Job Description Job DescriptionThe Manufacturing Operations Supervisor is a critical first-line leadership role within Cell Manufacturing. This position is responsible for direct management of personnel executing GMP cell processing operations for adherent and suspension cell cultures. The candidate will have strong leadership skills, GMP expertise, and commitment to patients.
The Supervisor will work one of the following shifts:Second Shift - Tuesday to Saturday, 2:30PM - 11PM
Second Shift - Sunday to Thursday, 2:30PM - 11PM
Key Duties and Responsibilities:- Builds and develops an efficient team of 2-8 direct reports capable of consistently producing clinical cellular product or intermediates according to cGMP standards. Includes hiring, orienting, training and coaching of personnel.
- Ensures cGMP compliance through direct oversight and education of team members.
- Shares responsibility of scheduling of personnel in coordination with other Manufacturing leadership.
- Manages direct reports' projects to achieve department and corporate goals, including managing timelines and leading group meetings.
- Leads, investigates, and collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments.
- Creates, revises, and reviews controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing.
- Receive and manage equipment alarms.
- Serves as a technical SME for the team, troubleshoots problems independently.
- Demonstrates the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking
- Other duties and projects as assign as required to meet departmental requirements.
Knowledge and Skills:- Extensive GMP experience, including as a lead or trainer
- Minimum of 3 years of cell culture experience, ideally in both adherent and suspension cultures
- A minimum of 0-2 years direct supervisory experience
- Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
- Expertise in cell processing and culture technologies for clinical materials production required
- Experience with bioreactors for cell culture
- Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems
Environment:- Works in a cleanroom and office setting
- Must be able to remain in a stationary position 50% during processing activities
- Frequently move about inside the cleanroom to accomplish process tasks
- Occasionally moves lab equipment and materials weighing up to 50 pounds.
Pay Range:$0 - $0
Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:On-Site Designated
Flex Eligibility Status:In this
On-Site designated role, you will work
five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Onsite
