Manufacturing Supervisor

2 weeks ago

San Diego, United States Belcan Full time

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.

*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.


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.

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