CMC Digitalization Consultant

December 10

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ValGenesis

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Software system for Validation Lifecycle Management Process • Paperless Validation • Validation Lifecycle Management System • Cleaning Validation • Electronic Validation

501 - 1000 employees

☁️ SaaS

💰 Private Equity Round on 2021-05

Description

ValGenesis is seeking a CMC Digitalization Consultant to guide our team through the initial phases of digitizing the Chemistry, Manufacturing, and Controls (CMC) process. •This role is crucial for shaping our next-generation SaaS solutions to meet industry standards, address compliance needs, and capture untapped market opportunities. •The consultant will collaborate with product leaders to bridge the gap between regulatory requirements, stakeholder needs, and innovative digital solutions. •Engagement Structure •The consultants will be engaged on a milestone-driven basis rather than a fixed-term contract. •Engagement Type: Contract Part-Time (10–15 hours per week, flexible schedule) •Milestones: Each phase will have a clearly defined scope, deliverables, and timeline, agreed upon upfront. •Sequential Approval: After the successful completion of each milestone, we will evaluate their work and decide whether to proceed to the next milestone. •Flexibility and Control: This approach allows us to assess the value of their contributions iteratively, ensuring alignment with our goals before committing to further phases. •Maximum Duration: The engagement will not exceed six months, but milestone renewals provide flexibility based on performance and project needs. •Core Activities •Process Mapping and Analysis: •Analyze the end-to-end CMC lifecycle, including development, manufacturing, quality, and regulatory workflows. •Identify inputs, outputs, workflows, dependencies, and pain points. •Define milestones and data flows critical for a successful digital platform. •Stakeholder Collaboration: •Engage cross-functional teams (R&D, Manufacturing, Quality, Regulatory, and IT) to understand user roles and needs. •Align requirements and document specific responsibilities for each stakeholder. •Regulatory Compliance Integration: •Ensure compliance with global standards (e.g., FDA, EMA, and ICH) and frameworks like FDA’s KASA. •Develop a roadmap for generating submission-ready documentation and regulatory workflows. •Biologics-Specific Expertise: •Incorporate solutions for unique challenges in biologics manufacturing, including complex validation and analytics. •Technology Evaluation and Guidance: •Recommend best practices and emerging technologies for digital CMC platforms. •Guide the integration of AI/ML solutions into our SaaS platform.

Requirements

Experience: •10+ years in life sciences, with a focus on CMC processes. •Proven track record in biologics manufacturing and regulatory submissions. •Experience implementing FDA KASA or similar frameworks. Technical Skills: •Familiarity with LIMS, QMS, PLM, or eCTD tools. •Expertise in statistical modeling for data analysis and process optimization. •Knowledge of AI/ML applications (preferred). Soft Skills: •Strong analytical and problem-solving abilities. •Excellent communication and documentation skills. •Ability to distill complex technical processes into actionable solutions

Benefits

We’re on a Mission •In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. •Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. •The Team You’ll Join •Our customer’s success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. •We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. •We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. •We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader.