Vice President, Process Development Protein Analytics

Vice President, Process Development Protein Analytics
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
Apr 7, 2021
Last Date
May 7, 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.

Encoded is seeking a Vice President to oversee development of rAAV manufacturing processes, and of analytical methods in the field of protein chemistry. This position is responsible for high-level strategic direction for platform development activities and formulation of CMC control strategies across multiple departments.

Responsibilities:

  • Management of upstream cell culture, downstream purification, drug substance formulation, and protein analytics functional groups
  • Guiding the strategic CMC direction for programs advancing from pre-clinical through clinical and on to commercial stage
  • Alignment and evolution of process control strategies through interactions with the collective CMC team
  • Establish, manage, and maintain a knowledge base of current and emerging Gene Therapy CMC regulatory requirements and guidance
  • Cross-functional establishment and communication of process development, drug substance formulation and protein analytics approaches and milestones
  • Ensure Process Development amp; Protein Analytics strategies are successfully executed, proactively modifying strategy and actions to adjust to technical outcomes and changes in regulatory environment
  • Oversee and lead Process Development amp; Protein Analytics regulatory filing content for relevant CMC sections of the IND amp; BLA submissions (planning, authoring, reviewing, coordination and product-related inspections)
  • Strategic leadership of analytical comparability studies and bridging studies for process and analytical method evolution during clinical development and commercialization
  • Facilitate process transfer and SME input (including technical problem solving) to cGMP manufacturing and QC
  • Employ risk assessment tools for process design, characterization, validation amp; life cycle management as well as for analytical development, qualification, validation amp; life cycle management
  • Proactively engage in development of IP strategies for process and analytical technologies
  • Evaluate and implement new technologies to drive innovation in gene therapy development, testing, and manufacturing
  • Hire, mentor and develop team members within the organization and manage departmental budgets

Requirements

  • PhD and 15 or more years of experience with increasing responsibility in process development and/or analytical development OR
  • Master’s and 18 or more years of experience with increasing responsibility in process development and/or analytical development OR
  • Bachelor’s and 20 or more years of experience with increasing responsibility in process development and/or analytical development
  • Deep technical expertise in either cell culture, purification, or protein chemistry, and demonstrated success leading one of these functions through clinical manufacturing campaigns and IND and/or BLA filings
  • Twelve or more years supervisory experience, including at least four years managing leaders of functional groups
  • Experience with early-stage and late-stage development of biologics or gene therapy products
  • Track record of supporting IP strategies for process and/or analytical technologies
  • Strong analytical skills, problem solving ability and presentation skills
  • Flexibility and ability to prioritize and manage multiple tasks simultaneously
  • Effective oral and written communication

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

Encoded Therapeutics, Inc. 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

Job Specification

Job Rewards and Benefits

Encoded Therapeutics

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