Associate Director, Analytical Development
Responsibilities
- Manage the internal analytical development lab by continuously assessing new technologies and implementing them to support the needs within AD/QC and from multiple cross-function teams.
- Lead the development of analytical methods for the purity/impurity 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), etc.
- Perform/guide routine maintenance of analytical equipment, HPLC systems, balance, pH meters, etc.
- Contribute to analytical method development, validation and transfer (mainly UHPLC-UV and LC-MS methods) at external labs 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 as needed.
- Write analytical protocol and report for in-house analytical activities and prepare analytical source documents to summarize analytical activities for regulatory filing.
- Lead extended characterization activities including, but not limited to impurity identification, analytical comparability, method bridging, high-order structure and reference standard characterization.
- Lead analytical comparability strategy and execution.
- Lead critical quality attribute (CQA) assessment for DS and DP.
- Communicate and manage external contract labs for characterization activities.
- Coach, mentor and manage direct reports for daily work and provide support to their career development.
- Work closely within AD/QC and with cross-function teams to initiate and streamline AD related processes.
- Contribute to budget planning by providing key information on extended characterization activities
- Author relevant IND/IMPD sections, briefing books to support regulatory filings
- Foster a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement
- Ph.D. in Chemistry or related area and 5+ years’ or Masters degree and 8+ years’ experience leading teams and projects in analytical development
- Experience with peptides, oligonucleotides, or/and peptide-oligo conjugate
- Experience leading CQA assessment and NDA-enabling characterization
- Experience leading analytical comparability and authoring regulatory filing sections
- Demonstrate prototypical leadership skills, planning, and organizational capabilities
- Effectively implement work plans cross-functionally
- Experience in the development, transfer, and validation of chromatographic methods (HPLC, GC, LC-MS, etc.).
- 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.
The estimate full-time salary range for this role is between $170,000 to $220,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.
PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.
About PepGen
PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.
For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
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