Lead, Reagent Operations in Fremont, CA at Apex Life Sciences

Date Posted: 8/7/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fremont, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/7/2018
  • Job ID:
    874575

Job Description


Those with an educational background in a Biological Sciences field and 3+ years of Supervisory Experience STRONGLY encouraged to apply!

Apex Life Sciences is looking for a Lead of Reagent Operations who plays a leadership role for reagent manufacturing and quality control activities within the Operations department and is responsible for planning and delivery of day-to-day support as required to meet company and customer demands. Lead takes responsibility for all aspects of the production including but not limited to: manufacturing, quality control, inventory and supply chain management. Lead must demonstrate and promote the company’s vision with great leadership skills and excellent organizational abilities.

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with additional hours as needed. Candidates living in the Fremont California area are encouraged to apply.

For immediate consideration, please send most updated version of resume to jrandolph@apexlifesciences.com

Lead of Reagent Operations responsibilities include, but are not limited to, the following:

  • Responsible for production planning to include forecasting and developing manufacturing work plans.
  • Works with Operations Associates to ensure manufacturing goals are met and all necessary tasks are completed.
  • Manages and participates in packaging functions including filling, labeling, kit packaging, etc.
  • Manages and participates in manufacturing functions needed to produce and troubleshoot reagents.
  • Directs oversight of manufacturing laboratories maintenance and EHS compliance.
  • Assists department management with customer inquiries, complaints and investigations related to production.
  • Supports ERP database for manufacturing and inventory management.
  • Ensures all reagents and kits produced meet established QC requirements.
  • Responsible for quality data review and analysis.
  • Performs quality control testing on raw materials, WIPS, finished goods.
  • Maintains and performs stability testing.
  • Ensures all equipment is maintained and calibrations are done in a timely manner to meet the quality requirements of the department.
  • Supports the Shipping team in delivery of products needed to fulfill orders.
  • Prepares and reviews SOPs, batch records, and other department documentation.
  • Supports inventory and supply chain functions.
  • Works with Operations personnel to ensure department is staffed and all necessary tasks are completed in a timely manner.
  • Responsible for document and record management functions.
  • Works with Operations personnel to ensure all records are accurately maintained and archived.
  • Conducts all necessary training for the production team and ensures all training records are maintained.
  • Works with staff to ensure timely completion of deviations and investigations; to develop and implement effective CAPAs.
  • Assists with capturing, measuring, and reporting critical KPI metrics.
  • Assists site management in ensuring compliance Lean initiatives and processes.
  • Adheres to site employee health and safety (EHS) requirements.
  • Adjusts work hours as needed to meet deadlines.
  • Provides cross-functional support to other areas of the department.
  • Uses an array of business software applications (e.g., Word, PowerPoint, Excel, and company systems)
  • Supports administrative functions of the department.
  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Conducts all activities in a safe and efficient manner
  • Owns the accountability and responsibility of delivering to client needs and timeliness

The ideal candidate would possess:

  • Result oriented with ability to plan and deliver against deadlines.
  • Strong computer, scientific, and organizational skills with attention to detail.
  • Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player
  • Proficient with SOP/ Batch records.
  • Familiar with cell and biochemical assays.
  • Good technical background in Biochemistry.
  • Project management skills.
  • Familiar with GMP/GLP processes.
  • Good understanding of basic laboratory equipment.
  • Familiar with ERP systems (inventory and production management).
  • Inventory management skills.
  • Basic Knowledge of laboratory safety.
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

Basic Minimum Qualifications:

  • Bachelor's degree in biology, biochemistry, or other biological sciences or equivalent directly-related experience.
  • Proven supervisory skills.
  • Must have strong analytical, organizational, decision making, and presentation skills.
  • Must be able to work in a fast-paced environment, managing multiple competing priorities and assignments.
  • Strong written and verbal communication skills required.
  • Strong interpersonal skills are essential to effectively interact with all teams, areas and levels of business. Good facilitation skills required.
  • Three (3) or more years of proven experience in a laboratory environment with supervisory responsibilities).

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.