Senior Director, CMC (Chemistry Manufacturing Controls)

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.

These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.

We are looking for an experienced Sr. Director, CMC, located in the US to join our Team. Ideal Candidates should possess a strong small molecule background, as well as CMC development experience, Regulatory & CMC writing and strong technical skills.

The CMC Senior Director is responsible for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. Responsibilities may include analysis/review of drug substance synthesis, pre-formulation and formulation evaluation, analysis of manufacture, scale-up and process validation, providing support of analytical methods development and validation, and evaluation of packaging and labeling components. The CMC Senior Director leads and/or participates in Health Authority (HA) communications including correspondences, teleconferences, and meetings. The CMC Senior Director reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, including reports, protocols, and other scientific documents. The CMC Senior Director will serve on project teams in various capacities, including but not limited to: Subject Matter Expert, Technical Lead, Assistant Consulting Project Lead, and Consulting Project Lead. The CMC Senior Director may manage 1 or more direct reports.

Key Responsibilities:

• Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development
• Guides the writing of regulatory/scientific documents written by other project team members
• Has advanced scientific knowledge of HA Regulatory Guidance and Regulations
• Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and preparing responses to inquiries
• Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects
• Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions
• Prepares product development plans and/or strategies from early development through Phase 4
• Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations
• May provide expertise in GMP and GLP audits, inspection readiness and remediation activities
• Participates in meetings with clients and leads discussions in scientific area(s) of expertise as subject matter expert
• Actively supports staff learning & development within the company
• Provides guidance and advises Project Leads, and/or Project Teams
• Adherence to project budgets and contracts including scope and scope changes, timeline deliverables and active management of resources o Manages projects as a Consulting Technical Lead as assigned
• Leads and/or participates in meetings with clients
• Provides mentorship to team members
• Acts professionally with peers and clients, knows business etiquette
• Possible future LM responsibilities
• Applies company policies and procedures to resolve a variety of issues
• Identifies and mitigates risk
• Assures good communication and relationships with clients
• Assists in the evaluation of potential technologies
• Reviews business development proposals, project cost structures and participates in bid defenses
• Monitors and evaluates industry trends to leverage service off