior staff in relevant principles and/or guidelines.
• Experience leading others with supervisory experience with 2 to 8 direct reports.
• Must be expert in use MS Office Suite.  

 

Education:

Chemical, Biochemical, or relevent Engineering/Scientific field.

 

Experience:

8+ years relevant experience.

 

Equivalency:

Masters with 6+ years experience, PhD with 4+ years expericence

 

 

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agre