Analytical Development Group Leader
2 weeks ago
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
PRIMARY RESPONSIBILITY
We are looking for an Analytical Development Group Leader to join the Process and Analytical Development group to lead early-stage and late-stage analytical assays development/optimization and tech transfer of release and characterization testing for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness. Additional responsibilities will include authorship and/or review of CMC sections of regulatory filings and supporting documents. You will collaborate in a cross functional manner to support successful testing of manufactured T Cell drug products for clinical trials. As a subject matter expert in analytical assays development of novel T cell products with familiarity of CMC cross-functional dynamics, you will be expected to demonstrate leadership while you provide strategic direction of analytical development activities and tactical scientific assistance to a team of Scientists and Associates, based on CMC needs. As Analytical Development Group Leader, you will be accountable for the team’s performance and development. Additionally, you will be expected to collaborate closely with our UK process and analytical development team. This is an excellent opportunity for career development, working closely with the Process Development team and cross-functional CMC groups, as an Analytical Development Group Leader of a team of high performing Scientists and Associates in a fast-paced and highly collaborative environment. Performance in this role will be monitored through group performance and stakeholder feedback from peers, senior management, and project team members.
KEY RESPONSIBILITIES
- Lead analytical assay development, optimization, qualification, and tech transfer to QC team, CRO or CMO partners for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness (30%)
- Effectively manage, train and mentor a diverse team of Scientists and Associates by communicating clearly, assigning responsibilities, providing oversight of projects, and career development opportunities (30%)
- Write protocols, reports, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use (20%)
- Collaborate with cross-functional teams across CMC, Quality, Regulatory, Translational and Research and interact with contract manufacturing organizations (CMOs) to ensure appropriate release assays implementation and conduct of analytical methods (10%)
- Author and review CMC content for IND submissions, amendments and BLA filing (10%)
Required
- Ph.D., M.Sc. or B.Sc. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 6 years (PhD), 8 years (M.S.) or 10 years (B.S.) of industry experience.
- Experience in working in cross-functional teams, familiar with CMC team matrix environment and internal/external collaborations to support successful manufacturing of T Cell drug products for clinical trials.
- Excellent track record of people management and career development support.
- Experience with analytical assay development, including bioassays, qPCR/ddPCR and flow cytometry.
- Experience with method qualification and/or validation, experience with analytical comparability a plus
- Strong technical skills with industry experience in writing regulatory documents, including CMC sections of INDs and BLA. Additional experience writing technical protocols, reports, and procedures required.
- Experience in transferring analytical assays into cGMP facility and serving as an SME with external CRO/CDMO.
- Outstanding critical thinking, collaborative mindset and organizational skills, leadership, and attention to details.
- Comfortable in a fast-paced environment.
- Prior experience with cell and gene therapy products and processes.
OTHER REQUIREMENTS
- Potential travel to other office locations for the company and CMOs to assist with tech transfer and troubleshooting activities.
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
Powered by JazzHR
cXjDywJulj
-
Analytical Development Group Leader
Found in: Talent US C2 - 1 week ago
Cambridge, United States Adaptimmune Full timePRIMARY RESPONSIBILITY We are looking for an Analytical Development Group Leader to join the Process and Analytical Development group to lead early-stage and late-stage analytical assays development/optimization and tech transfer of release and characterization testing for clinical stage of T cell Therapy products with a focus on pivotal and commercial...
-
Group Leader
17 hours ago
Cambridge, United States City of Cambridge, MA Full timeESSENTIAL DUTIES AND RESPONSIBILITIES: The Group Leader position is directly responsible, in partnership with Lead Youth Workers and Program Director, for a small cohort of Preteen/Middle School members between the ages of 9-13, including: team building, curricular development, behavior management, improving performance and maintaining culture consistent...
-
Cambridge, United States Spectrix Analytical Services, LLC Full timeJob Summary: **Responsibilities**: - Retrieve and prepare assay samples, prepare assay plates - Prepare and maintain instruments (Biomec, Genovac, LC/MS, automation platforms, shakers, centrfuges, liquid handlers) in good working condition and perform troubleshooting analysis and maintenance as required including tuning the MS - Run in vitro assays...
-
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
GROUP LEADER
Found in: Careerbuilder One Red US C2 - 2 days ago
Cambridge, MA 02138, USA, United States City of Cambridge, MA Full timeESSENTIAL DUTIES AND RESPONSIBILITIES: The Group Leader position is directly responsible, in partnership with Lead Youth Workers and Program Director, for a small cohort of Preteen/Middle School members between the ages of 9-13, including: team building, curricular development, behavior management, improving performance and maintaining culture consistent...
-
Senior Development Associate, Analytical Development
Found in: Resume Library US A2 - 1 week ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Research Associate, Analytical Development
14 hours ago
Cambridge, United States Garuda Therapeutics, Inc. Full timeJob DescriptionJob DescriptionGaruda Therapeutics is pioneering the development of off-the-shelf hematopoietic stem cell (HSC)-based cellular therapies for treating patients with blood, bone marrow, immune, and metabolic disorders. The company uses state-of-the-art technologies in developmental biology, gene-editing, stem cells, and mechanobiology to...
