FLSA Classification : Exempt/ Salary
Schedule: Monday - Friday; 8:00 am - 5:00 pm; On-Site
Department: CMC-PD/AD
Reports to: Principal Scientist, CMC-PD/AD
Supervisory responsibilities: No
Location: 13203 Murphy Rd., Suite 100 Stafford, TX 77477
Position Summary/objective: The Scientist position is a collaborative and interdisciplinary position responsible for process and analytical development for drug product manufacture of our pre-clinical and clinical phase programs. S/he will be expected to design, manage, execute relevant experiment and analyze data from complex scientific projects centered around understanding and improving our drug products.
Essential functions: - Design and conduct, or direct, studies that evaluate experimental aims and advance knowledge in the TCR-T cell therapy field.
- Hands-on laboratory work to include aseptic cell growth, cell transduction, manipulation procedures and conducting functional and phenotypic characterization of cellular products.
- Apply expertise in developing, transferring, qualifying and validating analytical assays for viral vectors (Lentivirus) to support the release and characterization of viral vectors for cell therapies in all phases of clinical development.
- Facilitate technology transfer of assays to assess identity, purity, safety, and potency of viral vectors and engineered cell therapies for QC release and stability testing.
- Act as subject matter expert in viral vector analytical development, partnering with external CDMOs for establishment, qualification and validation of analytical methods to support manufacturing of viral vectors.
- Ability to analyze and interpret large experimental data sets using basic and advanced techniques from laboratory instrumentation including but not limited to flow cytometry.
- Effectively visualize, document, and communicate results of experimental studies with scientists and non-scientist stakeholders.
- Ability to perform qPCR-based assays and analyze and interpret patient data for cross-functional teams, company press release.
- Ability to develop new assays and qualify according to agencies guidelines.
Secondary functions: - Write and review study plans, research/study reports, standard operating procedures and other technical documents related to cell therapy.
- Support in submission of regulatory documents e.g. Pre-IND/IND/IMPD and addressing questions from regulatory agencies.
- Other duties as assigned.
Competencies: - Independent Working: All tasks: Limited supervision.
- Communication: Proficient verbal & written communication skills. Intermediate degree of tact & diplomacy. Regular interaction with other teams or departments. Limited interaction with external business partners. Proficient presentation skills (structured & convincing presentation of complex topics to a large audience with heterogeneous knowledge/background.
- Problem solving: Strong ability to identify, deeply analyze & communicate problems. Deep understanding of impact on broader scope (e.g. beyond own team/department). Proficient ability to develop & independently implement solutions (within own area of responsibility).
- Critical thinking: Advanced critical thinking skills to analyze scientific questions. Ability to anticipate future risks. Good understanding & consideration of interfaces beyond own/narrow scope.
- Initiative: Pro-active attitude.Strong sense of responsibility within own/narrow scope. Fostering innovation & development in own area of expertise.
- Organizational skills: Advanced organizational skills required to design project plans & drive scientific projects in accordance. Deep understanding of priorities within own/narrow scope. Deep understanding of priorities within broader scope. Prioritization requires limited interaction with the supervisor.
- Coachability: Actively reflect on & suggest trainings supporting professional development within or beyond current area of responsibility. Actively reflect on & suggest trainings supporting future development of area of responsibility. High degree of self-reflection (awareness of own strengths & weaknesses). High responsiveness to constructive criticism & high ability to autonomously reflect on required improvements and to propose self-improvements & timely implementation of suggested improvements.
- Leadership skills, Training & Supervision: Basic leadership skills required for on-the-job trainings & guidance/support of team members (e.g. providing & receiving feedback, empathy, honesty, reliability). Train & supervise D level in specific area of expertise. Train C level during onboarding.
Work environment: This position works in a typical office and/or clinical lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, pathogens and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions, risk of electrical shock, sharps, or cuts, while performing tests.
Physical demands: - Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
- Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
- Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
- Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.
- Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
- Pushing - Exerting force upon an object so that the object moves away from the object.
- Pulling - Exerting force upon an object so that the object moves toward the force.
- Sitting - remaining in a sitting position for at least 50% of the time.
- Standing/Walking - remain on one's feet in an upright position at a workstation.
- Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.
Travel required: Domestic travel for team building activities e.g. department retreat, professional development or conferences 1-2 times a year.
Required education and experience: - PhD in a relevant discipline (molecular biology, immunology, biochemistry, cell biology, virology or related field).
- 3+ years of relevant experience leading and executing scientific studies including experience in cell therapy or cell therapy applications.
- Demonstrable experience with analytical development and method qualification/validation supporting early and/or late-stage development of viral vectors for cell and/ or gene therapy.
- Subject matter expertise in product characterization methods relevant to viral vector (including cell-based vector potency assays, infectious titer, titration assays, PCR / qPCR, ddPCR, sequencing, ELISA, MSD, and western blot).
- Experience working with Viral Vector CDMOs for method transfer, development, qualification and validation.
Preferred education and experience: - Strong understanding of viral vector (LV, AAV, etc.) biology.
- Hands-on experience in analytical characterization of viral vectors is preferred.
- Experience with FlowJo or related flow cytometric data analysis software, Graphpad, JMP software.
Additional eligibility requirements: Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job.
Work authorization/security clearance requirements: Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment
Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medicalconditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Other duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.