Skip to content

Job Openings

Manufacturing Supervisor, Synthesis and Production Microbiology

San Diego, CA 92127

Posted: 04/30/2024 Employment Type: Contract Job Category: Scientific Job Number: 597232 Pay Rate: 51.64 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience adn ranges between $40-50/hr

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  • Develop and draft new SOPs and DMRs; modify or obsolete outdated/ineffective SOPs and DMRs when appropriate.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.
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 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:
  • Bachelor’s degree or Master’s 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
  • Bachelor’s degree 4+ years of related GMP experience in a laboratory or commercial manufacturing setting
  • Master’s 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About San Diego, CA

Ready to embark on an exciting career journey in sunny Southern California? Explore our job opportunities in the thriving city of San Diego! Known for its stunning beaches, perfect weather, and vibrant culture, San Diego offers a unique combination of career growth and quality of life. With renowned attractions like Balboa Park, the San Diego Zoo, and the USS Midway Museum, along with a diverse culinary scene and a plethora of art galleries and theaters like the La Jolla Playhouse, there's always something new to experience. Whether you're a sports enthusiast looking to cheer for the Padres at Petco Park or seeking outdoor adventures at Torrey Pines State Natural Reserve, San Diego has something for everyone. Begin your job search today and discover why this picturesque city is the perfect place to elevate your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.