-
Cambridge, United States Vaxess Technologies Full timeLocation: Cambridge, MA Vaxess Technologies is developing next generation vaccines and therapies based on its proprietary MIMIX™ Microneedle Array Patch technology. MIMIX™ enables self-administration of vaccines and therapeutics to the skin with potential for improved shelf-stability, tolerability, and efficacy. We are committed to enabling products...
-
Senior Research Associate, Formulation and Analytical Development
Found in: Appcast US C2 - 7 days ago
Cambridge, United States Vaxess Technologies Full timeLocation: Cambridge, MA Vaxess Technologies is developing next generation vaccines and therapies based on its proprietary MIMIX™ Microneedle Array Patch technology. MIMIX™ enables self-administration of vaccines and therapeutics to the skin with potential for improved shelf-stability, tolerability, and efficacy. We are committed to enabling products...
-
Senior Research Associate, Formulation and Analytical Development
Found in: Appcast Linkedin GBL C2 - 6 days ago
Cambridge, United States Vaxess Technologies Full timeLocation: Cambridge, MA Vaxess Technologies is developing next generation vaccines and therapies based on its proprietary MIMIX™ Microneedle Array Patch technology. MIMIX™ enables self-administration of vaccines and therapeutics to the skin with potential for improved shelf-stability, tolerability, and efficacy. We are committed to enabling products...
-
Sharepoint Developer
2 weeks ago
Cambridge, United States Eliassen Group Full time**Must be local to Boston, MA to go onsite 1-2 days a week in Cambridge, MA.** Our government client is looking for a SharePoint Developer to join their team. Due to federal security clearance requirements, applicant must be a United States Citizen or Permanent Resident with the ability to obtain a Public Trust Clearance. We offer a great benefits package...
-
Vice President, Hematology Clinical Development
17 hours ago
Cambridge, United States Third Rock Ventures Full timeFulcrum Therapeutics is seeking an experienced VP, Hematology Clinical Development to join the clinical development organization to provide medical/scientific expertise to advance our innovative product candidates in our non-malignant hematology pipeline, including the continued clinical development of FTX-6058. In this role, you will lead the clinical...
-
Shift Leader
1 week ago
Cambridge, United States Blaze Pizza - 1154 Cambridge Full timeJob DescriptionJob DescriptionResponsibilities:Taking orders, preparing and firing GREAT pizzas that are in-line with company standardsOperating a point of sale system and cash handlingFood preparation, general cleaning, stocking items and maintaining a clean dining room for all our guestsAlways cultivating the guest experience by providing fast, courteous,...
-
Sharepoint Developer
Found in: Appcast Linkedin GBL C2 - 3 weeks ago
Cambridge, United States Eliassen Group Full time**Must be local to Boston, MA to go onsite 1-2 days a week in Cambridge, MA.**Our government client is looking for a SharePoint Developer to join their team.Due to federal security clearance requirements, applicant must be a United States Citizen or Permanent Resident with the ability to obtain a Public Trust Clearance. We offer a great benefits package that...
-
Sharepoint Developer
2 weeks ago
Cambridge, United States Eliassen Group Full time**Must be local to Boston, MA to go onsite 1-2 days a week in Cambridge, MA.**Our government client is looking for a SharePoint Developer to join their team.Due to federal security clearance requirements, applicant must be a United States Citizen or Permanent Resident with the ability to obtain a Public Trust Clearance. We offer a great benefits package that...
-
Sharepoint Developer
Found in: Appcast US C2 - 2 weeks ago
Cambridge, United States Eliassen Group Full time**Must be local to Boston, MA to go onsite 1-2 days a week in Cambridge, MA.**Our government client is looking for a SharePoint Developer to join their team.Due to federal security clearance requirements, applicant must be a United States Citizen or Permanent Resident with the ability to obtain a Public Trust Clearance. We offer a great benefits package that...
-
Scientist II, Analytical Development of Small Molecule Pharmaceuticals
Found in: Resume Library US A2 - 5 hours ago
Cambridge, Massachusetts, United States Biogen Full timeJob Description About This Role Biogen is seeking a qualified candidate to fill a Scientist II position within its Analytical Development organization. This individual will be an analytical scientist responsible for method development, drug characterization, and conducting experiments and investigations to support the development of small molecule...
-
Shift Leader
4 days ago
Cambridge, United States Amorino | Amorino Gelato JFK LLC | Cambridge Full timeAmorino is looking for enthusiastic, hard-working and ambitious Shift Leaders to join Cambridge's first store, located in Harvard Square! The ideal supervisor is motivated, outgoing and **committed to providing outstanding customer service every day**. They're the operational experts that keep each store running like clockwork. By managing a shift, running...
-
Cambridge, United States Garuda Therapeutics, Inc. Full timeJob DescriptionJob DescriptionGaruda Therapeutics is pioneering the development of off-the-shelf hematopoietic stem cell (HSC)-based cellular therapies for treating patients with blood, bone marrow, immune, and metabolic disorders. The company uses state-of-the-art technologies in developmental biology, gene-editing, stem cells, and mechanobiology to...
-
Vice President, Hematology Clinical Development
18 hours ago
Cambridge, United States Fulcrum Therapeutics, Inc. Full timeCompany Overview Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The...