Downstream Process Development Principal Engineer

Waltham, MA
Aug 26, 2020
Required Education
Position Type
Full time

Title: Downstream Process Development Principal Engineer

Affinia Therapeutics, Inc is a rapidly growing biotech company developing next generation gene therapies. We are backed by a strong syndicate of life science investors and have ambitious plans to positively impact the lives of patients around the world.

As an early employee you will play a key role in setting our culture and values. You will be working alongside the founding management team who have a track record of success in the industry. We have an unprecedented library of functional viruses, unique high-throughput screening methods, and vast datasets that are being mined with bioinformatics. The pace of work will be dynamic, fast and fun.

We are looking for a creative, engaging, and collaborative individual to join our Molecular Core Team. You will be part of a group dedicated in the production of small to medium scale vector material for preclinical studies.

We offer a great culture and competitive compensation and benefits.


  • Serve as a subject matter expert and key scientific and technical lead for downstream bioprocess development, working closely with manufacturing groups and leading tech transfer activities as needed.
  • Write, prepare and present technical data, technical reports and standard operating procedures (SOPs) for internal use and tech transfer.
  • Provide technical/scientific support in process development and qualification efforts for vector purification. 
  • Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality.
  • Seek continuous improvement opportunities and implement potential process improvements in conjunction with operations. 
  • Support tech transfer and start-up efforts of new products and equipment in the molecular core. 
  • Maintain an up-to-date notebook, participate in meetings, prepare presentations, and communicate to leadership as needed.

Basic Qualifications

  • PhD in biochemistry, chemical engineering, bioengineering or similar OR M.S. in the same fields followed by a minimum of 3 years of experience in support of biopharmaceutical manufacturing / process development. 
  • Strong technical writing ability.
  • Proven ability to effectively lead and participate on teams.
  • Deep understanding of downstream processes including but not limited to chromatography, TFF, CsCl purification, depth filtration and viral log reduction.

No Employment Agencies please, the Company is not responsible for any fees related to candidates that are unsolicited.

EEO Statement: Affinia Therapeutics is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.