Process Development Scientist II

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.

Grifols Diagnostic Solutions Inc is seeking a Process Development Scientist II. The focus of the Process Development Scientist II is to supervise team activities, manage project timelines and provide expert troubleshooting support for oligos and reagents.  The Process Development Scientist II will serve as Subject Matter Expert in all Oligos and Reagent/Sub Assembly processes. The Process Development Scientist II will troubleshoot processes, complete complex investigations and implement CAPAs as necessary. The Process Development Scientist II will manage continuous improvement activities and train personnel. The Process Development Scientist II will execute, and support process transfer activities such as notebook, development, validation, manufacturing reagents, transcripts and oligo builds following cGMP guidelines.

Primary responsibilities for role:

• Must be able to perform all Sr. Process Development Chemist and Process Development Scientist I responsibilities if required
• Plans and oversees the design and implementation of work instructions, area guidelines, knowledge base topics, and departmental SOPs as required
• May lead cross-functional project teams, train/supervise junior staff, and execute notebook, development, validation, and commercial builds following cGMP regulations
• Responsible for identifying process improvement projects in support of departmental objectives/corporate goals and evaluating project risks    
• Generate and improve processes and procedures to create documentation that is current with industry standards following cGMP regulations
• Train Operations, contractors and junior staff on transfer processes, procedures, DCM and SAP Change Control
• Drive selection of content/design tools for innovation and efficiency
• Act as qualified Reviewer (Design/Risk) and ECR/ECO/Change Control department approver
• Practice Design Control guidelines and improve associated documentation as required
• Using working knowledge, training and experience in conjunction with development and technical personnel
• Work with end users to improve documentation, reduce errors, enhance user comprehension and overall readability
• Oversee document changes to maintain consistency across product lines/processes
• Pro-actively initiate and oversee the management of multiple user documentation projects
• Oversee the development of documentation timelines & deliverables for projects
• Lead and review risk assessments, author complex pFMEA documentation
• Act as Core Team member for New Product Development projects
• Completes complex CAPA and QN investigations

Additional Responsibilities

• SME in cGMP regulations, Change Control, Design Control, CAPAs and Investigations 
• Oversees or leads projects ensuring that all timelines are met
• Leads transfer to manufacturing activities, QNs and CAPAs  
• New product line submission review

Knowledge, Skills, and Abilities

• Advanced understanding in device regulations, Design controls and new product line submissions are required
• Strong intrapersonal communication skills are required
• Indirect personnel leading experience is required
• Expert knowledge of cGMP/GLP, Microsoft Office, and in Change Control
• In depth knowledge of the appropriate analytical techniques for oligos and reagents is required
• In depth manufacturing and troubleshooting experience in oligo synthesis and HPLC purification
• Expert 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 expert technical knowledge and good independent judgement
• Analytical, troubleshooting and technical skills are required
• Chemical and manufacturing fundamentals are required
• Design control experience required

Education

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

Experience

• 8+ years of related experience in a laboratory or commercial manufacturing setting with a Bachelor’s degree
• 6+ years of related experience in a laboratory or commercial manufacturing setting with a Master's degree
• 2+ years of related experience in a laboratory or commercial manufacturing setting with a Docotoral degree
• 1 yr of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is preferred
• 2+ years of experience with oligo synthesizers and HPLC purification systems is required
• 4+ years of experience with FDA regulations is preferred

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.

The estimated pay scale for Process Development Scientist II role based in California, is $124,488.65 to $155,611.10. 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.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.  We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

California Personnel Privacy Policy and Notice at Collection

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

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