Manufacturing Manager

Summary

The Manufacturing Manager works within the manufacturing department and will provide hands- on technical support for all aspects of cGMP cell therapy manufacturing, including technology transfer, process validation, and manufacturing/process support. The manufacturing manager will work in both team-oriented and individual environments. S/he will assist in monitoring process performance at the contract manufacturing organization (CMO) and ensure successful delivery of products with regard to time, quality, and budget. The manufacturing manager is expected to be self-motivated to complete assigned tasks and communicate results to their supervisor in a timely manner.

Essential Job Functions and Duties

Core Responsibilites

• Person in plant (PIP) during manufacturing commercial readiness activities at the CMO.
• Subject Matter Expert (SME) at CMO and within the corporate organization to provide specific expertise to the operation team during the manufacturing process at CMO.
• Monitor Process Performance and assessment of manufacturing process at the CMO.
• Assist in planning, writing, and managing the execution of cGMP manufacturing protocols, batch records, operating procedures, plans, and reports.
• Provide Quality Assurance (QA) with technical support during manufacturing deviation investigations and CAPA development and completion.
• Coordinate and track lot release testing samples.
• Plan and track domestic and international material shipments.
• Accountable for the integrity and tracking of cGMP manufacturing department process data.
• Write and review manufacturing department CMC process sections for regulatory revisions and submissions.
• Summarizes and presents manufacturing and vendor technical reports and communicates results at departmental team meetings.

General Responsibilities

• Liaise with TissueGene functional groups and subcontractors.
• Manage cGMP cell bank and product inventories.
• Reports progress to supervisors and attend progress meetings regularly.
• Maintains a familiarity with current and emerging technologies through reading and understanding scientific and technical literature.
• Assists in coordinating domestic and international shipments of raw materials, samples and DS.
• Complies with KTG quality systems and all pertinent safety policies, rules and regulations.

Requirements

• BS or MS degree in Biology or related discipline.
• Strongly recommended: experience with Cells Culture and molecular biology techniques.
• 5-10 years of biotechnology, pharmaceutical cGMP manufacturing experience
• cGMP aseptic processing and tissue culture using Flask, HYPERStack, Cell Factory, and 3D cell culture experience preferred.
• Knowledge of GMP/GLP compliance
• Must be familiar with aseptic processing techniques in a cleanroom.
• Experience with fill finish and visual inspection of CGT is a plus.
• Strong interpersonal, attention to detail, communication, and organizational skills
• Good Documentation (GDP) and organization skills.
• Self-directed and self-motivated: demonstrated ability to work both independently and as a team member in a matrix environment.
• Ability to travel internationally as required.
• Exceptional oral and written English communication skills.

Work Conditions

• Work is performed onsite, at the office, CMO, and vendors. Some non-standard work hours (e.g., evening or weekend work) will be required. Approximately 50% of travel (including International) is required during cGMP manufacturing activities.

Physical Requirements

• Must be able to push, pull, lift or carry up to 20 pounds occasionally.
• Must be able to engage in at least 30 minutes of moderate-intensity physical activity.
• Must be able to sit or stand for extended periods.

Direct Reports

• N/A

Job Type: Full-time

Benefits:

• 401(k) 4% Match
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• Do you have experience with cell culture and Molecular biology techniques?
• Are you able and comfortable with traveling internationally

Experience:

• Manufacturing: 5 years (Required)

Ability to Commute:

• Rockville, MD 20850 (Required)

Willingness to travel:

• 50% (Required)

Work Location: In person