Supervisor, MTS - Oligonucleotide Production

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 is seeking a Supervisor MTS (Make to Stock) in San Diego CA to support our Manufacturing department. The Grifols Diagnostic Solutions (GDS) San Diego Manufacturing Department is responsible for producing Nucleic Acid-based Blood Screening products which consists of oligonucleotides reagents and kits. The main responsibility for the Supervisor MTS is to lead and oversee all production activities associated with oligo synthesis and production microbiology in a multi-product cGMP facility. The Supervisor will gather and analyze Key Performance Indicator (KPI) data related to manufacturing to identify opportunities for continuous improvement. The Supervisor must collaborate with cross-functional partners such as Supply Chain Manufacturing Sciences Manufacturing Technical Support Quality Assurance Quality Control Validation and Facilities to accomplish organizational objectives (e.g. meeting commercial demand new process transfers new manufacturing area commissioning and validation).

We are seeking individuals with at least a Bachelors degree in Biochemistry Chemistry Chemical Engineering Microbiology Biology or related field along with 6 years of related GMP experience in a laboratory or commercial manufacturing setting with a Bachelors degree 4 years of related GMP experience in a laboratory or commercial manufacturing setting with a Masters degree and 2 years of supervisory or team leadership experience.

Primary Responsibilities

• Supervise the activities of production operators to ensure safe and compliant synthesis and/or cellular extraction of commercial oligonucleotides for Blood Screening Products.
• Responsible for responding to addressing and providing guidance for production issues safety incidences and/or personnel issues.
• Responsible for all regulatory compliance (e.g. ISO 13485 FDA IVDR) activities for assigned area and assures group compliance to cGMP and regulatory requirements through monitoring trending and auditing. Ensure safety and compliance regulations are enforced.
• Responsible for establishing and modifying the oligo synthesis (e.g. AKTA Oligopilot HPLC systems) and/or production microbiology (i.e. BSL-2 and BSL-3 labs) production lines as a result of changing production needs and implementing process flow efficiencies/improvements.
• Responsible as Manufacturing liaison for Manufacturing Sciences in the development validation and transfer of new or existing oligo synthesis and production microbiology products to internal and external manufacturing organizations.
• Follow established manufacturing procedures and good documentation practices. Ensure batch records logbooks inventory forms in-process data spreadsheets and associated attachments are completed accurately and timely.
• Ensure applicable Change Control policies and procedures are followed for new or modifications to existing facilities equipment and processes.
• Investigate assigned nonconformances/deviations in a timely manner to identify root cause and implement appropriate corrective and preventive actions.
• Gather and analyze Key Performance Indicator (KPI) data from production processes labor utilization and environment to identify opportunities for continuous improvement and develop a culture of operational excellence.
• Develop and draft new SOPs and DMRs; modify or obsolete outdated/ineffective SOPs and DMRs when appropriate.
• Be a liaison to cross-functional partners (e.g. Supply Chain Manufacturing Sciences Manufacturing Technical Support Quality Assurance Quality Control Validation Facilities) promoting collaboration for organizational projects and goals.
• Ensure appropriate planning for successful execution of production activities with efficient use of resources to delivery products on-time in full.
• Ensure ERP (e.g. SAP) transactions are performed reviewed and analyzed to ensure successful execution and continuous improvement of production activities.
• Mentor train and develop personnel as well as evaluate the effectiveness of training
• Assist Manufacturing Manager in defining individual and group goals.
• Monitor adherence to corporate training initiatives and requirements.
• Lead special projects as needed.
• Support Manufacturing Manager for the preparation and subject matter expertise for regulatory audits (e.g. internal notified body regulatory authorities).
• May support direct Manufacturing Operations as needed.

Knowledge Skills Abilities

• Must have in-depth knowledge of commercial-scale manufacturing.
• Must have a thorough understanding of GDP cGMP and ISO 13485 regulations as they apply to commercial-scale manufacturing.
• Must have direct experience with oligo synthesis equipment (e.g. AKTA Oligopilot AKTA Pilot/Beckman Purification systems Dionex/Vanquish HPLC analytical systems rotary evaporators).
• Must have direct experience with cell culture nucleic acid extraction and working in a BSL-2/BSL-3 laboratory.
• Must have prior experience in managing or establishing a chemistry/biology laboratory with all applicable safety control systems.
• Must be creative highly organized self-motivated perceptive and innovative.
• Must have strong written and verbal communication skills.
• Must be able to handle multiple priorities and delegate responsibilities while maintaining quality.
• Must have excellent team building and/or leadership skills with small to medium-sized teams.
• Must have direct experience with Lean 5S and Operational Excellence.
• Must have experience with ERP systems (e.g. SAP) including goods movement transactions inventory management cost analysis labor routings and data extraction.
• Must have experience drafting and revising SOPs and DMRs.
• Must have strong critical thinking skills great attention to detail and be solution driven.
• Prior experience managing a diverse group of people with different strengths and skills is preferred.
• Prior experience in successful individual as well as team performance management is highly desired.
• Must be proficient using Microsoft Office software and tools.
• Must be flexible and willing to work evenings and weekends based on the production schedule needs.

Education

Typically requires a Bachelors degree or Masters degree in (Bio)chemistry Chemical Engineering Microbiology Biology or related field.

Experience

6 years of related GMP experience in a laboratory or commercial manufacturing setting with a Bachelors degree
4 years of related GMP experience in a laboratory or commercial manufacturing setting with a Masters degree
2 years of supervisory or team leadership experience

Occupational Demands

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Visually inspect components and final kits for compliance and specifications. Close vision (20 inches or less) will be utilized and some color identification will be required. Occasionally required to perform reaching bending stooping or kneeling motions. May be required to walk and stand for a considerable amount of time. Occasionally use hands/fingers to handle or feel open tightly sealed containers/tanks and utilize hand tools. Occasionally climb step stools/ladders as needed. May occasionally lift carry push pull or otherwise manipulate objects up to 10 pounds in weight. May lift carry push pull or otherwise manipulate objects up to 50 pounds in weight. May move heavier (greater than 50lbs) objects and/or materials using carts or pallet jacks.

Pay Scale

The estimated pay scale for theSupervisor MTSbased inSan Diego CAis$86448.95 to $108060.90per year. Additionally the position is eligible to participate in up to8% of the company bonuspool. We offer a wide variety of benefits including but not limited to:Medical Dental Vision PTO PPL 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.

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

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