Manufacturing Supervisor

Job Title: Manufacturing Supervisor Synthesis and Production Microbiology

Duration: 12 Month

Shift: 7:00 am 3:00 pm PST

Work Location: San Diego CA 92127

SUMMARY:

The main responsibility for the Synthesis and Production Microbiology Supervisor is to lead and oversee all production activities associated with oligo synthesis and production microbiology in a multiproduct 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 crossfunctional 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).

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. BSL2 and BSL3 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 inprocess 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 crossfunctional 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 ontime 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.

ADDITIONAL RESPONSIBILITIES:

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 indepth knowledge of commercialscale manufacturing. Must have a thorough understanding of GDP cGMP and ISO 13485 regulations as they apply to commercialscale 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 BSL2/BSL3 laboratory.

Must have prior experience in managing or establishing a chemistry/biology laboratory with all applicable safety control systems.

Must be creative highly organized selfmotivated 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 mediumsized 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:

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

Bachelors degree 4 years of related GMP experience in a laboratory or commercial manufacturing

Masters degree 2 years of supervisory / team leadership experience OCCUPATIONAL