Lead Quality Control and Analytical Development

THE ROLE

The Lead of Quality Control and Analytical Development is responsible for managing a team that provides quality oversight in support of clinical and commercial operations and analytical development of early and late-stage clinical products.

From a QC standpoint, the individual will assist in the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing on clinical/commercial pharmaceutical products and Active Pharmaceutical Ingredients (API). The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This includes, but is not limited to, assisting with QC checks and preparation of regulatory filings (Supplements and Annual Reports).

From an AD standpoint, the individual will support analytical development activities at CMO/CRO, troubleshoot analytical method issues, manage the reference standard program for development projects, manage stability study programs and generate shelf-life projections. As necessary, the individual will write CMC sections relevant to analytical methods, specifications, and stability studies.

RESPONSIBILITIES

Manages a team and directly performs the following:

• Review testing data (release, stability, etc.) from studies performed for Amylyx.  Identify trends and ensure data is analyzed to help understand degradation pathways and to help develop specifications.
• Lead and partner with Contract Laboratories through investigations (OOS and atypical results), and process change assessments through data mining, statistical analysis, and visualization. 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 (e.g., batch analysis, analytical methods, reference standard, etc) of regulatory filings (CTD/NDA/BLA or IND/IMPD).
• Lead the analytical development activities for early and late late-stage clinical products at CMO/CRO.
• Manage the analytical activities for process performance qualification, continuous process verification, cleaning studies/validation, shipping studies/validation, etc. for clinical products at CMO/CRO.
• Manage developing, validating, and standardizing complex GC, GC/MS, HPLC, LC/MS, ICP/MS analytical methods for isolation, detection, identification, and quantification of both drug substances and drug products of small molecules or/and large molecules.
• Lead analytical activities for formulation development, process development, forced degradation, extractable and leachable studies for commercial and clinical products as required.
• Manages the analytical testing, evaluates material and products at all stages of development process under stringent quality and time requirements.
• Provide analytical testing assessment for contract laboratories, and other contracted vendors used for clinical product manufacturing at CMO/CDMO as required.
• Ensure GMP compliance from analytical testing perspectives for the 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 as required. 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 as required.
• 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 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
• Travel may be required up to 10%, which may include on-site review of third-party laboratory and manufacturing operations.

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