Lead Quality Control and Analytical Development

$20,000 - $50,000/Yr

Promote Project - Cambridge, MA

Full-time - Mid Level

Cambridge, MA

About the position

The Lead of Quality Control and Analytical Development is responsible for managing a team that provides quality oversight for clinical and commercial operations, as well as analytical development of early and late-stage clinical products. This role involves overseeing analytical testing at contract laboratories and manufacturing facilities, ensuring compliance with regulatory standards, and collaborating with multidisciplinary teams to meet delivery schedules for analytical test reports. The individual will also support analytical development activities, troubleshoot method issues, and manage stability study programs.

Responsibilities

• Review testing data (release, stability, etc.) from studies performed for Amylyx.
• Identify trends and ensure data is analyzed to help understand degradation pathways and develop specifications.
• Lead and partner with Contract Laboratories through investigations (OOS and atypical results) and process change assessments.
• Conduct trend analysis of data including writing Annual Product Review sections.
• Develop, review, and approve specifications, stability protocols, method validation, and method transfer reports.
• Develop and maintain statistical models such as statistical process control, multivariate analysis, and process analytics.
• Conceptualize and deploy data science solutions in support of continuous improvement.
• Work with internal teams, CMOs, and testing laboratories to establish methods and specifications.
• Oversee management of the reference standard program to ensure compliance and timeliness of certificates of approval.
• Author and/or review QC sections of regulatory filings (CTD/NDA/BLA or IND/IMPD).
• Lead the analytical development activities for early and late-stage clinical products at CMO/CRO.
• Manage the analytical activities for process performance qualification, continuous process verification, cleaning studies/validation, shipping studies/validation for clinical products at CMO/CRO.
• Manage developing, validating, and standardizing complex analytical methods for drug substances and drug products.
• Lead analytical activities for formulation development, process development, forced degradation, extractable and leachable studies for commercial and clinical products.
• Manage analytical testing, evaluate material and products at all stages of the development process under stringent quality and time requirements.
• Provide analytical testing assessment for contract laboratories and other contracted vendors used for clinical product manufacturing.
• Ensure GMP compliance from analytical testing perspectives for drug products manufactured and tested for clinical studies.
• Collaborate with Quality Assurance for quality audits, investigations of OOS, deviations, change controls, CAPA, and temperature excursions.
• Review/approve deviations, OOSs/OOTs, Change Controls, CAPAs, and any other related Quality records.
• Support tracking, trending, stability data, batch failures, OOS/OOT, investigations, deviations, change controls, CAPA, product complaints.
• Manage authoring/review/approve SOP and policies related to CMC as required.
• Provide mentorship and guidance to junior associates.

Requirements

• Bachelor's (BS) degree in analytical chemistry, biochemistry, biology, chemical sciences, or in a relevant scientific discipline or equivalent.
• Minimum (8) years of experience (or MS with 5+ years of experience) in the pharmaceutical/bio-pharm manufacturing industry (managerial experience a plus).
• Managerial/Supervisory Experience a plus.
• Experience with Oligonucleotides and Peptide development programs as a plus.
• Analytical/QC laboratory experience.
• Proven ability to achieve results and success in a group environment and on cross-functional teams is required.
• Strong communication and interpersonal skills.
• Ability to manage multiple tasks and deadlines with attention to detail.
• Exhibit strong technical skills and the ability to critically evaluate raw data and results.
• Ability to prioritize responsibilities and multi-task in a fast-paced environment with changing priorities.
• Knowledgeable in cGMP regulations and ICH and/or other industry guidance.
• JMP and/or other statistical application experience a plus.
• Knowledge of Microsoft Office (Teams, Excel, SharePoint, etc.).
• Good understanding of product process and development, from discovery to commercialization.

Nice-to-haves

• Experience with Oligonucleotides and Peptide development programs as a plus.
• JMP and/or other statistical application experience a plus.