Associate Director, Quality Control

3 weeks ago


Boston, Massachusetts, United States PepGen Full time

Associate Director, Quality Control

Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities 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 contract organizations are key success factors, along with experienced leadership for the completion of planned QC 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
Lead and manage in-process, release, stability testing, etc. at CMOs/CTLs
Contribute to set specifications and reference standard qualification for raw materials, intermediates, DS and DP; Manage the inventory of qualified reference standards
Lead the stability design and manage stability programs
Oversee laboratory investigations and review investigation reports
Enable the timely completion of Quality System records associated with release and stability testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, lab investigations, OOS, deviations, and CAPAs)
Coach and mentor junior QC 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 QC related regulatory reports, submissions, and responses ensuring compliance with all applicable regulatory guidelines
Review and approve stability reports, analytical method validation protocols and reports.
Assist in negotiation of third-party contracts
Work closely within AD/QC and with cross-function teams (DS, DP, QA, reg CMC) to initiate and streamline QC related processes

Requirements:

Ph.D. in Chemistry or related area and >5 years' or Masters degree and >9 years' experience in quality control or relevant role
Proven track record moving projects from early development to commercialization as a QC lead
Experience with phase-appropriate method qualification, validation and transfer
HPLC, LC-MS or LC-MS/MS experience, preferably with synthetic peptides and oligonucleotides
Experience using statistical software (e.g., JMP) for setting specifications, stability data trending and establishment of shelf-life for late stage or commercial programs
Working knowledge of quality systems and domestic and international regulatory requirements
Demonstrate prototypical leadership skills, planning, and organizational capabilities.
Effectively implement work plans cross-functionally
Documented experience working in cGMP environment
Experience with oversight of CTLs, and management of stability program
Experience conducting and leading audits is a plus
Ability to work in a Hybrid environment by being on-site Tuesday – Thursday
Embrace our core values of Research, Innovation, Integrity, and Responsibility


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.
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.

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 or follow PepGen on Twitter and LinkedIn.



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