Your Role:

This position will oversee day to day production activities for Manufacturing personnel including batch record review, timecard approvals, performance reviews, training, and document or deviation reviews and approvals,

Essential Duties & Responsibilities:

• Oversee and actively participate in GMP manufacturing processes.
• Train and manage the performance of the GMP staff, ensure that department training (GMP, Safety, Corporate) is performed and documented.
• Monitor the maintenance of production equipment and facilities for the GMP manufacturing suites.
• Oversee complete documentation of all required production activities and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), corporate policies and safety practices.
• Develop documentation (i.e., batch records, SOPs and documents) to support equipment/facility operations.
• Ensure adherence to schedule as provided by Department head. Coordinate all manufacturing operations within the facility and regularly communicate the schedule within the manufacturing department and other groups as necessary.
• Investigate all failures (equipment, process, product) and assist in determining root cause. Responsible for ensuring appropriate CAPA are identified and implemented following approved SOPs.
• Ensure timely completion and submission of all Manufacturing Investigation Report and documentation of deviations to minimize production delays.
• Work with QA and others to troubleshoot production issues and drive Continuous Process Improvement Initiatives
• Ensure quality standards are always met or exceeded.
• Proactively assess resource needs and lead efforts to reduce production costs and improve efficiencies.
• Work closely with Leadership team and other departments to meet company goals and objectives.
• Provide leadership on projects and process improvement teams.
• Promote Career Development and communicate clear and objective performance appraisals.

Requirements:

• Bachelor's Degree and a minimum of 2-5 years' experience in a GMP biologicals production facility AND a minimum 1 year progressive supervisory or management experience.
• Experience with clinical cell culture production, aseptic processing, and/or Cell Therapy product manufacturing necessary.
• Experience in people management as a supervisor or Senior/Lead associate.
• Ability to work in a swing shift environment.

Skills:

• Experience with Manufacturing operations in a Controlled Environment
• Ability to work cross functionally with both internal and external stakeholders
• Driver of Continuous Process Improvement
• Familiarity with GMP regulations and Quality systems
• Experience in a life science or biotech environment desired
• Able to motivate and lead individuals to achieve desired goals
• Effective communication skills and the ability to influence others

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The anticipated base salary range has been established at $98,354 - $115,710/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.