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Director of Process Development

1 month ago

Lexington, United States Genezen Full time
Job DescriptionJob Description

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

WORKING AT GENEZEN

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

PURPOSE:

The Director of Process Development will be responsible for all facets of Process Development for Genezen in Lexington, MA. He/she will provide strong leadership, guidance, and scientific oversight to the Process Development team. This includes, but is not limited to Analytical Development, Upstream and Downstream Purification, and assisting with Technical Transfer.

The Director of Process Development must be an experienced technical leader to lead the process (upstream and downstream) and analytical development teams. The individual is passionate about building teams and a well-characterized, controlled, and efficient viral vector production processes. The role is client facing and will have strong knowledge of managing multiple programs to ensure flow in the resources and execution. The individual will foster cross-functional collaboration with Quality, EHS, and Manufacturing, while working closely with the CSO on strategic decision-making.

The Director of Process Development will direct the planning, execution and customer interaction during all late phase development and manufacturing programs and has profit and loss accountability for those activities. He/She will be responsible for all aspects of developing robust, scalable and efficient manufacturing processes to produce human clinical trial materials and the ability to scale to commercial. In addition, this position will develop budgets for labor and capital expenditures, and approve, from a delivery perspective all late phase proposals being made for customers.

ESSENTIAL JOB FUNCTIONS/DUTIES:

  • Responsible for building and development of the process development and analytical teams
  • Provide strategy, leadership, and scientific direction for development, design, scale-up and transfer of AAV, LVV and RVV production processes
  • The individual will have substantial input toward equipment and technology assessment, integration, automation, and closed-system evaluations for viral vector processes.
  • Continually seek and evaluate new potential technologies for rapid production and purification of AAV, LVV and RV vectors
  • Lead process improvements for clinical and commercially compliant manufacturing and analytical processes.
  • Implement cutting-edge analytical methods for viral vector process characterization.
  • Monitor and report on area performance to CSO, identifying opportunities for improvement and implementing process improvements. Coordinate, review and approve technical reports on key development findings
  • Designing lean and efficient process development programs that accelerate client timelines and maximize use of organizational resources.
  • Support Regulatory Affairs to prepare, file, and maintain appropriate regulatory body documents from technical standpoint
  • Manage resources for development teams to meet project deliverables
  • Assist in generation of schedules and budgets for PD/AD team activities
  • Collaborate with manufacturing, MSAT and QA to define and direct AAV, LVV and RVV process control strategies, define critical process parameters (CPPs) and establish acceptance criteria
  • As an viral vector process SME, support other functions including strategy for testing of raw materials, pre-clinical development, reference standards and assay validations, etc.
  • As necessary, assist in corporate development to support contracts and other legal documents to execute work plans and projects

SPECIAL JOB REQUIREMENTS:

  • Adaptability required as work schedule may change based on business needs
  • Excellent communication skills
  • Exceptional conflict management skills
  • Criminal background check required
  • Other duties as assigned
EDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredMS in Molecular Biology, Biochemistry, Chemistry or related field

Essential

PhD in Molecular Biology, Biochemistry, Chemistry or related field

Desired

ON-THE-JOB EXPERIENCE

A minimum of 10+ yrs hands on experience in Process Development of cell therapy and/or gene therapy products.

Essential

8+ years in a Leadership role

EssentialExtensive experience in process development, process optimization, process characterization and manufacturing of GMP gene and cell therapy viral vectors

Essential

SKILLS/ABILITIES

Strong ability to plan and troubleshoot, Baculoviral based AAV production, transient transfection-based viral vector production, TFF and chromatography unit operations.

Essential

Strong aptitude to interpret and manipulate data, define problems, establish facts, draw valid conclusions and make decisions.

Essential

Capable of maneuvering through abstract and concrete variables in situations where only limited standardization exists.

Essential

Hands on experience in designing and implementing experiments to evaluate processes, analytical methods, and formulations

Essential

Entrepreneurial experience dealing with customers in product development.

Essential

Understanding of guidelines required by FDA, EMEA, and other regulatory bodies

Essential

Must have strong strategic skills, along with the ability to be hands on

Essential

Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.

Essential

Prior experience in creating, building, implementing, and managing a high functioning Process Development Team

Essential

Excellent communication skills and ability to thrive in a fast-paced, dynamic environment.

Essential

Proven leadership experience, with a track record of building and managing high-performing teams.

Essential

Proficiency using JMP, Benchling and statistical software, or equivalent

Essential

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Ability to work in a BSL 2/3 environment with personal protective equipment.
  • While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
  • In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 9 observed holidays + 1 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Share Appreciation Rights
  • Choice of several healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance
  • Accidental Death & Dismemberment (AD&D) Insurance

ADDITIONAL DETAILS

  • Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in EVerify.
  • Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.