- Manage, grow, and mature the Analytical Development function and balance and prioritize resource allocation based on program priorities.
- Develop and provides strategic vision and tactical direction across multiple teams, laboratories (incl. contractors) and analytical techniques to develop a comprehensive understanding of our gene-modified cell therapy products from preclinical development through commercial launch.
- Lead and manage teams focused on analytical method design, development, technology transfer, qualification, and validation.
- Work with other functions (e.g., Process Sciences, MSAT, Translational Medicine) to establish appropriate analytical supports for process and product characterization.
- Maintain high autonomy and science-driven decision making throughout the Product Sciences teams within the context of a matrixed development organization and through processes fostering frictionless communication of development progresses and risks.
- Communicate very effectively to leadership team, peers, reporting lines and key partners and stakeholders across the organization.
- Drive excellence in the execution and continuous improvement of appropriate laboratory controls for sample management, data integrity, analytical instrumentation, and reagent performance.
- Author, Review and/or approve IND, IMPD, BLA and MAA sections and participate in interactions with regulatory bodies throughout the product development lifecycle.
- Maintain awareness of the current state of the field (literature, regulatory expectations, and competitive surveillance), and contribute to the broader cell and gene therapy industry and academic ecosystem through publications and conference presentations.
- Coaching and Mentorship of a high-performing team of Directors, Associate Directors, Principal Scientists, Scientists, and Research Associates in the fundamentals of rigorous and sound analytical development and product characterization, including creating opportunities for continuous professional development.
- PhD in chemical or biological sciences with 12+ years of biopharmaceutical experience, or equivalent.
- Experience in all stages of analytical development and product characterization from preclinical through product licensure, including intra- and inter-company technology transfers, CRO/CDMO management, and the evaluation of novel analytical technologies.
- Experience across a broad range of analytical cellular, genomic, proteomic, metabolomic, and biomolecular analytical techniques (incl. compendial methods, FACS, qPCR and ddPCR, NGS, cell-based bioassays, RNASeq, HPLC, and mass spectrometry)
- Experience with the management and operations of BSL2 laboratories.
- Expert proficiency deploying ICH principles for analytical method development, qualification, and validation.
- Expert proficiency in the statistical design of experiment and large dataset analytics
- Expert proficiency streamlining the generation, review, and approval of test methods, development reports, qualification reports, stability protocols, and product characterization studies in support of technology transfers and IND/IMPD/BLA/MAA filings.
- Fluency with global regulatory guidelines and requirements for advanced therapy medicinal products.
- Experience with analytical development for cell and gene therapies is a strong plus.
- Experience with the evaluation of exploratory biomarkers is a strong plus.
- Ability to explore creative approaches to accelerate analytical method development, evaluation of exploratory biomarkers, technology transfer, and comparability assessments.
- Ability to thoughtfully balance the three pillars of Quality, Speed, and Cost for effective product development.
- Outstanding leadership and management skills to inspire, coach, mentor, and grow a strong organization.
- Instinctive personal alignment with Affini-T's values, mission, and vision.
-
Senior Scientist, Product Sciences
2 weeks ago
Affini-T Watertown, United StatesJob Description · Job DescriptionAbout Affini-T TherapeuticsAffini-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 ...
-
Product Manager II, Data Science
2 days ago
DraftKings Boston, United StatesWe're defining what it means to build and deliver the most extraordinary sports and entertainment experiences. Our global team is trailblazing new markets, developing cutting-edge products, and shaping the future of responsible gaming. · Here, "impossible" isn't part of our voca ...
-
Product Manager II, Data Science
2 days ago
DraftKings Boston, United States Full timeWe're defining what it means to build and deliver the most extraordinary sports and entertainment experiences. Our global team is trailblazing new markets, developing cutting-edge products, and shaping the future of responsible gaming. · Here, "impossible" isn't part of our voca ...
-
BioSpace Cambridge, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
-
BioSpace, Inc. Cambridge, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all in ...
-
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · As part of the MSAT team, the Senior Manager of Drug Product Manufacturing Science and Technology, will manage tech transfer and process validation at contract drug product manufacturing sites. The Senior Manager of Drug Produc ...
-
Product Manager Ii, Data Science
1 day ago
DraftKings Boston, United StatesWe're defining what it means to build and deliver the most extraordinary sports and entertainment experiences. Our global team is trailblazing new markets, developing cutting-edge products, and shaping the future of responsible gaming. · Here, "impossible" isn't part of our vocab ...
-
Takeda Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that · the information I provide in my application will be processed in line with · Takeda's · Privacy Notice · and · Terms of Use . · I further attest that all ...
-
Takeda Pharmaceutical Company Ltd Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
-
Sapphire Innovations Cambridge, United StatesYour Responsibilities · As a Product Owner for Customer Experience, you will play a central role in understanding the perspectives of agencies, developers, and customers and integrating them into our product development process. · Your tasks will include analyzing customer feedba ...
