Manager/Senior Manager, Quality Control - Microbiology

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Working at Genezen:

Genezen wants employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. Every employee contributes to the success of the company and you can be part of that team.

Purpose:

Responsible management of the Microbiology laboratory and personnel and execution of the site Environmental and Personnel Monitoring program. This individual is expected to have strong, hands-on, and technical experience of microbiological assays (Endotoxin, Bioburden, TOC) and Environmental Monitoring.

The Microbiology Manager ensures strict adherence to all cGMP/GMP policies and standard operating procedures, provides microbiology technical expertise, and communicates effectively with other departments.

The Manager will also have a proven track record with Continuous Improvement and be a champion for change within the Microbiology team and the QC organization as a whole.

Essential Job Functions / Duties:

• Maintain a safe, efficient, functional, and compliant laboratory operation in accordance with GMP SOPs, guidelines and regulations.
• Coordinate day-to-day management of QC Microbiology operations, including high-level planning of activities and resources, guidance/performance review within QC, and maintaining or initiating communication cross-functionally.
• Manage and develop the performance of direct reports by setting clear goals, providing performance feedback, supporting career development and recognizing and rewarding exceptional performance.
• Oversee testing of in-process samples, drug substance and drug product release/stability and complaint samples.
• Oversee performance of environmental and utility monitoring according to SOPs, sample test requests, and approved protocols and investigations.
• Maintain data integrity to the highest industry standards.
• Oversee timely investigation of OOS, OOT, and other laboratory exceptions, and timely management of Deviations, Change Controls, and CAPA, and maintenance of critical reagents, controls, and laboratory supplies.
• Manage outsourced testing activities as necessary and ensure results are reported in a timely and compliant fashion.
• Develop, maintain, and continuously improve robust QC systems to ensure compliance in sample management, testing, data approval, data management, data archiving, and validation and calibration of QC equipment.
• Engage with Continuous Improvement projects cross-functionally that support site improvements and cost efficiency.
• Support and participate in internal and external inspections and audits including regulatory inspections.
• Collaborate with QC Tech Services for method validation, specification generation, stability studies and support life cycle management of methods, reference standards and critical reagents.
• Support new equipment validation and implementation.
• Provide QC data internally and actively support and participate in cross-functional teams (CMC, Quality Management, Management Review Meetings, SRB, etc.).
• Ensure timely issue escalation to Quality senior management and cross-functional support teams.

Special Job Requirements:

• Adaptability required as work schedule may change based on business needs.
• Criminal background check and drug screen required.
• Other duties as assigned.

Knowledge, Skills & Experience:

• Education: BS in Microbiology/Biology, or related scientific discipline (Essential).
• On-the-job experience: At least 8 years' GMP Quality Control experience with at least 4 years management experience (Essential).
• Advanced knowledge of global, especially US and EU GMP guidelines (Essential).
• Strong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence (Essential).
• Confident, independent, self-starter, proactive, and results-oriented with high performance and compliance standards (Essential).
• Strong ability to prioritize and operate with a sense of urgency (Essential).
• Solid organizational, analytical and problem-solving skills (Essential).
• Effective communication skills with the ability to interact with all levels of key stakeholders, with demonstrated interpersonal skills (Essential).
• Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment (Essential).
• Strong operational and business acumen (Essential).
• Exhibits highest integrity and commitment to ethics and compliance standards (Essential).
• Open and transparent in sharing data and information (Essential).

Compensation Range:

The compensation range for this position depends on the experience level of the successful candidate.

• Manager: $130,000 - $150,000
• Sr. Manager: $150,000 - $170,000

Physical Demands:

While performing the duties of this job, the employee is required to meet the following physical demands:

• Work environment: Regularly sit for long periods of time.
• Movement: Frequently required to stand, sit, use hands to finger, handle, or feel, and reach with hands and arms. Occasionally required to walk, climb or balance, and stoop, kneel, crouch, or crawl.
• Lifting: Frequently lift and/or move up to 10 pounds. Occasionally lift and/or move up to 25 pounds.
• Vision: Frequently utilize close vision and the ability to adjust focus.
• Communication: Frequently required to communicate by talking, hearing, using telephone and e-mail.

Genezen's Cures Value-Based Competencies:

• Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
• Urgency in Action for the Patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
• Resilience & Grit in Operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.
• Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principles.
• Solutions Driven for Our Partners: We are committed to being a proactive, collaborative, creative and open-minded partner.

Genezen's Benefits:

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holidays + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Additional Details:

• Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in E-Verify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.