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 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.
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 an 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 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.
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 an 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