Manager, Microbiology

Employer
StrideBio, Inc.
Location
Durham, North Carolina, US
Salary
Competitive
Posted
May 13, 2021
Closes
Jun 03, 2021
Ref
2178929675
Employment Type
Full time
Salary Type
Salary
StrideBio is a product-driven, fully integrated gene therapy company focused on creating and developing innovative genetic medicines with life-changing or curative potential for patients with devastating conditions, including monogenic rare disease and beyond.

We leverage our proprietary structure-inspired adeno-associated virus (AAV) vector engineering platform (STRIVE) to create unique and differentiated vectors that improve upon naturally occurring AAV serotypes to overcome current limitations of first-generation gene therapies. Combined with our genetic construct design expertise and in-house manufacturing capabilities, StrideBio is positioned to generate best-in-class genetic medicines that allow more patients to benefit with maximum efficiency, leading to improved treatment outcomes.

Our team is comprised of accomplished leaders and talented, passionate colleagues with a desire to translate innovative science into treatments. Together with our collaborators we are making rapid progress on our mission to bring novel medicines to patients who desperately need them. StrideBio's offices, labs and manufacturing facility are located in the heart of Research Triangle Park, NC, within 10 miles of downtown Durham and Raleigh-Durham International Airport. Please visit www.stridebio.com to learn more.

We are seeking a Manager, Microbiology to provide direction and oversight to the Microbiology/Environmental Monitoring (EM) Department meeting company and regulatory requirements. They will assume responsibility for the GMP compliance and adherence to company policies and SOPs within the area. Provide scientific and technical expertise in support of manufacturing operations. The primary responsibility of the Manager, Microbiology is to organize and direct the operational activities of the EM laboratory and Sterility laboratories (or provide oversight to outsourced sterility labs). In collaboration with Quality Systems and Quality Control, develop, analyze, and evaluate operational metrics and overall health of laboratory performance. Provide oversight for method development, qualification, validation, and other operational laboratory initiatives. Direct leadership and support to Micro/EM laboratory personnel. Identify and deploy operational best practices. Develop, deploy, and enforce standard operating procedures (SOPs) to ensure the safety and well-being of all laboratory personnel.

MAJOR RESPONSIBILITIES:
  • Manage the microbiological testing and disposition of finished product, in-process testing, validation, and raw material samples
  • Responsible for the company's environmental monitoring, sterility testing, and critical utilities monitoring program in all GMP aspects
  • Responsible for the evaluation of manufacturing environment against international standards of operation.
  • Manage testing, bioburden, endotoxin, organism ID, media growth promotion and other activities as appropriate
  • Supports operator qualifications, facility commissioning/qualification, cleaning, and sanitization activities from a microbiological standpoint
  • Understand, interpret, and communicate resulting data and the potential impact on product quality
  • Responsible for the evaluation of test methods against current USP and industry regulatory standards
  • Review and approve reports, investigations, validations required by company
  • Responsible for the GMP compliance of all functions and processes of the laboratory and for continuous improvement
  • Responsible for coordination and evaluation of media fills
  • Responsible for the compliance of supervised employees to training policies
  • Manage and develop reporting staff.
  • Provide training and guidance to analysts
  • Responsible for human and financial resources within the department, including periodic evaluations against plans and standards
  • Implement quality systems to reduce product testing time and increase timely response to internal customer requirements
  • Prepare, review, and implement SOPs and verify documents required
  • Assist with interpretation of results and facilitate the understanding of testing and data
  • Conduct training in lab quality assurance procedures
  • Participate in regulatory and internal audits as Subject Matter Expert
  • Initiates advances in methodology and/or technology use
  • Recruits, hires, and manages laboratory staff
  • Performs other duties as assigned

REQUIRED SKILLS:
  • Bachelor's degree in Microbiology or relevant Science
  • Minimum of 10 years' Micro Lab experience, with at least 2 years in a supervisory or management role
  • Experience in working in the QC Microbiology Laboratory supporting a pharmaceutical manufacturing facility.
  • Extensive knowledge of industry guideline including cGMP, microbial qualifications, regulatory guidelines (i.e.: FDA, EU, ICH, ISO)
  • Experience in quality of aseptic processes Grade A through Grade D production areas and knowledge of appropriate technology
  • Solid judgment and decision making in complex situations
  • Excellent written/verbal communications with ability to influence effectively at all levels within organization
  • Presentation skills required
  • Excellent MS Office (Word, Microsoft Excel, and Power Point) required

PREFERRED SKILLS:
  • Working knowledge of cGXP, ICH, FDA, EMEA, HPB a plus
  • Prior supervision of teams/staff
  • Experience working with biologics
  • Project management experience helpful

PHYSICAL REQUIREMENTS:
  • Must be able to work with computers for a majority of the day (looking into the screen for extended periods)
  • Must be able to use continuous repetitive motion (computer keyboard) for long periods
  • Must be able to concentrate on data/information for long periods
  • Ability to lift 25 lbs.
  • Must be able to legally drive, possess a valid, current NC state driver's license, and have a personal auto to drive to destinations for office needs (post office, retail stores for last-minute supply pickup, etc.

COMPENSATION & BENEFITS
  • Stock Options
  • Company-paid holidays
  • Paid time off
  • Health, dental and vision care
  • Disability
  • Life insurance
  • 401(k) plan + match
  • Paid parental leave
  • Concierge services
  • Employee Assistance Program
  • On-site gym membership, fully stocked kitchen, retail discount programs

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