Senior Scientist, Product Sciences

Watertown, MA
Full Time
Senior Manager/Supervisor
About Affini-T Therapeutics
Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the goal of inducing long-term responses in patients with solid tumors.

Affini-T Therapeutics is announcing a Scientist II/Senior Scientist opportunity at our headquarters in Watertown, MA.
Position Summary
The Scientist II/Senior Scientist will be a key member of the Product Sciences Group (Analytical Development) in CMC and will work in a matrix setting interacting with other functions in CMC, QA, Reg Affairs, R&D, Translational and Clinical team members.

The individual will be involved in technical oversight of analytical activities with internal and external partners (CDMOs, Analytical Contract Labs) and will assist in analytical technology transfers for Drug Product TCR candidates, including critical intermediates such as LVV and non-viral vectors and gene editing reagents. The Scientist II/Senior Scientist will assist in establishing specifications, product comparability studies and providing support in the preparation of regulatory submissions and health authority interactions. The individual will also be responsible for managing and coordinating analytical activities in support of manufacturing process development, IND enabling studies and clinical material characterization. The individual may be involved in laboratory activities to support this effort. 

The ideal candidate will have experience working with Quality Assurance and must have a high level of independence to carry out their responsibilities with minimal supervision. This is a unique opportunity to shape the CMC team and roadmap to product licensure at a small and rapidly growing biotechnology company.
Essential Duties and Responsibilities
The major tasks for this position are as follows:
  • Manage and execute clinical research activities for multiple trials.
  • Assist in Analytical Technology Transfer activities to contractors and provide technical assistance and supervision during routine QC / Manufacturing activities.
  • Assist in resolution of quality events (laboratory investigations, deviations, change controls, CAPAs, risk assessments, impact assessments, out-of-specification (OOS)).
  • Assist in the development and elaboration of phase appropriate method validation protocols, used for release and characterization.
  • Contribute to regulatory filings such as IND and BLA.
  • Establish processes, manage, and coordinate extended characterization testing of clinical product lots at Affini-T.
  • Serve as a liaison between Analytical Development and Process Development teams to coordinate and perform analytical testing in support of process and product characterization and understanding.
  • Develop and maintain analytical tracking and trending tools and systems to monitor product quality (QC release, in process data and characterization) stability, and method performance.

Desired and Required Qualifications
Education and Experience:  
  • Bachelors +9, Masters +6, PhD +4 in Biochemistry, Biology, or related field experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality control, or equivalent combination of education and experience.
  • Extensive hands-on experience spanning analytical development of biologics and cell therapies (e.g., flow cytometry, cell-based assays, PCR, HPLC, CE etc.).
  • Track record of successful analytical technology transfers and GMP manufacturing of clinical trial material.
  • Excellent working knowledge of GMP and GLP requirements.
  • Must have a good understanding of Quality Systems and demonstrate proficiency in the application of QA principles, concepts, industry practices, and standards. Good conceptual, strategic, analytical, problem solving, and organizational skills.
The successful candidate will have the following attributes:
  • Autonomous, take-charge, proven team player with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
  • High emotional intelligence, sound temperament and professional attitude.
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with all levels of the organization. Strong communication skills with outside contract organizations are required.
  • Results and detail-oriented; self-motivated, ability to work with minimal supervision.
  • Personal alignment with Affini-T’s values, mission, and vision.
Physical Requirements
  • Sit for extended periods of time (2 or more hours)


Apply for this position

Apply with Indeed
We've received your resume. Click here to update it.
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • 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.
Veteran status

Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
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

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
Please check one of the boxes below:

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.

You must enter your name and date
Human Check*