- Lead and grow a team of analytical scientists and research associates responsible for:
- Developing and optimizing analytical assays across different stages of drug development for gRNA, mRNA, lipids, and LNPs
- Testing non-GMP samples to support development studies such as comparability assessments, process development, stability, product and process characterization, etc.
- Collaborating closely with the R&D and Quality Control teams to transfer and qualify methods at CDMOs, CROs, and Verve's internal QC lab
- Enhancing our product and process understanding by characterizing impurities, defining CQAs, process troubleshooting, supporting process control strategies
- Improve lab management and operations including lab safety, budget, quality systems, data reporting/management, productivity initiatives, etc.
- Write and review regulatory filings and briefing books; represent the company in regulatory interactions
- Promote a culture of continuous improvement and collaboration
- Demonstrated history of effective leadership, including hiring and developing top talent
- Experience with method development, qualification, and validation for clinical and commercial products
- Experience in characterization of advanced therapies, ideally gene editing, RNA, and/or LNP products
- Experience with international regulatory interactions: writing filings, responding to information requests, scientific advice meetings, etc.
- Excellent written and verbal communication skills; strong communicator and influencer within all levels of the organization, including executive leadership
- BS in sciences, analytical chemistry, biochemistry, pharmacy, or related area, advanced degree preferred with 15+ years of progressive leadership experience
-
Moderna Cambridge, United StatesThe Role · Here's What You'll Do · Develop and qualify HPLC-UV and LC-MS-based enzyme activity assays for the detection of small molecules. · Develop and qualify plate-based fluorometric/colorimetric assays for the detection of small molecules. · Develop and qualify cell-based as ...
-
Director, Analytical Development
2 weeks ago
Cerevel Therapeutics Boston, United States Full timeCompany Overview · Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our p ...
-
Director, Analytical Development
1 week ago
Verve Therapeutics, Inc. Boston, MA, United StatesJob Description · Job Description · The Company · Verve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene- ...
-
Head, Analytical Development
2 weeks ago
Workday Boston, MA, 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 sub ...
-
Head, Analytical Development
1 week ago
Taleo BE Boston, MA, 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 sub ...
-
Director, Analytical Development
1 week ago
Verve Therapeutics, Inc. Boston, United StatesJob Description · Job DescriptionThe CompanyVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, ...
-
Head, Analytical Development
2 weeks ago
Takeda Boston, United States Full timeBy 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'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Analytical Development Director
21 hours ago
Next City Boston, United States Full timeManager, Analytical Development – Medical DevicesLocation: Boston · Working situation: Hybrid · Level: Manager Our client is a medical device company pursuing research into exciting combination products and therapies looking for a Manager Analytical Development with a passion f ...
-
Director, Analytical Development
3 days ago
Flagship Ventures Cambridge, United StatesThe Company: · FL85 is a Flagship-backed, privately held biotechnology company on a mission to transform the current approach to information molecule therapeutics to unlock their full therapeutic potential. In recent years, we have begun to experience the power of information mo ...
-
Director, Analytical Development
1 day ago
Orbital Therapeutics Cambridge, United StatesPosition Summary: · Orbital is seeking an experienced Director of Analytical Development who will be responsible for leading, directing, and implementing a comprehensive analytical strategy in support of programs within vaccine, immunomodulation, and protein therapeutics. This h ...
-
Associate Director, Analytical Development
5 days ago
PepGen Boston, United StatesReporting to the Senior Director, Analytical Development & QC, the Associate Director of Analytical Development will be acting as analytical project lead, responsible for supporting the analytical development needs of PepGen's pipeline. In addition, this position will be required ...
-
Vice President, Analytical Development
2 weeks ago
Verve Therapeutics, Inc. Boston, MA, United StatesJob Description · Job Description · The Company · Verve Therapeutics is a biotechnology company created with a singular focus: to protect the world from heart disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, the company aim ...
-
PepGen Boston, United StatesJob Description · Job DescriptionAssociate Director, Analytical Development · Position Summary · Reporting to the Senior Director, Analytical Development & QC, the Associate Director of Analytical Development will be acting as analytical project lead, responsible for supporting ...
-
EPM Scientific Boston, United StatesJob Description · Job DescriptionPrincipal Scientist - Analytical Development · Location: Boston, MA · Level: Principal Scientist · SUMMARY · A premier, mid-sized pharmaceutical company is actively hiring a Principal Scientist for their analytical development team. You will be pl ...
-
Sr. Scientist, Analytical Development
1 week ago
Scorpion Therapeutics Boston, United States Full time· Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most ...
-
Senior Scientist, Analytical Development
3 weeks ago
Cerevel Therapeutics Boston, United States Full timeCompany Overview · Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our p ...
-
Analytics Leadership Development Program
1 week ago
Takeda Boston, United States Full timeBy 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 ...
-
Analytics Leadership Development Program
1 week ago
Takeda Boston, United States Full timeBy 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'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Analytical Development Group Leader
3 hours ago
Adaptimmune Cambridge, United StatesJob Description · Job DescriptionAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, ...
-
Analytical Development Group Leader
1 week ago
Adaptimmune Cambridge, United States Full time· 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 ...
Vice President, Analytical Development - Boston, United States - Verve Therapeutics, Inc.
Description
Job Description
Job DescriptionThe CompanyVerve is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines. The company's initial three programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that have been extensively validated as targets for lowering low-density lipoprotein cholesterol (LDL-C), a root cause of cardiovascular disease. VERVE-101 and VERVE-102 are designed to permanently turn off the PCSK9 gene in the liver and are being developed initially for heterozygous familial hypercholesterolemia (HeFH) and ultimately to treat atherosclerotic cardiovascular disease (ASCVD) patients not at goal on oral therapy. VERVE-201 is designed to permanently turn off the ANGPTL3 gene in the liver and is initially being developed for homozygous familial hypercholesterolemia (HoFH) and ultimately to treat patients with refractory hypercholesterolemia. In 2023, Verve was named a Top Place to Work by The Boston Globe for the third consecutive year. Verve is headquartered in Boston, Massachusetts.
The PositionVerve is seeking a Vice President, Analytical Development to lead the CMC Analytical team reporting to the Chief Technical Operations Officer. The role will be working cross-functionally to develop and implement new methods and assays for the characterization of raw materials, RNA drug substances, and LNP drug products. This individual will act as a scientific thought leader for the CMC and company-wide analytical strategy at Verve.
Job ResponsibilitiesThe targeted salary range for this position is $288,000 - $360,000 per year. Verve is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Verve's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
EEO StatementVerve Therapeutics is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Recruitment & Staffing AgenciesVerve Therapeutics does not accept agency resumes unless contacted directly by internal Verve Talent Acquisition. Please do not forward resumes to Verve employees or any other company location; Verve Therapeutics is not responsible for any fees related to unsolicited resumes.
Vice President, Analytical Development professionals in Boston
-
Riddhisha Chitwadgi
Data Analyst | Machine Learning | Tableau | Python
-
Kunal Chopra
Candidate MS Business Analytics, NEU
-
binu ks
Transformation expert - Digital and Operations
-
Christopher Werth
General Manager
-
Pranay Gawas
Data Engineer
-
Devin McNerney
Student at Northeastern