Bulk Formulation Chemist Lead

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 Bulk Formulations Chemist Lead will be supporting the Manufacturing Team at Grifols Diagnostics Solutions, located in San Diego, CA. This position is responsible for the manufacture of bulk clinical and commercial kit reagents. Additional responsibilities include sub-assembly formulation, raw material prep and/or processing, QC testing reagent or component formulation and some in-process testing. Participate in transfer, support activities and continuous improvement on existing processes. May be assigned to one or more functional Manufacturing areas. Leads a team of direct reports, within the department including coaching, setting goals and expectations.   

 

Variable shifts may be required. 

 

To be successful in this role, we are looking for candidates with a minimum Bachelor's Degree in Microbiology, Biology, Chemistry, Chemical Engineering or related field. Master's degree in a related field is highly preferred. 5 to 7 years of related experience in a laboratory or commercial manufacturing setting with a Bachelor's degree. 1 to 3 years of related experience in a laboratory or commercial manufacturing setting with a Master's degree. At least 4 years of Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and ISO 13485 regulations is required. At least 3 years of experience with bulk/reagent formulation experience is required and at least 1 year of experience in a leadership role is highly preferred. 

                                                                                                                              

 Primary responsibilities for role:

• Leads a team of direct reports, within the department including coaching, reviews and identification of talent                                                   
• Lead team meetings, including daily morning team meeting                                                  
• Attend cross-functional meetings                                                       
• DHR Review: Document review, SAP transfer review, variance review and submission to quality
• Investigate variance discrepancies for completed process orders against the scheduled cost, hours and material quantity                                                          
• Responsible for reviewing schedule to maximize efficiency and assign personnel to production orders                                                
• Conduct one on one meetings with team members to facilitate coaching                       
• Responsible for maintaining the team training matrix                                                 
• Scrap coordinator responsible for identifying, monitoring and delegating to minimize scrap
• Perform QN/OTR investigations                                                         
• Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP)                                                     
• Support in the preparation and provide subject matter expertise for regulatory audits (e.g., internal, notified body, regulatory authorities).                                                
• Understands and executes written procedures in accordance with cGMP.                         
• Maintains detailed and accurate device history records with cGMP.                                                   
• Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.                                                   
• Follows all safety rules.                                                         
• Maintains accurate and complete training records.                                                    
• Open and close work orders.                                                 

 

Additional Responsibilities:

Adhere to target manufacturing timelines. Attentiveness and openness to learn new processes. Perform general equipment maintenance, operation and calibration. Perform direct Bulk Formulation production activities as needed.  Act as rework coordinator. Has delegation authority as supervisor for bulk formulation as needed. Responsible for initiating cross-functional meetings to discuss At-risk assessments for scheduled