Job Description
Job Description
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
Responsibilities:
- Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.
- Author, revise and review manufacturing batch records, SOPs, validation/qualification protocols, forms, logbooks, technical reports, CAPAs, change controls and any other document that may apply.
- Perform formulation, fill and finish for media fills and products, including cryopreservation media, cell culture media, and supplements in the controlled according to approved SOPs, batch records and protocols.
- Troubleshoot problems associated with equipment, process development, production including data analysis and internal record keeping. · Performs other related duties as assigned to meet departmental and company objectives.
- Provides comprehensive formal and informal leadership to promote a positive work environment and communicates overall business expectations to the manufacturing team.
- Prepares and communicates operational objectives to achieve department strategy, specifically around quality, safety, and operational efficiency.
- Reviews manufacturing staff performance regularly to continually enhance performance of individuals and overall work team.
- Promotes open and collaborative work environment with all peers and subordinates.
- Provides immediate supervision and assigns tasks to manufacturing operators/technicians.
- Monitor and prioritize workflow of production to meet deadlines.
- Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and policies to determine
- appropriate action. Acts as an advisor and becomes actively involved as required to meet
- schedules and resolve problems.
- Receives assignments in the form of objectives with goals and processes to meet goals.
- Provides guidance to employees according to established policies and management guidance.
- Ensures personnel are properly trained.
- Completes assigned duties such as, but not limited to, onboarding, conflict resolution, scheduling, performance reviews, investigations, and corrective actions implementation.
- Identifies and helps lead implementation of continuous improvement opportunities.
Requirements:
- Bachelor or a master’s degree in Life Science related field preferred or a minimum of three years related supervisory or lead role experience.
- Five (5+) years’ manufacturing experience in pharmaceutical, chemical, food, or other highly regulated environment.
- Thorough understanding of cGMP regulations and requirements and ability to translate to operational details and communicate to work staff.
- Demonstrated leadership and coaching skills, including interpersonal and organizational skills and ability to coach and mentor personnel to consistently high standards.
- Effective oral and written communication skills.
- Demonstrated problem solving skills in identifying and resolving issues.
- Ability to execute tactical plans and maintain established timelines and budgets.
- Ability to develop and maintain strong working relationships with primary support functions.
- Detail oriented with good time management and organizational skills.
- Ability to work well under pressure and prioritize assignments in a multi-task position.
- Motivated and able to work independently.
Akron provides its associates with the following general benefits:
- 401K plan with employer match
- PPO and EPO 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
EOE/DFW
Job Tags
Temporary work, Immediate start, Worldwide,