Scientist Analytical Development

Profile

TheScientist, Analytical Development* will be a key member of the Analytical Development group at **MEMBERS ONLY**SIGN UP NOW***.. The successful candidate will have great opportunities to use state-of art instruments, like UHPLC-TOF, UHPLC-MS, MALDI, etc. for studying various potential drug candidates to ultimately create transformational therapies for patients with neuromuscular disease. The candidate will contribute lab activities associated with method development and analytical support for drug discovery and development in-house and at contract testing labs. The successful candidate also will work very closely with experienced CMC and discovery teams to develop and qualify phase-appropriate chromatographic methods for characterization of various chemical entities like peptides, oligos and **MEMBERS ONLY**SIGN UP NOW***.´s proprietary enhanced delivery oligonucleotides (EDOs), which is essential to the quality of therapies for patients. In addition, this scientist will play a critical role in building a strong analytical development/QC team and shaping analytical CMC strategy for various programs at **MEMBERS ONLY**SIGN UP NOW***..

Responsibilities

• Develop analytical methods for the purity/potency analysis and impurity characterization of small molecules, peptides, Phosphonodiamidite Morpholino Oligomers (PMOs), and Peptide Conjugated Phosphorodiamidate Morpholino Oligomers (PPMOs).
• Provide analytical support to internal discovery and development activities, including sample management, sample analysis/characterization, and issuance of certificate of testing (COT) and certificate of analysis (COA), etc.
• Perform routine maintenance of analytical equipment, HPLC systems, balance, pH meters, etc.
• Contribute to analytical method transfer (mainly UHPLC-UV and LC-MS methods) to and between Contract Testing Laboratories (CTLs) and Contract Manufacturing Organizations (CMOs) and provide necessary technical support for method troubleshooting at CMOs and CTLs.
• Review method development and validation protocols and reports generated by CTLs and CMOs
• Review drug substance and drug product release and stability testing data generated by CTLs and CMOs.
• Write analytical protocol and report for in-house analytical activities and prepare analytical source documents to summarize analytical activities for regulatory filing.
• Work collaboratively with drug substance/drug product, supply chain, quality assurance and regulatory assurance teams to ensure timely availability of lot release and stability data.
• Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement

Requirements:

• BS/MS degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2 years relevant experiences or Ph.D. with at least 1 year relevant experiences in analytical method development in pharmaceutical/biotech setting. Title will depend on the experience level of the successful candidate.
• Experience in the development, transfer, and validation of chromatographic methods (HPLC, GC, LC-MS, etc.) is preferred.
• Familiarity with USP, EP, and ICH guidelines for analytical method development and validation.
• Good working knowledge of current Good Manufacturing Practices (cGMPs)
• Experience managing/working with quality control release/stability testing at a CTL or CMO is a plus.
• Ability to effectively prioritize and deliver on tight timelines and work in a fast paced/dynamic environment.

About **MEMBERS ONLY**SIGN UP NOW***.:

We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications through independent and partnered development pathways and are rapidly growing our team, especially at our U.S. headquarters in Boston, Massachusetts.

**MEMBERS ONLY**SIGN UP NOW***. is proud to be an equal opportunity workplace and is an affirmative action employer.

**MEMBERS ONLY**SIGN UP NOW***. requires all employees to be fully vaccinated for COVID-19 prior to starting work. The CDC defines fully vaccinated as two weeks after the second dose for Pfizer and Moderna, and two weeks after the single dose of Johnson & Johnson. **MEMBERS ONLY**SIGN UP NOW***. will require proof of vaccination and consider requests for exemption from this requirement as a reasonable accommodation for medical reasons or sincerely held religious beliefs where the accommodation would not cause **MEMBERS ONLY**SIGN UP NOW***. undue hardship or pose a direct threat to the health or safety of the employee or others.

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