-
Commercialization Scientist
2 weeks ago
Newly Weds Foods- Corporate Watertown, United StatesCOMMERCIALIZATION SCIENTIST · SUMMARY: · The Commercialization Scientist is a liaison between R&D Development Scientists, Quality Control, and Production. · This position requires a strong understanding of manufacturing, quality assurance requirements and formulation basics. · Th ...
-
Soliant Watertown, United StatesMinimum 1+ years speech therapy experience required. · Speech-Language Pathology Assistant (SLPA) Watertown, WI · Job Details: · Company: Soliant · Location: Watertown, WI · Responsibilities: · Collaborate with Speech-Language Pathologists to implement treatment plans and inter ...
-
Senior Planner
4 weeks ago
NYS Tug Hill Commission Watertown, United StatesThe NYS Tug Hill Commission is hiring a Senior Planner to assist local governments in the rural Tug Hill region in land use planning, local law development and revision, and general technical support to planning boards and other municipal boards. The Tug Hill Commission is a uniq ...
-
Senior Medical Director
2 weeks ago
C4 Therapeutics Watertown, United StatesAbout C4 Therapeutics: · C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives. C4T is progressing ...
-
Sonata Therapeutics: VP, Translational Medicine
2 weeks ago
Flagship Pioneering Watertown, United StatesVP, Translational Medicine · About Sonata: · Sonata Therapeutics is pioneering the development of Network MedicinesTM, a new class of therapeutics that reprogram diseased cells to release a defined array of signals that precisely coordinate multicellular networks to drive disea ...
-
UnitedHealth Group Watertown, United States Full time$40, Student Loan Repayment Or $30, Sign-on Bonus For Individuals Who Have Not Previously Participated In This Program · Optum Home & Community Care, part of the UnitedHealth Group family of businesses, is creating something new in health care. We are uniting industry-leading sol ...
-
Senior Scientist, Bioinformatics
2 weeks ago
CSL Seqirus North Waltham, United StatesWe have an exciting opportunity available for Senior Scientist, Bioinformatics & Data science, to join our Biopharmaceutical Product Development (BPD) department to shape the data analytics infrastructure, lead RNA-centric bioinformatics pipeline development and transform next-ge ...
-
Manager, Data Science
2 weeks ago
ZoomInfo Waltham, United StatesZoominfo is actively seeking a hands-on Manager of Data Science to join our Enterprise Data and Analytics team. In this strategic role, you will lead efforts to analyze and harness diverse datasets across our organization, with a primary focus on leveraging data science and machi ...
-
Senior Scientist, Formulation Development
1 week ago
Alkermes Waltham, United States Full timePosition Description · Join us in this exciting role as Sr. Scientist where you'll provide great impact in leading technical innovation while also designing and executing lab experiments for small molecule formulation development. · Provide technical leadership in designi ...
-
Principal Product Manager, Intent
2 weeks ago
ZoomInfo Waltham, United StatesWhat You'll Do: · Define and communicate the vision, strategy and roadmap for our proprietary AI/ML models that optimize client GTM motions · Collaborate with engineering, data science, data engineering, and other product teams to deliver models that are efficient, scalable and ...
Senior Director, Head of Product Sciences - Watertown, United States - Affini-T
Description
Job Description
Job DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is a 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 Senior Director, Head of Product Sciences opportunity at our headquarters in Watertown, MA.
Position Summary
The Head of Product Sciences role is situated within the larger CMC organization responsible for process development, analytical development, technology transfers, manufacturing, and supply of our drug product TCR T cell candidates, drug substance and critical intermediates such as gene editing reagents, viral (LVV) and non-viral vectors.
The Head of Product Sciences is a key leader at Affini-T Therapeutics who will have oversight of an eight person team, as well as the overall CMC Analytical Development effort and will partner with multiple interfaces (CMC functions, Regulatory, Quality, Discovery, Translational Medicine, Program Teams, and Contract Laboratories) to define the analytical control strategies for our cell therapies. They will drive scientific, technical, and executional excellence in the development and technology transfer of assays (immuno-, molecular, cytometry, and cell-based assays) used in the characterization and quality control of our TCR T cell therapy products and intermediates.
This is a unique opportunity to shape the analytical control strategy and roadmap to product licensure in a rapidly growing biotechnology company with a highly people- and patient-centric, science-driven culture. The ideal candidate will have extensive experience leading large teams in the robust interrogation of the structure-function of complex biologics, cell, or gene therapies, and embraces the privilege of leadership with humility, grace, and an indomitable will to succeed.
Essential Duties and Responsibilities
The major tasks for this position are as follows:
Education and Experience:
Powered by JazzHR
TDDSLqSe3z
