Description

Summary:

Responsible for technical and compliance support within the QC function while providing direct support to external analytical partners and collaborating with the Analytical Development team to implement high-quality, compliant analytics for orally-delivered enzyme therapeutics. The position reports to the Director of Quality Control and is located in Natick, MA.

Responsibilities:

• Manage execution and compliance of CMC control strategies, including compendial testing, in-process testing, release and stability testing of enzyme        therapeutics at CTO and CMOs
• Provide technical review of internal and external analytical procedures to ensure that test methods and laboratory procedures are scientifically sound and appropriate for their intended purpose.
• Act as QC Department SME on Anagram analytical procedures, including training on analytical procedures used internally and at CTO and CMOs.
• Must be able to travel regularly to CMOs and contract laboratories up to 40% of the time, including international travel.
• Ensure compliance with applicable cGMP guidelines at contract testing laboratories and for internal QC functions.
• Provide technical and compliance support for the timely and compliant execution of phase-appropriate assay transfer, assay qualification, and validation activities
• Perform QC review of in-process, release, and stability data to support Certificate of Analysis and shelf-life setting.
• Collaborate with other Tech Ops stakeholders in Process and Analytical Development, Quality, and Regulatory to evaluate data in support of setting appropriate product specifications, comparability criteria, and effective resolution of manufacturing investigations.
• Author and provide technical support and review for relevant documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents.
• Contribute to Quality Control budget planning.
• Author, review, and provide technical support for Quality System records associated with analytical testing (change control, lab investigations, OOS, deviations, and CAPAs)
• Track metrics to enable identify risks and priorities, and improvements initiatives.
• Assure ongoing readiness for regulatory inspection; participate in audits and inspections, and prepare responses to correspondence and findings, as needed.
• Accountable to the leader (and department team) for ensuring proactive execution of work assignments.

Requirements

Experience Requirements:

Extensive experience in Chemistry, Biology, Bioengineering, Drug Development, a related field, or some combination of the above.

• Experience in protein chemistry and associated analytical methods including HPLC-based methods, gel electrophoresis, enzymatic assays (preferred), immunoassays, and USP monograph testing consistent with dosage form (OSD)
• Extensive collaborative experience.
• Expertise in phase-appropriate GMP testing and Lab Operations.
• Expertise in technical writing and data presentation
• Demonstrated ability to prioritize and manage multiple projects.

Personal Attributes:

• Execution: Demonstrates and fosters a winning mind set, a sense of urgency, optimism, and ownership, and a strong drive to achieve goals and organizational success. Delivers business results for the organization. Accountable for effectively and efficiently completing work responsibilities and tasks with high quality. Demonstrates initiative, works to achieve results, meets or exceeds goals, and acts on opportunities to create value
• Collaboration: Promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-cultural communication and collaboration in all interactions. Credits others for their contributions and accomplishments.
• Communication: Prepares and delivers clear, concise, accurate, effective, and persuasive written and verbal materials/messages. Attentively and accurately listens to others. Promotes a free and timely flow of high-quality information between self and others and across the organization; encourages the open expression of ideas and opinions.
• Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively under conditions of change or uncertainty.

Education and Experience:

•  BA and/or MS with 5-10+ years of relevant industry experience.
•  3-5+ years of managing GMP functions and vendor relations
•  Expertise in phase appropriate GMP testing and Lab Operations
•  Expertise and education in protein chemistry required.
•  Expertise in qualification, validation, transfer, and life cycle management of analytical methods
•  Experience in health authority inspections, related observations, and implementation of CAPAs is a plus.
•  Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills.
•  Proven track record to collaborate effectively in a cross-functional matrix environment and collaborate with curiosity across functional and organizational lines.