OSI
Associate Director, Quality Control
OSI, Boston, Massachusetts, us, 02298
Associate Director, Quality ControlReporting 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 stageLead and manage in-process, release, stability testing, etc. at CMOs/CTLsContribute to set specifications and reference standard qualification for raw materials, intermediates, DS and DP; Manage the inventory of qualified reference standardsLead the stability design and manage stability programsOversee laboratory investigations and review investigation reportsEnable 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 bandwidthCollaborate with CTLs/CROs/CMOs and other external partners stateside and in Europe & AsiaLead QC related regulatory reports, submissions, and responses ensuring compliance with all applicable regulatory guidelinesReview and approve stability reports, analytical method validation protocols and reports.Assist in negotiation of third-party contractsWork 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 roleProven track record moving projects from early development to commercialization as a QC leadExperience with phase-appropriate method qualification, validation and transferHPLC, LC-MS or LC-MS/MS experience, preferably with synthetic peptides and oligonucleotidesExperience using statistical software (e.g., JMP) for setting specifications, stability data trending and establishment of shelf-life for late stage or commercial programsWorking knowledge of quality systems and domestic and international regulatory requirementsDemonstrate prototypical leadership skills, planning, and organizational capabilities.Effectively implement work plans cross-functionallyDocumented experience working in cGMP environmentExperience with oversight of CTLs, and management of stability programExperience conducting and leading audits is a plusAbility to work in a Hybrid environment by being on-site Tuesday – ThursdayEmbrace our core values of Research, Innovation, Integrity, and Responsibility
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.
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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 stageLead and manage in-process, release, stability testing, etc. at CMOs/CTLsContribute to set specifications and reference standard qualification for raw materials, intermediates, DS and DP; Manage the inventory of qualified reference standardsLead the stability design and manage stability programsOversee laboratory investigations and review investigation reportsEnable 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 bandwidthCollaborate with CTLs/CROs/CMOs and other external partners stateside and in Europe & AsiaLead QC related regulatory reports, submissions, and responses ensuring compliance with all applicable regulatory guidelinesReview and approve stability reports, analytical method validation protocols and reports.Assist in negotiation of third-party contractsWork 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 roleProven track record moving projects from early development to commercialization as a QC leadExperience with phase-appropriate method qualification, validation and transferHPLC, LC-MS or LC-MS/MS experience, preferably with synthetic peptides and oligonucleotidesExperience using statistical software (e.g., JMP) for setting specifications, stability data trending and establishment of shelf-life for late stage or commercial programsWorking knowledge of quality systems and domestic and international regulatory requirementsDemonstrate prototypical leadership skills, planning, and organizational capabilities.Effectively implement work plans cross-functionallyDocumented experience working in cGMP environmentExperience with oversight of CTLs, and management of stability programExperience conducting and leading audits is a plusAbility to work in a Hybrid environment by being on-site Tuesday – ThursdayEmbrace our core values of Research, Innovation, Integrity, and Responsibility
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.
#J-18808-Ljbffr