Manufacturing Manager Jobs

About The Position

Requirements

• Bachelor's degree in biology, chemistry, engineering, pharmaceutical sciences or related field.
• Must have at least 5 years of cGMP pharmaceutical, biotechnology, cell/gene therapy or relevant regulated experience.
• Must have professional management experience, preferably in the biopharmaceutical industry.
• Must have excellent communication skills both oral and written, interpersonal skills, and organizational skills.
• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
• This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• Current or future H-1B sponsorship is not available for this role.

Nice To Haves

• A background in science, a detail-oriented, quality-first mindset, along with a proven track record in being able to manage, train, and develop junior team members in a GMP compliant setting.
• Cross-functional collaboration, problem-solving, addressing bottlenecks, and balancing team needs are all a part of the everyday fun and excitement.
• If you enjoy both the science behind cell and gene therapy and supporting the people involved in producing these life-changing treatments, this could be a great fit.

Responsibilities

• Responsible for batch record review and harvest day batch disposition.
• Revising and reviewing SOPs, OJTs, MPRs, protocols, and other documents.
• Coordinate manufacturing activities with Supply Chain, Quality Assurance, Quality Control, Engineering, and Patient Operations.
• Able to identify manufacturing constraints and troubleshoot or escalate issues as needed.
• Must be glove & gown qualified to provide management on the floor during adverse events.
• Responsible for direct reports which include but are not limited to ensuring timely completion of training, personnel scheduling, conducting performance reviews, reviewing and approving timecards in a timely manner, etc.
• Monitor operations to ensure adherence to manufacturing policies and procedures in line with current regulatory guidelines.
• Ensure reports are compliant with all safety requirements and safe work practices.
• Participate in and lead change controls, CAPAs, and quality event investigations.
• Additional duties and responsibilities as assigned.

Benefits

• Annual discretionary bonus
• Equity opportunities
• Robust health/medical coverage options
• FSA/HSA options
• Company-paid basic dental and vision plans
• Lifestyle spending account (wellness reimbursements)
• 401(k) retirement plan
• Up to 160 hours of paid time off accrual per calendar year (prorated based on date of hire)