Associate Director, Manufacturing

Job Description

Job Description

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit

Responsibilities:

• Lead site start-up of internal Manufacturing in partnership with Site head of operations (VP MFG/MSAT)
• Manage the Manufacturing Team for Encoded Therapeutics, reporting to the VP of Manufacturing (MFG) and Manufacturing Sciences and Technology (MSAT)
• Execute the Manufacturing strategy, including identifying resource needs and the hiring and management internal and contract employees
• Ensure successful delivery of GMP material, including oversight of production planning/scheduling adherence, manufacturing batch execution, manufacturing batch close out, and deviation management
• Provide real-time manufacturing campaign support for internal manufacturing
• Partner with Quality Assurance to ensure on-time creation and lifecycle management of manufacturing systems and procedures required for the Quality Management System
• Work with the VP of MFG/MSAT to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes.
• Provide Operations support for equipment IQ, OQ, PQ activities, including procedure writing and provide operations input on internal equipment selection and deployment
• Ensure adherence to GxP guidelines as indicated by phase of manufacture

Requirements

• B.S in a relevant area of specialization (biochemical engineering, chemical engineering, biological sciences, virology, molecular biology, or biochemistry)

• At least 4 years of industry management experience or equivalent educational leadership experience
• At least 10 years of overall biotech/pharmaceutical/ gene therapy industry experience or equivalent educational experience
• Extensive working knowledge of cGMP systems and FDA/EU regulations
• Project management skills, including strategic and tactical projects/tasks, tracking and adhering to budgets, reporting project and campaign metrics, and other project management tools
• Hands-on industrial experience with cell culture, purification, and/or fill finish activities. Operations experience utilizing single-use disposables strongly preferred but not required. Previous gene therapy or viral manufacturing experience preferred but not required.
• Must be a team player and exhibit a willingness to meet project timelines and be a “working manager”
• Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
• Outstanding planning, organization, and multitasking skills
• Up to 20% travel to SSF Headquarters, external sites of manufacture, vendor locations, or other business requirements

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked kitchen

Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.

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