SITE HEAD OF CMC: Job Description
SwiftScale Biologics uses our cell-free protein synthesis platform to enable (1) fast protein therapeutic development through to clinical batches and (2) synthesis of proteins that are very difficult to express in cells. Our mission is to use our platform technology to enable our partners to advance dozens of novel therapeutics to the clinic where they can improve the lives of thousands of patients.
We are hiring a Site Head of CMC to develop and direct chemistry, manufacturing, and controls at our protein therapeutic clinical drug substance manufacturing site. The Site Head of CMC will develop CMC and QA strategies for all aspects of for the manufacturing site and ensure that the equipment operation, testing, and control systems meet current GMP standards and regulatory requirements.
We are looking for someone with a technical background and strong experience in CMC, QC, and QA to join our tight-knit team. Experience in co-authoring IND and IND-enabling documentation, SOPs, writing and performing IQ/OQ/PQ processes, equipment validation, physiochemical characterization, assay validation, and process monitoring within a GMP environment is required. Experience developing and implementing CMC strategies and GMP compliance in a new plant (greenfield) situation is preferred and the ability to rapidly adapt to changing processes in a fast-moving work environment is a must.
RESPONSIBILITIES:
- Develop and implement CMC and QA strategies for our cell-free protein synthesis platform including input material testing, process control strategies, and batch release criteria.
- Support activities for releasing or rejecting raw materials, intermediates, and drug substance batches by coordinating in-house and out-sourced analytics.
- Support manufacturing engineers in process validations, process control, process training programs, process improvement, risk management, and software validations and control.
- Develop SOPs protocols, IQ/OQ/IQ, and other bioprocess equipment documentation.
- Coordinate raw material and equipment vendor qualification and work with suppliers to resolve or improve quality issues
- Develop strategies and documentation for equipment validation.
- Help establish proper control points, cleaning methods, and settings for new equipment.
- Assist in writing of CMC section of IND and pre-IND filings
KNOWLEDGE, SKILLS & ABILITIES:
- Ability to apply cGMPs for biologics drug substance manufacturing in a phase appropriate, pragmatic, and compliant manner.
- Working with the technical team (and outside consultants), must be able to independently develop and generate qualification protocols (IQ, OQ, PQ), cleaning, and validation strategies.
- Familiar with Chemistry, Engineering and Manufacturing Control (CMC) and Quality Assurance (QA) operations related to protein therapeutics
- Understanding and direct experience with facility/cleanroom design requirements, operations, and quality systems required for a biologics drug substance manufacturing site is required.
- Self-motivated individual with a desire to work in a startup environment
- Detail oriented with strong organizational skills
EDUCATION/EXPERIENCE:
- Bachelor's degree in Life Sciences, Engineering, Regulatory Sciences or related discipline with 8+ years of experience in CMC and/or QA in biologics manufacturing.
- Strong knowledge of and direct experience with ISO and GMP requirements and documentation for a clinical biologics manufacturing site.
- Direct experience with setting and implementing CMC strategies for a new site.
- Experience with regulatory filings (including IND and pre-IND submissions).
We offer growth opportunities and very competitive salaries/benefits.