Job Title : Manufacturing Supervisor (Microbiology and Synthesis)

Pay Rate : $51.64 / hr

Location : San Diego, CA

Area Code : 619

ZIP Code : 92127

Shift : 1st shift; M-F 7am-3 : 30pm

Keywords : #ManufacturingSupervisor #Microbiology #Synthesis

Benefits :

• Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.
• On the job training / cross training to develop and expand skills, creating opportunity for advancement and personal development.

Tuition reimbursement available for relevant development opportunities.

• Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.
• Scheduled performance reviews create opportunities for advancement and pay increases.
• A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person.

Our team has grown with referrals and internal promotions.

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.

• 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.

Requirements :

• Bachelor's degree and 6 years of related GMP experience in a laboratory or commercial manufacturing setting
• Master's degree and 4 years of related GMP experience in a laboratory or commercial manufacturing setting
• 2 years of supervisory or team leadership experience
• 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.
• 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.

Last updated : 2024-06-04