The Associate, Manufacturing is responsible for supporting biological manufacturing. All functions and roles of the manufacturing process are required to be performed with adherence to cGMP and GDP to ensure successful, quality operations.
Performs manufacturing activities according to cGMP guidelines, including batch record execution and review, product and equipment changeover, manufacturing equipment troubleshooting, issue resolution.
Execute process operations in accordance with dynamic production timeline.
Ensures safety and cGMP compliance in manufacturing area at all times
Communicate transparently with management on all manufacturing related activities
Utilize Cell culture expansions and aseptic techniques
Develop and author necessary supporting cGMP documentation that supports all Cell Culture manufacturing processes.
Maintain aseptic gowning qualification status and participate in semi-annual media fills.
Engage cross-functionally with other departments in order to stream-line all operations supporting cGMP manufacturing.
Cross-train on and assist with multiple cell lines operations as required.
Contribute to and develop process improvement initiatives with all Cell Culture manufacturing equipment and operations.
Assist and/or execute ordering of material and ensure that equipment and materials are available for production runs.
Adhere to Standard Operating Procedures (SOPs) and cGMP guidelines.
Maintain and sustain all organizational training profile requirements.
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Bachelor’s degree in chemical engineering, genetics, molecular biology, biotechnology, microbiology, biochemistry, or a related field is required
Attention to detail, cleanliness, physical and mental flexibility
Good perception to implement what has been learned, following guidelines precisely
Understanding and application of safety and quality requirements
Solid adherence to cGMP
Ability to successfully work in a team environment with effective communication skills
Hands on approach to learned skills
Team player with good communication skills
Skill in Microsoft Word, Excel, and PowerPoint
Ability to read, understand and apply Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs)
Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC).
Ability to work on unscheduled days occasionally to support the dynamic production schedule and relevant timelines.
Ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment is required
Relevant industry or research experience is preferred
Bio-Manufacturing experience is preferred
Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day