Senior/Director Of Analytical Development & Qc

Reporting to the Senior Vice President of Chemistry and Manufacturing, the Director of Analytical Development & QC will be responsible for managing the analytical development and QC 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 expert leadership for the completion of planned analytical activities in accordance with agreed scope, timing, and budget and managing a group of talented analytical scientists. This is an exciting opportunity for the right individual to join the PepGen team at a time when significant growth is occurring

Responsibilities

• Coach and mentor scientists and managers in the group and help develop and expand the group in terms of technical expertise and bandwidth.
• Collaborate with CMOs and other external partners and assess opportunities stateside and in Europe & Asia
• Work with the PepGen CMC team to strategically drive and create the control strategy for peptides and oligos according to project goals and development stage
• Lead analytical related regulatory reports, submissions, and responses ensuring compliance with all applicable regulatory guidelines
• Review and approve analytical protocols, and results
• Lead product attribute criticality assessments from candidate nomination through IND, and ultimately commercial registration.
• Oversee setting of specifications and qualifications of reference standards for raw materials, intermediates, APIs and DP. Design and data analysis of stability studies
• Assist in negotiation of third-party contracts
• Oversee laboratory investigations and the review of investigation reports
• Manage day to day activities including timeline, budget management, and objective setting in a thriving and growing Analytical Development & QC group.

Requirements

• Ph.D. in Chemistry or related area and >8 years’ or Masters degree and >12 years experience leading teams and projects in analytical development.
• Demonstrate prototypical leadership skills, planning, and organizational capabilities
• Experience with peptides and oligonucleotides
• Tactically ensure the proper/right sequencing and build/set up the requisite analytical methods for successful transfer to CMO’s
• Proven track record moving projects from early development to commercialization.
• Effectively implement work plans cross functionally
• Documented experience working in cGMP environment

About PepGen

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

PepGen is proud to be an equal opportunity workplace and is an affirmative action employer.

Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.