Manager, Quality Control (Pharma/Biotech Experience Required)

Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated scientific professionals to join our rapidly expanding team. This role is an exciting opportunity to play a critical role within our organization that is accelerating the biotech industry’s capabilities through the development of high-quality solutions to support the development and commercialization of advanced therapies. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer highly competitive benefits and perks to our highly valued associates.

Responsibilities:

• Completes regular reviews of trends in test results and use of resources; solicits participation from staff for the setting of goals and improvement measures.
• Represent the department with active participation in cGMP inspections and other audits, tours or meetings as required.
• Manage investigations and troubleshoot existing methods to assess impact of out of specification materials of finished product.
• Reviews and approves all laboratory processes, validations, and reports in conjunction with approved QC SOPs.
• Oversees laboratory operations to ensure compliance with GMP, GLP’s and internal quality standards through direction, authoring, reviewing and approving standard operating procedures (SOPs) for all Quality Control activities.
• Assist in the development, administration and maintenance of the capital budgets for the department.
• Assess and continuously improve stability programs and ensure execution within required timelines.
• Review and approve POS’s as related to QC activities, and internal communications to obtain additional details as necessary.

Requirements:

• BS in Biology, Chemistry or related field.
• 5+ years of experience working as a leader in a GMP laboratory.
• Outstanding verbal and written communication skills.
• Intermediate to expert level administrative knowledge of MS Office applications; proven ability to leverage digital technology and resources.
• Proven ability to successfully manage projects and timelines, organize/track information, prioritize accordingly.

In addition to competitive compensation, we offer a comprehensive benefits package including:

401K plan with employer match

PPO and HMO medical insurance plan availability

Company paid dental and vision insurance

Company paid short-and long-term disability

Company paid life insurance

Company paid holidays

Generous paid time off allowances

Employee referral bonus

Employee gym reimbursement program

Employee recognition program

    EOE/DFW