Back to jobs

Scientist II/III - Downstream Process Development

Lexington, MA

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.

JOB SUMMARY

The Downstream Process Development Scientist will be responsible for developing and optimizing purification processes for Adeno-associated viruses (AAV), Lentiviral vectors (LVV) and Retroviral Vectors (RVV) at Genezen Lexington, MA facility. The ideal candidate will have extensive experience in downstream processing, including chromatography, Tangential flow filtration, and formulation techniques. This role involves designing and executing experiments, analyzing data, and collaborating with cross-functional teams to establish scalable and robust downstream processes that meet both client and regulatory requirements.

This is a client-facing position that demands constant interaction and adherence to strict timelines. The individual must collaborate with cross-functional teams to establish and implement the best regulatory and laboratory practices and lead the execution of complex experiments.

ESSENTIAL JOB FUNCTIONS

  • Develop and optimize downstream processes for AAV purification, including clarification, chromatography, filtration, and formulation.
  • Scale-up processes from bench-scale to pilot and production scales up to 2000L, ensuring consistency and efficiency
  • Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality
  • Develop and support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity
  • Conduct process characterization studies to identify and control critical process parameters.
  • Support the commercial function in the assessment of new opportunities and provide appropriate technical input to prospective customers, including the demonstration of capability at customer visits
  • Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members
  • Maintain open communication via one-on-one and team meetings
  • Stay current with relevant technologies and needs to be adept at identifying new approaches
  • Perform and lead single-use system design, selection, implementation, and control strategies
  • Collaborate closely with upstream processing, analytical development, quality control, and quality assurance teams to ensure integrated process development and transfer.
  • Maintain external technical relationships and collaborate with equipment and material suppliers
  • Stay current with advancements in downstream processing technologies and methodologies.
  • Propose and implement innovative solutions to enhance process efficiency, product purity, and yield.
  • Serve as process SME for regulatory and client audits
  • Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area

SPECIAL JOB REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

 

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS, MS, or PhD in biological engineering

Desired

ON-THE-JOB EXPERIENCE

 

4-5  years of relevant industry experience

Desired

Solid foundation in the fundamentals of biochemical engineering, virology and cell biology

Essential

Entrepreneurial experience dealing with customers in product development

Desired

Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations

Desired

Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing

Desired

SKILLS / ABILITIES

 

Working knowledge Downstream process and AKTA chromatography and tangential flow filtration.

Desired

Ability to interface successfully with multi-disciplined teams

Desired

Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools

Desired

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
  • Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
  • Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
  • Occasionally exposed to extremely loud noise levels
  • Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

  •  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, 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.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...

If you're willing to share, please provide the link to your LinkedIn Profile.

Where did you hear about Genezen? *
Select...

This position requires a criminal background check and drug screening.

Genezen is an Equal Opportunity Employer.

Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Genezen’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.