Process Development Scientist I

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Job description

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:

Summary: The focus of the Process Development Scientist I is to lead junior staff in lab activities, create new SOPs and Manufacturing Instructions, technically support Operations and participate in new product development Core Team activities. The Process Development Scientist I will serve as Subject Matter Expert in all Oligos and/or Reagent/Sub Assembly processes. The Process Development Scientist I will train Manufacturing personnel in new processes and will lead Oligo and/or Reagents troubleshooting, investigations and continuous improvement activities of existing processes.

Primary responsibilities for role:

Must be able to perform all Sr. Process Development Chemist responsibilities if required

Directs junior staff on all Oligo and Reagent Manufacturing Sciences/Support activities

Technical expert in scale-up/down processes and obtains all necessary supporting justifications for any required changes

Creates notebook, development and validation documentation (protocols, SOPs, MIs and reports)

Oversees build schedule for notebook, development and validation lots as appropriate

Act as subject matter expert in Change Orders and SAP Change Control processes

Contributes to work instructions, area guidelines, knowledge base topics, style guides/templates, and department SOPs

Technical expert representing operations on new product core teams

Manages multiple projects and timelines

Interfaces with Supply Chain & Manufacturing to establish due dates

Provides recommendations, or alternatives, for manufacturing processes described in the Manufacturing Instruction documents

Leads multiple Pilot Plant complex projects: process improvement, transfer to MFG, QN, CAPA and RA. Supports Pilot Plat lab activities as required

Leads risk assessment and simple pFMEA documentation

Completes moderate CAPA and QN investigations

Knowledge, Skills, and Abilities:

Working knowledge of cGMP/GLP, proficiency in Microsoft Office, proficiency in Change Control

In depth knowledge of the appropriate analytical techniques (for oligos and reagents) is required

In depth manufacturing experience in oligo synthesis and HPLC purification

Development and Problem-Solving experience in oligo synthesis and purification

Ability to effectively and actively communicate with cross-functional partners (e.g., Supply Chain, Manufacturing Sciences, Warehouse)

Ability to train junior personnel effectively

Good organizational skills and attention to detail

Team oriented, attentive and willing to learn new processes

Demonstrated technical writing skills

Ability to write, review, mark-up and format documents in Word

Demonstrated ability to multitask, prioritize and complete goals

Demonstrated sound technical knowledge and good independent judgement

Analytical, troubleshooting and technical skills are required

Chemical and manufacturing fundamentals are required

Strong intrapersonal communication skills are required

Indirect personnel leading experience is preferred

Experience synthesizing and purifying oligos is required

Design control proficiency preferred"

Education:

Typically requires a Master's Degree or PhD in Microbiology, Biology, (Bio)Chemistry, Chemical Engineering or related field

Equivalency:

Depending on area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered inplace of the stated requirements.

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.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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