Senior Manager/ Associate Director MFG Req# 2120

Senior Manager/ Associate Director MFG Req# 2120
Encoded Therapeutics, United States

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
May 16, 2021
Last Date
Jun 16, 2021
Location(s)

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 www.Encoded.com.

The Encoded MFG team is seeking a foundational leader to execute against the internal and external pillars of our Manufacturing Strategy. The Manufacturing team will build a dynamic workforce to ensure flawless execution of clinical manufacturing while also taking the first steps to build out platform manufacturing tools and systems. The team goals for 2021 are to manage external sites of manufacturing for real time campaign support while concurrently providing operations input and support on internal equipment selection and commissioning in partnership with a cross functional team of Engineering, MSAT, and Development personnel.

*Travel up to 25% expected as part of internal and external network engagement once business operations return to baseline.

Responsibilities:

  • Manage the Manufacturing Team for Encoded Therapeutics, reporting to the Head of Manufacturing and Manufacturing Sciences and Technology
  • 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 and external sites of 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 Director 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)
  • 10 or more years of relevant experience in the manufacturing environment
  • 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

Preferred Qualifications:

  • MS with 8 or more years of relevant experience
  • 2 years or more of industry management experience or equivalent educational leadership experience
  • 7years or more of overall biotech/pharmaceutical/ gene therapy industry experience or equivalent educational experience
  • Operations experience utilizing single-use disposables
  • Previous gene therapy or viral manufacturing experience

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 ADamp;D
  • Professional development opportunities
  • Team-building events
  • Fully stocked kitchen
  • Purple Tie dry cleaning service
  • Fitness center

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,

Job Specification

Job Rewards and Benefits

Encoded Therapeutics

Information Technology and Services - California, United States
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