Director of QC and Analytical

HK Recruiting - Hollister, CA, United States

JOB DESCRIPTION

The Director of QC & Analytical is primarily responsible for establishing and maintaining an uncompromising level of scientific excellence and integrity throughout the company and directing the Analytical Lab & Quality Control Lab efforts by developing analytical methods that support production and troubleshoot process quality issues.

RESPONSIBILITIES

  • Reviews, critiques, and approves the implementation of policies, procedures, and changes that can affect the integrity, consistency, quality, and/or chemical nature, stability, or composition of our products

  • Keeps current with analytical instrumentation, assays and analytic methods and acquires the necessary hardware/software/instruments to assure that our client's capabilities are sufficient to definitively answer pressing scientific questions that affect product quality

  • Develops analytical methods that support production, including design support

  • Develops and validate test methods for raw materials and finished goods

  • Completes assigned projects that require research and development

  • Oversees and directs the work of employees in the Analytical Lab and Quality Control Lab.

  • Responsible for acquiring and implementing approved equipment for the Analytical Lab, and training and managing others in its proper use and maintenance.

  • SME on Aseptic Processing Techniques, including implementation of programs and processes.

  • Interact with Engineer, and Operations as SME for Water Systems, Controlled Environments, and

  • Aseptic Processing Areas regarding certifications, validations or qualifications.

  • Work with supply chain to establish, maintain, and or validate methods for clean manufacturing environments, and processes.

  • Timely troubleshoots, analyzes, and solves Complaint Investigation, NC’s or CAPA’s

  • Develops a High Throughput Analytical Chemistry Group while maintaining morale, performing continual education, development, and training of direct reports, and company-wide as needed.

  • Mentors direct reports and guide them to the next level in their careers

  • Troubleshoots chemical formulation and process issues

  • Works with the Engineering team to implement process scale-ups

  • Is the primary point of contact for complex science, and environmental-related queries

QUALIFICATIONS 

  • Bachelor’s Degree in Chemistry, Biology, or related field; Masters, or PhD strongly preferred

  • Minimum 10 years experience in a Medical Device, Pharmaceutical, or Biotech environment, with 3 years specific experience applying and using a variety of scientific principles and performing molecular biology techniques. (Use of HPLC, LCMS, and analytical instrumentation preferred)

  • Minimum 5 years experience within Sterility Assurance, and Aseptic Processing Techniques.

  • Microbiology experience (Tissue culture, Bioburden, Endotoxin experience preferred)

  • Experience with 21CFR Part 820, Part 210, 211 GMP environment is required, and ISO 13485 Preferred)

  • Knowledge of sterilization, Microbiology Testing, and regulatory inspections of such areas

  • Ability to handle multiple projects concurrently



Posted On: Tuesday, May 25, 2021



Apply to this job