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Analytical Methods Development Lead
In-Process & Release Testing
Location: Hatfield, PA 

The primary role of the In-Process & Release Testing Lead, Analytical Methods Development, is to build and oversee the activities of a team responsible for the development and qualification of analytical methods used for the process development, QC testing, and analytical characterization for Code Bio’s innovative technology and genetic medicines pipeline.  The team will also be responsible for executing the testing required for process development activities and for preclinical/non-clinical product manufacturing.

The responsibilities of this role are diverse and rewarding.  The successful candidate will have the opportunity to build a high-performance analytical team, participate in laboratory expansion activities and influence analytical CMC strategy for a growing company and novel technology.  Initially, the successful candidate will lead a team of 1-2 individuals and the role will require a combination of hands-on work, in addition to hiring, training, and overseeing new scientists.  The individual will interface with partners in Research & Development, Process Development in multiple parts of the method development and product development lifecycle.  The role relies on a diverse set of skills, including strong scientific and technical aptitude, planning and organization, and customer interactions.

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: