- Lead an Analytical Development team consisting of scientists and associates.
- Define and execute a phase-appropriate analytical strategy in support of programs as they advance through various phases of research and development, including establishing methods/specifications for the release and characterization of drug substance and drug product, as well as stability and comparability studies.
- Provide direction/oversight of analytical activities conducted at CDMOs by evaluating/assessing analytical capabilities, leading tech transfer of analytical methods developed internally, coordinating method development externally, oversight of QC testing and stability programs, and review of CDMO-generated analytical documentation (e.g., SOPs, method validation protocols, stability reports, change controls, etc.)
- Collaborate with regulatory and QA experts, contributing to regulatory filings by assisting in the writing and/or reviewing of analytical sections.
- Lead the method development and routine testing functions for internal teams, including process development (drug substance and drug product), preclinical manufacturing, and the Research organization (RNA science, LNP science, immunology).
- Communicate effectively and respectfully both internally and externally across all levels to help make/influence key decisions with supporting information and rigorous data.
- Monitor industry trends (technological and regulatory) to remain current on best practices.
- Ph.D. or M.S. in Chemistry, Biochemistry, or a related field is required. Ph.D. is preferred.
- 8+ years of relevant experience in the biotech/pharma industry is required, including 5+ years managing direct reports in Analytical Development.
- Previous experience managing QC and/or routine testing for preclinical materials/research is a plus.
- Direct experience and deep technical expertise in developing analytical methods for the characterization and release of biologics is required, with strong preference for experience with RNA, LNPs, VLPs, and their raw materials and impurities.
- Experience using a combination of internal and external resources to accomplish goals, including tech transfer to, and management of, analytical/QC activities at CDMOs, CROs.
- Experience with stability program design and oversight is required.
- Familiarity and understanding of regulatory standards and current best practices, including GMP, ISO, and ICH guidelines.
- Strong technical writing skills and experience creating documents in support of tech transfer and regulatory submissions (e.g., preIND, IND, BLA, etc.).
- Excellent project management and operations management skills as applied to Analytical Development and QC.
-
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
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
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
1 day 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 ...
-
Analytical Development Group Leader
18 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 ...
-
Research Associate, Analytical Development
4 days ago
Garuda Therapeutics, Inc. Cambridge, United StatesGaruda 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- ...
-
Research Associate, Analytical Development
5 days ago
Garuda Therapeutics, Inc. Cambridge, United StatesJob Description · Job 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 technologie ...
-
Co-op, Analytical Development
1 week ago
Tessera Therapeutics Somerville, United States Full timeCo-op, Analytical Development · Tessera Fall Co-op Program: Designed for students as an alternate academic study in their Bachelors or Masters program. Eligible students would be those attending schools with an established co-op program for academic credit. · Duration: June 24 ...
-
Associate Director, Analytical Development
6 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 ...
-
Vice President, Analytical Development
1 day 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, ...
-
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 ...
Director, Analytical Development - Cambridge, United States - Orbital Therapeutics
Description
Position 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 highly accountable, high integrity individual will also lead, motivate, and grow the Analytical Development team.
Responsibilities:
