Associate Director, Analytical Development
3 weeks ago
Associate 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 the analytical development needs of PepGen’s pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations are key success factors, along with experienced leadership for the completion of planned analytical activities in accordance with agreed scope, timelines and budget. This is an exciting opportunity for the right individual to join the PepGen team at a time when significant growth is occurring.
Responsibilities
- Work with the PepGen CMC team to support the creation of the control strategy for peptides, oligos and peptide-oligo conjugates according to project goals and development stage
- Set specifications and lead qualifications of reference standards for raw materials, intermediates, APIs and DP
- Design and data analysis of stability studies
- Manage in-process, release, stability testing, etc. at CMOs/CTLs
- Oversee laboratory investigations and the review of investigation reports
- Coach and mentor junior scientists in the group and help develop and expand the group in terms of technical expertise and bandwidth
- Collaborate with CTLs/CROs/CMOs and other external partners stateside and in Europe & Asia
- Lead analytical related regulatory reports, submissions, and responses ensuring compliance with all applicable regulatory guidelines
- Review and approve analytical protocols, and results
- Assist in negotiation of third-party contracts
Requirements
- Ph.D. in Chemistry or related area and >5 years’ or Masters degree and >9 years’ experience leading teams and projects in analytical development
- Proven track record moving projects from early development to commercialization
- Experience with peptides and oligonucleotides
- Demonstrate prototypical leadership skills, planning, and organizational capabilities
- Effectively implement work plans cross-functionally
- Tactically ensure the proper/right sequencing and build/set up the requisite analytical methods for successful transfer to CTLs/CMOs
- Documented experience working in cGMP environment
- Direct experience as analytical project lead is preferred
About the Team
We are a team of passionate and creative scientists committed to analytical development and quality control of innovative EDO platform. We value honest communication with open mindset. We are looking to enhance our group with another collaborative team member who shares our values, excitement about the possibilities our EDO platform offers and commitment to make a meaningful difference for patients.
About PepGen
PepGen Inc. 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, or 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 that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.
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.
Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
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