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.

To be successful in this role, we are looking for candidates with a minimum Bachelor's Degree in Microbiology, Biology, Chemsitry, 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 processes. Meet with vendors for manufacturing needs.

Knowledge, Skills, and Abilities:

• Demonstrated job specific technical knowledge

• Advanced working knowledge of Microbiology, Biology, or Chemistry.

• Working knowledge of laboratory safety and record keeping.

• Advanced working knowledge of ERP system.

• Working knowledge of GDP, GMP and ISO Reg. Blood Borne Pathogen Training.

• Advanced knowledge in the operation of analytical balances, pipettes, filter integrity testers, peristaltic pumps, water baths and spectrophotometers.

• Advanced level experience in the set-up and operation of reagent bulk tanks and mixers.

• Is fully trained and competent on the operation of simple and complex laboratory equipment and processes.

• Ability to troubleshoot manufacturing issues and implement solutions.

• Must have strong critical thinking skills, great attention to detail and be solution driven.

• Working knowledge of Microsoft Office software.

• Attention to detail, good organizational skills and team-oriented.

• Ability to follow oral and written instructions.

• Must have strong written and verbal communication skills.

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

• Must be able to multi-task to adhere to target manufacturing and project deadlines

• Must have direct experience with Lean, 5S, and Operational Excellence.

• Project Management skills are highly desired

• Ability to lead or participate on cross-functional teams

• Team building and/or leadership skills with small teams are highly desired

Education:

Typically requires bachelor's degree in Microbiology, Biology, Chemistry, Chemical Engineering or related field. Master's degree in related field is highly preferred.

Experience:

• 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

• 4 years of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required

• At least 3 years bulk/reagent formulation experience is required.

• At least 1 year of experience in a leadership role is highly preferred.

Equivalency:

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

Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.

Pay Scale:

The estimated pay scale for this Bulk Formulation Chemist Lead role based in San Diego, California ranges between $69,658 - $87,074. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 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!

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Learn more about Grifols (http://www.grifols.com/es/web/international/home)

Req ID: 513115

Type: Regular Full-Time

Job Category: Manufacturing