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Process Development Lead
Location: Hatfield, PA 

The primary role of the Process Development Lead is the development and scale-up of the manufacturing processes and equipment required for the production of 3DNA and associated formulations.  This will be accomplished by working with an internal team and external vendors.  This individual will also support the tech transfer of process to any external contract manufacturing organizations hired by Code Bio and provide training and support to the manufacturing team during tech transfer.  

 

This role is a great opportunity to be at the ground level of a quickly growing company and progress to building a high performing Process Development Team, participate in laboratory expansion activities and influence CMC strategy for a novel technology.  Initially, the successful candidate will lead a team of 1-2 individuals. The role will require a combination of hands-on work, in addition to hiring, training and overseeing new team members. You will interface with partners in Research and Development, Analytical Methods Development, Regulatory, as well as other disciplines supporting the product lifecycle. The role relies on a diverse set of skills including strong scientific, technical aptitude and well-developed planning and organization skills.

 

This position reports to the Vice-President, Preclinical and Process Development at Code Bio.

 
Responsibilities
  • Develop and scale manufacturing processes and equipment required for the production of 3DNA and associated formulations.

  • Work with external vendors collaborating to support the development and scalability of the required technology

  • Design and execute evaluation studies of this technology

  • Collect and trend process data

  • Write, draft and review technical documentation including SOP’s, manufacturing batch records, technical and development reports.

  • Support the tech transfer of process technologies to in-house or external manufacturing teams.

  • Provide training support to the manufacturing team during tech transfer.

  • Support the preparation of data packages for regulatory agencies, presentations and publications

  • Manage a high performing team

Education and Experience
  • BS degree in chemistry, bio/chem engineering or related scientific discipline with generally 10+ years of experience in the Bio/Pharmaceutical industry.  Advanced degree in chemistry, bio/chem engineering or related sciences with generally 6+ years of experience in the Bio/Pharmaceutical industry. Previous experience in process development or process engineering, with a strong understanding of process equipment design and manufacturing scale up is required.

  • A successful candidate will have experience in process development and scaleup, process optimization and process unit operations amenable to the GMP manufacturing of biopharmaceutical products.  Previous direct lab experience (hands on) required.

  • A working knowledge of molecular biology methodologies is strongly desired.

  • Ability to translate scientific knowledge to execution of manufacturing methodologies

  • Prior work experience in developing processes for use in the manufacture of pharmaceutical products.  A working knowledge of cGMP required. 

  • Prior experience managing a team required.

Skills, Abilities and Competencies
  • Excellent planning and organizational skills

  • Customer-focused attitude, and the ability to work with others

  • Flexible and comfortable with a fast-paced and evolving business environment
    Ability to work in parallel on multiple projects

  • Self- organizer, keen attention to detail

  • Excellent communication skills

  • Self -motivated and independent minded

  • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and functions

  • Responsive, can-do attitude

  • Ability to quickly adapt to rapidly changing environment and demands

We offer a competitive salary and benefit package, including an employer matched 401k. Code Bio  is proud to be an Equal Opportunity Employer.

Interested individuals should send a cover letter and CV to careers@codebiotx.com or: